Comparison of Conventional and Large Diameter Femoral Heads for the Prevention of Hip Dislocation - Full Text View

Sponsored by:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00175500

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

MedlinePlus related topics: Dislocations Hip Injuries and Disorders Hip Replacement

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

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 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

Unspecified

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175500

Contacts

Contact: Lorna Ottley

604-875-4111 ext 69313

lottley@arthritisresearch.ca

Locations

Canada, British Columbia
Vancouver General Hospital	Recruiting
Vancouver, British Columbia, Canada, V5Z 1L8
Contact: Lorna Ottley 604-875-4111 ext 69313 lottley@arthritisresearch.ca

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Donald Garbuz, MD

University of British Columbia

More Information

Responsible Party:	University of British Columbia ( Dr. Donald Garbuz )
Study ID Numbers:	C02-0530
Study First Received:	September 11, 2005
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00175500
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Post-Arthroplasty Hip Dislocation

Study placed in the following topic categories:

Hip Dislocation
Dislocations
Wounds and Injuries
Disorders of Environmental Origin
Hip dislocation

Additional relevant MeSH terms:

Hip Injuries

ClinicalTrials.gov processed this record on January 16, 2009