2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use
NCT01284283 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102
Last updated 2022-07-29
Summary
This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use.
Conditions
- Primary Arthrosis
- Post Traumatic Arthritis
- Rheumatoid Arthritis
- Osteoarthritis
Interventions
- DEVICE
-
Scandinavian Total Ankle Replacement System (STAR Ankle)
For total ankle replacement
Sponsors & Collaborators
-
Encore Medical, L.P.
lead INDUSTRY
Principal Investigators
-
Stefan Maartense, MD · Stryker Nordic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-11-30
- Primary Completion
- 2021-03-31
- Completion
- 2021-03-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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