Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatment weight-bearing recommendation
Phase phase 1/phase 2
Sponsor Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein
Collaborator Verein zur Förderung der Erforschung und Bekämpfung rheumatischer Erkrankungen Bad Bramstedt e. V.
Start date January 2002
End date August 2004
Trial size 352 participants
Trial identifier NCT00266396, vffr-35

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

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

Secondary Outcomes

Measure
Leg specific stiffness and pain, both measured by the WOMAC.
time frame:
Physical component summary of the SF­36
time frame:
Lequesne Hip resp. Knee Score
time frame:

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title A Randomized Trial of Weight-Bearing Recommendations After Total Hip or Total Knee Arthroplasty
Principal investigator Thoralf R Liebs, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2005.
Information provided to ClinicalTrials.gov by Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein.