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Clinical Trials/NCT01288586
NCT01288586CompletedNot Applicable

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 enrollmentStarted: October 5, 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
87
Locations
5
Primary Endpoint
The primary objective for this study is to examine the long-term survivorship of the STAR Ankle
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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  • •Subjects who were withdrawn or withdrew consent to participate in the investigation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

Investigators

Sponsor
Stryker Trauma and Extremities
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (5)

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