f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Actual Conditions of Use Study (STAR 2)

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Study Status Delayed
Application Number /
Requirement Number
P050050 / PAS002
Date Original Protocol Accepted 05/27/2009
Date Current Protocol Accepted 05/06/2022
Study Name Actual Conditions of Use Study (STAR 2)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Detailed Study Protocol Parameters
Study Objectives This is a retrospective, Real-World Evidence multi-center study.

The purpose of this study is to examine the safety and survivorship of the STAR™ Ankle under actual conditions of use, employing the approved instructions for use, labeling, and instrumentation.

This study will enroll a minimum of 500 on-label subjects across approximately 5 sites in the United States, consecutively implanted per site, who are to be assessed in this clinical investigation. Each site will have a minimum of fifty patients, with subject patient primary surgery dates taking place between 2015-2019.
Study Population A minimum of 500 adult male or female subjects, who meet all the study criteria (listed in 4.6), that received treatment with the STAR ankle implant for ankle replacement for treatment of a painful arthritic ankle joint due to osteoarthritis, posttraumatic arthritis or rheumatoid arthritis. Patients sets at each site will be on-label and consecutive.
The study plan is to enroll all on-label, consecutive patients per site with primary STAR surgery dates between 2015 and 2019. With this surgery date range, the potential patient follow-up period should be between approximately two years at a minimum to seven years maximum. With this new patient follow-up range, the longer time periods for this subject study will be between the PAS2 and PAS8 study bounds.
Sample Size No. of subjects: 500 on-label subjects
No. of sites: 5 (Each site will have a minimum of 50 patients).
Sites location: US

Key Study Endpoints Primary Objective:
To examine the safety and survivorship of the STAR™ Ankle under actual conditions of use, employing the approved instructions for use, labeling, and instrumentation. The primary endpoint consists of evaluating key safety and survivorship parameters associated with the STAR™ Ankle, with specific elements listed below.
1. Reoperations - incidence rates and times to event will be collected.
2. Revisions - incidence rates and times to event will be collected.
3. Removals - Incidence rates and times to event will be collected.
4. Occurrence and types of serious device-related adverse events.

Secondary Objective:
Information regarding the following patient and treatment parameters will be gathered and assessed in the course of evaluation:
Nature/reason for revision, onset, duration, severity, relationship to the device, relationship to the operative procedure, and outcome of any adverse event

Follow-up Visits and Length of Follow-up Duration of follow-up will vary based upon date of primary STAR surgery. All available patient records through the present will be collected per patient, such that patients with surgery dates in 2015 may have up to seven years of follow-up, while those patients with surgery dates in 2019 may have approximately two years of follow-up.
Interim or Final Data Summary
Actual Number of Patients Enrolled 2
Actual Number of Sites Enrolled 4

Actual Conditions of Use Study (STAR 2) Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 03/29/2010 03/29/2010 On Time
1 year report 05/27/2010 05/28/2010 Overdue/Received
18 month report 11/25/2010 11/18/2010 On Time
2 year report 05/27/2011 05/27/2011 On Time
3 year report 05/26/2012 05/25/2012 On Time
4 year report 05/27/2013 05/28/2013 Overdue/Received
5 year report 06/26/2014 06/27/2014 Overdue/Received
6 year report 06/26/2015 06/26/2015 On Time
7 year report 06/26/2016 06/24/2016 On Time
8 year report 11/28/2017 11/28/2017 On Time
interim report 05/25/2018 05/25/2018 On Time
9 year report 10/31/2019 10/31/2019 On Time
10 year report/final 02/26/2021 02/26/2021 On Time

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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