Back to resultsComparison of Conventional and Large Diameter Femoral Heads for the Prevention of Hip Dislocation
Primary Purpose
Hip Dislocation
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Large Diameter Femoral Head
Sponsored by
About this trial
This is an interventional prevention trial for Hip Dislocation focused on measuring Post-Arthroplasty Hip Dislocation
Eligibility Criteria
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.
Sites / Locations
- Vancouver General Hospital
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
To compare polyethylene wear in the two groups
To compare the difference in functional and quality of life measures in the two groups
To compare radiographic findings in the two groups
To estimate the rate of re-revision in the two groups
Full Information
NCT ID
NCT00175500
First Posted
September 11, 2005
Last Updated
September 20, 2011
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00175500
Brief Title
Comparison of Conventional and Large Diameter Femoral Heads for the Prevention of Hip Dislocation
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Dislocation
Keywords
Post-Arthroplasty Hip Dislocation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Large Diameter Femoral Head
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
To compare polyethylene wear in the two groups
Title
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
Title
To compare radiographic findings in the two groups
Title
To estimate the rate of re-revision in the two groups
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Garbuz, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Comparison of Conventional and Large Diameter Femoral Heads for the Prevention of Hip Dislocation
We'll reach out to this number within 24 hrs