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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: University of British Columbia

Current Primary Outcome: 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 ]

Original Primary Outcome: To compare the difference in dislocation rate at two years between those receiving a large ball (36/40 mm femoral head) versus those receiving a 32 mm femoral head in patients undergo revision hip arthroplasty.

Current Secondary Outcome:

  • To compare polyethylene wear in the two groups [ Time Frame: Unspecified ]
  • 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 ]
  • To compare radiographic findings in the two groups [ Time Frame: Unspecified ]
  • To estimate the rate of re-revision in the two groups [ Time Frame: Unspecified ]


Original Secondary Outcome:

  • 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 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


Information By: University of British Columbia

Dates:
Date Received: September 11, 2005
Date Started: September 2007
Date Completion: December 2012
Last Updated: September 20, 2011
Last Verified: September 2011