• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • 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...


             

ODE Lead MOTION Extend Study


Suggest Enhancement / Report Issue | export reports to excelExport to Excel
General
Study Status Progress Adequate
Application Number P150017 / PAS001
Study Name ODE Lead MOTION Extend Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Evaluate and confirm long-term the established safety and effectiveness of the Cartiva SCI implant.
Study Population Description Subjects treated with Cartiva SCI in the PMA study.
Sample Size All sites which enrolled subjects in the MOTION study will be invited to participate in the PAS, and all subjects at the participating sites and who meet the above inclusion/exclusion criteria will be invited to enroll in the PAS. This includes 135 Cartiva subjects (119 randomized and 16 roll-in) eligible for study participation. Assuming a 15% lost to follow-up rate, it’s estimated that 115 subjects will have 5-year device status determined.



A one group ¿2 test with a 0.05 one-sided significance level will have 80% power to detect the difference between the Null hypothesis proportion, ¿0 + ¿, of 0.235 and the Alternative proportion, ¿A, of 0.142 when the sample size is 115.





Data Collection The primary endpoint will evaluate the long-term safety of the Cartiva implant by demonstrating the following:



1. Durability of the implant over the longer term. This will be addressed using survival analysis starting at Month 24 to determine the rate of implant removals among devices that survived to Month 24. A complementary survival analysis starting at index surgery to end of study will also be performed.

2. There are no unanticipated safety concerns that arise after Month 24 up to 5 years. This will be addressed by a) determining the incidence of serious device-related adverse events per year and overall from Month 24 to Year 5; and b) summarizing device-related radiographic complications1 over time from Month 24 to Year 5. Note that this analysis will address both device and procedure related complications and serious device-related adverse events whether observed previously in the MOTION study or novel.



Secondary

1) Evaluation of maintenance of range of motion

2) Wear characteristics or device degradation for any Cartiva implant removed

3) Pain and function over time (VAS, FAAM ADL and Sports)

4) Evaluation of radiographic findings (radiolucency, bony reactions, and heterotopic ossification) looking at presence or progression from 24 months to 5+ years as well as correlation with the 5+ years clinical outcomes (effectiveness and safety).

Follow-up Visits and Length of Follow-up Each patient will be asked to return for clinical and radiographic evaluations at 5 years post-operative. If a subject, is already past their 5-year visit window, the subject’s 5+ year visit will be used for the 5-year time point. The follow-up window is 4 years and 8 months, or later from surgery. If a subject is unwilling to return to clinic but can provide the status of their implant that information will be included and used for the analysis of the primary endpoint which is survivorship of the implant. The subject will also be asked to complete the subject assessments (VAS and FAAM).


ODE Lead MOTION Extend Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/30/2016 11/30/2016 On Time
one year report 07/01/2017 06/21/2017 On Time
18 month report 12/30/2017    
two year report 07/01/2018    
three year report 07/01/2019    
four year report 06/30/2020    
five year report 06/30/2021    


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

Related Links

-
-