NCT00746616

Durom(R) Hip Resurfacing System Multicenter Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to gather clinical information on the safety and efficacy of the resurfacing devices in the young, active patient with advanced hip disease. Study enrollment has been temporarily suspended due to a change in the surgical technique.

Detailed description

Safety will be evaluated based on the frequency and incidence of any device related adverse events or unanticipated adverse device events. The efficacy will be measured by comparing the overall functional performance based on the Harris Hip Score, implant survivorship, and radiographic parameters, including radiolucencies, osteolysis, stem subsidence, cup migration, and change in cup angle and a change in the femoral shaft angle.

Conditions

• Advanced Hip Disease

Interventions

Type	Name	Description
DEVICE	Durom Hip Resurfacing System	Hip resurfacing devices in the young, active patient with advanced hip disease instead of traditional total hip arthroplasty.

Timeline

• Start date: 2007-06-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2008-09-04
• Last updated: 2013-04-10

Locations

5 sites across 1 country: United States