f Post-Approval Studies (PAS) Database
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

  • Print
  • Share
  • E-mail

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.

Learn more...


Long Term PAS

Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Study Status Progress Adequate
Application Number /
Requirement Number
P010014 / PAS001
Date Original Protocol Accepted 04/21/2004
Date Current Protocol Accepted 01/04/2013
Study Name Long Term PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a prospective, multi-center, non-randomized study to evaluate two-year post-operative complications among patients implanted with Oxford Meniscal Unicompartmental Knee System and 9-year long-term survivorship of the device.
Study Population This device is indicated for use in patients with osteoarthritis or avascular necrosis limited to the medial compartment of the knee and intended to be implanted with bone cement. The study population includes patients who are 18 years or older, undergoing primary knee arthroplasty for either Osteoarthritis or Avascular necrosis of the medial compartment of the knee, and meet other inclusion/exclusion criteria will be included in this study.
Sample Size 389 knees
Key Study Endpoints For Phase 1 (0-2 years), the study endpoint is complications, which is defined as "Any untoward medical occurrence in a patient administered a medical device and which does not necessarily have to have a causal relationship with this treatment. For Phase II, the study endpoint is "removal and/or revision of any component of the device".
Follow-up Visits and Length of Follow-up In Phase 1, patients will be followed clinically at 6 weeks, 6 months, 1- year and 2- year post-operation. Information gathered includes all adverse events and survival data. In Phase II (3-9 year), only the device survival data will be gathered through patient direct mailing and/or phone call annually.
Interim or Final Data Summary
Interim Results As of April 2, 2010, there have been 5 deaths reported due to pancreatic cancer (n=1), heart failure (n=1), leukemia (n=1), terminal illness (n=1) and unknown cause (n=1); as well as 11 revisions out of 388 knees implanted.
Actual Number of Patients Enrolled The patient population includes 354 patients and 388 knees that underwent primary partial knee arthroplasty for either osteoarthritis or avascular necrosis of the medial compartment.
Actual Number of Sites Enrolled A total of 6 clinical sites enrolled patients in the post-approval study.
Patient Follow-up Rate The patient post-operative follow-up rates in the study were as follows: 98.2% at 6 weeks, 86.4% at 3 years, 84.2% at 6 years, 82.9% at 8 years and 82.4% at 9 years. The overall follow up rate is 86.8%.
Final Safety Findings There were 130 complications in 388 knees (16.8 complications/ 100 patient years) from the PAS group and there were 4 complications in 125 knees (1.6 complications /100 patient years) from the historical control IDE group (p-value <0.001). The overall 9-year revision rate is at least 12.4%.
Final Effect Findings The 9-year cumulative device survivorship for all patients in this post-approval study was 86.56% (95% CI: 82.54, 89.71)
Study Strengths & Weaknesses Study strengths included an adequate sample size and follow-up rate. A study weakness was the absence of optimal comparability for the collection of complication data between the post-approval study and historical control-IDE groups.
Recommendations for Labeling Changes The labeling of this device should be updated with the results of this post-approval study.

Long Term PAS Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 year Report 04/18/2007 04/18/2007 On Time
2 year report 04/20/2008 04/29/2008 Overdue/Received
36 month report 04/20/2009 04/21/2009 Overdue/Received
5 year report 04/20/2010 05/03/2010 Overdue/Received
6 year report 06/21/2011 06/22/2011 Overdue/Received
7 year report 04/19/2012 04/19/2012 On Time
8 year report 04/19/2013 04/29/2013 Overdue/Received
9 year report 04/19/2014 04/21/2014 Overdue/Received
10 year report 04/18/2015 04/20/2015 Overdue/Received
11 year report 04/18/2016 04/19/2016 Overdue/Received
12 year report 04/18/2017 04/19/2017 Overdue/Received
13 year report 04/18/2018 04/12/2018 On Time
final report 06/17/2019 06/17/2019 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

Additional Resources