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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
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.
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
Safety endpoints to be measured are: • Device failure or device removal/revision • Radiographically confirmed loosening and migration • Complications
Time frame: 12 months
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Orthopedic Associates of Dallas
Dallas, Texas, United States