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

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00266396
Enrollment
352
Registered
2005-12-16
Start date
2002-01-31
Completion date
2007-01-31
Last updated
2016-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Total Hip Arthroplasty, THA, Total Knee Arthroplasty, TKA, Total Hip Replacement, THR, Total Knee Replacement, TKR

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.

Interventions

BEHAVIORALRecommend full weight-bearing

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

BEHAVIORALRecommend parital weight-bearing

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

Sponsors

Verein zur Förderung der Erforschung und Bekämpfung rheumatischer Erkrankungen Bad Bramstedt e.V
CollaboratorOTHER
Landesversicherungsanstalt Schleswig-Holstein
CollaboratorUNKNOWN
Landesversicherungsanstalt Freie und Hansestadt Hamburg
CollaboratorUNKNOWN
Deutsche Arthrose-Hilfe
CollaboratorOTHER
Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Physical function, measured by means of the Western Ontario and McMaster universities (WOMAC) osteoarthritis indexBaseline, 3, 6, 12 and 24-months after surgery

Secondary

MeasureTime 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-36Baseline, 3, 6, 12 and 24-months after surgery
Lequesne Hip resp. Knee ScoreBaseline, 3, 6, 12 and 24-months after surgery
Patient satisfactionBaseline, 3, 6, 12 and 24-months after surgery
Quality-Adjusted Life YearsBaseline, 3, 6, 12 and 24-months after surgery

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026