Overview

This trial is active, not recruiting.

Condition hip dislocation
Treatment large diameter femoral head
Sponsor University of British Columbia
Start date September 2007
End date April 2009
Trial size 400 participants
Trial identifier NCT00175500, C02-0530

Summary

About ten percent of revision hip replacements will dislocate. Although dislocation is not a life-threatening problem, it is stressful and costly and requires hospitalization to treat. Subjects who have repeated dislocations live with the constant fear of another dislocation. The purpose of this study is to test the effectiveness of a large ball prosthesis in preventing post-surgical dislocation. A large diameter ball has greater freedom of movement before it impinges; therefore, theoretically, it should not dislocate as easily.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Measure
To compare the difference in dislocation rate between those receiving a large ball (36/40 mm femoral head) versus those receiving a 32 mm femoral head in patients who undergo revision hip arthroplasty
time frame: at two years

Secondary Outcomes

Measure
To compare polyethylene wear in the two groups
time frame: Unspecified
To compare the difference in functional and quality of life measures in the two groups
time frame: at 3, 12 and 24 months post surgery
To compare radiographic findings in the two groups
time frame: Unspecified
To estimate the rate of re-revision in the two groups
time frame: Unspecified

Eligibility Criteria

Male or female participants at least 19 years old.

Inclusion Criteria: 1. Eligible patients will be those undergoing revision hip arthroplasty, either first revision or subsequent re-revision. 2. Revision must require replacement of both the acetabular component and femoral component, except when revising femur only with well-fixed Trilogy socket. 3. The acetabular component must have a minimum outer diameter of 50 mm. 4. The femoral component inserted should be a Zimmer Versys™ beaded full-coated stem or Zimmer ZMR™ stem or collarless polished taper (CPT™) 5. Patients must be able to reply to questionnaires in either French or English. Exclusion Criteria: 1. Patients who are undergoing revision for recurrent dislocation. 2. Revision of the acetabulum requiring structural allograft or reconstruction ring. 3. Revision of the acetabulum requiring the use of cemented all-polyethylene cups. 4. Revision of the acetabulum using a liner cemented into an existing metal shell. 5. Intra-operative decision to use a constrained liner.

Additional Information

Official title A Randomized Multi-Centre Controlled Trial of Large Diameter (36/40 mm) Versus Conventional Diameter (32 mm) Femoral Heads for the Prevention of Post Revision Arthroplasty Dislocation
Principal investigator Donald Garbuz, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2011.
Information provided to ClinicalTrials.gov by University of British Columbia.