Overview

This trial is active, not recruiting.

Conditions osteoarthritis, avascular necrosis, rheumatoid arthritis
Treatment cormet hip resurfacing
Phase phase 4
Sponsor Corin
Start date April 2008
End date December 2015
Trial size 160 participants
Trial identifier NCT00722007, Cormet (P050016) New Enroll

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
hip resurfacing
cormet hip resurfacing Corin Cormet
Cormet Hip Resurfacing implant

Primary Outcomes

Measure
to compare composite clinical success and revisions in the post approval study to the IDE study
time frame: 24 months

Secondary Outcomes

Measure
Harris Hip Score components including total score, pain, function and range of motion
time frame: 24 months
device survival
time frame: 24 months
device related adverse events
time frame: 24 months
radiographic evaluation including radiolucencies, component migration, femoral subsidence and tilt
time frame: 24 months

Eligibility Criteria

Male or female participants of any age.

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).

Additional Information

Official title Cormet Resurfacing Hip System Post PMA-Approval Study Post-approval Study Group (New Enrollment)
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).
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Corin.