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


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General
Study Status Delayed
Application Number /
Requirement Number		 P150030 / PAS002
Date Original Protocol Accepted 10/17/2016
Date Current Protocol Accepted 12/07/2018
Study Name Short to Mid-Term f/u of New US Patients
Device Name R3 DELTA CERAMIC HIP SYSTEM
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 Objectives The study design is prospective cohort, new enrollment.
Study Population The study population is comprised of US patients who receive the device in the post market environment. The comparator group is comprised of patients in the European premarket cohort.
Sample Size A total of 183 study subjects will be enrolled.
Key Study Endpoints 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.
Follow-up Visits and Length of Follow-up Patients will be followed for 3 years
Interim or Final Data Summary
Interim Results Number of study sites enrolled 10 sites
Number of subjects enrolled 189 subjects
Follow-up rate Complete follow-up of patients at 3-years is 90/161 (56%)
Summary of Interim Results
There were no reports of unanticipated adverse device effects.
Four (4) deaths occurred, One (1) failure and revision for recurrent dislocation
Strengths and Weaknesses
A strength of the study is its adequate power to detect differences in short-term device survival between the US post-market cohort and the European ore-market cohort. A weakness of the study is the absence of long-term follow-up to assess long-term device performance


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

Reporting 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 04/16/2018 On Time
two year report 10/17/2018 10/15/2018 On Time
three year report 10/17/2019 10/15/2019 On Time
four year report 10/16/2020 10/16/2020 On Time
5 year report 10/16/2021 10/12/2021 On Time
6 year report 10/16/2022 10/14/2022 On Time
7 year report 10/16/2023 10/31/2023 Overdue/Received
final report 03/29/2024    


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

Additional Resources

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