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

Stryker Trauma and Extremities5 sites in 1 country87 target enrollmentOctober 5, 2009

ConditionsPrimary Arthrosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Primary Arthrosis
Sponsor: Stryker Trauma and Extremities
Enrollment: 87
Locations: 5
Primary Endpoint: The primary objective for this study is to examine the long-term survivorship of the STAR Ankle
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 5, 2009

End Date

November 14, 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Stryker Trauma and Extremities

Responsible Party

Sponsor

Eligibility Criteria

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•Subjects who were withdrawn or withdrew consent to participate in the investigation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

Outcomes

Primary Outcomes

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

Time Frame: 8 year

Obtain information on the revision and removal rate for the STAR Ankle over time.

Secondary Outcomes

American Orthopaedic Foot and Ankle Society questionnaire will be used to evaluate and monitor the progress of patients following foot and ankle surgery.(8 year)