Post-PMA Approval Study: 10 Year Follow-Up IDE Subjects (PAS:IDE)
This study is enrolling participants by invitation only.
Sponsor:
Corin
Information provided by (Responsible Party):
Corin
ClinicalTrials.gov Identifier:
NCT00721994
First received: July 23, 2008
Last updated: June 10, 2013
Last verified: June 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoarthritis Avascular Necrosis Rheumatoid Arthritis |
Device: Cormet Hip Resurfacing System |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Corin:
Primary Outcome 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Harris Hip Score components including total score, pain, function and range of motion [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- device survival [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
- device related adverse events [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
- radiographic evaluation including radiolucencies, component migration, and femoral subsidence and tilt [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
- whole blood trace metals and renal function [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
blood specimens for metal ion testing and renal function testing
| Estimated Enrollment: | 350 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | May 2018 |
| Estimated Primary Completion Date: | May 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
IDE subjects who received the Cormet Hip Resurfacing device
|
Device: Cormet Hip Resurfacing System
Cormet Hip Resurfacing System
Other Name: Corin Cormet
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
IDE study subjects at 5 IDE study sites
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:
- none
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721994
Locations
| United States, Florida | |
| Space Coast Orthopaedics Ctr. | |
| Merritt Island, Florida, United States, 32953 | |
| Kennedy White Orthopedics | |
| Sarasota, Florida, United States, 34233 | |
| United States, Illinois | |
| Southern Illinois University School of Medicine | |
| Springfield, Illinois, United States, 62702 | |
| United States, Maryland | |
| Good Samaritan Hospital | |
| Baltimore, Maryland, United States, 21239 | |
| United States, Ohio | |
| Cleveland Center for Joint Reconstruction | |
| Cleveland, Ohio, United States, 44113 | |
Sponsors and Collaborators
Corin
Investigators
| Study Director: | Yassaman Najmabadi, BS CRA | Corin |
More Information
No publications provided
| Responsible Party: | Corin |
| ClinicalTrials.gov Identifier: | NCT00721994 History of Changes |
| Other Study ID Numbers: | PAS: IDE subjects |
| Study First Received: | July 23, 2008 |
| Last Updated: | June 10, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Corin:
|
hip resurfacing osteoarthritis avascular necrosis rheumatoid arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Necrosis Osteonecrosis Osteoarthritis Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Bone Diseases |
ClinicalTrials.gov processed this record on June 13, 2013