f Post-Approval Studies (PAS) Database
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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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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) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Long term


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General
Study Status Redesigned/Replaced Study
Application Number /
Requirement Number		 P040051 / PAS001
Date Original Protocol Accepted 05/12/2006
Date Current Protocol Accepted 05/12/2006
Study Name Long term
Device Name STELKAST SURPASS ACETABULAR SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The study design is a prospective cohort. This 10-year postapproval study would be conducted to evaluate the longer-term safety and effectiveness of the Stelkast Surpass Acetabular System. The recruitment of patients, physicians and health care facilities in the post-approval study for this device has been inadequate.Due to enrollment problems. in a letter dated, July 14, 2009, FDA requested a revised post-approval study. The new protocol is not approved yet [Aug 13,2010]. The description presented here is for the old study
Study Population Patients who have been implanted with Stelkast Surpass Acetabular System is a ceramic/ceramic acetabular bearing couple for a total hip prosthesis.
Sample Size 300 subjects enrolled
Key Study Endpoints Study endpoints include device revision and Harris Hip Score during the first five years of follow-up.
Follow-up Visits and Length of Follow-up Patients will undergo clinical and radiographic examination for their first five ears of follow-up. During their last 5 years of follow-up patients will receive questionnaires regarding the status of their total hip replacements.


Long term Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 05/12/2007 05/10/2007 On Time
2 year report 05/11/2008 05/07/2008 On Time
3 year report 05/11/2009 05/06/2009 On Time
5 year report 05/11/2011 05/10/2011 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

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