Cormet Post-PMA Study: New Enrollment (PASNew)

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

The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis
• Intervention / Treatment: Device: Cormet Hip Resurfacing

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).

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20006
      • George Washington University
  • Florida
    • Tampa, Florida, United States, 33637
      • Florida Orthopaedic Institute
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Sinai Hospital of Baltimore
  • New York
    • Rochester, New York, United States, 14620
      • Lattimore Orthopaedics P.C.
  • Oregon
    • Salem, Oregon, United States, 97301
      • Willamette Orthopedic Group LLC
  • Texas
    • Houston, Texas, United States, 77043
      • Memorial Bone and Joint Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cormet Hip Resurfacing Post-PMA Group; hip resurfacing	Device: Cormet Hip Resurfacing; Cormet Hip Resurfacing implant; Other Names: Corin Cormet

What is the study measuring?

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+

Collaborators and Investigators

• Sponsor: Corin

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2008
• Primary Completion (Actual): April 11, 2014
• Study Completion (Actual): May 12, 2014

Study Registration Dates

• First Submitted: July 23, 2008
• First Submitted That Met QC Criteria: July 24, 2008
• First Posted (Estimate): July 25, 2008

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: osteoarthritis; rheumatoid arthritis; avascular necrosis; hip resurfacing
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Osteoarthritis; Necrosis
• Other Study ID Numbers: Cormet (P050016) New Enroll