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

Hip Dislocation Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00175500
• Other study ID #: C02-0530
• Status: Active, not recruiting
• Phase: N/A
• First received: September 11, 2005
• Last updated: September 20, 2011
• Start date: September 2007
• Est. completion date: December 2012

Study information

• Verified date: September 2011
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: December 2012
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dislocations
• Hip Dislocation

Intervention

Device:
• Large Diameter Femoral Head
Unspecified

Locations

Country	Name	City	State
Canada	Vancouver General Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To compare polyethylene wear in the two groups		Unspecified	No
Secondary	To compare the difference in functional and quality of life measures in the two groups		at 3, 12 and 24 months post surgery	No
Secondary	To compare radiographic findings in the two groups		Unspecified	No
Secondary	To estimate the rate of re-revision in the two groups		Unspecified	No