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| General |
| Study Status |
Delayed |
Application Number /
Requirement Number |
P100006 S005/ PAS001 |
| Date Original Protocol Accepted |
06/11/2019
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| Date Current Protocol Accepted |
06/11/2019
|
| Study Name |
Long-term PAS
|
| Device Name |
AUGMENT INJECTABLE
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
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?
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| Study Population |
study group: AUGMENT Injectable graft with fused joints stabilized by metallic fixation hardware
control group: autograft with fused joints stabilized by metallic fixation hardware
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| Sample Size |
88 projected from 179 potential prior subjects
actual sample size may be modified to address discrepancies
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| Key Study Endpoints |
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
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| Follow-up Visits and Length of Follow-up |
Subjects will be followed out to at least 5 years post-op
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| Interim or Final Data Summary |
| Interim Results |
Based on the small amount of data available, the longer-term clinical outcomes and rates and types of adverse events appear to be comparable between the two study groups.
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| Actual Number of Patients Enrolled |
69
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| Actual Number of Sites Enrolled |
15
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| Patient Follow-up Rate |
overall: 69/168 (41.0%)
Augment Injectable: 51/123 (41.4%)
Autograft bone control: 18/45 (40.0%)
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| Study Strengths & Weaknesses |
Because the subjects were enrolled over an extended period of time and the study has not been
completed, final conclusions of longer-term effectiveness and safety cannot yet be made.
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