Cormet Hip Resurfacing System Post-PMA Study Group (New Enrollment)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Corin
- Enrollment
- 147
- Locations
- 6
- Primary Endpoint
- The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female patient who meets eligibility criteria consistent with product labeling
- •skeletally mature
- •mentally capable of completing follow-up forms
- •Will be available for follow-up out to 2 years and annually thereafter until the last patient reaches the two-year evaluation
- •Has been deemed a candidate for hip replacement by diagnosis of the investigator
- •consented to participate in the clinical study
Exclusion Criteria
- •Patient with active or suspected infection in or around the hip joint;
- •Patient with bone stock inadequate to support the device
- •Patient with severe osteopenia
- •Patient with a family history of severe osteoporosis or severe osteopenia;
- •Patient with osteonecrosis or avascular necrosis (AVN) with \>50% involvement of the femoral head (regardless of FICAT Grade)
- •Patient with multiple cysts of the femoral head (\>1cm)
- •In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock.
- •Patient with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery;
- •Female of child-bearing age due to unknown effects on the fetus of metal ion release.
- •Patient with known moderate or severe renal insufficiency;
Outcomes
Primary Outcomes
The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24
Time Frame: Month 24+
Composite Clinical Success (CCS) is based upon the following: There has been no revision, removal, or replacement of any device component on or prior to the exact 24 month anniversary (i.e., relative day 730); and Month 24 Harris Hip Total score (HHS) ≥ 80 points.
Secondary Outcomes
- Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events(Month 24+)
- The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively(Month 24+)
- Survival Rate Using Kaplan-Meier Survival Curves(Month 24+)
- Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+(Month 24+)