Ergometer Cycling After Replacement of the Hip or Knee Joint

Phase 1

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT00951990
• Lead Sponsor: Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2006-04
• Study Completion: 2008-08
• Study First Submitted: 2009-08-02
• Study First Submitted QC: 2009-08-03
• Study First Posted: 2009-08-04
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 457

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
WOMAC Physical Function	3 months to 24 months

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	3 months to 24 months
WOMAC Pain and Stiffness	3 months to 24 months
SF-36	3 months to 24 months
Lequesne Hip or Knee Score	3 months to 24 months

Trial Locations

Locations (5)

Rheumaklinik Bad Bramstedt, Department of Orthopedic Surgery; 🇩🇪 Bad Bramstedt, Germany

Ostseeklinik Damp, Department I of Orthopedic Surgery; 🇩🇪 Damp, Germany

University of Schleswig-Holstein Medical Center, Department of Orthopedic Surgery; 🇩🇪 Kiel, Germany

University of Schleswig-Holstein Medical Center, Lübeck Campus; 🇩🇪 Lübeck, Germany

Wedel Hospital, Department of Surgery; 🇩🇪 Wedel, Germany