N/A
Completed N=147
Cormet Post-PMA Study: New Enrollment
Source: ClinicalTrials.gov NCT00722007 ↗Enrolled (actual)
147
Serious AEs
22.5%
Results posted
Jul 2019
Primary outcomePrimary: The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24 — 104 Implants
Summary
The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24 |
104 | — |
| SECONDARY Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+ |
109; 10; 6; 1; 2; 87 | — |
| SECONDARY Survival Rate Using Kaplan-Meier Survival Curves |
155 | — |
| SECONDARY Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events |
9 | — |
| SECONDARY The Number of Procedures (Unilateral & Bilateral) With Any Radiographic Findings at Month 24 Post Operatively |
1; 1; 1; 0; 0; 0 | — |
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;
- 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).
Data sourced from ClinicalTrials.gov (NCT00722007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.