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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-Novation PAS


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General
Application Number P050039 / PAS002
Current Plan Approved 12/09/2010
Study Name OSB Lead-Novation PAS
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 multi-center, open-label clinical study. Prospective and retrospective enrollment

is allowed.
Study Population Description Patients who are scheduled to undergo total hip arthroplasty with a hard bearing

prosthesis should be screened for enrollment in this post approval study. Likewise,

patients who previously underwent total hip arthroplasty with the NOVATION Ceramic

AHS with one of the femoral stems allowed in this protocol may be screened for

enrollment. Screening of patients who previously received the device should include any

patients who have subsequently undergone revision, as the events leading to the revision

will provide valuable information about the safety and effectiveness of the device.

Patients who meet all inclusion criteria and no exclusion criteria will be asked to participate in the study.
Sample Size Up to ten (10) centers will participate in this study.

125 hips.
Data Collection The objective of this study is to gather supplementary long-term information regarding

the safety and efficacy of the NOVATION Ceramic AHS.



Efficacy Endpoints

¿ Survivorship of the NOVATION Ceramic AHS at 2, 5, and 10 years follow-up



¿ Patient success (defined by inclusion of all the criteria below) will be provided

annually out to 5 years follow-up:

o Absence of revision

o Total Harris Hip Score ≥ 80

o No complete radiolucencies as determined by radiographic evaluation of 3

views: acetabular AP view (3 zones1), femoral stem AP view (7 Gruen2

zones), and femoral stem lateral view (7 Gruen zones).

Complete radiolucency is defined to be present if there is any radiolucency

present in all the zones comprising that view. Absence of complete

radiolucency is defined to be present if none of these three views have

complete radiolucency.



A non-successful patient outcome will be characterized as one or more of the

following:

o Revision of any device component of the NOVATION Ceramic AHS;

o Total Harris Hip Score less than 80; or

o Complete radiolucencies as defined above.



● Harris Hip Score, SF-12, and radiographic findings will be evaluated, as per the

Study Procedures section, and reported annually until all patients have reached 5

years of follow-up.



Safety Endpoint

¿ Complication rates, including incidence, severity, and relation to device.



Follow-up Visits and Length of Follow-up

Visit Windows

Subjects shall have visits completed within the following allowable windows:

Visit Visit Window

Preop (baseline) Within 2 months prior to surgery

6 Week +/- 2 weeks

6 Month +/- 1 month

Annual Visits (Years 1-5) +/- 2 months

Annual Questionnaires (Years 6-10) +/- 2 months



10 years





OSB Lead-Novation PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
12 month report 08/03/2011 07/25/2011 On Time
yearly report 08/03/2012 07/02/2012 On Time
Yearly report-active surveillance 08/28/2012 08/28/2012 On Time
year report 08/03/2013 07/05/2013 On Time
12-Month Interim-Active Surveillance Status Report 08/30/2013 08/28/2013 On Time
yearly report 08/30/2014 07/03/2014 On Time
Active Surveillance Report 09/04/2014 09/04/2014 On Time
yearly report 08/27/2015 07/01/2015 On Time
Active Surveillance Report 09/04/2015 08/27/2015 On Time
Active Surv Report 03/04/2016 02/29/2016 On Time
yearly active surveillance report 08/27/2016 08/30/2016 Overdue/Received


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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