Weight-bearing Recommendation After Replacement of the Hip or Knee Joint

NCT ID: NCT00266396

Last Updated: 2016-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2007-01-31

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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

weight-bearing recommendation

Weight-bearing recommendation after THA and TKA

Group Type: EXPERIMENTAL

Recommend full weight-bearing

Intervention Type: BEHAVIORAL

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

Recommend parital weight-bearing

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Verein zur Förderung der Erforschung und Bekämpfung rheumatischer Erkrankungen Bad Bramstedt e.V

OTHER

Sponsor Role: collaborator

Landesversicherungsanstalt Schleswig-Holstein

UNKNOWN

Sponsor Role: collaborator

Landesversicherungsanstalt Freie und Hansestadt Hamburg

UNKNOWN

Sponsor Role: collaborator

Deutsche Arthrose-Hilfe

OTHER

Sponsor Role: collaborator

Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Thoralf R Liebs

Consultant Orthopaedic Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thoralf R Liebs, MD

Role: PRINCIPAL_INVESTIGATOR

University of Schleswig-Holstein Medical Center, Kiel Campus

Locations

Ostseeklinik Damp, Department I of Orthopedic Surgery

Damp, , Germany

University of Schleswig-Holstein Medical Center, Kiel Campus

Kiel, , Germany

University of Schleswig-Holstein Medical Center, Lübeck Campus

Lübeck, , Germany

Wedel Hospital, Department of Surgery

Wedel, , Germany

Countries

Germany

Other Identifiers

vffr-35

Identifier Type: -

Identifier Source: org_study_id