Weight-bearing Recommendation After Replacement of the Hip or Knee Joint

Study Overview
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Brief Summary
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Despite the widespread use of total hip and knee arthroplasty, there is a notable lack of consensus regarding postoperative treatment, mostly because of the lack of well-designed studies testing the efficacy and effectiveness of such practices. In particular, there are no evidence-based recommendations on the amount of weight that the patient should be advised to bear on the operated leg after the operation.

Official Title
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A Randomized Trial of Weight-bearing Recommendations After Total Hip or Total Knee Arthroplasty

Conditions
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Osteoarthritis

Intervention / Treatment
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* Behavioral: Recommend full weight-bearing
* Behavioral: Recommend parital weight-bearing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient who is about to receive unilateral hip or knee replacement surgery on an elective basis for diagnosis of osteoarthritis or femoral head necrosis Exclusion Criteria: A history of septic arthritis, Hip fracture, Intraoperative complications, History of implant surgery on the joint to be operated on, Rheumatoid arthritis, Amputations, Inability to complete the questionnaires because of cognitive or language difficulties.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: weight-bearing recommendation<br>Weight-bearing recommendation after THA and TKA | Behavioral: Recommend full weight-bearing<br>* The full weight-bearing group is trained in 4-point gait with crutches and is recommended to put as much weight as tolerated on the leg on which surgery has been performed, immediately after surgery<br>Behavioral: Recommend parital weight-bearing<br>* The partial weight-bearing group is trained in 3-point gait with crutches and is instructed to limit weight-bearing of the affected leg to 20kg for a period of six-weeks. Scales are used to train these participants not to exceed 20kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function, measured by means of the Western Ontario and McMaster universities (WOMAC) osteoarthritis index |  | Baseline, 3, 6, 12 and 24-months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg specific stiffness and pain, both measured by the WOMAC. |  | Baseline, 3, 6, 12 and 24-months after surgery | 
| Physical component summary of the SF-36 |  | Baseline, 3, 6, 12 and 24-months after surgery | 
| Lequesne Hip resp. Knee Score |  | Baseline, 3, 6, 12 and 24-months after surgery | 
| Patient satisfaction |  | Baseline, 3, 6, 12 and 24-months after surgery | 
| Quality-Adjusted Life Years |  | Baseline, 3, 6, 12 and 24-months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Hip Arthroplasty, THA, Total Knee Arthroplasty, TKA, Total Hip Replacement, THR, Total Knee Replacement, TKR