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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Verein zur Förderung der Erforschung und Bekämpfung rheumatischer Erkrankungen Bad Bramstedt e. V.
Landesversicherungsanstalt Schleswig-Holstein
Landesversicherungsanstalt Freie und Hansestadt Hamburg
Information provided by:
Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00266396
First received: December 15, 2005
Last updated: NA
Last verified: December 2004
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
 Behavioral: Weight-bearing recommendation
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial of Weight-Bearing Recommendations After Total Hip or Total Knee Arthroplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein:

Primary Outcome Measures:
  • Physical function, measured by means of the Western Ontario and McMaster universities (WOMAC) osteoarthritis index

Secondary Outcome Measures:
  • Leg specific stiffness and pain, both measured by the WOMAC.
  • Physical component summary of the SF­36
  • Lequesne Hip resp. Knee Score

Estimated Enrollment: 352
Study Start Date: January 2002
Estimated Study Completion Date: August 2004
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266396

Locations
Germany
Ostseeklinik Damp, Department I of Orthopedic Surgery
Damp, Germany, 24351
University of Schleswig-Holstein Medical Center, Kiel Campus
Kiel, Germany, 24105
University of Schleswig-Holstein Medical Center, Lübeck Campus
Lübeck, Germany, 23538
Wedel Hospital, Department of Surgery
Wedel, Germany, 22880
Sponsors and Collaborators
Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein
Verein zur Förderung der Erforschung und Bekämpfung rheumatischer Erkrankungen Bad Bramstedt e. V.
Landesversicherungsanstalt Schleswig-Holstein
Landesversicherungsanstalt Freie und Hansestadt Hamburg
Investigators
Principal Investigator: Thoralf R Liebs, MD University of Schleswig-Holstein Medical Center, Kiel Campus
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00266396     History of Changes
Other Study ID Numbers: vffr-35
Study First Received: December 15, 2005
Last Updated: December 15, 2005
Health Authority: Germany: Ethics Commission

Keywords provided by Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein:
Total Hip Arthroplasty
THA
Total Knee Arthroplasty
TKA
 Total Hip Replacement
THR
Total Knee Replacement
TKR

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 13, 2013