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Smith & Nephew BHR FDA-required Post-Approval Studies

Post-Approval Studies

  • In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
  • The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH’s effort to ensure that all PAS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant’s reporting status for each submission due.

Links

  • Post-Approval Studies Workshops

Contact Information

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

General
Application Number P040033
Protocol Approved 05/09/2006
Study Name UK Study
Study Status Progress Adequate
General Study Protocol Parameters
Study Design Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N) No
Data Source New Data Collection
Comparison Group No Control
Analysis Type Analytical
Study Population Transitional Adolescent B: 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study design is a single arm, cohort study.
Study Population Description Study population is as per device indication. Patients who underwent Birmingham Hip Resurfacing (BHR) System, a metal on metal resurfacing artificial hip replacement system, surgically implanted to replace a hip joint. The BHR System is intended for patients who, due to their relatively youneger age or increased activity level may not be suitable for traditional total hip arthroplasty, due to an increased possibility of requiring future ipsilatcral hip joint revision. Study population is as per device indication. Patients who underwent Birmingham Hip Resurfacing (BHR) System,

 

Sample Size The sample size is 350 patients.
Data Collection Study endpoints include OSHIP scores and device survival.
Followup Visits and Length of Followup At the time of PMA submission, all subjects had passed their 5 year post-implantation anniversary. Subjects will be followed annually through the use of self-assessment questionnaires until they reach 10 years of follow-up. At the ten year interval, a final clinical and radiographic examination will occur in addition to the questionnaire. At the time of PMA submission, all subjects had passed their 5 year post-implantation anniversary.

 

UK Study Schedule

Report Schedule

Report
Date Due

FDA Receipt
Date

Reporting Status

2 year report

05/22/2008

05/16/2008

On Time

3 year report

07/08/2009

07/06/2009

On Time

4 year report

05/08/2010

05/06/2010

On Time

5 year report-final report

07/07/2011

07/05/2011

On Time

6 year report

05/07/2012

Overdue

Show All Studie

Links on this page:

Page Last Updated: 06/29/2012

U.S. Food and Drug Administration

10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Email FDA

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