CompletedNot Applicable

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

United States87 participantsStarted 2009-10-05

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

The study population consists of all living subjects who participated in the continued access arm of the IDE clinical trial. Inclusion Criteria: * 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. Exclusion Criteria: * Subjects who were withdrawn or withdrew consent to participate in the investigation * Subjects who do not consent to participate in long-term or provide personal contact information to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)

What they're measuring

The primary objective for this study is to examine the long-term survivorship of the STAR Ankle

Timeframe: 8 year

Trial details

NCT IDNCT01288586

SponsorStryker Trauma and Extremities

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2016-11-14

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