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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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Ceramic Transcend Hip


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General
Study Status Completed
Application Number /
Requirement Number		 P010001 / PAS001
Date Original Protocol Accepted 02/03/2003
Date Current Protocol Accepted  
Study Name Ceramic Transcend Hip
Device Name CERAMIC TRANSCEND HIP ARTICULATION SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives There is No PAS study protocol for this examination. As per approval order the sponsor agreed to provide long term (i.e., 5 years) data for a minimum of 175 procedures selected from the original PMA complete follow-up cohort and 25% of N=630 Continued Access Procedures. A minimum of 175 procedures were to have completed the Hip Survey and underwent independent radiographic review at a minimum of 5 postoperative years.
Study Population This device is indicated for primary total hip arthroplasty in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, congenital hip dysplasia, and traumatic arthritis. The study population is subjects from the premarket cohort.
Sample Size 175 Patients
Key Study Endpoints Used the Ceramic TRANSCEND Hip Study Survey form and A-P and lateral radiographs of the implanted hip.
Questions on the Ceramic TRANSCEND Hip Study Survey Form: 1. Is your artificial hip in place? Yes or No; If not, when was it removed? 2. How well do you feel your artificial hip is functioning?; Excellent, good, fair, poor; 3. Have you had x-rays taken of your hip in the last year? Yes or No; 4. Do you expect to have your hip implant removed or replaced in the immediate future? Yes or No; If yes, when?___________________; Name of doctor who will remove or replace your hip implant_________________
Follow-up Visits and Length of Follow-up Required continued follow-up through 5 years with annual assessments.


Ceramic Transcend Hip Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
Final Report 11/05/2010 11/05/2010 On Time
response to R10 A1 RDEF-final report 04/19/2012 04/20/2012 Overdue/Received


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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