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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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Long-Term F/U of IDE COC36 patients


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General
Study Status Completed
Application Number P070026 S004/ PAS001
Date Current Protocol Accepted 03/10/2015
Study Name Long-Term F/U of IDE 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 Multi-center, cohort study
Study Population Description Patients will be enrolled from the IDE study
Sample Size It is anticipated that up to 80 subjects from the IDE study implanted

with the 36 mm device will consent to participate.

Data Collection Device revision is the primary endpoint; secondary endpoints

include Harris Hip Scores and radiographic findings.

Follow-up Visits and Length of Follow-up Patients will be followed for 10 post-operative years,

These subjects will be evaluated at the time of consent

(approximately 5 to 7 years post-op), again at a minimum 8 year follow-up interval, and finally at a minimum 10 year follow-up interval.

Interim or Final Data Summary
Actual Number of Patients Enrolled 81 Subjects from among COC36 IDE study subjects.
Actual Number of Sites Enrolled 57 sites were enrolled for the post-approval study.
Patient Follow-up Rate 92% had follow-up with complete datasets at year 8 of follow-up.

81% had follow-up with complete datasets at year 10 of follow-up.
Final Safety Findings No significant differences were noted in the Harris Hip outcomes (total or any sub-score) as well as the acetabular and femoral radiographic summaries. Those who received all approved components (PMA cohort) had a slightly higher percent with any complication compared to subjects who received at least one non-PMA approved component (non-PMA cohort): 88.2% vs. 66.7% (p-value = 0.0237). The percent of subjects with systemic adverse events was slightly higher among the PMA cohort vs. the non-PMA cohort: 76.5% of Subjects vs. 56.7% of Subjects, respectively (p-value = 0.0825). The percentages of Subjects with Surgical Site adverse events was not significantly different for the PMA cohort vs. the non-PMA cohort: 29.4% vs. 26.7%, respectively (p-value = 1.000).
Final Effect Findings The 10-year device survivorship estimate is 96.6%, with a lower 95% confidence limit of 89.7% for those who received all approved components (PMA cohort). The 10-year device survivorship estimate is 96.7%, with a lower 95% confidence limit of 87.3% for those who received one or more non-PMA components.
Study Strengths & Weaknesses Results provided further evidence of the clinical utility and safety of this device.
Recommendations for Labeling Changes Post-approval study findings should be part of the device labeling.


Long-Term F/U of IDE 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
three year report 04/01/2016 04/01/2016 On Time
four year report 05/16/2017 05/16/2017 On Time
five year report 04/01/2018 03/30/2018 On Time
Final Report 04/02/2019 01/17/2019 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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