A Phase 3 interventional study of Scandinavian Total Ankle Replacement (STAR) in Osteoarthritis, Post-Traumatic Arthritis and Rheumatoid Arthritis, sponsored by Link America, Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-01-04.
Sponsored by Link America, Inc. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the safety of the S.T.A.R. device for patients with bilateral disease.
The specific objectives are to show that the safety data of the S.T.A.R. ankle arthroplasty is similar for treatment of single ankle disease (as defined in the pivotal study) and bilateral ankle disease. The bilateral disease may be identified at the time of enrollment or may have progressed after enrollment and treatment of the first ankle in the pivotal study.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 21 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →This is the only study on the registry with Link America, Inc. as lead sponsor.
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Exclusion Criteria:
The S.T.A.R. ankle system is the study device. The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants. Both ankles of every subject will be treated with the STAR ankle.
Device: Scandinavian Total Ankle Replacement (STAR)
The device has three parts: two metal bearing surfaces (cobalt-chromium alloy) plates with bars that fit into the bone and one plastic (polyethylene) spacer that moves between the metal plates like a ball bearing. The materials in the S.T.A.R. device are the same materials used in total hip and knee implants.
Safety endpoints to be measured are: • Device failure or device removal/revision • Radiographically confirmed loosening and migration • Complications
Time frame: 12 months
This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.
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