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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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ODE Lead-Post-Approval Clinical Study


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General
Study Status Progress Adequate
Application Number P120024 / PAS001
Date Current Protocol Accepted  
Study Name ODE Lead-Post-Approval Clinical Study
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The PAS is a continuation of the completed pivotal IDE study which was a prospective, randomized (2:1), single-masked, controlled, multi-center, non-inferiority clinical trial to evaluate the safety and effectiveness of the activL® Disc (investigational device) as compared to two different lumbar total disc replacement devices as a combined control group (Charité or ProDisc-L according to investigator preference) in treating single-level DDD of the lumbar spine (L4/L5, or L5/S1) that has been unresponsive to at least six months of conservative treatment.
Study Population Description The IDE study population consisted of subjects with Degenerative Disc Disease (DDD) of the lumbar spine (L4-L5, or L5-S1) from the investigator?s practice who had failed to improve with conservative treatment for at least six months prior to enrollment. Subjects who presented for evaluation or treatment of lower back pain or leg pain were potential candidates for the study and were to be evaluated for inclusion based on the following inclusion/exclusion criteria. A screening form was completed for subjects evaluated. A subject was considered to be enrolled after signing the consent form and meeting all eligibility criteria.



The PAS study population consists of the subjects treated during the IDE study. No new patients will be treated as part of this PAS.

Sample Size The PAS sample size was calculated based on the formula of Farrington and Manning (Statistics in Medicine, 1990, 1447-1454). Calculations were performed in ADDPLAN, version 6. The following assumptions were used for the sample size calculations:

?s= 62%

??= 70%

? = 0.05 (one-sided type 1 error of 0.05)

? = 0.20 (80% power)

? = 15%

2:1 randomization ratio



Note: Success rates were estimated for both treatment groups, based upon the observed 4 year data to date for the post-approval composite endpoint of individual subject success.



Design Characteristic Solution

Sample Size at 7 Years Total: 111

(activL®: 74; Control: 37)

p-value required to pass NI at end of trial 0.05



Utilizing a delta of 10% as required by FDA, the sample size is as follows:

?s= 62%

??= 70%

? = 0.05 (one-sided type 1 error of 0.05)

? = 0.20 (80% power)

? = 10%

2:1 randomization ratio



Note: Success rates are estimated for both treatment groups, based upon the observed 4 year data to date for the post-approval composite endpoint.



Design Characteristic Solution

Sample Size at 7 Years Total: 184

(activL®: 123; Control: 61)

p-value required to pass NI at end of trial 0.05

Data Collection PAS Primary Endpoint

The primary study endpoint for the PAS is the same composite of effectiveness and safety measures for an individual subject (individual subject success) as was used in the IDE. Primary endpoint data will be evaluated annually; however the primary evaluation time point will be 7 years post-surgery:



?Improvement of at least 15 points in the ODI score at 7 years compared to baseline;

?Maintenance or improvement in neurological status at 7 years compared to baseline as measured by motor and sensory evaluations. A decrease of one grade in either evaluation will be considered a failure.

?Maintenance or improvement in motion at the index level, defined as:

7 year ROM ? preoperative ROM > 0 (with +2º measurement error applied) in a patient who does not meet the definition of fusion.

?No device failures requiring Subsequent Surgical Intervention (SSI) (e.g., revision, re-operation, removal, or supplemental fixation at the level of the original implant).

?Absence of serious device-related adverse events as adjudicated by the CEC.



In addition, because the ROM success component of the primary endpoint was such a notable driver of the difference in overall success rates in favor of activL when comparing the two randomized treatment groups during the IDE, FDA will request an additional analysis of overall success without the ROM success component for the PAS as was done during the IDE.



PAS Powered Secondary Endpoints

?Back Pain, measured at rest using a visual analog scale (VAS). A patient will be considered a responder if, at the 7 year visit, they achieve at least a 20 mm VAS improvement compared to baseline on a 100 mm VAS scale.

?Leg Pain, measured at rest using a visual analog scale (VAS). A patient will be considered a responder if, at the 7 year visit, they achieve at least a 20 mm VAS improvement compared to baseline in the leg with the maximum pain at baseline on a 100 mm VAS scale, with no worsening in the other leg.



PAS Unpowered Secondary Endpoints

?The mean Oswestry Disability Index score, as well as the mean improvement, will be compared between groups across all study visits. The incidence of both 15% and 15 point improvements will be compared.

?Quality of Life, measured using the Short Form-36 Questionnaire (SF-36) will be compared between groups across all study visits; improvement of 15% in the overall score at each visit compared to baseline will be considered clinically significant.

?Disc height (incidence of 3mm change), as measured by standard lateral radiographs, will be compared between groups across all study visits.

?Incidence of subsidence of the device (>3 mm) at all study visits.

?Neurological status at all study visits compared to baseline.

?Safety: The individual incidence rates of all adverse events at all study visits through 7-years follow-up.



Follow-up Visits and Length of Follow-up 7 years

Annually


ODE Lead-Post-Approval Clinical Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 02/08/2016 02/02/2016 On Time
one year report 06/10/2016 06/10/2016 On Time
18 month report 12/09/2016 12/09/2016 On Time
Final Report 08/31/2017 08/31/2017 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
20993-0002

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

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