• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

  • Print
  • Share
  • E-mail
-

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.

Learn more...


           

Short-Mid-Term F/u of New COC36 patients


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Inadequate
Application Number P070026 S004/ PAS002
Date Current Protocol Accepted 06/26/2020
Study Name Short-Mid-Term F/u of New COC36 patients
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Design Description A prospective, non-controlled, non-randomized, multicenter study. A minimum of 170 subjects will be prospectively enrolled into the study. Study sites will be comprised of both IDE study sites, as well as newly recruited sites. Subjects will be seen for a preoperative (pre-op) clinic visit at the time of consent, and then at 6-weeks, 1-year, 2-years, 3-years, 4-years and a minimum of 5-years postoperatively (post-op). If Subjects are not willing or able to return for a clinical and radiographic follow-up in the 3- and/or 4-year interval, then a telephone interview may be utilized for the purpose of determining device survivorship/patient satisfaction and case report form (CRF) 4b will be used. It is anticipated that a minimum of 136 unrevised subjects in this PAS will have a minimum 5-year post-op clinic evaluation.

Up to fifteen (15) sites will participate, consisting of up to 5 sites who participated in the IDE study and the remainder being newly recruited sites.

Study Population Description Newly enrolled subjects at participating sites who meet the inclusion/exclusion criteria for this study.

Sample Size 170 patients

Data Collection Primary endpoint:

Device survivorship, which will be estimated with a Kaplan-Meier survivorship analysis at 5-years post-operatively.



Secondary endpoints:

Device survivorship will also be estimated at each year post- operatively.

Harris Hip scores, Subject-hip outcomes, radiographic evaluation, and type and frequency of AEs will also be estimated at each year post-operatively.



Follow-up Visits and Length of Follow-up Study Duration: The anticipated duration of this investigation is approximately seven years from the time of study initiation given that

It may take up to a minimum of 2-years from the time of study initiation to enroll new subjects.

Each subject will be followed until they have completed their minimum 5-year follow-up.

The study will be closed when all subjects are at 5-years post-operatively.







Short-Mid-Term F/u of New COC36 patients Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/01/2013 10/01/2013 On Time
one year report 04/02/2014 04/02/2014 On Time
18 month report 10/01/2014 10/01/2014 On Time
two year report 04/02/2015 03/31/2015 On Time
quarterly report 10/24/2015 10/13/2015 On Time
quarterly report 01/24/2016 01/19/2016 On Time
three year report 04/01/2016 04/01/2016 On Time
quarterly report 07/20/2016 07/20/2016 On Time
Quarterly Report 10/18/2016 10/18/2016 On Time
quarterly report 01/23/2017 01/23/2017 On Time
clarifications to R29 Report 04/18/2017 04/18/2017 On Time
four year report 05/16/2017 05/17/2017 Overdue/Received
quarterly report 07/20/2017 07/20/2017 On Time
quarterly report 10/18/2017 10/18/2017 On Time
six year report 04/01/2018 03/30/2018 On Time
quarterly report 07/23/2018 07/23/2018 On Time
quarterly report 10/23/2018 09/11/2018 On Time
seven year report 04/01/2019 03/28/2019 On Time
eight year report 04/02/2020 03/23/2020 On Time
nine year report 04/02/2021 03/29/2021 On Time
10 year report 04/02/2022    


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

-
-