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

Stryker Trauma and Extremities

Status: Completed

Conditions: Primary Arthrosis

Treatments: Device: Scandinavian Total Ankle Replacement System (STAR Ankle)

Study type: Observational

Funder types: Industry

Identifiers

NCT01288586

STAR 8 Year

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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• Subjects who were withdrawn or withdrew consent to participate in the investigation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)

Trial design

87 participants in 1 patient group

Device

Description:

Scandinavian Total Ankle Replacement System (STAR Ankle)

Treatment:

Device: Scandinavian Total Ankle Replacement System (STAR Ankle)