Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects
Overview
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.
Full Title of Study: “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”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: June 2017
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.
Interventions
- Device: Cormet Hip Resurfacing System
- Cormet Hip Resurfacing System
Arms, Groups and Cohorts
- 1
- IDE subjects who received the Cormet Hip Resurfacing device
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- Harris Hip Score components including total score, pain, function and range of motion
- Time Frame: 10 years
- device survival
- Time Frame: 10 years
- device related adverse events
- Time Frame: 10 years
- radiographic evaluation including radiolucencies, component migration, and femoral subsidence and tilt
- Time Frame: 10 years
- whole blood trace metals and renal function
- Time Frame: 10 years
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Corin
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Kathy Trier, Ph.D., Study Director, Corin
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