Clinical trial NCT00266396: Weight-bearing Recommendation After Replacement of the Hip or Knee Joint
Official title: A Randomized Trial of Weight-bearing Recommendations After Total Hip or Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Osteoarthritis
Keywords: Total Hip Arthroplasty
THA
Total Knee Arthroplasty
TKA
Total Hip Replacement
THR
Total Knee Replacement
TKR
Lead sponsor: Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein
Sponsor class: OTHER
Collaborators: name: Verein zur Förderung der Erforschung und Bekämpfung rheumatischer Erkrankungen Bad Bramstedt e.V
name: Landesversicherungsanstalt Schleswig-Holstein
name: Landesversicherungsanstalt Freie und Hansestadt Hamburg
name: Deutsche Arthrose-Hilfe
First posted: 2005-12-16
Enrollment: 352
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Physical function, measured by means of the Western Ontario and McMaster universities (WOMAC) osteoarthritis index
timeFrame: Baseline, 3, 6, 12 and 24-months after surgery
Secondary outcomes:
measure: Leg specific stiffness and pain, both measured by the WOMAC.
timeFrame: Baseline, 3, 6, 12 and 24-months after surgery
measure: Physical component summary of the SF-36
timeFrame: Baseline, 3, 6, 12 and 24-months after surgery
measure: Lequesne Hip resp. Knee Score
timeFrame: Baseline, 3, 6, 12 and 24-months after surgery
measure: Patient satisfaction
timeFrame: Baseline, 3, 6, 12 and 24-months after surgery
measure: Quality-Adjusted Life Years
timeFrame: Baseline, 3, 6, 12 and 24-months after surgery
Other outcomes:
Locations:
city: Damp
country: Germany
facility: Ostseeklinik Damp, Department I of Orthopedic Surgery
city: Kiel
country: Germany
facility: University of Schleswig-Holstein Medical Center, Kiel Campus
city: Lübeck
country: Germany
facility: University of Schleswig-Holstein Medical Center, Lübeck Campus
city: Wedel
country: Germany
facility: Wedel Hospital, Department of Surgery
Study officials:
affiliation: University of Schleswig-Holstein Medical Center, Kiel Campus
name: Thoralf R Liebs, MD
role: PRINCIPAL_INVESTIGATOR
References: