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

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ClinicalTrials.gov Identifier: NCT00266396
Recruitment Status : Completed
First Posted : December 16, 2005
Last Update Posted : April 6, 2016
Sponsor:
Collaborators:
Verein zur Förderung der Erforschung und Bekämpfung rheumatischer Erkrankungen Bad Bramstedt e.V
Landesversicherungsanstalt Schleswig-Holstein
Landesversicherungsanstalt Freie und Hansestadt Hamburg
Deutsche Arthrose-Hilfe
Information provided by (Responsible Party):
Thoralf R Liebs, University of Schleswig-Holstein

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Behavioral: Recommend full weight-bearing Behavioral: Recommend parital weight-bearing Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial of Weight-bearing Recommendations After Total Hip or Total Knee Arthroplasty
Study Start Date : January 2002
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: weight-bearing recommendation
Weight-bearing recommendation after THA and TKA
Behavioral: Recommend 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
Behavioral: Recommend 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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Deutsche Arthrose-Hilfe
Investigators
Principal Investigator: Thoralf R Liebs, MD University of Schleswig-Holstein Medical Center, Kiel Campus

Responsible Party: Thoralf R Liebs, Consultant Orthopaedic Surgeon, University of Schleswig-Holstein
ClinicalTrials.gov Identifier: NCT00266396     History of Changes
Other Study ID Numbers: vffr-35
First Posted: December 16, 2005    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Thoralf R Liebs, University of 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