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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

Fusion, AEs, Surg Procedures


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General
522 Number / Requirement Number PS090007 / PSS001
Current Plan Approved 05/04/2012
Study Name Fusion, AEs, Surg Procedures
Root Document Number K073439 
General Study Protocol Parameters
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective randomized clinical trial to compare incident rates of certain events (see study endpoints section) in the treatment group to those of the control group. The treatment group will include patients treated with the TRANSITION Stabilization System at one or two levels of the thoracic, lumbar and/or sacral spine, with or without interbody fusion. The control group will include patients treated with the REVERE Stabilization System, at one or two levels of the thoracic, lumbar and/or sacral spine, with or without interbody fusion.

Study Population Description Patients with acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine in skeletally mature patients: degenerative spondylolisthesis with objective evidence of neurologic impairment, kyphosis, and failed previous fusion (pseudoarthrosis).

Sample Size 360 patients at 20 sites

Data Collection Fusion, Oswestry Disability Index scores, radiographic findings and device related adverse events

Follow-up Visits and Length of Follow-up Patients will be followed for 24 months: pre-op; discharge; 6 months; 12 months and 24 months.

Final Study Results
Interim Safety Information To sites are enrolled


Fusion, AEs, Surg Procedures Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report due 11/02/2012 11/05/2012 Overdue/Received
1 yr report 05/03/2013 05/08/2013 Overdue/Received
18 month report 11/02/2013 11/05/2013 Overdue/Received
2 year report 05/04/2014 05/02/2014 On Time
3 year report 05/04/2015 05/04/2015 On Time
4 yr report 05/03/2016    


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance 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). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies 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 522 PS 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 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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