Durom(R) Hip Resurfacing System Multicenter Trial

Zimmer Biomet5 sites in 1 country40 target enrollmentJune 2007

ConditionsAdvanced Hip Disease

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Advanced Hip Disease
Sponsor: Zimmer Biomet
Enrollment: 40
Locations: 5
Primary Endpoint: Device Survival
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 2007

End Date

March 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zimmer Biomet

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient selection without bias to race or gender
•Patient is greater than or equal to 18 and less than or equal to 65 years of age.
•Female patients only:
•actively practicing a contraceptive method, or
•surgically sterilized, or
•post-menopausal
•Pre-operative Harris Hip Score less than or equal to
•Primary surgical hip candidate, suffering from hip pain and/or disability due to degenerative joint disease (inflammatory or non-inflammatory), based on physical examination and history, including the following diagnosis:
•non-inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis or osteoarthritis
•inflammatory joint disease (IJD), e.g. rheumatoid arthritis

Exclusion Criteria

•Patient with an acute, chronic, local or systemic infection.
•Patient who is skeletally immature.
•Patient with a severe muscular, neural or vascular disease that endangers the involved extremity.
•Patient with an insufficient acetabular or femoral bone stock in which good anchorage of the implants are unlikely or impossible, including but not limited to:
•patient with severe osteopenia
•patients with a family history of severe osteoporosis or osteopenia
•patients with osteonecrosis or avascular necrosis (AVN) with \> 50% involvement of the femoral head (regardless of FICAT grade)
•patients with multiple cysts of the femoral head \> 1cm
•Patient with total or partial absence of the muscular of ligamentous apparatus.
•Patient has known moderate to severe renal insufficiency.