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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 PAS


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General
Study Status Progress Adequate
Application Number P100006 S005/ PAS001
Date Current Protocol Accepted 06/11/2019
Study Name 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 Adult: >21
Detailed Study Protocol Parameters
Study Design Description The study is designed to assess the long-term (out to 6 years post-op) performance of AUGMENT Injectable compared to autograft by continued follow-up of available subjects from several prospective clinical studies (protocols BMTI-2009-01, BMTI-2010-01, and BMTI-2006-01 (autograft only)). No new subjects will be enrolled. Subjects and radiologists will remain blinded. Subjects will be informed of their treatment after the last evaluation.

Study is intended to address the following questions:

Can it be assessed and confirmed that bridging bone occurs in the long-term after AUGMENT® Injectable has been resorbed?

Are the improvements in clinical outcomes associated with the use of AUGMENT® Injectable sustained long-term?

Does the promotion of existing tumors from a nonmalignant to malignant state at longer time-points in patients treated with AUGMENT® Injectable exceed the expected rate of promotion in patients not treated with AUGMENT® Injectable or other growth factors used to promote fusion?

Study Population Description study group: AUGMENT Injectable graft with fused joints stabilized by metallic fixation hardware

control group: autograft with fused joints stabilized by metallic fixation hardware

Sample Size 88 projected from 179 potential prior subjects

actual sample size may be modified to address discrepancies
Data Collection Primary Effectiveness Endpoints:

Pain on weight bearing (via VAS)

Confirmation of bridging bone via CT

Subject function as determined by AOFAS, FFI

Primary Safety Endpoints:

Presence of all treatment related adverse events (i.e., description, frequency, incidence, time to onset of first event, severity, duration, treatments administered, etc.)

Presence of serious unanticipated adverse device effects

rhPDGF-BB antibody status

Significant medical conditions, including incidence of cancer

Presence of clinically important events

Functional Assessments

Subjects will assessed using the pain, function and quality of life data instruments:

Fusion Site Pain via VAS score (FSP)

Weight Bearing Pain Assessment at Fusion Site via VAS score (WBP)

Graft Harvest Site Pain via VAS score (GHSP)

Foot Pain and Disability Index (FFI)

AOFAS Hindfoot/Ankle Score (AOFAS)

Safety Assessments

Subjects will be assessed for safety parameters and events, including:

Presence of all treatment related adverse events

Presence of serious unanticipated adverse device effects (UADE)

rhPDGF-BB antibody status

Presence of clinically important events as defined below:

- Musculoskeletal and connective tissue disorders (severe pain,

swelling and/or arthralgia in the treated foot/ankle joint(s));

- Additional surgery of the original treated joint due to non-union.

- Neoplasms benign, malignant and unspecified (including cysts

and polyps) (all lower level terms associated with neoplasms)

- Complications related to bone graft harvest site
Follow-up Visits and Length of Follow-up Subjects will be followed out to at least 5 years post-op


Long-term PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/11/2018 12/11/2018 On Time
one year report 06/12/2019 06/10/2019 On Time
two year report 06/11/2020    
three year report 06/11/2021    
four year report 06/11/2022    
five year report 06/11/2023    


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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