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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Stryker Trauma GmbH
ClinicalTrials.gov Identifier:
NCT01288586
First received: November 4, 2010
Last updated: April 7, 2015
Last verified: April 2015
  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:


Further study details as provided by Stryker Trauma GmbH:

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 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Device
Scandinavian Total Ankle Replacement System (STAR Ankle)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288586

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

No publications provided

Responsible Party: Stryker Trauma GmbH
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: April 7, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Stryker Trauma GmbH:
Post Traumatic Arthritis
Rheumatoid Arthritis
Osteoarthritis

ClinicalTrials.gov processed this record on August 26, 2015