Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects
PAS:IDE
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
1 other identifier
observational
231
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2008
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 23, 2008
CompletedFirst Posted
Study publicly available on registry
July 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedNovember 21, 2018
November 1, 2018
9.1 years
July 23, 2008
November 20, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
10 years
Secondary Outcomes (5)
Harris Hip Score components including total score, pain, function and range of motion
10 years
device survival
10 years
device related adverse events
10 years
radiographic evaluation including radiolucencies, component migration, and femoral subsidence and tilt
10 years
whole blood trace metals and renal function
10 years
Study Arms (1)
1
IDE subjects who received the Cormet Hip Resurfacing device
Interventions
Eligibility Criteria
IDE study subjects at 5 IDE study sites
You may qualify if:
- 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
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Corinlead
Study Sites (5)
Space Coast Orthopaedics Ctr.
Merritt Island, Florida, 32953, United States
Kennedy White Orthopedics
Sarasota, Florida, 34233, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Good Samaritan Hospital
Baltimore, Maryland, 21239, United States
Cleveland Center for Joint Reconstruction
Cleveland, Ohio, 44113, United States
Biospecimen
blood specimens for metal ion testing and renal function testing
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kathy Trier, Ph.D.
Corin
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2008
First Posted
July 25, 2008
Study Start
May 1, 2008
Primary Completion
June 1, 2017
Study Completion
August 1, 2017
Last Updated
November 21, 2018
Record last verified: 2018-11