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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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OSB Lead-Long Term PAS


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General
Study Status Progress Adequate
Application Number P110009 / PAS001
Current Plan Approved 05/08/2014
Study Name OSB Lead-Long Term PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The primary objective of the study is to evaluate the long-term

overall success rate (see primary end-points for the definitions) of the investigational device as compared to the control in subjects enrolled in the pivotal IDE study of the Mobi-C (2- levels) device (IDE Number G050212).

Design-Prospective Cohort, a long term follow-up of the IDE

patients ( investigational and controls)

Study Population Description All eligible Mobi-C patients (n=221 -randomized and n=8 - training cases) treated at two contiguous levels All eligible fusion patients (n=99- randomized at 24-months) treated at two contiguous levels under the LDR-001 Pivotal Study (IDE G050212)
Sample Size Investigational¿n=221 -randomized and n=8 -training cases at treated at two contiguous levels. Control¿ all eligible fusion patients (n=99) treated at two contiguous levels
Data Collection For Mobi-C: Pain/Disability Improvement of at least 25% in the Neck Disability Index (NDI) at 5 years and 7 years; no device failures at the index level requiring revision, re-operation, removal, or supplemental fixation; absence of major complications defined as 1) neurologic deterioration, 2) radiologic failure and 3) adverse events determined to be major complications and related to the study

For Fusion ACDF: evidence of bridging trabecular bone and <2º

total angular motion (from flexion to extension) and <50% radiolucency along the graft/endplate interface and for Mobi- C® subjects radiologic failure is defined as evidence of continuous bridging bone and <2º total angular motion.

Follow-up Visits and Length of Follow-up 7 years at 7th year
Interim or Final Data Summary
Actual Number of Patients Enrolled Out of a total of 339 subjects from the IDE study, 328 subjects were eligible for the PAS, as Mobi-C (221 randomized and 8 training) or ACDF (99) patients treated at two contiguous levels.
Actual Number of Sites Enrolled The pivotal clinical study on two-level Mobi-c involved 24 sites.
Patient Follow-up Rate At the 84-months, the total follow up rate was 82%; however, only 136 two-level Mobi-C subjects (66.3%) and 48 ACDF subjects (57.1%) had Actual ‘in-window’ efficacy data at the final timepoint.
Final Safety Findings No unexpected Mobi-related adverse events were identified in this PAS. As a result, two-level Mobi-c TDR is rendered as a safe alternative to the standard of care procedure (ACDF).
Final Effect Findings Based on the overall success as defined by the protocol-specified composite primary endpoint and alternative primary endpoints, the two-level Mobi-C TDR was shown to be as effective as control ACDF treatment. Non-inferiority for the two-level Mobi-C compared to ACDF with respect to individual subject success was demonstrated up to the time point of 84 months.
Study Strengths & Weaknesses Although this Extended Follow-Up study demonstrated non-inferiority of the investigational two-level Mobi-c device, a further performance analysis of the two-level Mobi-c disc may help with elucidating possible long-term complications such as underdiagnosed Adjacent Level Disease and progressing Heterotopic Ossification, which can hamper long-term motion preservation as the general premise of TDR. In addition, further research on possible sex-based differences in the performance of two-level Mobi-c may augment the current device indications and may enable more informed pre-implantation risk-benefit assessment for the sex-stratified patient subgroups. Further research efforts may be also recommended for clarifying possible sex-related differences in Mobi-c performance at one level vs. two contigious levels: in contrast to a trend to higher overall success rates among males with one-level Mobi-c (P110002), males with the two-level Mobi-c experienced overall success less frequently, compared to their female counterparts (P110009).
Label Changes The current labeling for two-level Mobi-c is recommended to be updated based on long-term device performance (7-years). The labeling changes should include the following in particular:



Language that reflects that owing to possible indeterminate results of radiographic imaging (i.e., shoulder obstruction), the actual incidence of Adjacent Level Disease may be higher than that reported in both – Mobi-c and ACDF - study groups.

Language describing the progression of Heterotopic Ossification which is statistically significant over time (i.e., 84 months vs. 24-months), but for which the clinical significance (e.g., possible ROM limitation despite the anticipated motion preservation in Mobi-c patients) has not been determined.

Language that mentions the possibility of sex-related trends in two-level Mobi-c performance, including the following:

long-term (84-month) overall success outcomes were more frequent among females with two-level Mobi-c vs. females with two-level ACDF, whereas the same trend for males did not reach statistical significance;

males with two-level Mobi-c were less likely to have long-term (84-month) overall success outcomes compared to females with two-level Mobi-c;

long-term, clinically significant Heterotopic Ossification (Grade 3-4) was more likely to occur in males with two-level Mobi-c, compared to their female counterparts



OSB Lead-Long Term PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 02/21/2014 02/21/2014 On Time
one year report 08/23/2014 08/21/2014 On Time
18 month report 02/21/2015 02/23/2015 Overdue/Received
two year report 08/23/2015 08/20/2015 On Time
Final Report 05/27/2016 05/31/2016 Overdue/Received


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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