Cormet Resurfacing Hip System Post PMA Approval Study (PMA #P050016)Pre-market (IDE) Study Group 10 Year Follow-Up With Metal Ion and Renal Function Data Collection Clinical Investigation Plan

Corin5 sites in 1 country231 target enrollmentMay 2008

ConditionsOsteoarthritis Avascular Necrosis Rheumatoid Arthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Corin
Enrollment: 231
Locations: 5
Primary Endpoint: 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
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

August 2017

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Corin

Responsible Party

Sponsor

Eligibility Criteria

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

Not provided

Outcomes

Primary Outcomes

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

Time Frame: 10 years

Secondary Outcomes

device survival(10 years)
device related adverse events(10 years)
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)
whole blood trace metals and renal function(10 years)