The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
147
Cormet Hip Resurfacing implant
George Washington University
Washington D.C., District of Columbia, United States
Florida Orthopaedic Institute
Tampa, Florida, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Lattimore Orthopaedics P.C.
Rochester, New York, United States
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.
Time frame: Month 24+
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)
Time frame: Month 24+
Survival Rate Using Kaplan-Meier Survival Curves
Kaplan-Meier survival curves were completed for all implants (unilateral \& bilateral) for Month 24
Time frame: Month 24+
Number of Procedures (Unilateral & Bilateral) With Any Device Related Adverse Events
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Willamette Orthopedic Group LLC
Salem, Oregon, United States
Memorial Bone and Joint Clinic
Houston, Texas, United States
Time frame: Month 24+