Weight-bearing Recommendation After Replacement of the Hip or Knee Joint
Phase 1
Completed
- Conditions
- Osteoarthritis
- Registration Number
- NCT00266396
- Lead Sponsor
- Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 352
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method Quality-Adjusted Life Years 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 Leg specific stiffness and pain, both measured by the WOMAC. Baseline, 3, 6, 12 and 24-months after surgery
Trial Locations
- Locations (4)
Ostseeklinik Damp, Department I of Orthopedic Surgery
🇩🇪Damp, Germany
University of Schleswig-Holstein Medical Center, Kiel Campus
🇩🇪Kiel, Germany
University of Schleswig-Holstein Medical Center, Lübeck Campus
🇩🇪Lübeck, Germany
Wedel Hospital, Department of Surgery
🇩🇪Wedel, Germany
Ostseeklinik Damp, Department I of Orthopedic Surgery🇩🇪Damp, Germany