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

Primary Arthrosis Clinical Trial

— STAR 8  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288586
• Other study ID #: STAR 8 Year
• Status: Completed
• Phase: N/A
• First received: November 4, 2010
• Last updated: March 24, 2017
• Start date: October 5, 2009
• Est. completion date: November 14, 2016

Study information

• Verified date: March 2017
• Source: Stryker Trauma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Other known NCT identifiers

• NCT00586144
• NCT00586768

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: November 14, 2016
• Est. primary completion date: November 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

The study population consists of all living subjects who participated in the continued access arm of the IDE clinical trial.

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• Subjects who were withdrawn or withdrew consent to participate in the investigation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

Related Conditions & MeSH terms

• Primary Arthrosis

Intervention

Device:
• Scandinavian Total Ankle Replacement System (STAR Ankle)
Total Ankle Replacement

Locations

Country	Name	City	State
United States	St. Alphonsus Medical Group, Coughlin Foot & Ankle Clinic	Boise	Idaho
United States	Duke University	Durham	North Carolina
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Oakland Bone & Joint Specialists	Oakland	California
United States	Foundations of Orthopedic Research and Education	Temple Terrace	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Stryker Trauma GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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