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

Completed

• Conditions: Primary Arthrosis
• Interventions: Device: Scandinavian Total Ankle Replacement System (STAR Ankle)

• Registration Number: NCT01288586
• Lead Sponsor: Stryker Trauma and Extremities

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-05
• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-02
• Primary Completion: 2016-11-14
• Study Completion: 2016-11-14
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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• Subjects who were withdrawn or withdrew consent to participate in the investigation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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Device	Scandinavian Total Ankle Replacement System (STAR Ankle)	Scandinavian Total Ankle Replacement System (STAR Ankle)

Primary Outcome Measures

Name	Time	Method
The primary objective for this study is to examine the long-term survivorship of the STAR Ankle	8 year	Obtain information on the revision and removal rate for the STAR Ankle over time.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

St. Alphonsus Medical Group, Coughlin Foot & Ankle Clinic; 🇺🇸 Boise, Idaho, United States

Foundations of Orthopedic Research and Education; 🇺🇸 Temple Terrace, Florida, United States

Kansas University Medical Center; 🇺🇸 Kansas City, Kansas, United States

Oakland Bone & Joint Specialists; 🇺🇸 Oakland, California, United States

Duke University; 🇺🇸 Durham, North Carolina, United States