Cormet Post-PMA Study: New Enrollment

Not Applicable

Completed

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).

Recruitment & Eligibility

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).

Arm && Interventions

Group	Intervention	Description
Cormet Hip Resurfacing Post-PMA Group	Cormet Hip Resurfacing	hip resurfacing

Primary Outcome Measures

Name	Time	Method
The Number of Unilateral Procedures Which Achieved Composite Clinical Success (CCS) at Month 24	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 Outcome Measures

Name	Time	Method
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+	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
Survival Rate Using Kaplan-Meier Survival Curves	Month 24+	Kaplan-Meier survival curves were completed for all implants (unilateral \& bilateral) for Month 24
Number of Implants (Unilateral & Bilateral) With Harris Hip Scores (HHS) Components Including Total, Pain & Function Scored at Month 24+	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)

Locations (6): Sinai Hospital of Baltimore
🇺🇸
Baltimore, Maryland, United States
Florida Orthopaedic Institute
🇺🇸
Tampa, Florida, United States
Memorial Bone and Joint Clinic
🇺🇸
Houston, Texas, United States
Lattimore Orthopaedics P.C.
🇺🇸
Rochester, New York, United States
Willamette Orthopedic Group LLC
🇺🇸
Salem, Oregon, United States
George Washington University
🇺🇸
Washington, District of Columbia, United States