Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects

Completed

• Conditions: Rheumatoid Arthritis; Osteoarthritis; Avascular Necrosis
• Interventions: Device: Cormet Hip Resurfacing System

• Registration Number: NCT00721994
• Lead Sponsor: Corin

Brief Summary

primary endpoint of this Study is maintenance of "at least good clinical status" for a period of 10 years following initial implantation among Cormet procedures enrolled inthe pre-market IDE.

Detailed Description

Maintaining "at least good clinical status" will be determined based upon the composite clinical success (CCS) criterion which includes no revision, removal, or replacement of any device component and a Harris Hip Total score of greater or equal to 80 points.

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-24
• Study First Posted: 2008-07-25
• Primary Completion: 2017-06
• Study Completion: 2017-08
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-20
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

Inclusion Criteria

• subjects enrolled in the Cormet IDE study at the 5 identified clinical sites
• Individuals who agree to participate in the study by signing the informed patient consent form

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Cormet Hip Resurfacing System	IDE subjects who received the Cormet Hip Resurfacing device

Primary Outcome Measures

Name	Time	Method
to monitor the clinical performance of the Cormet implant system for a period of up to 10 years postoperative in order to confirm that there are no unexpected reductions in device performance following PMA approval	10 years

Secondary Outcome Measures

Name	Time	Method
radiographic evaluation including radiolucencies, component migration, and femoral subsidence and tilt	10 years
Harris Hip Score components including total score, pain, function and range of motion	10 years
device survival	10 years
device related adverse events	10 years
whole blood trace metals and renal function	10 years

Trial Locations

Locations (5)

Space Coast Orthopaedics Ctr.; 🇺🇸 Merritt Island, Florida, United States

Southern Illinois University School of Medicine; 🇺🇸 Springfield, Illinois, United States

Kennedy White Orthopedics; 🇺🇸 Sarasota, Florida, United States

Good Samaritan Hospital; 🇺🇸 Baltimore, Maryland, United States

Cleveland Center for Joint Reconstruction; 🇺🇸 Cleveland, Ohio, United States