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CompletedNCT01288586STAR 8Updated Mar 27, 2017

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

An observational study in Primary Arthrosis, sponsored by Stryker Trauma and Extremities. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-27.

Sponsored by Stryker Trauma and Extremities · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
87
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Primary Arthrosis

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Keywords

  • Post Traumatic Arthritis
  • Rheumatoid Arthritis
  • Osteoarthritis
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 87 is below the median of 100 across 792 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Stryker Trauma and Extremities is the lead sponsor of 43 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

The study population consists of all living subjects who participated in the continued access arm of the IDE clinical trial.

Inclusion criteria

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

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  • Subjects who were withdrawn or withdrew consent to participate in the investigation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)
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
87 participants (actual)

Groups and cohorts

  • Device

    Scandinavian Total Ankle Replacement System (STAR Ankle)

    Device: Scandinavian Total Ankle Replacement System (STAR Ankle)

Interventions

  • DeviceScandinavian Total Ankle Replacement System (STAR Ankle)

    Total Ankle Replacement

    Also known as: STAR

06

What researchers measure

Primary outcomes

  1. The primary objective for this study is to examine the long-term survivorship of the STAR Ankle

    Obtain information on the revision and removal rate for the STAR Ankle over time.

    Time frame: 8 year

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

07

Study locations

5 sites
  • Oakland Bone & Joint Specialists
    Oakland, California 94612, United States
  • Foundations of Orthopedic Research and Education
    Temple Terrace, Florida 33637, United States
  • St. Alphonsus Medical Group, Coughlin Foot & Ankle Clinic
    Boise, Idaho 83706, United States
  • Kansas University Medical Center
    Kansas City, Kansas 66160, United States
  • Duke University
    Durham, North Carolina 27703, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01288586
Lead sponsor
Stryker Trauma and Extremities
Responsible party
Sponsor
First posted
Feb 2, 2011
Start date
Oct 5, 2009
Primary completion
Nov 14, 2016
Completion
Nov 14, 2016
Last update
Mar 27, 2017

Study contacts

Richard Jay, DPM
study director · Stryker Nordic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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