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

This study is currently recruiting participants.
Verified March 2012 by Small Bone Innovations, Inc.
Sponsor:
Information provided by (Responsible Party):
Small Bone Innovations, Inc.
ClinicalTrials.gov Identifier:
NCT01288586
First received: November 4, 2010
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Primary Arthrosis
 Device: Scandinavian Total Ankle Replacement System (STAR Ankle)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Small Bone Innovations, Inc.:

Primary Outcome Measures:
  • The primary objective for this study is to examine the long-term survivorship of the STAR Ankle [ Time Frame: 8 year ] [ Designated as safety issue: No ]
    Obtain information on the revision and removal rate for the STAR Ankle over time.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: January 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Device
Single Arm
 Device: Scandinavian Total Ankle Replacement System (STAR Ankle)
Total ankle replacement
Other Name: STAR

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01288586

Contacts
Contact: Abigail Allen 202-552-5800 aallen@mcra.com

Locations
United States, California
Oakland Bone and Joint Recruiting
Oakland, California, United States, 94612
Principal Investigator: Roger A Mann, MD            
United States, Florida
Foundations of Orthopedic Research and Education Recruiting
Temple Terrace, Florida, United States, 33637
Principal Investigator: Arthur Walling, MD            
United States, Idaho
St. Alphonsus Foot and Ankle Clinic- Dr. Coughlin Recruiting
Boise, Idaho, United States, 83706
Principal Investigator: Michael J Coughlin, MD            
United States, North Carolina
James Nunley-Duke University Recruiting
Durham, North Carolina, United States
Principal Investigator: James Nunley, MD            
Sub-Investigator: James DeOrio, MD            
Sub-Investigator: Mark Easley, MD            
Sponsors and Collaborators
Small Bone Innovations, Inc.
Investigators
Study Director: Jim O'Connor Small Bone Innovations
  More Information

No publications provided

Responsible Party: Small Bone Innovations, Inc.
ClinicalTrials.gov Identifier: NCT01288586     History of Changes
Obsolete Identifiers: NCT00586144, NCT00586768
Other Study ID Numbers: STAR 8 Year
Study First Received: November 4, 2010
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Small Bone Innovations, Inc.:
Post Traumatic Arthritis
Rheumatoid Arthritis
Osteoarthritis

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013