Staged Versus Simultaneous Bilateral Knee Arthroplasty
Study Details
Study Description
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?"
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Total Knee Arthroplasty (TKA) Patient will have complete replacement - Simultaneous vs Staged |
Procedure: Simultaneous Knee Arthroplasty (UKA)
Patient will have both knees completed under one anesthetic.
Procedure: Staged Knee Arthroplasty (UKA)
Patient will have knees completed under 2 anesthetics.
|
| Active Comparator: Unicompartmental Knee Arthroplasty (UKA) Patient will have half-knee replacement (partial) - Simultaneous vs Staged |
Procedure: Simultaneous Knee Arthroplasty (UKA)
Patient will have both knees completed under one anesthetic.
Procedure: Staged Knee Arthroplasty (UKA)
Patient will have knees completed under 2 anesthetics.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
- 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.
- Complications [Intraoperative, 6 months, 12 months, 18 months, 24 months]
Evaluation type and frequency of complication (adverse events).
- Hospital stay [Up to 1 week]
Number of days in hospital
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Calgary | Calgary | Alberta | Canada | T2P 3C5 |
| 2 | Concordia Hospital | Winnipeg | Manitoba | Canada | R2K 3S8 |
| 3 | St. Joseph's - McMaster University | Hamilton | Ontario | Canada | L8N 4A6 |
| 4 | London Health Sciences Centre | London | Ontario | Canada | N6A 5W9 |
| 5 | Ottawa Hospital Research Institute | Ottawa | Ontario | Canada | K1H 8L6 |
| 6 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
| 7 | McGill University | Montréal | Quebec | Canada | H3A 0G4 |
Sponsors and Collaborators
- Orthopaedic Innovation Centre
Investigators
- Principal Investigator: Eric R. Bohm, MD, University of Manitoba
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- B2017-046