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Completed

NCT Number: NCT01288586

Post-Approval Study to Investigate the Long Term (8 Year) Survivorship of 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.

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Key information

Conditions

Primary Arthrosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oakland Bone & Joint Specialists, Oakland, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Subjects who were withdrawn or withdrew consent to participate in the investigation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

Treatment and study plan

Scandinavian Total Ankle Replacement System (STAR Ankle)

Device

Total Ankle Replacement

Other names: STAR

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Stryker Trauma and Extremities

Industry

Registry information

Official study title

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

Acronym: STAR 8

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Feb 2, 2011
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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