Cormet Post-PMA Study: New Enrollment

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis

Intervention / Treatment
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* Device: Cormet Hip Resurfacing


Participation Criteria
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Eligibility Criteria
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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; Patient who is immunosuppressed with diseases such as AIDS or person receiving high doses of corticosteroids; Patient who is severely overweight; Patient with known or suspected metal sensitivity (e.g., jewelry).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cormet Hip Resurfacing Post-PMA Group<br>hip resurfacing | Device: Cormet Hip Resurfacing<br>* Cormet Hip Resurfacing implant<br>* Other names: Corin Cormet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at 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. | Month 24+ | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ | All unilateral and bilateral implants have been assessed using the following grading: Total HHS: Excellent (90-100); Good (80-89); Fair (70-79); Poor (<70) Pain HHS: None; Slight; Mild; Moderate; Marked; Totally Disabled Function HHS: Normal (40-47); Mild Dysfunction (30=<39); Moderate Dysfunction (20=<29); Severe Dysfunction (10=<19); Disabled (0=<9) | Month 24+ | 
| Survival Rate Using Kaplan-Meier Survival Curves | Kaplan-Meier survival curves were completed for all implants (unilateral & bilateral) for Month 24 | Month 24+ | 
| 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 | The following was assessed: Radiolucency Acetabular Component: I; II; III Radiolucency Femoral Component: Superior; Tip; Inferior Cup Migration and Tilt: Superior/Inferior Migration > 4mm; Medial/Lateral Migration > 4mm; Varus/Valgus Tilt > 4 degrees Stem Migration and Tilt: Subsidence of Femoral Component > 4mm and Stem tilting > 4 degrees Other Assessments: Anteversion of the Head ≥ 5mm; Retroversion of the Head ≥ 5 mm; Hypertrophy in Any Zone; Resorption in Any Zone; Lysis in Any Zone; Osteolysis | Month 24+ | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hip resurfacing, osteoarthritis, avascular necrosis, rheumatoid arthritis