Post-Approval Study to Investigate the Long Term (8 Year) Survivorship of STAR Ankle Among Continued Access Study Patients
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Osteoarthritis (OA), Orthopedic |
| Therapuetic Areas: | Rheumatology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/8/2016 |
| Start Date: | January 2011 |
| End Date: | December 2016 |
Post-Approval Study to Investigate the Long Term (8 Year) Survivorship of Scandinavian Total Ankle Replacement (STAR) Ankle Among Continued Access Study Patients
The purpose of this study is to examine the long term survivorship of the Scandinavian Total
Ankle Replacement (STAR). Specifically, this study focuses on the revision and/or removal
rate of any component of the STAR ankle.
Ankle Replacement (STAR). Specifically, this study focuses on the revision and/or removal
rate of any component of the STAR ankle.
The study population consists of all living subjects who participated in the continued
access arm of the IDE clinical trial.
Inclusion Criteria:
- Only patients that participated in the continued access study make up the patient
cohort for this long-term follow-up study.
- Willing and able to give informed consent.
Exclusion Criteria:
- Subjects who were withdrawn or withdrew consent to participate in the investigation
- Subjects who do not consent to participate in long-term or provide personal contact
information to the sponsor(solely for the purposes of tracking subjects to help
ensure follow-up compliance)
We found this trial at
5
sites
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Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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