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

NCT00175500 | Unknown

• 1 other identifier: C02-0530
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Hip Dislocation

Keywords

Post-Arthroplasty Hip Dislocation

Outcome Measures

Primary Outcomes (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

  at two years

Secondary Outcomes (4)

• To compare polyethylene wear 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 compare radiographic findings in the two groups

• To estimate the rate of re-revision in the two groups

Interventions

Large Diameter Femoral Head DEVICE

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1L8, Canada

Location

MeSH Terms

Conditions

Hip Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Hip Injuries

Study Officials

• Donald Garbuz, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: December 1, 2012
• Last Updated: September 22, 2011

Record last verified: 2011-09

Locations

CA (1)