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

Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein4 sites in 1 country352 target enrollmentJanuary 2002

ConditionsOsteoarthritis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein
Enrollment: 352
Locations: 4
Primary Endpoint: Physical function, measured by means of the Western Ontario and McMaster universities (WOMAC) osteoarthritis index
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2002

End Date

January 2007

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein

Responsible Party

Principal Investigator

Thoralf R Liebs

Consultant Orthopaedic Surgeon

University Hospital Schleswig-Holstein

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Physical function, measured by means of the Western Ontario and McMaster universities (WOMAC) osteoarthritis index

Time Frame: Baseline, 3, 6, 12 and 24-months after surgery

Secondary Outcomes

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)