Ergometer Cycling After Replacement of the Hip or Knee Joint

April 4, 2016 updated by: Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein

A Multicenter Randomized Controlled Trail of Ergometer Cycling After Hip and Knee Replacement Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

457

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Bramstedt, Germany, 24576
        • Rheumaklinik Bad Bramstedt, Department of Orthopedic Surgery
      • Damp, Germany, 24351
        • Ostseeklinik Damp, Department I of Orthopedic Surgery
      • Kiel, Germany, 24105
        • University of Schleswig-Holstein Medical Center, Department of Orthopedic Surgery
      • Lübeck, Germany, 23538
        • University of Schleswig-Holstein Medical Center, Lübeck Campus
      • Wedel, Germany, 22880
        • Wedel Hospital, Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
WOMAC Physical Function
Time Frame: 3 months to 24 months
3 months to 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
WOMAC Pain and Stiffness
Time Frame: 3 months to 24 months
3 months to 24 months
SF-36
Time Frame: 3 months to 24 months
3 months to 24 months
Patient satisfaction
Time Frame: 3 months to 24 months
3 months to 24 months
Lequesne Hip or Knee Score
Time Frame: 3 months to 24 months
3 months to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein

Collaborators

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

Investigators

  • Study Chair: Joachim Hassenpflug, PhD, University of Schleswig-Holstein Medical Center, Department of Orthopedic Surgery, Kiel Campus, 24105 Kiel, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

August 2, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (Estimate)

August 4, 2009

Study Record Updates

Last Update Posted (Estimate)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • vffr-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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