Post-Approval Study to Investigate the Long Term (8 Year) Survivorship of STAR Ankle Among Continued Access Study Patients

Completed

Conditions studied: Primary Arthrosis

In brief

The purpose of this study is to examine the long term survivorship of the Scandinavian Total Ankle Replacement (STAR). Specifically, this study focuses on the revision and/or removal rate of any component of the STAR ankle.

Key facts

Study ID

NCT01288586

Run by

Stryker Trauma and Extremities

People needed

87

Starts

2009-10-05

Expected to finish

2016-11-14

Last updated by the study team

2017-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Only patients that participated in the continued access study make up the patient cohort for this long-term follow-up study.
• Willing and able to give informed consent.

You may not qualify if…

• Subjects who were withdrawn or withdrew consent to participate in the investigation
• Subjects who do not consent to participate in long-term or provide personal contact information to the sponsor(solely for the purposes of tracking subjects to help ensure follow-up compliance)

Where it is running

• Oakland Bone & Joint Specialists — Oakland, California, United States
• Foundations of Orthopedic Research and Education — Temple Terrace, Florida, United States
• St. Alphonsus Medical Group, Coughlin Foot & Ankle Clinic — Boise, Idaho, United States
• Kansas University Medical Center — Kansas City, Kansas, United States
• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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