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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-Long Term


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General
Application Number P050039 / PAS001
Current Plan Approved 12/09/2010
Study Name OSB Lead-Long Term
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, multi-center, open label clinical study. Up to ten (10) centers around the United States will participate in this study. However, because of the lack of progress on the original PAS, FDA asked the sponsor to redesign the PAS. The PAS was revised per a FDA letter dated 7/14/09. The new protocol is not approved yet [Aug 13, 2010]. The description presented here is for the old study.
Study Population Description The study population is comprised of patients implanted in the United States and potentially outside the United States in Greece and/or France. Sample size and power calculations are not provided in the protocol. Patients who receive the Novation Ceramic Articulation System for Non-inflammatory Degenerative Joint Disease
Sample Size prospective and retrospective cohort, active surveillance, up to 10 clinical sites in prospective and retrospective cohort, and 7 sites in active surveillance

Data Collection The first phase of the study extending through 5 years of patient follow-up, will consist of clinical examination, including the determination of a Harris Hip Score, radiographic examination and the collection of subject self-assessment data. These data will be obtained pre-operatively, immediately post-operatively, at three months, and annually up to five years. An independent radiographic review will be conducted at five years



In the second phase, during postoperative years 6-10, an outcomes questionnaire will be mailed to subjects to determine the status of their hip replacement. No clinical and/or radiographic examinations are proposed for this time period.



The study endpoints are as follows:



Efficacy Endpoints

1) Survivorship of the Novation Ceramic AHS system at 2, 5, and 10 years.

2) Patient success defined as:

- Absence of revision

- Harris Hip Score greater than or equal to 70

- No complete radiolucencies



The following endpoints will also be evaluated at the 2-year follow-up:

- Harris Hip Score

- Radiographic assessment

- SF-12



Safety endpoints will encompass complication rates, including incidence, severity and the relationship to the device.

Follow-up Visits and Length of Follow-up The length of patient follow-up is 10 years. Follow-up visits will occur pre-operatively, immediately post-operatively, at six weeks, six months, and annually up to five years.

Study subjects will receive annual questionnaires from postoperative years 6 through 10.

Final Study Results
Interim Safety Information Study is being revised


OSB Lead-Long Term Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 07/04/2008 07/03/2008 On Time
2 year report 07/04/2009 07/01/2009 On Time
3 year report 07/04/2010 07/06/2010 Overdue


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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