Last updated on November 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

David Thordarson, MD

Cedars Sinai Medical Center
Los Angeles, CA United States

Shannon Rush, DPM

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

Lindsay Mattfolk

Kaiser Permanente
San Francisco, CA United States

Allen Grant, MD

William Beaumont Hospital
Royal Oak, MI United States

Gregg Lundeen, MD

Reno Orthopaedic Center
Reno, NV United States

Kenneth Mroczek, MD

Kenneth Mroczek, MD-NYU
New York, NY United States

Keith L Wapner, MD

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

Lindsay Mattfolk

Center for Foot and Ankle Restoration
Dallas, TX United States