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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of British Columbia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00175500
First received: September 11, 2005
Last updated: September 20, 2011
Last verified: September 2011
  Purpose

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 Intervention
Hip Dislocation
Device: Large Diameter Femoral Head

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

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 [ Time Frame: at two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare polyethylene wear in the two groups [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To compare radiographic findings in the two groups [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • To estimate the rate of re-revision in the two groups [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2007
Estimated Study Completion Date: December 2012
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Large Diameter Femoral Head
    Unspecified
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00175500     History of Changes
Other Study ID Numbers: C02-0530
Study First Received: September 11, 2005
Last Updated: September 20, 2011
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Dislocations
Hip Dislocation
Wounds and Injuries
Hip Injuries

ClinicalTrials.gov processed this record on October 19, 2014