Post-Approval Study to Investigate the Long Term (8 Year) Survivorship of STAR Ankle Among Continued Access Study Patients
STAR 8
1 other identifier
observational
87
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2009
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 5, 2009
CompletedFirst Submitted
Initial submission to the registry
November 4, 2010
CompletedFirst Posted
Study publicly available on registry
February 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2016
CompletedMarch 27, 2017
March 1, 2017
7.1 years
November 4, 2010
March 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary objective for this study is to examine the long-term survivorship of the STAR Ankle
Obtain information on the revision and removal rate for the STAR Ankle over time.
8 year
Secondary Outcomes (1)
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
Study Arms (1)
Device
Scandinavian Total Ankle Replacement System (STAR Ankle)
Interventions
Total Ankle Replacement
Eligibility Criteria
The study population consists of all living subjects who participated in the continued access study.
You may qualify if:
- 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.
You may not qualify if:
- Subjects who were withdrawn or withdrew consent to participate in the investigation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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Oakland Bone & Joint Specialists
Oakland, California, 94612, United States
Foundations of Orthopedic Research and Education
Temple Terrace, Florida, 33637, United States
St. Alphonsus Medical Group, Coughlin Foot & Ankle Clinic
Boise, Idaho, 83706, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
Duke University
Durham, North Carolina, 27703, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Richard Jay, DPM
Stryker Nordic
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2010
First Posted
February 2, 2011
Study Start
October 5, 2009
Primary Completion
November 14, 2016
Study Completion
November 14, 2016
Last Updated
March 27, 2017
Record last verified: 2017-03