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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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Long Term Study

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Study Status Progress Adequate
Application Number P070001 / PAS001
Date Current Protocol Accepted 08/12/2008
Study Name Long Term Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective cohort to continue follow-up of the subjects who participated in (1) the IDE premarket study and (2) the continued access study.

Study Population Description The study population is as per device indication. The study includes IDE and CAS subjects. This device is indicated for skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable symptomatic cervical disc disease (SCDD). Symptomatic cervical disc disease is defined as neck or arm (radicular) pain and/or a functional/neurological deficit with at least one of the following conditions confirmed by imaging (CT, MRI, or X-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or loss of disc height. The ProDiscTM-C Total Disc Replacement is implanted via an open anterior approach. Patients receiving the ProDiscTM-C Total Disc Replacement should have failed at least six weeks of non-operative treatment prior to implantation of the ProDiscTM-C Total Disc Replacement.
Sample Size 239 ProDiscTM -C (103 Randomized and 136 Continued Access) and 106 ACDF patients for a total of 345 patients
Data Collection A patient will be considered an overall success if all of the following conditions are met:

The patient's NDI score improves by at least 20% over preoperative baseline value;

The patient's neurologic parameters, i.e. motor sensory, and reflexes are maintained or improved as compared to preoperative baseline value

No removals, revisions, re-operations or additional fixation were required to modify any implant

No adverse events occur which are related to the treatment.

Follow-up Visits and Length of Follow-up Data will be collected at 36, 48, 60, 72 and 84 months postoperative
Interim or Final Data Summary
Interim Safety Information So far, since the approval of the device (December 17, 2007), a total of 86 Adverse Events (AEs) from 40 ProDisc-C patients (39% of 103) and 98 AEs from 47 ACDF control patients (44% of 106) have been reported in the post-approval period follow-up of the IDE cohort as of November 23, 2009. During the same period, 188 AEs from 74 ProDisc-C patients (54% of 136) reported in the CAS cohort. For implant-related AEs, the CAS cohort had 2 cases (1 upper extremity pain and one index level surgery); and ACDF patients in the IDE cohort had 1 implant-related surgery.
Actual Number of Patients Enrolled PDC: 103

ACDF: 106

PDC-CA: 135

Total: 345
Actual Number of Sites Enrolled Clinical sites: 14
Patient Follow-up Rate At 84-month:

PDC: 93.9%

ACDF: 92.8%

PDC-CA: 83%
Final Safety Findings Death: There were 12 instances of death for enrolled subjects though 10 deaths (10/345, 2.9%) occurred within the

study window. There are 3 deaths in the PDC cohort (3/103, 2.9%), which is not significantly different from the

control group

Adverse events: PRODISC C is not statistically different from ACDF when categorizing the data by the

number of AEs. In the PDC group, there are 47 mild AEs (47/103, 45.6%), 38 moderate AEs (38/103,

36.9%), and 38 severe AEs (38/103, 36.9%).

Device Underwent Surgical Intervention: 6 PDC subjects (6/103, 5.8%), 6 PDC-CA (6/135, 4.4%) subjects

and 18 ACDF (18/106, 17.0%) subjects underwent subsequent surgical interventions at the index level.
Final Effect Findings The results of Overall Success analyses indicate that the PRODISC C maintains non-inferiority to the

ACDF control group in 7-year follow-up in both the primary analysis (Sponsor’s definition) and the

additional analysis (FDA’s definition) of Overall Success.
Study Strengths & Weaknesses This is a clinical study with a control group as the comparator which increased the internal validity in

clinical interpretation. This study has a long range of follow-up (7 years) with a decent follow-up rate for

a large sample size (345 patients).
Recommendations for Labeling Changes Labeling change is recommended to reflect the long-term data from the post-approval study. The

labeling change should include a new section on the label showing a summary of the post-approval

study methods (including study objectives, design, population, number of enrolled sites/subjects, key

endpoints, follow–up visits etc.), final results and study strengths and limitations of the PAS.

Long Term Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
Long term study 6 month report 06/16/2008 06/18/2008 Overdue/Received
1 year report 12/16/2008 12/17/2008 Overdue/Received
18 month report 06/16/2009 06/18/2009 Overdue/Received
2 year report 12/16/2009 12/22/2009 Overdue/Received
3 year report 12/24/2010 12/23/2010 On Time
4 year report 12/16/2011 12/19/2011 Overdue/Received
5 year report 12/15/2012 12/17/2012 Overdue/Received
6 year report 12/15/2013 12/13/2013 On Time
7 year report 12/15/2014 12/15/2014 On Time
audit report 10/16/2015 10/15/2015 On Time
audit update report 01/16/2016 01/15/2016 On Time
final report 08/31/2016 08/31/2016 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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