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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

87 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-10-05

Study Completion Date

2016-11-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Arthrosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Device

Scandinavian Total Ankle Replacement System (STAR Ankle)

Intervention Type DEVICE

Total Ankle Replacement

Interventions

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Scandinavian Total Ankle Replacement System (STAR Ankle)

Total Ankle Replacement

Intervention Type DEVICE

Other Intervention Names

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STAR

Eligibility Criteria

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* Subjects who were withdrawn or withdrew consent to participate in the investigation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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No