Skip to main content
OpenTrials
Completed

NCT Number: NCT00266396

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ostseeklinik Damp, Department I of Orthopedic Surgery, Damp, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Recommend full weight-bearing

Behavioral

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

Recommend parital weight-bearing

Behavioral

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

Primary outcomes

  1. 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

  1. Leg specific stiffness and pain, both measured by the WOMAC.

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

  2. Physical component summary of the SF-36

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

  3. Lequesne Hip resp. Knee Score

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

  4. Patient satisfaction

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

  5. Quality-Adjusted Life Years

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

Sponsors and collaborators

Lead sponsor

Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein

Other

Collaborators

  • Deutsche Arthrose-Hilfe
  • Landesversicherungsanstalt Freie und Hansestadt Hamburg
  • Landesversicherungsanstalt Schleswig-Holstein
  • Verein zur Förderung der Erforschung und Bekämpfung rheumatischer Erkrankungen Bad Bramstedt e.V

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2007
Study completion
2007
First posted
Dec 16, 2005
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.