Last updated on April 2018

2-Year Post-Approval Study to Investigate the Scandinavian Total Ankle Replacement System (STAR) Ankle Under Actual Conditions of Use

Brief description of study

This post-approval study is being conducted to examine the performance of the STAR Ankle under actual conditions of use.

Detailed Study Description

This investigation is a prospective, multi-center, single-arm study. 98 subjects are to be enrolled in this clinical investigation. Enrolled subjects will be assessed at Pre-Operative, Operative/Discharge, and at 6 Weeks, 6, 12, and 24 Months after the index procedure. Safety, efficacy, and effectiveness analyses will be performed for all follow-up points during the study.

Clinical Study Identifier: NCT01284283

Contact Investigators or Research Sites near you

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Jeffrey McAlister, DPM

The CORE Institute
Phoenix, AZ United States
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David Thordarson, MD

Cedars Sinai Medical Center
Los Angeles, CA United States
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Shannon Rush, DPM

Palo Alto Medical Research Foundation (Sutter Health)
Palo Alto, CA United States
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Lindsay Mattfolk

Kaiser Permanente
San Francisco, CA United States
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Allen Grant, MD

William Beaumont Hospital
Royal Oak, MI United States
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Gregg Lundeen, MD

Reno Orthopaedic Center
Reno, NV United States
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Kenneth Mroczek, MD

Kenneth Mroczek, MD-NYU
New York, NY United States
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Keith L Wapner, MD

University of Pennsylvania Health Systems-PA Foot and Ankle Surgeons
Philadelphia, PA United States
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Lindsay Mattfolk

Center for Foot and Ankle Restoration
Dallas, TX United States
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