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Ergometer Cycling After Replacement of the Hip or Knee Joint

This study has been completed.
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 (German Arthrosis Society)
Information provided by:
Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT00951990
First received: August 2, 2009
Last updated: April 6, 2010
Last verified: April 2010
  Purpose

Despite the widespread use of hip and knee replacement surgery, there is a considerable lack of consensus regarding postoperative treatment and rehabilitation, mostly because of the lack of well-designed studies testing the efficacy and effectiveness of such practices.

In particular there are no recommendations regarding the use of ergometer cycling after hip or knee replacement surgery.

Therefore the investigators initiated a multicenter controlled clinical trial evaluating the effect of ergometer cycling versus no ergometer cycling after hip or knee replacement surgery.


Condition Intervention Phase
Osteoarthritis
Behavioral: Ergometer Cycling
Behavioral: No ergometer cycling
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 Multicenter Randomized Controlled Trail of Ergometer Cycling After Hip and Knee Replacement Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • WOMAC Physical Function [ Time Frame: 3 months to 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC Pain and Stiffness [ Time Frame: 3 months to 24 months ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: 3 months to 24 months ] [ Designated as safety issue: No ]
  • Patient satisfaction [ Time Frame: 3 months to 24 months ] [ Designated as safety issue: No ]
  • Lequesne Hip or Knee Score [ Time Frame: 3 months to 24 months ] [ Designated as safety issue: No ]

Enrollment: 457
Study Start Date: January 2005
Study Completion Date: August 2008
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Ergometer Cycling
    Ergometer Cycling under the guidance of a physical therapist after the second postoperative week. These training sessions were scheduled to be performed three times a week for a time period of at least three weeks. The resistance of the ergometer was set to a minimum (for example 30 Watts). Physical therapists were informed to pay special attention, that the height of the saddle is set so that the forefoot reaches the pedal with the knee in extension.
    Behavioral: No ergometer cycling
    Patients of the no ergometer cycling group did not receive any ergometer cycling after surgery
  Eligibility

Ages Eligible for Study:   18 Years and older
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 of 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 of complete the questionnaires because of cognitive or language difficulties
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951990

Locations
Germany
Rheumaklinik Bad Bramstedt, Department of Orthopedic Surgery
Bad Bramstedt, Germany, 24576
Ostseeklinik Damp, Department I of Orthopedic Surgery
Damp, Germany, 24351
University of Schleswig-Holstein Medical Center, Department of Orthopedic Surgery
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 (German Arthrosis Society)
Investigators
Study Chair: Joachim Hassenpflug, PhD University of Schleswig-Holstein Medical Center, Department of Orthopedic Surgery, Kiel Campus, 24105 Kiel, Germany
  More Information

Publications:
Responsible Party: Thoralf R Liebs, University of Schleswig-Holstein Medical Center
ClinicalTrials.gov Identifier: NCT00951990     History of Changes
Other Study ID Numbers: vffr-37
Study First Received: August 2, 2009
Last Updated: April 6, 2010
Health Authority: Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on November 27, 2014