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Comparison of Conventional and Large Diameter Femoral Heads for the Prevention of Hip Dislocation

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ClinicalTrials.gov Identifier: NCT00175500
Recruitment Status : Unknown
Verified September 2011 by University of British Columbia.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2005
Last Update Posted : September 22, 2011
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Hip Dislocation Device: Large Diameter Femoral Head Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 Start Date : September 2007
Actual Primary Completion Date : April 2009
Estimated Study Completion Date : December 2012

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Primary Outcome Measures :
  1. 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 Measures :
  1. To compare polyethylene wear in the two groups
  2. 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 ]
  3. To compare radiographic findings in the two groups
  4. To estimate the rate of re-revision in the two groups


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175500


Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1L8
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Donald Garbuz, MD University of British Columbia

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00175500     History of Changes
Other Study ID Numbers: C02-0530
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 22, 2011
Last Verified: September 2011

Keywords provided by University of British Columbia:
Post-Arthroplasty Hip Dislocation

Additional relevant MeSH terms:
Joint Dislocations
Hip Dislocation
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries
Hip Injuries