Cormet Post-PMA Study: New Enrollment

NCT ID: NCT00722007

Last Updated: 2019-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 147 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-24
• Study Completion Date: 2014-05-12

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).

Conditions

Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cormet Hip Resurfacing Post-PMA Group

hip resurfacing

Group Type: EXPERIMENTAL

Cormet Hip Resurfacing

Intervention Type: DEVICE

Cormet Hip Resurfacing implant

Interventions

Cormet Hip Resurfacing

Cormet Hip Resurfacing implant

Intervention Type: DEVICE

Other Intervention Names

Corin Cormet

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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corin

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Willamette Orthopedic Group LLC

Salem, Oregon, United States

Memorial Bone and Joint Clinic

Houston, Texas, United States

Countries

United States

Other Identifiers

Cormet (P050016) New Enroll

Identifier Type: -

Identifier Source: org_study_id