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Ergometer Cycling After Replacement of the Hip or Knee Joint

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00951990
First Posted: August 4, 2009
Last Update Posted: April 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Controlled Trail of Ergometer Cycling After Hip and Knee Replacement Surgery

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 ]

Secondary Outcome Measures:
  • WOMAC Pain and Stiffness [ Time Frame: 3 months to 24 months ]
  • SF-36 [ Time Frame: 3 months to 24 months ]
  • Patient satisfaction [ Time Frame: 3 months to 24 months ]
  • Lequesne Hip or Knee Score [ Time Frame: 3 months to 24 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (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 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
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): 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:
Liebs TR, Herzberg W, Rüther W, Haasters J, Russlies M, Hassenpflug J. Ergometer cycling after hip or knee replacement surgery: a randomized controlled trial. J Bone Joint Surg Am. 2010 Apr;92(4):814-22. doi: 10.2106/JBJS.H.01359.
Liebs TR, Herzberg W, Rüther W, Russlies M, Hassenpflug J; Multicenter Arthroplasty Aftercare Project, MAAP. Quality-Adjusted Life Years Gained by Hip and Knee Replacement Surgery and Its Aftercare. Arch Phys Med Rehabil. 2016 May;97(5):691-700. doi: 10.1016/j.apmr.2015.12.021. Epub 2016 Jan 11.
Liebs TR, Nasser L, Herzberg W, Rüther W, Hassenpflug J. The influence of femoral offset on health-related quality of life after total hip replacement. Bone Joint J. 2014 Jan;96-B(1):36-42. doi: 10.1302/0301-620X.96B1.31530.
Liebs TR, Herzberg W, Gluth J, Rüther W, Haasters J, Russlies M, Hassenpflug J. Using the patient's perspective to develop function short forms specific to total hip and knee replacement based on WOMAC function items. Bone Joint J. 2013 Feb;95-B(2):239-43. doi: 10.1302/0301-620X.95B2.28383.
Liebs TR, Herzberg W, Roth-Kroeger AM, Rüther W, Hassenpflug J. Women recover faster than men after standard knee arthroplasty. Clin Orthop Relat Res. 2011 Oct;469(10):2855-65. doi: 10.1007/s11999-011-1921-z. Epub 2011 Jun 23.
Liebs TR, Kloos SA, Herzberg W, Rüther W, Hassenpflug J. The significance of an asymmetric extension gap on routine radiographs after total knee replacement: A new sign and its clinical significance. Bone Joint J. 2013 Apr;95-B(4):472-7. doi: 10.1302/0301-620X.95B4.31080.

Responsible Party: Thoralf R Liebs, University of Schleswig-Holstein Medical Center
ClinicalTrials.gov Identifier: NCT00951990     History of Changes
Other Study ID Numbers: vffr-37
First Submitted: August 2, 2009
First Posted: August 4, 2009
Last Update Posted: April 6, 2016
Last Verified: April 2016

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


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