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U.S. Department of Health and Human Services

Post-Approval Studies

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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

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

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General
Application Number P040033
Most Recent Protocol Version Approved 05/09/2006
Study Name UK Study
Study Status Completed
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 Transit. Adolescent B (as adults) : 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,   show the rest ...
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.   show the rest ...
Final Study Results
Actual Number of Patients Enrolled A total of 350 patients and 400 hips were enrolled in the study.

Actual Number of Sites Enrolled Two study sites in the United Kingdom participated in the study.
Patient Followup Rate The follow-up rate for clinical examination was 89.5% at 10 post-operative years.
Final Safety Findings Heterotopic ossification of all grades was seen in 12.0% at 10 years; however, grade III   show the rest ...
Final Effectiveness Findings At the 10 year follow up, 281/319 (88.1%) had OSHIP (Oswestry-modified Harris Hip Scores) of   show the rest ...
Study Strengths and Weaknesses An important study strength is the 89.5% follow-up rate over 10 years.



A weakness of the   show the rest ...
Recommendations for Labeling Changes Yes. Ten-year device performance data can be updated


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

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