Status:
COMPLETED
Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects
Lead Sponsor:
Corin
Conditions:
Osteoarthritis
Avascular Necrosis
Eligibility:
All Genders
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...
Eligibility Criteria
Inclusion
- 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
- none
Key Trial Info
Start Date :
May 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT00721994
Start Date
May 1 2008
End Date
August 1 2017
Last Update
November 21 2018
Active Locations (5)
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1
Space Coast Orthopaedics Ctr.
Merritt Island, Florida, United States, 32953
2
Kennedy White Orthopedics
Sarasota, Florida, United States, 34233
3
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
4
Good Samaritan Hospital
Baltimore, Maryland, United States, 21239