Staged Versus Simultaneous Bilateral Knee Arthroplasty
- Conditions
- Knee Osteoarthritis
- Interventions
- Procedure: Simultaneous Knee Arthroplasty (UKA)Procedure: Staged Knee Arthroplasty (UKA)
- Registration Number
- NCT03564730
- Lead Sponsor
- Orthopaedic Innovation Centre
- Brief Summary
The purpose of this study is to assist surgeons and patients in answering the question "Should I have both knees replaced at the same time, or should I just do one and wait to do the second one?"
- Detailed Description
This is a multi-center randomized controlled trial of 224 patients in order to clearly delineate differences in post-operative outcomes and the trajectory of recovery between simultaneous and staged bilateral KA. The primary outcome measure is difference in generic health related quality of life between the two groups measured 1 year following surgery. Secondary outcome measures include differences in joint specific scores, time off work, satisfaction and costs.
This trial will inform patients and clinicians about differences in recovery, function and efficacy of the procedure to aid in the selection of treatment pathway to best suit the patient.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 224
- Patients considering bilateral knee arthroplasty
- Patients must sign the consent form
- Patients must be willing to complete the study questionnaires for the duration of the study
- Patients who require simultaneous bilateral knee replacement surgery in order to manage significant bilateral flexion or valgus knee contractures where staged procedures may result in suboptimal outcomes by increasing the risk of post-operative flexion contracture in the "first replaced" knee
- patients who are unable to complete the questionnaires
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Total Knee Arthroplasty (TKA) Simultaneous Knee Arthroplasty (UKA) Patient will have complete replacement - Simultaneous vs Staged Total Knee Arthroplasty (TKA) Staged Knee Arthroplasty (UKA) Patient will have complete replacement - Simultaneous vs Staged Unicompartmental Knee Arthroplasty (UKA) Simultaneous Knee Arthroplasty (UKA) Patient will have half-knee replacement (partial) - Simultaneous vs Staged Unicompartmental Knee Arthroplasty (UKA) Staged Knee Arthroplasty (UKA) Patient will have half-knee replacement (partial) - Simultaneous vs Staged
- Primary Outcome Measures
Name Time Method Veterans Rand 12-item Health Survey Score (VR-12) 1 Year The VR-12 is a 12-item questionnaire corresponding to eight principal physical and mental health domains including general health perceptions, physical functioning, role limitations due to physical and emotional problems, bodily pain, energy-fatigue, social functioning and mental health; patient-reported.
- Secondary Outcome Measures
Name Time Method Hospital stay Up to 1 week Number of days in hospital
Complications Intraoperative, 6 months, 12 months, 18 months, 24 months Evaluation type and frequency of complication (adverse events).
Joint function (Oxford-12 knee score) Pre-operative, 6 months, 12 months, 18 months, 24 months The Oxford Knee Score (OKS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option (0-4). A total of the 12 items will indicated the joint function; lower total score = poorer function.
Transfusion rate Up to 1 week Number of unit transfused during hospital stay.
Costs of knee replacement surgery Up to 1 week An attempt to calculate costs of surgery using length of stay data to calculate cost between Simultaneous vs Staged procedures. Length of stay will be calculated in days/hours.
Return to work Pre-operative, 6 months, 12 months, 18 months, 24 months Assessment of ability to return to work and time away from work following surgery.
Patient satisfaction 6 months, 12 months, 18 months, 24 months Evaluate change in patient-reported satisfaction using a Likaert scale; 1=Very Satisfied to 5=Very Unsatisfied.
Trial Locations
- Locations (8)
University of Calgary
🇨🇦Calgary, Alberta, Canada
St. Joseph's - McMaster University
🇨🇦Hamilton, Ontario, Canada
Kingston Health Sciences Center - KGH
🇨🇦Kingston, Ontario, Canada
Ottawa Hospital Research Institute
🇨🇦Ottawa, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
McGill University
🇨🇦Montréal, Quebec, Canada
Concordia Hospital
🇨🇦Winnipeg, Manitoba, Canada