Study of the Scandinavian Total Ankle Replacement (STAR) for the Treatment of Bilateral Degenerative Ankle Disease
Completed · Phase 3
Conditions studied: Osteoarthritis, Post-Traumatic Arthritis, Rheumatoid Arthritis
In brief
The purpose of this study is to evaluate the safety of the S.T.A.R. device for patients with bilateral disease.
Key facts
- Study ID
- NCT00586781
- Run by
- Link America, Inc.
- People needed
- 21
- Starts
- 2001-09-01
- Last updated by the study team
- 2008-01-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Moderate or severe pain, loss of mobility and function of the ankle
- Primary arthrosis, post traumatic arthrosis or rheumatoid arthrosis
- At least six months of conservative treatment for severe ankle conditions
- Bilateral ankle disease that have not been enrolled in the pivotal study or single ankle disease and enrolled in the pivotal study but have subsequently developed ankle disease in the contralateral ankle and require surgical intervention
- Willing and able to give informed consent
You may not qualify if…
- Patients who have not reached skeletal maturity
- Active or prior deep infection in the ankle joint or adjacent bones
- Prior arthrodesis at the involved site
- History of prior mental illness or patient demonstrates that their mental capacity may interfere with their ability to follow the study protocol
- Obesity (weight greater than 250 lbs)
- History of current or prior drug abuse or alcoholism
- Any physical condition precluding major surgery
- Prior surgery and/or injury that has adversely affected the ankle bone stock
- Severe osteoporotic or osteopenic condition or other conditions that may lead to inadequate implant fixation in the bone
- Insufficient ligament support
Where it is running
- Mayo Clinic — Jacksonville, Florida, United States
- University of Iowa — Iowa City, Iowa, United States
- Kansas University Medical Center — Kansas City, Kansas, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Orthopedic Associates of Dallas — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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