NCT00722007

Cormet Post-PMA Study: New Enrollment

Cormet Hip Resurfacing System Post-PMA Study Group (New Enrollment)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Corin · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.

Detailed description

This study tracks the performance of the Cormet Hip Resurfacing system in the post-approval environment to see if there are significant changes in device performance from the pre-market IDE setting as compared to the post-approval setting. Specifically this study will compare the proportion of subjects achieving a Month 24 composite clinical success (CCS) criterion and 24 month cumulative revision rate among the newly enrolled post-approval study subjects to the IDE subjects' performance on CCS as reported in the Pre-Market Application (PMA).

Conditions

• Osteoarthritis
• Avascular Necrosis
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DEVICE	Cormet Hip Resurfacing	Cormet Hip Resurfacing implant

Timeline

• Start date: 2008-04-24
• Primary completion: 2014-04-11
• Completion: 2014-05-12
• First posted: 2008-07-25
• Last updated: 2019-07-02
• Results posted: 2019-07-02

Locations

6 sites across 1 country: United States