Originally published September 2015
The number of hip and knee arthroplasties performed in Canada has increased in the last five years, but the demand for these interventions is increasing even faster. This situation is making it hard for provinces to reach established wait time benchmarks.1,2
Hip and knee arthroplasties are also two of the top interventions involved in CMPA orthopaedic cases. The procedures can greatly improve quality of life, yet they may also carry significant clinical risks for patients.
In a five-year review of medical-legal cases involving elective hip or knee arthroplasty, the outcomes were generally favourable for the member. The experts in the cases were supportive of physicians’ care when:
- informed consent was obtained and the consent discussion was adequately documented
- an acceptable standard was met while performing the intervention but also when appropriate post-operative follow-up care was arranged
- a complication was addressed appropriately, including transfer or referral, if indicated
The patients in this series post-operatively experienced either a temporary or permanent impairment that often left them with considerable loss of function, such as foot drop, leg length discrepancy, or persistent pain. More serious complications included infection, deep vein thrombosis (DVT), pulmonary embolism, stroke, or sepsis. Seven per cent of patients died. Obesity was the most common patient co-morbidity and was frequently observed in patients who experienced surgical complications. Cardiovascular disease and diabetes may also have affected clinical outcomes.
In cases where peer experts were critical of the care, three-quarters were related to an intra-operative event.
The main pre-operative issue in the CMPA cases was a lack of informed consent. The deficiency was usually due to an inadequate discussion and documentation of the proposed procedure, the potential for complications and risks, and the reasonable availability of treatment alternatives. Patients often alleged that they were not advised of the possibility of poor outcomes and of the potential complications associated with the surgery, such as vascular injury and persistent pain.
In one regulatory authority (College) case, a patient was left with a 2 centimetre leg length discrepancy after a hip arthroplasty, and complained about a lack of informed consent. Although the College supported the surgical care, it counselled the surgeon on the importance of discussing and documenting this known risk with the patient before surgery.
In the cases with intra-operative issues, deficient clinical judgment or technical skill, or lack of experience was often a factor. The most common concern was with technical skills including the incorrect choice or size of prosthesis and implant malposition. In a few cases, intra-operative imaging could have led to proper or improved implant positioning. These issues were more common with hip arthroplasty, and revision surgery was sometimes necessary.
Other intra-operative problems concerned an injury to a nerve (e.g. sciatic, popliteal) during the hip or knee surgery, or injury to the popliteal artery during the knee surgery. These injuries were sometimes due to inadequate protection of surrounding anatomical structures in the surgical field.
In a few cases, the femur was fractured during surgery. Most of the time, however, experts considered this to be an inherent risk of the procedure.
Lastly, non-adherence to surgical safety protocols was responsible for the few wrong-sided surgeries in this series of cases.
In the post-operative period (both early and late), the timely recognition and treatment of complications was a major issue in the cases reviewed. Some of the diagnostic delays were attributed to a surgeon’s failure to do the following: adequately re-assess a patient, consider other causes for persistent or new symptoms, order further investigations, or follow up on test results. In some cases, other healthcare providers were also found to have contributed to the delays, including residents or nurses who did not communicate changes in patients’ conditions to the surgeon. In a few cases, inadequate office systems made it difficult for discharged patients to contact the surgeon with their questions or concerns.
Infection was more common following hip arthroplasty, while ongoing pain was more frequent with knee arthroplasty. Some patients required additional surgeries (e.g. revision) due to implant malposition, infection, intra-operative fractures, or implant dislocation; others required longer rehabilitation times.
Case example: A patient is left with ongoing knee pain, despite appropriate care
A 50-year-old man with severe osteoarthritis of the left knee undergoes an uneventful knee arthroplasty. After surgery, the patient has a great deal of pain that proves difficult to manage. He also does not comply well with physiotherapy because of the pain. When the patient’s knee pain and stiffness persist, the surgeon performs a left knee manipulation under anaesthesia to increase range of motion, which is repeated three weeks later. Following the second manipulation, the patient obtains 95° of flexion and some pain relief. The patient requires narcotic analgesia for a short time afterwards and his flexion subsequently increases to 110°. The patient does not return for follow-up appointments and complains to the College alleging failure to properly perform the surgery.
The College finds no fault with the surgeon’s care. There was clear indication for the arthroplasty, and the orthopaedic surgeon obtained a second opinion that concurred with the indication for surgery. The consent discussion was well documented and included the potential risks and benefits of the surgery, particularly the risks associated with his age and weight as well as those of DVT, mechanical failure, and infection. The post-operative X-rays showed the prosthesis to be in good position with no sign of loosening, and there was no documentation of any major complications from the surgery.
Risk management considerations
Based on a review of the expert opinions in the medical-legal cases involving hip or knee arthroplasty, the following risk management considerations have been identified:
- Consider any relevant risk factors, including co-morbidities, that could have an impact on the patient’s surgery and recovery, and consider further specialist consultation if indicated.
- The consent discussion should provide appropriate information on the risks and benefits of the proposed surgery, the alternative options, the expected outcomes, and how a patient’s pre-existing conditions could increase the risk of complications. The patient (and family or caregiver, if appropriate) should be given the opportunity to ask questions. The discussion should be adequately documented in the medical record.
- Generally, a surgical safety checklist should be completed for procedures and should include:
- a review of the patient’s medical record for relevant risk factors or considerations
- confirmation of having obtained and documented the patient’s informed consent
- verification of the patient’s identity, the planned procedure, and the operative site
- confirmation that the correct operative site and side have been marked; for example, use an “operate through your initials” approach3
- confirmation that pre-operative antibiotics were administered and venous thromboembolism prophylaxis was instituted, as appropriate
- Exercise care to protect vital structures such as nerves and vasculature, and document, when appropriate, any efforts to visualize or protect these structures.
- Document the operative report in a timely manner and include information on:
- the technique and prosthesis
- anatomical findings and variants
- difficulties encountered in the procedure
- Clarify the roles and responsibilities with respect to communication between all the healthcare team members caring for the patient.
- Incorporate clinical care pathways, clinical practice guidelines, and decision tools, as appropriate.
- Give patients or caregivers clear written or verbal pre- and post-operative instructions. The instructions should include the steps and special precautions that patients should take after the procedure, the symptoms and signs that should alert them to seek further medical attention, and when and who they should consult if they experience complications. Any verbal instructions should be recorded in patients’ medical records, and any written instructions should be added to the records with a notation of the date they were provided.
- Canadian Institute for Health Information. Hip and Knee Replacements in Canada: Canadian Joint Replacement Registry 2014 Annual Report. Accessed May 28, 2015 from: https://secure.cihi.ca/free_products/CJRR%202014%20Annual%20Report_EN-web.pdf
- Canadian Institute for Health Information. Wait Times for Priority Procedures in Canada 2014. Accessed on May 4, 2015 from: https://secure.cihi.ca/free_products/2014_WaitTimesAiB_EN.pdf
- Canadian Orthopaedic Association, "COA Position statement for a surgical safety checklist," 2008. Accessed May 12, 2015 from: http://www.coa-aco.org/library/health-policy/guidelines-to-reduce-the-incidence-of-wrong-level-spinal-surgery.html