We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01288586
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Stryker Trauma GmbH

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.

Condition or disease Intervention/treatment
Primary Arthrosis Device: Scandinavian Total Ankle Replacement System (STAR Ankle)

Study Type : Observational
Actual Enrollment : 87 participants
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
Actual Study Start Date : October 5, 2009
Primary Completion Date : November 14, 2016
Study Completion Date : November 14, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Device
Scandinavian Total Ankle Replacement System (STAR Ankle)
Device: Scandinavian Total Ankle Replacement System (STAR Ankle)
Total Ankle Replacement
Other Name: STAR



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, 27703
Sponsors and Collaborators
Stryker Trauma GmbH
Investigators
Study Director: Richard Jay, DPM Stryker Nordic

Responsible Party: Stryker Trauma GmbH
ClinicalTrials.gov Identifier: NCT01288586     History of Changes
Obsolete Identifiers: NCT00586144, NCT00586768
Other Study ID Numbers: STAR 8 Year
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017

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

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases