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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

Tracking Information
First Submitted Date  ICMJE December 15, 2005
First Posted Date  ICMJE December 16, 2005
Last Update Posted Date April 6, 2016
Study Start Date  ICMJE January 2002
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2005)
Physical function, measured by means of the Western Ontario and McMaster universities (WOMAC) osteoarthritis index
Change History Complete list of historical versions of study NCT00266396 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
  • Leg specific stiffness and pain, both measured by the WOMAC. [ Time Frame: Baseline, 3, 6, 12 and 24-months after surgery ]
  • Physical component summary of the SF-36 [ Time Frame: Baseline, 3, 6, 12 and 24-months after surgery ]
  • Lequesne Hip resp. Knee Score [ Time Frame: Baseline, 3, 6, 12 and 24-months after surgery ]
  • Patient satisfaction [ Time Frame: Baseline, 3, 6, 12 and 24-months after surgery ]
  • Quality-Adjusted Life Years [ Time Frame: Baseline, 3, 6, 12 and 24-months after surgery ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2005)
  • Leg specific stiffness and pain, both measured by the WOMAC.
  • Physical component summary of the SF-36
  • Lequesne Hip resp. Knee Score
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Weight-bearing Recommendation After Replacement of the Hip or Knee Joint
Official Title  ICMJE A Randomized Trial of Weight-bearing Recommendations After Total Hip or Total Knee Arthroplasty
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • 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
Study Arms Experimental: weight-bearing recommendation
Weight-bearing recommendation after THA and TKA
Interventions:
  • Behavioral: Recommend full weight-bearing
  • Behavioral: Recommend parital weight-bearing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: December 15, 2005)
352
Original Enrollment  ICMJE Same as current
Actual Study Completion Date January 2007
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00266396
Other Study ID Numbers  ICMJE vffr-35
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Thoralf R Liebs, University of Schleswig-Holstein
Study Sponsor  ICMJE Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Thoralf R Liebs, MD University of Schleswig-Holstein Medical Center, Kiel Campus
PRS Account Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP