Staged Versus Simultaneous Bilateral Knee Arthroplasty

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Control Trial of Staged Versus Simultaneous Bilateral Total Knee Arthroplasty

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Simultaneous Knee Arthroplasty (UKA)
* Procedure: Staged Knee Arthroplasty (UKA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized to either simultaneous or staged bilateral KA procedures using randomly generated numbers permuted in blocks of 10.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total Knee Arthroplasty (TKA)<br>Patient will have complete replacement - Simultaneous vs Staged | Procedure: Simultaneous Knee Arthroplasty (UKA)<br>* Patient will have both knees completed under one anesthetic.<br>Procedure: Staged Knee Arthroplasty (UKA)<br>* Patient will have knees completed under 2 anesthetics.<br>|
| Active Comparator: Unicompartmental Knee Arthroplasty (UKA)<br>Patient will have half-knee replacement (partial) - Simultaneous vs Staged | Procedure: Simultaneous Knee Arthroplasty (UKA)<br>* Patient will have both knees completed under one anesthetic.<br>Procedure: Staged Knee Arthroplasty (UKA)<br>* Patient will have knees completed under 2 anesthetics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Veterans Rand 12-item Health Survey Score (VR-12) | 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. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Joint function (Oxford-12 knee score) | 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. | Pre-operative, 6 months, 12 months, 18 months, 24 months | 
| Return to work | Assessment of ability to return to work and time away from work following surgery. | Pre-operative, 6 months, 12 months, 18 months, 24 months | 
| Patient satisfaction | Evaluate change in patient-reported satisfaction using a Likaert scale; 1=Very Satisfied to 5=Very Unsatisfied. | 6 months, 12 months, 18 months, 24 months | 
| Complications | Evaluation type and frequency of complication (adverse events). | Intraoperative, 6 months, 12 months, 18 months, 24 months | 
| Hospital stay | Number of days in hospital | Up to 1 week | 
| Transfusion rate | Number of unit transfused during hospital stay. | Up to 1 week | 
| Costs of knee replacement surgery | 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. | Up to 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bilateral, staged, simultaneous