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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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10 Year Extended f/u of IDE Subjects

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Study Status Completed
Application Number P090029 S003/ PAS001
Study Name 10 Year Extended f/u of IDE Subjects
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description 10 Year Extended Follow-up of IDE Subjects Treated with the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels is a 10-year post-approval study (PAS) to evaluate the longer term safety and effectiveness of the PRESTIGE LP™ Cervical Disc.

This study has a multi-center, prospective, randomized, controlled design. The bi-level ACD-LP treatment will be compared to the control treatment, a bi-level anterior cervical fusion procedure involving cortical ring allograft and the ATLANTIS® Cervical Plate System.

Study Population Description Patients who have been diagnosed with symptomatic cervical degenerative disc disease at two adjacent levels (from C3-C7) according to the specified inclusion/exclusion criteria as stated in the protocol (Version G).
Sample Size 397 subjects treated in the pivotal investigational device exemption (IDE) study (209 2-level PRESTIGE LP™ subjects and 188 2-level ACDF control subjects)
Data Collection The primary endpoint was (individual subject) overall success at 24 months, a composite variable which included safety and effectiveness considerations, and was defined as follows:

1. Postoperative Neck Disability Index (NDI) score improvement of at least a 15-point increase from preoperative;

2. Maintenance or improvement in neurological status;

3. No serious adverse event classified as implant associated or implant/surgical procedure associated (as determined by an independent clinical adjudication committee); and

4. No additional surgical procedure classified as a “failure.

Secondary endpoints, measured in both treatment groups, included neck pain, arm pain, quality of life (SF-36 Physical Component Score [PCS] and Mental Component Score [MCS]), gait assessment (Nurick’s classification), subject satisfaction, subject perceived effect, physician perception of results, radiographic success (defined differently in the two treatment groups), range of motion, Functional Spinal Unit (FSU) height, implant condition, heterotopic ossification, and return to work.

Follow-up Visits and Length of Follow-up 120 months (+/-3 months)
Interim or Final Data Summary
Actual Number of Patients Enrolled 181 subjects in the Investigational (INV) cohort (down from 209 enrolled in the IDE trial due to clinical sites not participating at 120 months); 160 subjects in the Control (CTR) cohort (down from 188 enrolled in the IDE trial)
Actual Number of Sites Enrolled 19 investigational sites
Patient Follow-up Rate INV follow-up rate was reported as 86.0% at 120 months; CTR follow-up rate was reported as 84.9% at 120 months
Final Safety Findings There was no difference in the risk of subjects experiencing an adverse event between the INV group and the CTR group. There were fewer subjects experiencing a secondary surgical intervention in the INV group compared to the CTR group
Final Effect Findings Bayesian analyses shows a posterior probability of non-inferiority of essentially 100% and a posterior probability of superiority of 99.9% for overall success of the INV group compared to the CTR group.
Study Strengths & Weaknesses This Extended Follow-up study successfully demonstrated superiority of the 2-level Prestige LP disc compared to the 2-level ACDF control group. While the closure of several clinical sites introduce a potential source of bias related to possible clinical differences between patients in the 120 month PAS group and patients not participating, an analysis of the baseline demographic data and last observed effectiveness outcomes for missing subjects compared to subjects observed at 120 months indicate that there is no statistically significant difference between groups. Additional results of a tipping point sensitivity analysis show that the non-inferiority and to a lesser degree the superiority conclusions, are robust to the missing data.
Recommendations for Labeling Changes Labeling changes were recommended to reflect the 120 month outcomes.

10 Year Extended f/u of IDE Subjects Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 01/05/2017 12/20/2016 On Time
one year report 07/07/2017 07/06/2017 On Time
18 month report 01/05/2018 12/01/2017 On Time
two year report/Final Report 09/28/2018 09/14/2018 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

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