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Clinical Trials/NCT00175500
NCT00175500UnknownNot Applicable

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

University of British Columbia1 site in 1 country400 target enrollmentStarted: September 1, 2007Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
400
Locations
1
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Eligible patients will be those undergoing revision hip arthroplasty, either first revision or subsequent re-revision.
  • •Revision must require replacement of both the acetabular component and femoral component, except when revising femur only with well-fixed Trilogy socket.
  • •The acetabular component must have a minimum outer diameter of 50 mm.
  • •The femoral component inserted should be a Zimmer Versys™ beaded full-coated stem or Zimmer ZMR™ stem or collarless polished taper (CPT™)
  • •Patients must be able to reply to questionnaires in either French or English.

Exclusion Criteria

  • •Patients who are undergoing revision for recurrent dislocation.
  • •Revision of the acetabulum requiring structural allograft or reconstruction ring.
  • •Revision of the acetabulum requiring the use of cemented all-polyethylene cups.
  • •Revision of the acetabulum using a liner cemented into an existing metal shell.
  • •Intra-operative decision to use a constrained liner.

Outcomes

Primary Outcomes

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

  • To compare radiographic findings in the two groups
  • To compare the difference in functional and quality of life measures in the two groups(at 3, 12 and 24 months post surgery)
  • To estimate the rate of re-revision in the two groups
  • To compare polyethylene wear in the two groups

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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