Legal Issues Surrounding Electronic Medical Records

                 Legal Issues Surrounding Electronic Medical Records

                                                  Dr KS Dhillon LLM

What is electronic medical record (EMR)?

Traditionally medical records have been paper based. The hospitals have been collecting handwritten patient medical data and storing it securely as per the legal requirement of handling and storing patients confidential medical data.
Over the last couple of decades there has been a push to record, process, store and transfer health information electronically. This electronically recorded, processed and stored medical data is known as electronic medical records (EMRs). The electronic application not only helps in recording clinical data, X-rays and laboratory findings but also helps in making decisions, making request for medication from the pharmacy and placing and receiving orders regarding patient care [1]. The EMR system would require the use of a computer system with the necessary software along with a network.
The touted benefits of the EMR include improvement in quality of patient care, decrease in health care costs, reduction in storage space requirements and easy of searching the patients records. Electronic data can be more easily retrieved and modified and updated thereby increasing efficiency. By using appropriate templates the doctors can safe time and make less mistakes [1].
Some believe that these electronic systems which are faster than the paper system can save time, lives, and money [1].
Despite the touted benefits of the EMR the transition from paper to electronic recording has been very slow. In the USA the Healthcare Information and Management Systems Society (HIMSS) has planned the implementation and use of the EMR system in 7 stages. As of 2013 EMR implementation was in stage 2 and stage 3. In stage 6, about 100 % of the hospitals were expected to be covered. Stage 7, would see the building of the regional and national network that would integrate all the EMR systems in the country [1]. In the US as of 2013 only 25.5% of the hospitals had a comprehensive EMR.
In Malaysia, the Ministry of Health, in 2001 claimed that Hospital Selayang was the first hospital in the world to have a comprehensive ICT paperless system using the Total Hospital Information System (THIS)[2].
The capital cost of equipping a hospital with THIS is about 80 to 100 million ringgit in Malaysia and this constitutes almost 40% of the total development cost of a 800-1000 beds hospital. So far the Malaysian government has spent more than 600 million Ringgit for the project and this does not
include operation and maintenance cost of the system [2]. As of 2015 only 21 out of 138 public hospitals (15%) had implemented either the Total Hospital Information System (THIS), the Intermediate Hospital Information System (IHIS) or Basic Hospital Information System (BHIS).
Though firewalls and encryption do permit safer and secure transfer of health information, confidentiality of patient information and other legal risks remains a concern.

Legal Risks of EMRs

The legal system relies on precedent and is slow to adopt new technologies such as EMRs. Hence it can offer little help in the navigation from paper-based to electronic record [3]. Though EMRs may be able to solve problems of missing clinical information that was seen with paper records, there is no legal precedent addressing the responsibility of clinicians reviewing the large amount of clinical information available in the integrated EMRS. Many find it difficult to review the complete electronic record within a reasonable timeframe [3].
Furthermore EMRs introduce several more liabilities. Large amounts of perfectly legible data can be stored in EMRs which makes it easily discoverable, unlike incomplete or illegible handwritten records which are not easily discoverable. Hence the EMR data can be a liability to the doctor and the health provider.
EMRs can store extremely huge amount of data which can lead to information overload resulting in the doctor overlooking key information in the system. This again can be a new form of liability. In this mountain of information, doctors can miss critical information which can affect treatment decision which would make doctors and the hospital liable for negligence [3].
With EMRs the doctors legal responsibility and accountability increases. The electronic records will identify the person who reviewed or failed to review key information such abnormal findings recorded in the EMR. Failure to identify and address important abnormal findings can lead to legal challenges. With paper records it is not always possible to tell who accessed the records. Lapses in management of the patient can easily be detected with EMRs[3].
There are some document related issues with EMRs which can introduce new liabilities. Some EMRs contain progress note documentation templates which allow test results to be automatically imported. This automatically imported test and clinical findings may not be within the clinical preview of the the person inadvertently importing the information and signing the note electronically and this may introduce new liabilities [3]. Notes that are copied and pasted may contain lots of information that appear similar and display information that is no longer correct.

Ethical issues with EMRs

Data in EMRs can more easily be accessed by many individuals as compared to data in paper records. Data in paper records can also be accessed by others but it is difficult to track who accessed the paper records. Since more people have access to electronic data the potential for privacy breach increases. When many people have access to electronic data the question of ownership of data also arises. Who actually owns this protected health information?[3]
In the past ‘several electronic health records (EHR) vendors (eg, Cerner, GE, and Allscripts [formerly Eclipsys]) have sold deidentified copies of their patient databases to pharmaceutical companies, medical device makers, and health services researchers’ [3]. Although the data is deidentified, it is not difficult to reidentified the data using publically available external data sources[3].
There are EHR user guidelines but what happens when unauthorized personnel access the the data and also what happens when unintentional or unavoidable violation of the guidelines take place? An example would be when a person who is logged in has to rush off for an emergency and someone standing by accesses the data. These situations raise complex ethical and legal issues[3].
This electronic data-driven approach in medicine has a long way to go. There are many unaddressed issues to be sorted out. Who will ‘oversee the data aggregation, verification and validation, and analysis; who will have data access; who will make the final data interpretations; and assuming that everyone agrees they are correct, who will adjudicate the ethical disagreements that inevitably surface when data are used to inform new health care policies’ [3]. There is a dire need for ‘nonpartisan, multidisciplinary, expert review-panels composed of clinicians, statisticians, informaticians, ethicists, and patient advocates’ to sit together and address these issues rather than pushing half baked electronic systems done the throat of unwilling users.
The goal of providing higher quality, lower-cost health care through widespread EHR remains elusive.

Risk for medical malpractice claims

Doctors are at an increased risk of medical malpractice claims when the EMR is being implemented and in the initially phase these EMRs can be a thorn in physicians' side.The transition period from a familiar to unfamiliar system introduces risk of error. The impact of the EMRs on the medical malpractice claims, however, is still unclear [4].
When there is malpractice litigation, EMRs can provide clear, complete, organized and legible data and documentation that can prove a malpractice claim. Pre-trial discovery from the EMRs can increase the chances of prosecutors finding some evidence of wrongdoing among an entire team of providers [4].
When there are errors in the accuracy of the clinical content in the EMR or the the manner of presentation of clinical data is poor, the EMR vendor cannot be held liable and the malpractice risk for physician increases. Invariable there will be various limitations related to liability of the EMR vendor in the EMR contract [4]. Another issue that is likely to crop up is, what happens to the old medical records whenever the system is upgraded? Will the complete old records be maintained or only certain screenshots will be maintained due cost constraints.

Likelihood of medical errors

Estimates in the USA show that adverse drug events (ADEs) will injure or kill 770,000 people in hospitals every year [5]. The most common cause of these ADEs is prescribing errors [6]. Computerized physician order entry (CPOE) systems built into the EMRs are expected to reduce prescribing errors and save hundreds of billions in annual costs. However, many believe that too much dependence on an EMR will result in small mistakes quickly turning into medical errors [4].
Koppel et al [7] published a study in 2005 which identified and quantified  the role of CPOE in facilitating prescription error risks. They found that the CPOE systems facilitated 22 different types of medication error risks, which included pharmacy inventory displays being mistaken for ‘dosage guidelines, inflexible ordering formats that generated wrong orders, and CPOE display screens that prevented a coherent view of the patient's medications’[4].  They study also revealed that 75 percent of clinical staff surveyed said that they encountered these error risks weekly or sometimes more often.
Doctors overreliance on functions such as cut and paste can perpetuate mistakes while leaving a trail of errors which are less likely to be discovered and corrected [8]. The cut and paste function also raises issues regarding ownership of the records when a legal investigation is carried out. There are also issues of risk of bugs, viruses or other technological inefficiencies with EMRs which was not there with paper records [8]. An accidental click of the mouse can be dangerous and harmful in some circumstances.

Breaches, theft and unauthorized access to protected health information

Way back in 1996 the US Congress recognized that advances in electronic technology could erode the privacy of health information and the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104-191, was passed to improve the efficiency and effectiveness of the health care system. HIPAA provisions mandated Federal privacy protections for individually identifiable health information [9]. The Department of Health and Human Safety USA posts all data breaches on a public website. In 2009 there were 2.4 million patients affected by health data breach and in 2010, 5.4 million patients were affected. The most common cause of breaches was theft of patient data. Human error, loss of records and intentional unauthorized access to protected information were the other causes of breaches [4].
The Department of Health & Human Services (HSS) does not take HIPAA violations lightly. In 2011, a computer was stolen from the administrative office of California based Sutter Health which potentially exposed the private data of about 4 million patients. The Department of HHS and the Office for Civil Rights issued a civil money penalty of $4.3 million against Largo, Md.-based Cignet Health for the HIPAA violation. Two days later, HHS and the Office for Civil Rights announced that Massachusetts General Hospital in Boston had agreed to pay $1 million to settle potential HIPAA violations [4].
In Malaysia we have the Personal Data Protection Act 2010 which protects the patients physical and mental health data. Section 9 of the Act (Security Principle) makes the data user responsible for taking practical steps to ‘protect the personal data from any loss, misuse, modification, unauthorized or accidental access or disclosure, alteration or destruction’ [10]. The Act requires protection of the place of storage and the equipment where the data is stored. Measures have to be taken to ensure the reliability, integrity and competence of personnel having access to the personal data; and measures have to be  taken to ensure the secure transfer of the personal data [10].
It is not known if the Personal Data Protection Act 2010 will have the bite of HIPAA or it will remain all bark and no bite as was the case with the HIPAA in its early days.
Hospitals would have to have comprehensive policies and procedures in place and their staff have to be trained to comply with the policies and procedure to prevent breaches, theft and unauthorized access to protected health information. Impermissible use or disclosure of protected patient information should be thoroughly investigated and appropriate remedial action taken. Accurate documentation related to the incident and the investigation should be retained.

What healthcare leaders need to do?

The physicians and other health care workers in the hospital have to be well-informed about compliance and legal risks of the EMRs. The training process is not always easy. Initiatives in EMR education are important to make sure that the doctors and staff do not take legal risks out of ignorance [4].
It can be difficult to train doctors to use the new software because they are usually ‘trained to autonomously practice medicine’ and change is difficult for them. One on one personalised training in a private environment is often most useful and productive. In the one to one environment the doctor can think about and discuss the impact of the software on their workflow [4]. The cooperation between the hospital IT department and the doctors must be enhanced and promoted by the health care leaders.

References

1. PeterChris Okpala.  The Electronic Medical Record (EMR). Journal of Applied Medical Sciences. 2013; 2 (2): 79-85.
2. Roshidi Hassan et al. Implementation of Total Hospital Information System (THIS) In Malaysian Public Hospitals: Challenges and Future Prospects. International Journal of Business and Social Research (IJBSR). 2012;2 (2): 33-41.
3. Perritt HH. Law and the Information Superhighway. 2nd ed. Somerset, NJ: Aspen Publishers; 2009.
4. Molly Gamble. 5 Legal Issues Surrounding Electronic Medical Records. 2012. at https://www.beckershospitalreview.com/legal-regulatory-issues/5-legal-issues-surrounding-electronic-medical-records.html accessed on 28/4/2018.
5. Lesar TS, Lomaestro BM, Pohl H. Medication prescribing errors in a teaching hospital: a 9-year experience.  Arch Intern Med. 1997;157:1569-1576.
6. Leape L, Bates D, Cullen D.  et al.  System analysis of adverse drug events.  JAMA. 1995;274:35-43.
7. Koppel R, Metlay JP, Cohen A, et al. Role of Computerized Physician Order Entry Systems in Facilitating Medication Errors. JAMA. 2005;293(10):1197–1203. doi:10.1001/jama.293.10.1197.
8. Mangalmurti SS, Murtagh L, Mello MM. Medical Malpractice Liability in the Age of Electronic Health Records. N Engl J Med 2010;363(21) 2060-2067. 
9. HIPAA for Professionals; Health Information Privacy; U.S. Department of Health & Human Services at https://www.hhs.gov/hipaa/for-professionals/index.html accessed on 1/5/2018.
10. LAWS OF MALAYSIA ACT 709, PERSONAL DATA PROTECTION ACT 2010 at http://www.pdp.gov.my/images/LAWS_OF_MALAYSIA_PDPA.pdf accessed on 1/5/2018.

Consent to medical treatment and information requirements for a valid consent for medical treatment.

Consent to medical treatment and information requirements for a valid consent for medical treatment.

                                     Dr KS Dhillon LLM

‘Every human being of adult years and sound mind has a right to determine what shall be done with his body; and a surgeon who performs an operation without his patient’s consent, commits an assault’...Benjamin Cardozo, Supreme Court justice, USA

It is trite law that a consent must be obtained from a person with capacity before any examination, test or treatment can be carried out [1]. There is detailed jurisprudence in English law as far as consent to medical intervention  is concerned.The question is whether the patient is asked to consent to physical intervention or to the risks associated with that intervention [2]. Hence there are two types of consent, the ‘real consent’ and an informed consent.

The Tort of Battery and ‘Real’ Consent

A doctor commits a legal wrong of battery or assault if he subjects a patient to physical intervention without valid consent or alternative legal justification.
Legally, for consent to the physical intervention, all that the patient needs to know is, what that physical intervention will involve. Broadly there are three category of situations which can lead to a charge of battery. The most common situation is when a patient is subjected to treatment against his/her will [3]. Sometimes it may involve a situation where a procedure other than the one consented to is carried out [4] or where a patient is deliberately and fraudulently misled [5].
The information provided when obtaining a consent has to be relevant and the information need not be elaborate. The Court in Chatterton v Gerson [6] pointed out that ‘once the patient is informed in broad terms of the nature of the procedure that is intended, and gives her consent that consent is real’. Hence the patient only needs to understand the general nature of the operation for the consent to be valid and therefore the law terms it as ‘real’ consent.
The standard for deciding what information needs to be disclosed to the patient to make the patient ‘broadly aware’ of the nature of intervention and obtain a ‘real’ consent to prevent action in battery is determined by the medical profession [6].
For ‘real’ consent there is no requirement to provide information about risk involved and about other options available. For these reasons ‘real’ consent is easily obtainable.
Informed consent to medical procedure is a more complicated matter.

The Tort of Negligence and ‘Informed Consent

None disclosure of a non-negligent risk associated with an intervention by the clinician, could be actionable in negligence if the risk eventuates since valid consent to those risks was not obtained. Such a consent is known as informed consent. There is a definite difference between ‘real’ and ‘informed’ consent and the information required for informed consent is therefore very different. When giving an informed consent not only information about the the nature of the procedure is needed but also information about the risks associated with the said procedure is needed. Having to consent to possible risk raises the question of alternative procedures and their corresponding risk and also the possibility of non-intervention.
In English law it is evident that doctors have a duty to inform the patient of alternative treatment which have lower risk [7]. Even if the risk is not lower it is duty of doctors to inform the patient of alternative interventions [8].
A failure to disclose the risk and benefits of a procedure and alternative intervention does not render a ‘real consent’ invalid but it would mean that the doctor has not obtained an informed consent.
Action of battery is regarded as inappropriate for interventions without informed consent because the law believes that doctors act in good faith and in the interest of the patient when they carry out medical treatment [6]. Battery on the other hand is associated with bad faith and it is usually carried out intentionally [9]. Therefore, the Courts believe that the doctor must have inadvertently failed to disclose a risk and could not have battered a patients in whose best interest they are acting.
The courts are usually reluctant to entertain a tort of battery in medical cases even when a wrong intervention is performed. A claim in negligence, can in principle, be sought in such cases. Bristow J in Chatterton v Gerson [6] however, felt that trespass would be the appropriate cause of action in such a case.
The level of information required to avoid a charge of battery when obtaining a ‘real consent’ is low. All that is necessary is to make the patient  ‘broadly aware’ of the nature and purpose of the action by reference to the reasonable doctor’s view of what is relevant. The same however is not true as far as informed consent is concerned.
Till 2015, the English Courts used to take a similar position to setting standards, as for ‘real consent’, where a reasonable doctor’s view prevailed, when taking an informed consent.
In Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [10] relying on the Bolam test [11] the House of Lords held that a patient would be considered to have been adequately informed about the risks if the doctor had disclosed risks which the medical profession thought was reasonable to disclose.
However, in 2015 this reliance on the reasonable doctor’s view changed. In  Montgomery v Lanarkshire Health Board, the Supreme Court  departed from Sidaway in how standards are set by declaring that information
about risks and alternative treatments should no longer be based on Bolam.
The court held that the doctor is:
‘under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments. The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it’ [8].
Hence, when obtaining informed consent the level of information that needs to be disclosed has to be referenced to the patient’s perspective, and not that of the doctor.
Though the law of informed consent has been quite clear over the last 30 years, there still remains lack of clarity about the standard used to judge whether a consent is properly ‘informed’ or not. There appears to be significant differences between what the doctor and the patient views as relevant information for medical treatment.  The large numbers of high profile legal challenges concerning non-disclosure of medical risk information, in English law, bears testimony to this fact [12].

What are the elements of full informed consent?

Following the decision by the Supreme Court in Montgomery it has become important that the patient is given an opportunity to be an informed participant in his/her health care decisions. The following points have to be taken into consideration and discussed when obtaining an informed consent:

• The nature of the procedure or intervention has to discussed and the patient should be made to understand what is involved
• The patient has to be made aware of reasonable alternatives to the proposed intervention which are available
• All the relevant risks, benefits, and uncertainties related to each alternative has to be discussed with the patient
• The doctor has to make sure that the patient comprehends the information provided. The discussion should be carried on in layperson's terms
• The patient must be willing to accept the intervention proposed by the doctor

This gives rise to the next question.

How much information is considered "adequate"?

In the past the reasonable physician standard was used to determine how much information has to be provided. That would mean that the doctor would decide how much information to provide the patient about the intervention based on the common practice among doctors. The courts have found that this standard is inadequate since it has become apparent that doctors do not provide a lot information. In the reasonable physician standard the focus is on the doctors rather than on the patient and is inconsistent with the concept of patient autonomy and with the goals of informed consent.
Currently most jurisdictions use the reasonable patient standard for informed consent. It involves providing information which an average patient would want to have to participate in the decision making process.
Patients have to be given sufficient information about the condition, investigation and treatment options, benefits, possible side effects or complications, and the likely outcome if treatment is not undertaken, so that they can make an informed decision to undergo treatment, procedure or operation.
There is a legal duty for the doctor to warn the patient about material risk inherent in the proposed treatment or intervention. ‘Material’ risk was defined in Rogers v. Whitaker  [13]. A risk is ‘material’ in a given circumstance if a reasonable person in the patients position, if warned of the risk, is likely to attach significance to it or if the doctor is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it. Known risks that are common though their detriment is slight and those that are uncommon but their outcome is severe should be disclosed. It is also important to know whether knowing about a risk is likely to influence a patient’s decision. Failure to disclose these risks may be a breach of the doctors duty of care to the patient and this could give rise to legal action for negligence.

Pre-prepared material/brochure and informed consent

Prepared patient information forms and brochures (translated when necessary) are sometimes used in hospitals before obtaining informed consent. These material can be useful for the patient to stimulate discussion about the procedure and its risks and it helps the doctor to guide the direction of the discussion. This material however cannot be used as a substitute to ascertain that the patient has understood the nature and risk of the procedure. Providing this material does not discharge the legal duty of the doctors when obtaining an informed consent. The doctor still has to make sure the patient is aware of the intervention planned and all material risks involved. The doctor has to ask the patient if any of the information provided is unclear. It is the doctor's duty to make sure that the pre-prepared material is up to date, accurate and appropriate for the patients. An inadequate or inaccurate information sheet would mean that that the patient was inadequately informed and this could have legal implication if litigation ensues. When additional information is provided to the patient it should be specifically noted by hand on the information sheet. Interpreters have to be used when there are language problems. In some countries professional interpreters are used when dealing with non-English speaking patients [14].

When can the duty to inform be breached?

The duty to inform the patient cannot usually be breached. However there are two situations where the duty to inform may be breached.

1. Rarely a situation may arise, where the patient expressly directs the doctor to make the decisions and does not want any information that is being provided. In such situations the doctor should at least provide the  basic information about the diagnosis and treatment.
2. On other occasions the duty to inform may be breached when the doctor exercises “therapeutic privilege” and withholds the information, when he holds a reasonable belief that disclosure of the risks could prove damaging to the patient’s health. Here the doctor has to make a judgment call, on reasonable grounds, that the information provided could cause serious harm to the patient’s physical or mental health. Several factors govern therapeutic privilege and this can include the personality, temperament or attitude of the patient as well as their level of understanding. Other factors include the nature of the treatment to be provided and the likelihood and severity of adverse effects which can result from the treatment.

Exercising ‘therapeutic privilege’ denies the patient his /her right to participate in decision making and this privilege should be sparingly used. The scope of this privilege remains uncertain and consultation with other colleagues is useful when making a decision to exercise ‘therapeutic privilege’ [14].

What information should the doctor provide the patient when obtaining the informed consent?

When obtaining an informed consent the following points should be brought up in the discussion with the patient:

1. The possible or most likely illness that the patient has;
2. The planned approach to investigations and treatment, including what the approach entails
3. The expected benefits of the intervention
4. The common side effects and material risk associated with the intervention
5. Whether the procedure is experimental or is conventional and established
6. The person who would be carrying out the procedure
7. Are other options for diagnosis and treatment available
8. The degree of uncertainty involving the the diagnosis and outcome of the intervention
9. What is the likely outcome of not undergoing the intervention for diagnosis and or treatment
10. Long term physical and non-physical adverse effects associated with the proposed intervention [14].

Conclusion

From the legal point of view a consent must be obtained from a person with capacity before any examination, test or treatment can be carried out.
A legal wrong of battery or assault can easily be avoided by obtaining a ‘real consent’ by informing the patient in broad terms the nature of the procedure that is intended. The nature of information to be given to patient to obtain ‘real consent’ is determined by the medical profession.
Obtaining an informed consent on the other hand is more complicated. The law in this area has changed over the years. When obtaining an informed consent the level of information that needs to be disclosed has to be referenced to the patient’s perspective, and not that of the doctor as in the past. Patients now have to be given sufficient information about the condition, investigation and treatment options, benefits, possible side effects or complications, and the likely outcome if treatment is not undertaken, so that they can make an informed decision to undergo treatment, procedure or operation. It is now the legal duty of the doctor to warn the patient about material risk inherent in the proposed treatment or intervention.
Prepared patient information forms and brochures can be used to provide information to the patient. These forms, however, cannot be used as a substitute to ascertain that the patient has understood the nature and risk of the procedure. Providing this material does not discharge the legal duty of the doctors when obtaining an informed consent.
The duty to inform can very rarely be breached. Doctors should use ‘therapeutic privilege’ to withhold information from patients very sparingly, because it denies the patient his /her right to participate in decision making.
Although the law of informed consent has been quite clear over the last 30 years, there still remains lack of clarity about the standard used to judge whether a consent is properly ‘informed’ or not.

References

1. Mental Capacity Act 2005 s.
2. Chico V and Taylor MJ. Using and disclosing confidential patient information and the English common law: What are the information requirements of a valid consent? Medical Law Review, Vol. 26, No. 1, pp. 51–72.
3. Re B (Adult, refusal of medical treatment) [2002] 2 All ER 449; Re C (Adult, refusal of treatment) [1994] 1 All ER 819.
4. Devi v West Midlands RHA [1980] CLY 687.
5. Appleton v Garrett (1997) 8 Med LR 75.
6. Chatterton v Gerson[1981] QB 432, 443.
7. Birch v University College Hospitals NHS Trust [2008] EWHC 2237 (QB).
8. Montgomery v Lanarkshire Health Board [2015] UKSC 11.
9. Wilson v Pringle [1987] QB 237.
10. Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] UKHL 1.
11. Bolam v Friern Hospital Management Committee [1957] 1 WLR 582.
12. Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital [1985] UKHL 1; Montgomery v Lanarkshire Health Board [2015] UKSC 11; Chester v Afshar [2004] UKHL 41; Al Hamwi v Johnston and another [2005] EWHC 206 (QB) and Pearce v United Bristol Healthcare NHS Trust [1998] EWCA Civ 865.
13. Rogers v Whitaker [1992] HCA 58; (1992) 175 CLR 479.
14. Policy Directive -- Consent to Medical Treatment - Patient Information. Ministry of Health, NSW, Australia at http://www1.health.nsw.gov.au/pds/ActivePDSDocuments/PD2005_406.pdf accessed on 19/4/18.

Fractures of the distal femur

                                     Fractures of the distal femur 

                                                  Dr KS Dhillon FRCS

Introduction

Distal femur fractures are not common and can be difficult to treat. In the 1960s the common mode of treatment of such fractures was conservative. However with the advent of better fixation devices in the 1970s, surgical fixation of the fractures became the standard mode of treatment. The functional outcome of treatment of such fractures, though many would believe is poor, is according to the literature surprisingly good. Despite the development of post-traumatic osteoarthritis in about a third of the patients the functional outcome remains good in majority of the patients.

Anatomy of the distal femur

The femur becomes trapezoidal in cross section distally where it forms the  knee joint. The medial condyle extends more distal than lateral condyle at the knee joint and the anatomical axis is about 6 to degrees valgus. The posterior halves of the medial and lateral condyles extend posteriorly beyond the posterior cortex of the femoral shaft. In the axial plane the medial femoral cortex slopes about 25 degrees and the lateral cortex slopes about 10 degrees.
The hamstring muscles and the quadricep muscle pull the distal fracture fragment proximally, the adductor magnus displaces it into varus and the gastrocnemius extend the distal fragment.

Epidemiology

Distal femur fractures account for about 6% of all femur fractures and are 10 times less frequent than proximal femur fractures (1).  The most widely used classification for distal femur fractures is the AO/OTA classification (1).

Classification of distal femur fractures.

The AO/OTA classification is widely used to classify the distal femur 

fractures. The fractures are broadly divided into three types. Type A, B and C.

Classification

The distal femur fracture represented by the number 33 and subdivided into three groups:
    1. 33A-- extra-articular metaphyseal fractures which are subdivided into three
         33A.1—simple metaphyseal fracture
         33A.2--- metaphyseal wedge fracture
         33A.3--- metaphyseal complex fracture
    2. 33B-- partial articular fracture which are also divided into three
          33B.1 – lateral sagittal fracture
          33B.2 – medial sagittal fracture
          33B.3--- frontal (Hoffa). Type B3 can be subdivided into three
                          B3.1---anterior and lateral flake
                          B3.2—unicondylar posterior
                          B3.3 – bicondylar posterior

   3. 33C-- complete articular with both condyles detached from the metaphysis.
           33C.1-- articular simple and metaphyseal simple fracture
           33C.2 --- articular simple and metaphyseal multifragmentary fracture
           33C.3 --- multifragmentary articular and metaphyseal fracture
   

Treatment of distal femur fractures

Fractures of the distal femur are fortunately uncommon. They constitute about 0.4% of all fractures and about 3% of femoral fractures[2]. The treatment of these fractures is difficult. In 1966 Stewart et al [3] claimed that "fractures in the distal third of the femur continue to perplex the surgeon. Whether they are transverse, oblique, or comminuted, or supracondylar or intercondylar in a T, Y or V fashion their management still evokes much controversy because of the consistently poor results obtained". However over the years the outcome of treatment has improve with better fixation devices.

Conservative treatment

On rare occasions distal femur fractures can be treated conservatively with a hinged brace and early knee mobilization. Such treatment is useful in patients with undisplaced fractures, in patients who are non-ambulatory and those who are unfit for surgery.

Surgical treatment

Various devices such as external fixators, nails, plates and screws are available to stabilize fractures of the distal femur.

External fixation

External fixators are used to temporarily immobilize the fractured bone till soft tissue healing is adequate for internal fixation of the fracture especially in open fractures. This technique cannot be used for definitive treatment of distal femur fracture because it does not provide adequate stability and it immobilizes the knee joint.

Antegrade intramedullary nailing

Antegrade nailing is indicated in type A extra-articular fractures of the distal femur. It is the method of choice for treatment of segmental femur fractures involving the distal femur.

Retrograde intramedullary nailing

Retrograde nailing is suitable for patients with extra-articular distal femur fracture who have concomitant fracture of the tibia (floating knee) which can be treated though the same approach.
Screw fixation
Type B fractures can be treated with screw fixation through the medial or lateral approach to the condyles. With little or no displacement percutaneous screw fixation is possible. The use of two 6.5 mm screws is  more effective than several 3.5 mm screws for osteosynthesis of these fractures [4]. In the fixation of Hoffa fractures, lag screws placed posterior to anterior provided more stable fixation than anterior posterior placement[5].

Angled blade plate

The 95 degree angled blade plate can be used for stabilization of the supracondylar and intercondylar fractures of the distal femur. The blade plate is preshaped to fit the anatomy of the distal femur.the blade is seated about 2 cm proximal to the knee joint line and the tip of the blade should not protrude beyond medial cortex to prevent damage to the medial structures.

Dynamic condylar screw (DCS)

The 95 degrees DCS is used for similar indications as the angle blade plate. Here the blade is replaced by a cannulated screw which attaches to the plate. The placement is similar to the blade plate.
Plates
There are various plates available to stabilize the distal femur fractures. The older version is the condylar buttress plate and the newer version are the locking condylar buttress plate and the locking compression plate. Plates are useful for fixing more fragile bone especially in the elderly. Biomechanical studies appear to show that locking plates are better than other modes of fixation [6].
A cochrane database systematic review by Griffin et al [7] in 2015, however, found that the currently available evidence for interventions used in treating fractures of the distal femur in adults, is incomplete and insufficient to inform current clinical practice.

Outcome of treatment of distal femur fractures

There is paucity of literature on the long term outcome of treatment of distal femoral fractures.
Egund and Kolmert [8] retrospectively reviewed 62 patients with distal femur fractures at a mean follow up of 5 years. Some of the patients were treated with traction and others had open reduction and internal fixation. They found that displaced bicondylar fractures healed mostly with varus and anterior angulation, medial unicondylar fractures with varus and lateral unicondylar fractures with valgus angulation. Most of the healed supracondylar fractures showed varus angulation. Three patients (5.8%) developed arthrosis in the femoro-tibial (grade I or II) and 14 patients (27%) had OA of  the patellar area. Intercondylar or transcondylar diastasis, or step off of 3 mm or more predisposed the patients to osteoarthritis.
Rademakers et al [9] conducted a retrospective study to analyze the long-term (5–25 years) functional and radiologic outcome of surgically treated intra-articular fractures of the distal femur. They studied 67 consecutive patients with intra articular fractures of the distal femur. Thirty-two patients had a long term follow up with functional and radiological evaluation . At a mean follow-up of 14 years (range 5–25 years), the mean range of knee flexion was 118° (range 10–145°). The Neer score showed good to excellent results in 84% of the patients and HSS score was good to excellent in 75% of the patients. Patients with isolated fractures of the distal femur had significantly better functional scores (Neer/HSS 90 points) compared with those with multiple fractures.
The Ahlbäck score showed a moderate to severe posttraumatic osteoarthritis in 36% of all patients. Despite the OA, 72% of the patients  scored a good to excellent functional result. Ten percent (seven patients) of the patients had deep wound infection and in two patients the infection became chronic and they had knee arthrodesis.
Thomson et al [10] reported a 50% incidence of OA in 22 patients (23 fractures) with type C distal femur fractures who were followed up for a mean period of 80 months (6.6 years). The physical function component of the SF-36 was approximately 2 standard deviations below the US population mean. None of the patients had a subsequent knee replacement.
Another long term follow up study of supracondylar fractures of the femur was published  by Kolb et al (11). They retrospectively studied the outcome in 41 patients with supracondylar fracture of the femur. Eighty percent of the patients were followed up for a mean of 9.5 years (7-12 years). They found that the mean Neer score was 82 points with a score of 89 points in isolated supracondylar fractures and 72 points in patients with associated fractures. The results were good to excellent in 82% of the patients. No mention was made of OA of the knee in this study.

Conclusion

Fractures of the distal femur are not common. They can occur in isolation or may occur in combination with other fractures. The AO/OTA classification of distal femur fractures is widely used and has prognostic significance. Unlike in the past, distal femur fractures are now routinely treated surgically. Various fixation devices are available. There is no evidence of superiority of one device over the other. The functional outcome of treatment is good to excellent in vast majority of the patients.The outcome is better in patients with isolated fractures as compared to those with combination injuries. About one third of the patients develop post-traumatic osteoarthritis. Despite the presences of post-traumatic OA, over 70% of the patients with OA have good to excellent functional outcome.

References

1. Florian Gebhard, Phil Kregor, Chris Oliver. AO Surgery Reference - AOTrauma - AO Foundation at https://www2.aofoundation.org Accessed on 10/11/2016. 
2. Court-Brown M, Caesar B. Epidemiology of adult fracture: a review. Injury. 2006; 37: 691-697.
3. Stewart M J., Sisk T D. Wallace S L. Fractures of the distal third of the femur. J. Bone Joint Surg. 1966; 48-A: 784-807.
4. Khalafi A, Hazelwood S, Curtiss S, Wolinski P. Fixation of the femoral condyles: a mechanical comparison of small and large fragment screw fixation. J Trauma. 2008; 64: 740-744.
5. Jarit GJ, Kummer FJ, Gibber MJ, Egol KA. A mechanical evaluation of two fixation methods using cancellous screws for coronal fractures of the lateral condyle of the distal femur (OTA type 33B). J Orthop Trauma. 2006; 20: 273-276.
6. Ehlinger M, Ducrot G, Adam P, Bonnomet F. Distal femur fractures. Surgical techniques and a review of the literature. Orthopaedics & Traumatology: Surgery & Research. 2013; 99(3): 353-360.
7. Griffin XL, Parsons N, Zbaeda MM, McArthur J. Interventions for treating fractures of the distal femur in adults. Cochrane Database Syst Rev. 2015 Aug 13;(8):CD010606. doi: 10.1002/14651858. CD010606.pub2.
8. Egund N and KolmertL. Deformities, Gonarthrosis and Function After Distal Femoral Fractures, Acta Orthopaedica Scandinavica. 2009; 53:6: 963-974.
9. Rademakers MV. Kerkhoffs GMM, Sierevelt IN, Raaymakers EL, Marti RK. Intra-Articular Fractures of the Distal Femur: A Long-Term Follow-up Study of Surgically Treated Patients. Journal of Orthopaedic Trauma. 2004;18 (4): 213-219.
10. Thomson AB, Driver R, Kregor PJ, Obremskey WT. Long-term functional outcomes after intra-articular distal femur fractures: ORIF versus retrograde intramedullary nailing. Orthopedics. 2008 Aug;31(8):748-50.
11. Kolb K, Grutzner P, Koller H, Windisch C, Marx F, Kolb W. The condylar plate for treatment of distal femoral fractures: a long-term follow-up study. Injury. 2009;40(4):440–8. doi: 10.1016/j.injury. 2008.08.046.

Orthopaedic surgeon as an expert witness in medicolegal proceedings

         Orthopaedic surgeon as an expert witness in medicolegal proceedings

                                                    KS Dhillon LLM

Introduction

Orthopaedic surgeons are increasingly being requested by solicitors to provide medical reports for medicolegal proceedings and to appear in court as an expert witness. There is not much information available to malaysian orthopaedic surgeons who are increasingly getting involved in such medicolegal work. This area of expertise is not included in our undergraduate or postgraduate curriculum. The Malaysian Medical Council (MMC) website provides some information under the section on ‘Ethical Code & Guidelines’ and subsection ‘Expert Witness’ (1). The latest amendment of the section on expert witness by the Malaysian Medical Council was at its meeting on 17 May 2016 (2). However the amendments do not amount to significant reforms.

Expert Witness Guidelines

The Malaysian Medical Council Expert Witness Guidelines define who is an expert witness and what qualifications are necessary to be an expert witness. It also outlines the responsibilities of an expert witness. The guidelines describes what expert evidence is and what a expert report should contain. It also advises on what to do when there is conflict of interest with regards to the patient or any other party.
In the introductory preamble of the guidelines the following paragraph appears ‘[t]he MMC’s guidance “Good Medical Practice” sets out the principles which underpin good care. When registered medical practitioners (“RMP”) act as expert witnesses, they take on a different role from that of a RMP providing treatment or advice to patients. However, the principles set out in “Good Medical Practice” also apply to RMPs who are expert witness’.
A in depth reading of the good medical practice guidelines shows that the guidance is mainly about doctor patient relationship and not about how to be a good expert witness. There should be a distinction between an individual who is a patient and who is a litigant.The rules that govern dealing with a patient and that when acting as an expert witness are different. However the Malaysian guidelines do not provide any clarity on this subject.
The Australian guideline on ‘Good Medical Practice’ on the other hand makes a clear distinction between these two roles (3). At 8.7 under the heading ‘Medico-legal, insurance and other assessments’ the guideline states that ‘[w]hen you are contracted by a third party to provide a medico-legal, insurance or other assessment of a person who is not your patient, the usual therapeutic doctor–patient relationship does not exist’. In such a situation good medical practice involves being courteous and alert to the needs of the person and to obtain consent and also to explain the reason  for the assessment and after the assessment to provide an impartial report. If any unrecognised serious medical problem is discovered during the examination, it is the duty of the doctor to inform the person or his/her treating doctor.
Probably the most comprehensive guidelines for doctors is the American Medical Association (AMA) Code of Medical Ethics 2016 (4). The guidelines have a separate comprehensive section on medical testimony at section 9.7.1. This section stresses on the importance of medical evidence in various administrative and legal proceedings and obligation of doctors to assist in the administration of justice. The guideline emphasises on the need to be honest and impartial and that the testimony should not be influenced by financial consideration. The guideline warns against receiving compensations that are ‘contingent on the outcome of litigation’.
Doctors who act as fact witnesses, for their patients, in legal claim, must remember the importance of confidentiality. The testimony should reflect facts of the case and honesty is of paramount importance.
Expert witnesses should only testify in their area of training and experience. The testimony should be objective and independent and it should reflect  the ‘current scientific thought and standards of care that have gained acceptance among peers in the relevant field’ at the time when the incident happened. Theoretical testimony should be avoided but if that is not possible, then the basis of the theory should be characterised.
In the USA, state medical licensing board and the specialty societies are entrusted with the responsibility of assessing ‘claims of false or misleading testimony and issuing disciplinary sanctions as appropriate’, to maintain high standards of medical testimony.
In the USA several medical specialities have established their own guidelines based on the ethical standards set by AMA (5). The American  Academy of Orthopaedic Surgeons (AAOS)  has produced its own code of medical ethics and professionalism for orthopaedic surgeons (6).
 In the UK, similar guidelines are available for witnesses of fact and expert witnesses. The guidelines are set in a 4 pages document produced by the General Medical Council in 2013(7). It stresses on the need for honesty, confidentiality, competence, knowledge, being up to date and the need to work within the limits of one's competence, beside being always impartial. It also reminds the doctors that in providing medical testimony the doctor’s overriding duty is to the court, irrespective who is instructing or paying the doctor.
The guidelines, however, are silent about other important aspects of medical testimony such as judicial immunity of expert witness, penalty for false testimony and possible sanctions by regulatory bodies.

Judicial Immunity of the Expert Witness

Historically, in English law, witnesses in legal proceedings have enjoyed judicial immunity since Cutler v Dixon: KBD 1585 (8). Evidence provided by an expert witness was protected from civil liability. The basis of this immunity is public policy considerations where there is an assumption that if there is a risk of civil proceeding based on the evidence, then the witness will not be willing to provide frank and full evidence. This however changed when the Supreme Court of the United Kingdom on 30 March 2011 abolished this immunity in Jones v Kaney [2011] UKSC 13, by a 5-2 majority (9). The majority was of the opinion that the reason for the immunity, that the witness would be reluctant to provide true opinion and that there may be a proliferation of vexatious claim is no longer tenable. The majority were of the opinion that the court has to respect the fundamental rule that every wrong should have a remedy which is the cornerstone of any system of justice. However the immunity to a defamation civil suit would continue.
Following this decision in Jones v Kaney things may change for both the expert witness and the maybe for the client as well, although the British Courts do not believe it will happen. Now that a client who believes he has been wronged by the expert testimony may file a legal redress against the expert which in turn may result in shortage of experts available who are willing to testify. So far this landmark decision is not binding in Malaysia and judicial immunity of the expert witness remains.
In Australia too the doctrine of immunity for expert witnesses is still in force.  In Commonwealth of Australia v Griffiths[10] the court confirmed that the key objectives of the doctrine is to make sure that the expert witness is able to  give evidence freely; and also to make sure that the same evidence is not tried repeatedly in multiple actions. This immunity, as in UK, does not extend to considerations of the expert’s conduct by the regulatory professional bodies.
In the USA there has been a gradual erosion of the expert immunity over the years and now most courts ‘view professional witness malpractice as an actionable claim’ (11). Most often the party hiring the expert sues the expert for negligence and less often the expert hired by the opposing counsel gets sued (11).
What happens if the expert witness provides false testimony?

False testimony

A doctor who provides false testimony under oath or lies in his deposition when acting as an expert can be prosecuted for the crime of perjury. The statement made must, however, be “material” to the subject of the proceeding.There is no immunity for lying in sworn testimony. The prosecution for perjury is carried out by the government prosecutors and not by any of the parties involved in the litigation.
In Malaysian law, false evidence is defined under section 191 of Act 574, of the penal code. The Act defines false evidence as ‘whoever, being legally bound by an oath, or by any express provision of law to state the truth, or being bound by law to make a declaration upon any subject, makes any statement which is false, and which he either knows or believes to be false, or does not believe to be true, is said to give false evidence’.
The punishment for false evidence is provided for under section 193 of the same Act. It states that ‘whoever intentionally gives false evidence in any stage of a judicial proceeding, or fabricates false evidence for the purpose of being used in any stage of a judicial proceeding, shall be punished with
imprisonment for a term which may extend to seven years, and shall
also be liable to fine…’ (12).
Besides the government, state authorities or professional bodies can also mete out punishment for expert witness malfeasance.

Sanctions by state authority and/or professional body. 

There are three systems that operate to regulate expert medical testimony in most countries. This would include the legislature, the judiciary and medical regulatory bodies such as the medical council or the medical professional organizations (13). There are precedents in the USA and the UK where medical regulatory bodies have taken disciplinary action against doctors for expert witness malfeasance.
In the USA, Dr Austin, a neurosurgeon and member of American Association of Neurological Surgeons (AANS), had his membership suspended by the AANS after he testified as an expert for the plaintiff against Dr Ditmore, another member of AANS. At the conclusion of the malpractice trial, Dr. Ditmore complained to the AANS about Dr. Austin’s medical testimony. Investigations by the AANS showed that Dr. Austin’s
testimony did not have evidentiary basis and had violated AANS expert witness guidelines and the AANS ethics code. Dr. Austin subsequently sued the AANS,without success (14).
In the UK, the most well known case of disciplinary action by General medical Council (GMC) for expert witness malfeasance was that involving Professor Sir Roy Meadow. His name was struck off the medical register by the Fitness to Practise Panel (FPP) of the General Medical Council (GMC) in 2005, following a complaint by Sally Clark’s father. He was found guilty of serious professional misconduct for providing statistical evidence that was inaccurate and misleading at the trial of Sally Clark who was convicted of killing her two children. She was, however, subsequently released after the second appeal.   
Professor Meadow appealed to the High Court and the High court in February 2006 allowed his appeal and quashed the order of the GMC. The GMC appealed to the Appeals Court in July 2006. At the Appeal Court, the Master of the Rolls, Sir Anthony Clarke MR, broke down the appeal into two parts, the first being whether an expert witness has immunity from disciplinary proceeding by the GMC for evidence given by him at legal proceedings. The second was an appeal by the GMC to squash the High Court Judge’s ruling that Professor Meadow was not guilty of serious professional misconduct.
 The Appeals Court unanimously concluded that FPP had jurisdiction to entertain the allegations against Professor Meadow, which in essence meant that there is no expert witness immunity from disciplinary proceeding by the GMC for evidence given in legal proceeding.
The Appeals Court with a majority of two to one upheld the decision of the High Court Judge that Professor Meadow was not guilty of professional misconduct and dismissed the GMC appeal on this important matter (15).
A more recent case, in UK, involved a paediatric neuropathologist, Dr Waney Squier (16). A panel of the Medical Practitioners Tribunal Service (MPTS), the statutory successor to the FTPP, decided to strike her name off the medical register for expert witness malfeasance in the “shaken baby” cases. She appealed to the High Court. At the High Court, the judge, Mr Justice Mitting acquitted her of dishonest testimony and he found that the tribunal's determinations were “in many significant respects flawed.”
The judge made several interesting concluding observations. He was of the opinion that since this case before the MPTS was a complex case which required ‘an understanding of the context in which expert evidence is given in a court’, it would have been proper to have a lawyer with judicial experience as the chair of the inquiry. The rules of General Medical Council (Constitution of Panels, Tribunals and Investigation Committee) 2015 do not prohibit such an appointment. The Judge’s comments probable meant that if a lawyer with judicial experience had been appointed as the chair, the shortcomings in the tribunal's determinations could have been avoided. This would have prevented pain and suffering for the accused and also save time and money for all parties involved.
In the UK, doctors can be prosecuted again after acquittal by the GMC, although there is law against double jeopardy in most countries. The Council for Healthcare Regulatory Excellence (CHRE) has the powers to refer a doctor to the High Court after they have been acquitted of of serious professional misconduct by the GMC. The first case of this nature involved Dr Ruscillo (a GP) who was found to be not guilty of serious professional misconduct by the GMC but the CHRE felt it was an unduly lenient penalty.
The Council appealed the acquittal and Dr Ruscillo challenged the appeal.The case went to the Court of Appeal and the court held that this acquittal could be a subject of an appeal according the law (17).
Although, regulatory bodies such as the Malaysian medical council and the GMC do mete out punishment to errant expert witnesses, these regulatory bodies can also err.

Failings of the regulatory bodies

The body that regulates and sanctions doctors in Malaysia is the Malaysian Medical Council. The president of the Council is the director general of health and the council has 11 elected members who are doctors and three nominated member from the civil service who are also doctors. In addition there 18 nominated member from six universities who are also doctors (18) Hence in Malaysia the doctors set the standards and they regulate themselves. In the UK too, self-regulation which provided a lot of freedom in dealing with problems within the profession was the norm till the GMC came under lot of condemnation following the Bristol Inquiry (19) and Shipman Inquiry (20).
Between 1991 and 1995 at the Bristol Royal Infirmary cardiac unit there was an unusually high death rate among children going for heart surgery due to poor care, and poor team work. The problems were brought to light by whistleblower, consultant anaesthetist Dr Stephen Bolsin who could not get a job in UK after the exposure and had to migrate to Australia.The Bristol inquiry resulted in several reforms by the government and professional bodies.
Dame Janet Smith headed the Shipman Inquiry which looked into issues arising from the case of Dr Harold Shipman (GP) who murdered over 200 of his patients. The inquiry did a thorough forensic examination of the GMC and found it to be severely wanting. The GMC had been accused of being a judge and prosecutor (21). Dame Janet Smith’s fifth report which was over 1000 pages long made several recommendation for reforms to the GMC (22).
There have been many amendments to the 1983 medical act (UK) and last being in 2016. The GMC is an independent body which now has lay members besides the medical members. Complaints against doctors are investigated by the GMC. Two senior GMC staff who are known as case examiners (one medical and one non-medical) look into the complaints and they can come to the following conclusion:

• No further action
• Issue a warning
• Agree undertakings - for example to re-train or work under supervision.
• Refer the case to a medical practitioners tribunal (MPT) of the Medical Practitioners Tribunal Service (MPTS) when action on registration may be appropriate.

The Medical Practitioners Tribunal Service is an independent body which reports to GMC twice a year and also to parliament. It carries out hearings for doctors whose fitness to practise is suspect. The tribunal has both medical and lay members.
Although there have been major reforms in the the regulatory bodies in the UK, to date no such reforms have been carried out in Malaysia. The Malaysia Medical Council is not an independent body unlike the GMC. It is an arm of the ministry of health and is financed by the ministry of health. It is regulated by doctors with no representatives from advocacy groups and the council has no lay members to represent the lay complainants (23). The MMC appears to be ‘largely representative of stakeholder groups in the medical profession’ (23). The public perception is that as far as the MMC is concerned the medical profession comes first and that the regulatory process does not appear to safeguard public interest (23). Inquires on the scale of the likes of the Bristol and Shipman inquiry have not and are unlikely to happen in Malaysia in future.

Conclusion

More and more malaysian orthopaedic surgeon’s are getting involved in medicolegal work especially in third party personal injury claims and also some in medical negligence proceedings. However there is not much information available to these surgeons to prepare them for this new role which is very different from the usual one of providing treatment or advice to patients. The rules that govern dealing with a patient and that when acting as an expert witness are different and the Australian Medical Council has made a clear distinction between the two roles, although the MMC believes that the same rules apply to both roles.
Since 2011, UK law does not provide judicial immunity to expert witnesses against civil proceeding. Proceedings against defamation remain in the UK. However, in Malaysia, expert witnesses still enjoy immunity against civil proceedings. There is no immunity for expert witnesses, from criminal proceeding, for false testimony.
Regulatory bodies such as the the MMC and the GMC can take disciplinary action against doctors for expert witness malfeasance. This can include erasure of the name from the medical register.
Failings of the GMC had invited a lot of public criticism in the past which led to a series of reforms to improve its function and image. However no major reforms have occurred in the MMC over the years although the malaysian model of governance is usually based on the British model.

References

1. Official portal of Malaysian Medical Council. Safeguarding patients, guiding doctors at http://www.mmc.gov.my/index.php/ethical-code-guidelines, acessed on 4/9/2017.
2. Expert witness at http://www.mmc.gov.my/images/contents/ethical/Expert%20Witness_17052016.pdf,  accessed on 4/9/2017.
3. Good medical practice: a code of conduct for doctors in Australia at http://www.medicalboard.gov.au/Codes-Guidelines-Policies/Code-of-conduct.aspx, accessed on 4/9/2017.
4. AMA Code of Medical Ethics at https://www.ama-assn.org/delivering-care/ama-code-medical-ethics, accessed on 4/9/2017.
5.  Kass JS and Rose RV. Ethical Challenges for the Medical Expert Witness. AMA Journal of Ethics. 2016; Volume 18, Number 3: 201-208.
6. Code of medical ethics and professionalism for orthopaedic surgeons at https://www.aaos.org/WorkArea/DownloadAsset.aspx?id=31334, accessed on 5/9/2017.
7. Acting as a witness in legal proceedings  at http://www.gmc-uk.org/Acting_as_a_witness_in_legal_proceedings.pdf_58832681.pdf, accessed on 4/9/2017.
8. Cutler v Dixon KBD ((1585) 4 Co Rep 14b, [1585] 76 ER 886,[1585] EngR 96).
9. Jones v Kaney SC 135 Con LR 1, [2011] 2 WLR 823, [2011] BLR 283, [2011] 2 AC 398, [2011] 14 EG 95, [2011] 2 All ER 671, [2011] UKSC 13, UKSC 2010/0034.
10. Commonwealth of Australia v Griffiths and Another (2007) 70 NSWLR 268; [2007] NSWCA 370.
11.  Bal BS. The Expert Witness in Medical Malpractice Litigation. Clin Orthop Relat Res. 2009 Feb; 467(2): 383–391.
12. LAWS OF MALAYSIA, Act 574, PENAL CODE, as at 1 January 2015, at http://www.agc.gov.my/agcportal/uploads/files/Publications/LOM/EN/Penal%20Code%20%5BAct%20574%5D2.pdf. Accessed on 9/92017.
13. Kesselheim AS and Studdert DM, Role of Professional Organizations in Regulating Physician Expert Witness Testimony, JAMA. 2008;299(14):1667-1668.
14. U.S. District Court for the Northern District of Illinois. Austin v. American Ass'n of Neurological Surgeons, 120 F. Supp. 2d 1151 (N.D. Ill. 2000).
15. General Medical Council v Meadow [2006] EWCA Civ 1390.
16. Squier v GMC [2016] EWHC 2739 (Admin).
17. Ruscillo v The Council for the Regulation of Health Care Professionals [2004] EWCA Civ 1356.
18. Malaysian Medical Council at http://www.mmc.gov.my/index.php/council, accessed on 11/9/2017.
19. Learning from Bristol: the report of the public inquiry into children's heart surgery at the Bristol Royal Infirmary 1984 -1995, at http://webarchive.nationalarchives.gov.uk/20090811143746/http://www.bristol-inquiry.org.uk/ accessed on 11/9/2017.
20. The Shipman report at http://webarchive.nationalarchives.gov.uk/20090808160144/http://www.the-shipman-inquiry.org.uk/fifthreport.asp, accessed on 11/9/2017.
21. Smith R. The GMC: expediency before principle. BMJ. 2005 Jan 1;330(7481):1-2.
22. The General Medical Council, The Shipman Inquiry: The fifth report at http://www.gmc-uk.org/6a_The_Shipman_InquiryThe_Fifth_Report.pdf_25398772.pdf, accessed on 11/9/2017.
23. Nik Rosnah & Wan Abdullah. Medical Regulation in Malaysia: Towards an Effective Regulatory Regime.Policy and Society, 2002;21(1): 96-124.

Medial and lateral collateral ligament injuries of the knee

                     Medial and lateral collateral ligament injuries of the knee

                 

                                                            Dr KS Dhillon FRCS

Anatomy of the collateral ligaments

There are two collateral ligaments, one on either side of the knee. The one on the medial side is referred to as the medial collateral and and the other on the lateral side is referred to as the lateral collateral collateral ligament.

Medial collateral ligament

The medial collateral ligament (MCL) has two components, the superficial and the deep components.
The superficial medial collateral ligament has one femoral and two tibial attachments and is the largest structure on the medial aspect of the knee[1]. The proximal femoral attachment is at a round to oval depresion about 3.2 cm proximal and 4.8 cm posterior to the medial femoral epicondyle[1]. There is no attachment between the superficial and deep collateral.
There are two distal attachments of superficial medial collateral ligament.
The attachment of the proximal of the two distal attachments is mainly to soft tissues especially to the anterior arm of the semimembranosus and the distal component has bony attachment anterior to the posteromedial crest of the tibia. The distal component forms the posterior floor of the pes anserine bursa and it also blends with the semimembranosus tendon[1]. Between the two distal attachments pass the inferior medial genicular artery and vein, along with its corresponding nerve branch from the tibial nerve. The average overall length of the superficial medial collateral ligament is  between 10 and 12 cm[1].
The deep medial collateral is formed by thickening of the medial capsule of the knee and it is clearly seen along its anterior border where it is parallel to the superficial collateral. Posteriorly it merges with the central arm of the posterior oblique ligament. It consists of the proximal meniscofemoral and the distal meniscotibial component. It is attached to the meniscus at the joint level and to the medial femoral condyle proximally and the medial tibial plateau distally[1].
The lateral collateral ligament (LCL) is part of a complex of ligaments at the  posterolateral corner of the knee. This complex consists of the LCL, the arcuate ligament, the popliteus ligament, the popliteofibular ligament, the, the short lateral ligament, and the posterolateral joint capsule. Unlike the MCL the LCL is separated from the lateral meniscus by a fat pad.
There appears to be little consensus in the literature regarding the bony attachments of the lateral (fibular) collateral ligament (FCL). Cadaveric dissections and review of the literature by Chappell et al [2] showed that in about half of the instances the proximal attachment is at the apex of the lateral epicondyle and in the other half the attachment is posterior and proximal to the LE. The distal attachment is to lateral aspect of the fibular head by two or three bands [2].The average length of the ligament is about 48.3 mm and the average width is about 4mm [2]. There is a wide variation in the dimensions of the length of ligament reported in the literature varying from 35mm to 72mm [3].

Collateral ligament injuries

Collateral ligament injuries are caused by excessive varus or valgus force applied on the knee with a varus force producing a LCL injury and a valgus force causing a MCL injury. Most patient are able to walk after such injuries and the pain is localised to the medial or the lateral side of the knee. Collateral ligament injuries usually do not produce mechanical (pop, locking) symptoms or symptoms of knee instability. Swelling is usually present over the area of injury and redness may appear after a few days.
Examination shows localised tenderness and swelling at the site of the injury. Tenderness at the proximal or distal attachment may indicate an avulsion injury of the ligament.
Valgus stress testing with the knee in 25-30 º flexion would show laxity when the MCL is torn and varus stress testing with the knee in 20-25 º of flexion would show laxity if the LCL is torn. Laxity on the medial side with knee in extension would indicate a tear of the anterior cruciate ligament (ACL) in addition to the MCL tear. A laxity on the lateral side with the knee in extension would indicate a tear of the posterior capsule and other lateral structures in addition to the LCL tear.
The severity of ligament injury is clinically graded from I to III:

• Grade I - Less than 5 cm laxity (partial tear)
• Grade II - 5-10 cm laxity
• Grade III - More than 10 cm laxity (complete tear)

The diagnosis of collateral tears is always clinical. An X-ray of the knee should however be done to exclude a bony avulsion of the ligament. A varus and valgus stress X ray can be useful for demonstrating ligament laxity. An MRI is usually not needed to make a diagnosis of collateral ligament injury.
An MRI is not very reliable for differentiating grades of injury. Grade 1 injuries usually show periligamentous edema, grade II injuries show partial disruption of the ligamentous structures and grade III injuries show complete disruption of the ligament[4].

Treatment of collateral ligament injuries

All three grades of isolated collateral ligament injuries can be treated conservative with good results. Initially treatment includes cryotherapy, elevation and compression to reduce pain and swelling. Grade I injuries can be treated without a brace while grade II and III injuries are treated with brace and early mobilization. Muscle strengthening exercise are carried out in all patient with ligament injury. The injuries require about 4 to 6 weeks to heal. It may take longer for grade III injuries.
Derscheid et al [5] reported a return to unprotected sports, of football players with Grade I MCL sprains, after an average of 10.6 days and those with grade II sprains after 19.5 days.
Jones et al [6] reported achieving a stable knee in 22 out 24 high school football players with isolated Grade III injuries of the MCL, with conservative treatment. The average recovery time in these patients was 29 days. The players returned to competitive sports at a mean time of 34 days. Similar good outcome of conservative treatment of grade III MCL injuries have been reported by other authors [7,8].
Studies comparing conservative and surgical treatment of grade III MCL tears show that there is no subjective or objective differences between the surgically and non-surgically managed group [9,10]. Bony avulsion injuries, however, benefit from surgical intervention [11].
Chronic valgus instability may result when grade III MCL injuries are inadequately treated and fail to heal. Such instability which affect activities of daily living and affect inability to participate in athletic activities would be an indication for surgical treatment.
Lateral collateral injuries are rare [12] and there is scarcity of literature on the treatment of LCL injuries [13]. Good functional outcome of conservative treatment of grade I and grade II injuries has been reported [14,15]. The numbers of patients in these studies has been very small. Surgery is usually recommended for grade III  posterolateral knee injuries with acute repair of avulsed structures, reconstruction of midsubstance tears [16]. However the number of cases in the published reports has been small and the evidence is therapeutic Level IV evidence. There is a lack of publications comparing operative versus non-operative treatment of grade III LCL injuries. Grade III injuries are often associated with tears of the cruciate ligament which makes treatment more complicated.

Long term outcome of collateral injuries

There is a paucity of literature on the long term outcome of treatment of collateral ligament injuries of the knee.
In 1996 Lundberg and Messner [17] published the long term outcome of treatment of partial medial collateral ligament ruptures. They prospectively followed up 38 patients with partial tears of the MCL. The patients were seen at 3 months, 4 years, and 10 years after the initial trauma. Clinical and radiological examination was carried out. At 4 years follow up the median  Lysholm score was 100 (range, 64 to 100) and 87% of the patients had normal knee function during strenuous activities. At 10 years, the median Lysholm score was 95 (range 73 to 100) and the patients continued to performed on a similarly high activity level as at 4 years. Early signs of osteoarthritis was seen in 13% of the patients but none had joint space reduction.
In 1997 Lundberg and Messner [18] published the 10 years outcome of treatment of isolated and combined medial collateral ligament ruptures. They studied a matched-pair of 40 patients with acute isolated partial medial collateral ligament injury and acute combined medial collateral and anterior cruciate ligament injury. All patients in the first group were treated conservatively and the later group were treated by repair of both ligaments. At 10 years follow up both group of patients had similarly high knee functional Lysholm score and similar activity levels (recreational team sports). There was residual laxity in patients with combined injury. Post traumatic osteoarthritis (OA) was present in half of the knees with combined injuries. There was no OA in patients with isolated injuries. Although the long term functional outcome was good in both groups of patients, the patients with combined injuries had more repeat injuries and more repeat surgeries, increased sagittal laxity, and a higher incidence of radiographic osteoarthritis.
Kannus [19] in 1989 published an average of 8 years follow up of 11 patients with Grade II sprains and 12 patients with Grade III sprains of the lateral collateral ligament who were treated conservatively. He found that the result in Grade II sprains was generally good, despite the fact that some residual laxity persisted. On the other hand in Grade III sprains, the results were not  so good with a high incidence gross lateral laxity, ACL insufficiency, muscle weakness, and posttraumatic osteoarthritis of the injured knee.

Conclusion

The collateral ligaments are the medial and lateral static stabilizers of the knee against varus and valgus stress. The medial collateral injury is the commonest ligament injury to the knee. The ligament injuries are graded into three depending on its severity.Grade I and II injuries are treated conservatively and healing is usually good because of the good vascularity around the ligaments and long term outcome of such injuries is good.
There is controversy, however, with regards to the treatment of grade III injuries. Such injuries are often associated with injury to other structures around the knee and surgical treatment is often recommend. The long term outcome of treatment of grade III injuries is not very good with patients having residual laxity, muscle weakness and OA of the knee in some instances. There is, however, paucity of literature on the long term outcome of treatment of collateral ligament injuries of the knee especially in the recent years.

References

1. LaPrade RF, Engebretsen AH, Ly TV, Johansen S, Wentorf FA, Engebretsen L. The anatomy of the medial part of the knee. J Bone Joint Surg Am. 2007 Sep;89(9):2000-10.
2. Chappell TM, Panchani PN, Moore GD, Tubbs RS, Shoja MM, Loukas M, Kozlowski PB, Khan KH, DiLandro AC, D'Antoni AV. Morphometry of the fibular collateral ligament: anatomic study with comprehensive review of the literature. Clin Anat. 2014 Oct;27(7):1089-96. doi: 10.1002/ca.22416. Epub 2014 May 20.
3. Jun Yan, , Sanjuro Takeda, Kotaro Fujino, Goro Tajima, Jiro Hitomi. Anatomical Reconsideration of the Lateral Collateral Ligament in the Human Knee: Anatomical Observation and Literature Review. Surgical Science. 2012, 3, 484-488.
4. Naraghi AM, White LM. Imaging of Athletic Injuries of Knee Ligaments and Menisci: Sports Imaging Series. Radiology 2016 281:1, 23-40.
5. Derscheid GL, Garrick JG. Medial collateral ligament injuries in football. Nonoperative management of grade I and grade II sprains. Am J Sports Med. 1981;9(6):365–8.
6. Jones RE, Henley MB, Francis P. Nonoperative management of isolated grade III collateral ligament injury in high school football players. Clin Orthop Relat Res. 1986 Dec;(213):137-40.
7. Indelicato PA. Nonoperative management of complete tears of the medial collateral ligament. Orthop Rev. 1989 Sep;18(9):947-52.
8. Indelicato PA, Hermansdorfer J, Huegel M. Nonoperative management of complete tears of the medial collateral ligament of the knee in intercollegiate football players. Clin Orthop Relat Res. 1990 Jul;(256):174-7.
9. Indelicato PA. Non-operative treatment of complete tears of the medial collateral ligament of the knee. J Bone Joint Surg Am. 1983;65(3):323–9.
10. Reider B, et al. Treatment of isolated medial collateral ligament injuries in athletes with early functional rehabilitation. A five-year follow-up study. Am J Sports Med. 1994;22(4):470–7.
11. Wilson TC, Satterfield WH, Johnson DL. Medial collateral ligament “tibial” injuries: indication for acute repair. Orthopedics. 2004;27(4):389–93.
12. DeLee JC, Riley MB, Rockwood CA Acute straight lateral instability of the knee Am J Sports Med. 1983; 11: 404-411.
13. Chahla, J., Moatshe, G., Dean, C., LaPrade, R. Posterolateral Corner of the Knee:Current Concepts. The Archives of Bone and Joint Surgery, 2016; 4(2): 97-103.
14. Kannus P. Nonoperative treatment of grade II and III sprains of the lateral ligament compartment of the knee. Am J Sports Med. 1989; 17(1):83-8.
15. Krukhaug Y, Molster A, Rodt A, Strand T. Lateral ligament injuries of the knee. Knee Surg Sports Traumatol Arthrosc. 1998; 6(1):21-5.
16. Geeslin AG, LaPrade RF. Outcomes of Treatment of Acute Grade-III Isolated and Combined Posterolateral Knee Injuries. A Prospective Case Series and Surgical Technique. J Bone Joint Surg Am. 2011;93:1672-83.
17. Lundberg M, Messner K.Long-Term Prognosis of Isolated Partial Medial Collateral Ligament Ruptures. A Ten-Year Clinical and Radiographic Evaluation of a Prospectively Observed Group of Patients. Am J Sports Med. 1996 Mar-Apr;24(2):160-3.
18. Lundberg M, Messner K. Ten-year prognosis of isolated and combined medial collateral ligament ruptures. A matched comparison in 40 patients using clinical and radiographic evaluations. Am J Sports Med. 1997 Jan-Feb;25(1):2-6.
19. Kannus P. Nonoperative treatment of grade II and III sprains of the lateral ligament compartment of the knee. Am J Sports Med. 1989 Jan-Feb;17(1):83-8.

Lower limb alignment, joint orientation and tibial malunions

              Lower limb alignment, joint orientation and tibial malunions 

                                                           Dr KS Dhillon

What is normal lower limb alignment and joint orientation?

The lower limb alignment is determined by the orientation and shape of the the femur and the tibia as well as the orientation of the hip, knee and ankle joints. The femur and the tibia each has two axis, the mechanical and the anatomical axis.
The mechanical axis runs from the centre of the proximal joint to the centre of the distal joint and this axis remains the same in the sagittal and frontal planes. The anatomical axis on the hand runs through the middle of the diaphysis of the long bone and it can be straight in both planes as in the tibia or it can be straight in one plane (frontal) and curved in another plane (sagittal) as in the femur. For practical purposes the mechanical axis of the lower limb is always considered in the frontal plane.
The angle which is formed between the joint line and the anatomic or mechanical axis is known as the joint orientation angle. The normal lateral distal femur angle (mLDFA) between the femoral mechanical axis and the knee joint line is 87 degrees and between the knee joint line and the femoral anatomical axis (aLDFA) is 81 degrees (79 to 83 degrees).
The medial proximal tibial angle (MPTA) is 87 degrees (85 to 90 degrees) both with the anatomical and mechanical axis because both these axis are the same.
The normal angle between the femoral and tibial mechanical axis was always believed to be 0 degrees. Eckhoff DG et al [1], however, have challenged the ‘concept of a mechanical axis consisting of a straight line through the centers of the femoral head, distal aspect of the femur, and the
talus’.
In a study of the three-dimensional mechanics, kinematics, and morphology of the knee they found that only 2% of individuals have a neutral hip-knee-ankle axis. This is probably due to the the wide variability of the bow in the tibia and femur and the lack of correlation between the bow of the tibia and femur in a given limb. They found that of the 180 subjects studied 57% had a varus angulation at the knee and 40.5% had a valgus angulation. The measurements ranged between 12.2 degrees varus to 15.6 degrees valgus. The median varus however was 2.5 degrees and the median valgus was 1.5 degrees.
Short Xray films of the knee are often used to evaluate the lower limb alignment. Howell et al [2] studied the longitudinal shapes of the tibia and femur and found that they are unrelated and are variable. They measured the angle formed by the anatomic axis of the proximal fourth of the tibia and the mechanical axis of the tibia, as well as the angle formed by the anatomic axis of the distal fourth of the femur and the mechanical axis of the femur and they were able to study the bow of the femur and the tibia in normal individuals.
They found that the angle formed by the anatomic axis and the mechanical axis of both the tibia and femur varied widely and the bow of the tibia and femur varied widely. The angle formed by the tibial mechanical and anatomic axis varied 11 degrees from -4 degrees to 6 degrees. The angle formed by the anatomic and mechanical axes of the femur varied 10 degrees from -1 degree to 8 degrees [2].
The bow of the tibia (the offset of the anatomic axis from the center of the talus) varied 5.7 cm and the bow of the femur (the offset of the anatomic axis from the center of the femoral head) varied 7.2 cm. 
Tang et al [3] found that in the chinese population the angle between the femoral and tibial mechanical axis was not 0 degrees. There was a larger medial inclination of knee joint (varus) in their subjects. Their females had a significantly larger varus alignment of the lower extremity as compared to the caucasian population. They also found that the medial inclination of the tibial plateau was 5.4 ± 2.5 degrees for women and 4.9 ± 2.3 degrees for men which was greater than the commonly reported 3 degrees.
Felson et al [4] did a study to find out if anatomic alignment measured from a knee radiograph can substitute for mechanical alignment from full limb films. They studied 143 subjects who had knee X-rays and full limb films. They found that that the agreement of alignment from knee X-ray to full limb film was only moderate. The anatomic alignment as assessed from the knee radiograph was not exactly the same as the mechanical alignment as measurement from the full limb x-rays. There were knees that were valgus on the knee X-ray that were varus on full limb film and vice versa.

Tibial malunions

The incidence of malunion after treatment of tibial fractures varies between 0% to 31.7% [5]. Court-Brown et al [6] reported a malunion rate of 2.4% in a study of 125 closed and type I open tibial fractures which were treated by nailing. Malunion was defined as shortening of more than 1 cm and or more than 5 degrees of angulation or rotation.
Freedman and Johnson [7] found 12% malalignment in 133 fractures of the tibial treated by nailing. They defined malalignment as 5 degree angulatory deformity in any plane. Malalignment was seen in 58% of proximal third fractures, 7% of middle third fractures, and 8% of distal third fractures.
Bedi et al [8] report a 13.8% incidence of malunion in patients who had treatment for tibial fractures.
Vallier et al [9] reported a 29% incidence of more than 5° of malalignment after nailing as compared with 5.4% after plating of tibial fractures.
Abdel-Salam et al [10] reported a 15.5% incidence of malunions in patients who had plaster cast treatment for tibia fractures. They however defined malunions as angulations of more than 10° or a 2.5 cm or more of shortening.
Jindal [11] reported a malunion incidence of 32% in patients with fracture of the tibia who were treated with a cast.
Wiss et al [12] followed up 101 patients with fracture of the tibia treated by nailing. They found a 4.9% incidence of malunion of the tibia. They defined malunion as an angulation of more than 7° or a more than 1 cm of shortening.
Gregory et al [13] followed up 38 patients with fracture of the tibia treated by nailing and they found a malunion incidence of 7.9%. They defined malunion as angulation of 5° or more and rotation of 10° or more and 1 cm or more of shortening.
A review of literature shows that the criteria for malunion varies, ranging from 5° of varus, valgus, and anterior or posterior angulation, 1 cm of shortening, and 5° of rotation in most studies, to as high as 10° of angulation and 2.5 cm of shortening [5].

Long term outcome of tibia malunion

Good intermediate-term results of treatment of tibial fractures have been reported in majority of the patients in an era when most tibial fractures were treated conservative with a plaster cast [14]. Tibial malunions are more come when fractures are treated with a cast as compared to when they are treated with internal fixation. Tibial malunion has been shown to increase contact stresses in the medial or the lateral compartment of the knee depending on whether it varus or valgus malunion [15]. Similarly contact stress can increase in the ankle when there is malunion of the tibia and there have been suggestions that these increase in stresses can lead to osteoarthritis (OA) of the joints [15,16].
There have been several clinical studies published which showed no association between malunions of the tibia and OA of the knee and ankle [17,18].
Van der Schoot et al [19] on the other hand showed that in patients with more than 5 degree angular malunion of the tibia there was a higher incidence of knee and ankle OA as compared to the uninjured side. They found a significant correlation between symptoms in the knee and arthritis but there was no significant relationship between symptoms and ankle arthritis or malalignment.
A more detailed examination of the paper shows that the clinical outcome at an average follow up of 15 years was good in the patients. They reviewed 88 patients out of 106 who were treated for a fracture of the tibia. They found that 49% of the patients had 5 degrees or more of angular deformity and out of these patients 58% had OA of the knee and or ankle. Thirty-one percent of the patient with no malunion had OA. The incidence of grade 2 to 3 OA was low. For the knee it was 4.5% and for the ankle it was 14.5%. Only 13.5 of the patients had symptoms of the knee or ankle or both. About 6.5% of the patients complained of pain at the fracture site. The relationship for symptoms and OA was significant only for the knee and not for the ankle. There was no mention of further surgery for the OA in this report.
The authors concluded that despite the high incidence of OA, there was no relation between malalignment and clinical symptoms. The OA could also be partly due to trauma to the joints at the time the fracture occurred.
The most comprehensive, though retrospective, report, on the long term outcome of tibial fractures which addresses the the issue of malunions is the one by Milner et al [20].
They assessed 164 patients who had tibial shaft fractures 30 to 43 years prior to the review. The subjects were evaluated with regards to lower limb joint pain, stiffness, and disability (assessed with WOMAC osteoarthritis questionnaire); clinical signs of osteoarthritis; and radiographic evidence of knee, ankle, and subtalar joint OA.
Fifteen percent of the patients reported at least moderate knee pain, 6% at least moderate ankle pain and 13% reported at least moderate disability. They found that knee OA was frequently bilateral. The study showed no significant univariate association between malunions of the tibia and the development of osteoarthritis.
The malalignment was assessed using the mechanical hip-knee-ankle angle outside the normal range of 6.25° of varus to 4.75° of valgus. Overall malalignment was seen in 15% of the subjects (17 patients). In about half of the patients (9 patients) the malalignment was due to the fracture malunion and in the rest (8 patients) the malalignment predated the fracture. Most of the subjects in whom OA was observed had normal overall alignment of the lower limb.
The authors concluded that the outcome of treatment tibial shaft fractures is good at thirty-year follow up despite the fact that mild OA is common. They also concluded that fracture malunion is not the cause of the higher prevalence of symptomatic ankle and subtalar osteoarthritis in the injured limb. Varus malalignment occurs occasionally and may produce OA of the medial compartment of the knee, but other undefined factors, rather than malalignment due to malunion, are responsible for the OA after tibial shaft fractures.
Lefaivre et al (21) reported a 14 years follow up of a  small series of patients with fracture of the tibia who were treated by nailing. They found a 35.4% incidence of OA despite the absence of radiographic malalignment. The incidence of knee OA was 16.1%, ankle OA also 16.1%  and 3.2% of the patients had both knee and ankle OA despite the absence of malunion.

Treatment of tibia malunion

The precise definition of a malunion remains elusive and the limits of deformity which can lead to OA also remains imprecise. A tibial malunion, however, can result in angular, rotational and or transitional deformity as well as shortening or lengthening of the bone. When the deformity and or limb length inequality should be corrected remains unresolved. Generally it is believed that surgical intervention is necessary when there is functional (limp, pain) and or cosmetic disability (mark deformity) [22]. Pain at the knee and ankle due to the malunion is relatively uncommon [23].
Though tibial malunion is quite common, treatment of malunion is not often described and the patient numbers are small in the published reports [23].
There remains little agreement in literature as to the degree of limb length inequality that is clinically significant. Most authors agree that the current indication for lengthening of the lower limb would be a disparity exceeding 5 to 6 cm [24]. Usually limb length inequality of 2 cm or less does not require any treatment because such discrepancies are well tolerate [25]. Limb length inequality of between 2 cm and 5 cm is usually treated with a shoe raise.
Correction of length can be carried out by compression osteotomy for shortening of bone and a distraction osteotomy for lengthening the bone. Large length discrepancies can be corrected by gradual distraction, following a metaphyseal corticotomy, using external fixators. The gradual distraction can also correct angular, rotational and translational deformities.
Angular and rotational deformities are corrected with an osteotomy at the level of the deformity followed by internal or external fixation. Several techniques for correction of tibial malunion have been described which can  achieve excellent results but surgery can be associated substantial risk and recovery time. These risks should be discussed at length with patients when planning such surgery [22].

References

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2. Howell SM, Kuznik K, Hull ML, Siston RA. Longitudinal shapes of the tibia and femur are unrelated and variable. Clin Orthop Relat Res. 2010 Apr;468(4):1142-8.
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7. Freedman E, Johnson EE. Radiographic analysis of tibia fracture malalignment following intramedullary nailing. Clin Orthop 1995; 315:25-33.
8. Bedi A, Le TT, Karunakar MA. Surgical treatment of nonarticular distal tibia fractures. J Am Acad Orthop Surg 2006;14:406-16.
9. Vallier HA, Le TT, Bedi A. Radiographic and clinical comparisons of distal tibia shaft fractures (4 to 11 cm proximal to the plafond): plating versus intramedullary nailing. J Orthop Trauma 2008;22:307-311.
10. Abdel-Salam A, Eyres KS, Cleary J. Internal fixation of closed tibial fractures for the management of sports injuries. Br J Sports Med 1991;25:213-7.
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12. Wiss DA, Stetson WB. Unstable fractures of the tibia treated with a reamed intramedullary interlocking nail. Clin Orthop 1995;315:56-63.
13. Gregory P, Sanders R. The treatment of closed, unstable tibial shaft fractures with unreamed interlocking nails. Clin Orthop 1995; 315:48-55.
14. Nicoll EA. Fractures of the tibial shaft. A survey of 705 cases. J Bone Joint Surg Br. 1964;46:373-87.
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16. Wu DD, Burr DB, Boyd RD, Radin EL. Bone and cartilage changes following experimental varus or valgus tibial angulation. J Orthop Res. 1990; 8:572-85.
17. Merchant TC, Dietz FR. Long-term follow-up after fractures of the tibial and fibular shafts. J Bone Joint Surg Am. 1989;71:599-606.
18. Kristensen KD, Kiaer T, Blicher J. No arthrosis of the ankle 20 years after malaligned tibial-shaft fracture. Acta Orthop Scand. 1989;60:208-9.
19. van der Schoot DK, Den Outer AJ, Bode PJ, Obermann WR, van Vugt AB. Degenerative changes at the knee and ankle related to malunion of tibial fractures. 15-year follow-up of 88 patients. J Bone Joint Surg Br. 1996;78:722-5.
20. Milner SA1, Davis TR, Muir KR, Greenwood DC, Doherty M. Long-term outcome after tibial shaft fracture: is malunion important?  J Bone Joint Surg Am. 2002 Jun;84-A(6):971-80.
21. Lefaivre KA, Guy P, Chan H, Blachut PA. Long-term follow-up of tibial shaft fractures treated with intramedullary nailing. J Orthop Trauma. 2008 Sep;22(8):525-9.
22. Mechrefe AP, Koh EY, Trafton PG, DiGiovanni CW. Tibial malunion. Foot Ankle Clin. 2006 Mar;11(1):19-33, vii.
23. Wu, C. C.; Chen, W. J.; Shih, C. H. Tibial shaft malunion treated with reamed intramedullary nailing: a revised technique. Arch Orthop Trauma Surg. 2000; 120: 152-156.
24. Stanitski DF. Limb-length inequality: assessment and treatment options. J Am Acad Orthop Surg. 1999 May-Jun;7(3):143-53.
25. Gross RH. Leg length discrepancy: how much is too much? Orthopedics.  1978;1(4):307-10.