In January 2005, the oversight responsibility of the Post-Approval 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).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 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 PAS 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 PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Subject enrollment milestones not met,
Follow-up rate below 80%
General Study Protocol Parameters
Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N)
New Data Collection
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
New enrollment, multi-center, prospective cohort
Study Population Description
The study population is comprised of patients aged 50 years and older who have lumbar
spinal stenosis, suffers symptoms of neurogenic intermittent claudication, have moderately impaired physical function, and are able to relieve their symptoms when they bend forward or flex their spines.
The sample size is 240 patients and 30 clinical sites
The primary endpoint is the Zurich Claudication
Questionnaire (ZCQ) score.
Secondary endpoints include Oswestry Disability Index scores
and MRI changes in adjacent discs.
Followup Visits and Length of Followup
The length of follow-up is 5 years.
Office visits are scheduled preoperatively, and at 6 weeks
2, 3, 4, and 5 years postoperatively.
Categorical data will be summarized using frequency tables with
proportions, exact 95% confidence intervals presented. Summaries of continuous data will include mean, standard deviation, median, minimum and maximum. To represent device survival assessment, Kaplan- Meier analyses will be conducted.