Primary Arthrosis
Conditions
Keywords
Post Traumatic Arthritis, Rheumatoid Arthritis, Osteoarthritis
Brief summary
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.
Interventions
Total Ankle Replacement
Sponsors
Stryker Trauma and Extremities
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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* Subjects who were withdrawn or withdrew consent to participate in the investigation * Subjects who do not consent to participate in long-term or provide personal contact information to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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary objective for this study is to examine the long-term survivorship of the STAR Ankle | 8 year | Obtain information on the revision and removal rate for the STAR Ankle over time. |
Secondary
| Measure | Time frame |
|---|---|
| American Orthopaedic Foot and Ankle Society questionnaire will be used to evaluate and monitor the progress of patients following foot and ankle surgery. | 8 year |
Countries
United States
Outcome results
None listed