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.
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 Type
OBSERVATIONAL
Enrollment
231
Cormet Hip Resurfacing System
Space Coast Orthopaedics Ctr.
Merritt Island, Florida, United States
Kennedy White Orthopedics
Sarasota, Florida, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Good Samaritan Hospital
Baltimore, Maryland, United States
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
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
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Cleveland Center for Joint Reconstruction
Cleveland, Ohio, United States