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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00175500
Enrollment
400
Registered
2005-09-15
Start date
2007-09-30
Completion date
2012-12-31
Last updated
2011-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Dislocation

Keywords

Post-Arthroplasty Hip 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.

Interventions

DEVICELarge Diameter Femoral Head

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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 arthroplastyat two years

Secondary

MeasureTime frame
To compare polyethylene wear in the two groups
To compare the difference in functional and quality of life measures in the two groupsat 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026