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

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OSB Lead-Short to Mid-Term f/u of New US Patients


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General
Study Status Study Pending
Application Number P150030 / PAS002
Date Current Protocol Accepted  
Study Name OSB Lead-Short to Mid-Term f/u of New US Patients
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Prospective cohort A total of 10 US sites will be enrolled. The US sites will represent a broad cross-section of hospitals.
Study Population Description US patients who receive the device in the post market environment
Sample Size A total of 183 study subjects will be enrolled.
Data Collection The primary endpoint is overall study success at 3 years post procedure. Success is defined the same way it was in the premarket cohort, to allow comparison. Overall Success is defined as:

No component revision, and

Modified Harris Hip Score (mHHS) of at least 80 points, and

No radiographic failure, defined as:

No radiolucencies greater than 2 mm in 50% or more in any of the cup or stem zones, no femoral or acetabular subsidence greater than or equal to 5 mm from baseline, and no acetabular cup inclination changes greater than 4 degree.

Secondary endpoints include clinical assessments of pain and function using the Harris Hip Score, radiographic findings and implant survivorship.
Follow-up Visits and Length of Follow-up Patients will be followed for 3 years


OSB Lead-Short to Mid-Term f/u of New US Patients Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 04/17/2017 04/17/2017 On Time
one year report 10/17/2017 10/12/2017 On Time
18 month report 04/17/2018    
two year report 10/17/2018    
three year report 10/17/2019    
four year report 10/16/2020    
five year report 10/16/2021    


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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