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

March 24, 2017 updated by: Stryker Trauma GmbH

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612
        • Oakland Bone & Joint Specialists
    • Florida
      • Temple Terrace, Florida, United States, 33637
        • Foundations of Orthopedic Research and Education
    • Idaho
      • Boise, Idaho, United States, 83706
        • St. Alphonsus Medical Group, Coughlin Foot & Ankle Clinic
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27703
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population consists of all living subjects who participated in the continued access study.

Description

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  • Subjects who were withdrawn or withdrew consent to participate in the investigation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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Device
Scandinavian Total Ankle Replacement System (STAR Ankle)
Device: Scandinavian Total Ankle Replacement System (STAR Ankle)
Total Ankle Replacement
Other Names:
  • STAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 year

Secondary Outcome Measures

Outcome Measure
Time Frame
American Orthopaedic Foot and Ankle Society questionnaire will be used to evaluate and monitor the progress of patients following foot and ankle surgery.
Time Frame: 8 year
8 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stryker Trauma GmbH

Investigators

  • Study Director: Richard Jay, DPM, Stryker Nordic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2009

Primary Completion (Actual)

November 14, 2016

Study Completion (Actual)

November 14, 2016

Study Registration Dates

First Submitted

November 4, 2010

First Submitted That Met QC Criteria

February 1, 2011

First Posted (Estimate)

February 2, 2011

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STAR 8 Year

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Arthrosis

Clinical Trials on Scandinavian Total Ankle Replacement System (STAR Ankle)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe