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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Actual Conditions of Use Study (STAR 2)


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General
Application Number P050050 / PAS002
Current Plan Approved 09/01/2016
Study Name OSB Lead-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
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The post approval study is a prospective, multicenter, single-arm study involving five new investigators in five different investigational sites. Neither subjects nor investigators are blinded to treatment and the study does not include a contemporaneous control. The subjects from the Continued Access Cohort (CAC) of the IDE study will serve as the historical control in the PAS.
Study Population Description Consecutive patients presenting for treatment of a painful arthritic and or deformed arthritic ankle joint who have not responded to conventional medical therapy and meet all inclusion/exclusion criteria, due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis.

Sample Size Approximate sample sizes will be 98 for ACU and at least 300 subjects for CAS, and the margin of non-inferiority is 15%. Using the hypotheses identified above, a sample

size was calculated as:

Sample size = 83 subjects

Sample size with 15% loss to follow-up = 98



All calculations are based on 80% power for correct conclusion of non-inferiority, an alpha of 0.05, and d = 15%. For all tests, it was assumed that the underlying overall success rate is the same as that observed for the CAS at 2 years post-operative, which is 62.3%.

Data Collection The primary outcome matches the primary outcome used in the IDE study. Overall patient success is defined as:

a. greater than or equal to 40 point improvement in total Buechel-Pappas Scale score

b. No device failures, revisions, or removals

c. Radiographic success (no clinically significant radiographic evidence of loosening, tilting or migration greater than 4mm)

d. No major complications

Secondary Endpoints

In addition, information on the following efficacy outcomes is being assessed:

Total Buechel-Pappas Scale score

Pain Visual Analog Scale (VAS) (100mm scale)

Quality of Life (SF-36)

AOFAS The following radiographic endpoints are being assessed by anterior/posterior and lateral radiographs:

Radiolucency

Migration

Information regarding the following outcomes is being assessed:

All adverse events, including information concerning the nature, onset, duration, severity, and relationship to the device and operative procedure.

Follow-up Visits and Length of Follow-up 24 months


OSB Lead-Actual Conditions of Use Study (STAR 2) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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