Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft

Study Overview
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Brief Summary
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The objective of this long-term study is to evaluate the long-term effectiveness and safety of AUGMENT® Injectable Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated under protocol BMTI-2009-01 or BMTI-2010-01 or treated with autograft under protocol BMTI-2006-01. Subjects will be asked to consent and return to provide long-term follow-up data at or after 60 months (5 years) have elapsed since their original surgery as a subject in protocol BMTI-2009-01 or BMTI-2010-01. STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Injectable Bone Graft is maintained and remains comparable to that of autologous bone graft over long-term subject follow-up. REGULATORY PHASE: Post-approval study

Official Title
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A Prospective, Controlled, Multi-Center, Post-Approval Trial to Evaluate the Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions

Conditions
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Ankle and Hindfoot Arthrodesis

Intervention / Treatment
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* Device: AUGMENT® Injectable Bone Graft
* Procedure: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be willing and able to provide informed consent and be available for the planned follow-up evaluations and radiologic tests; and Must have been included in the Augment Injectable propensity score matching population from the Augment Injectable summary of safety and effectiveness data (SSED). Exclusion Criteria: 1) Subjects that were excluded from the safety analysis in the BMTI-2009-01 or BMTI-2010-01 study. These subjects were consented, but never treated as part of the BMTI-2009-01 or BMTI-2010-01 protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Autograft<br>Standard Rigid Fixation plus autograft | Procedure: Standard of Care<br>* Autologous Bone Graft<br>|
| AUGMENT® Injectable<br>Standard rigid fixation plus AUGMENT® Injectable Bone Graft | Device: AUGMENT® Injectable Bone Graft<br>* AUGMENT® Injectable Bone Graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on weight bearing via Visual Analog Scale (VAS) | Subjects were asked to stand and report pain on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable). | Visit 1 (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmation of bridging bone via computerized tomography (CT) | Overall Assessment of Osseous Bridging (% Bone Bridging; CT Scans) Absent (0-24%) Minimal (25-49%) Moderate (50-74%) Complete (75-100%) | Visit 1 (Day 0) | 
| AOFAS (American Orthopaedic Foot & Ankle Society) Hindfoot and Ankle Score | Subjects were asked to report pain, functionality and ability levels while the physician performed assessments based on alignment, abnormality, motion, and stability. The total score ranges from a low of zero to a high of 100, with subscales measuring pain (40 points), function (50 points), and alignment (10 points), with higher scores showing better outcomes. | Visit 1 (Day 0) | 
| Foot Function Index, FFI | The Foot Function Index (FFI) measures the impact of foot pathology on function in terms of pain, disability and activity restriction. The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales all ranging from 0-100. To obtain a sub-scale score, the item scores for a sub-scale are totaled and then divided by the maximum total possible for all of the sub-scale items which the subject indicated were applicable. Any item marked as not applicable is excluded from the total possible. Sub-scales are an average of the completed ratings within that sub-scale. The total foot function score is an average of the three sub-scale scores and ranges from 0-100. Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment. | Visit 1 (Day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankle Fusions, AUGMENT® Injectable Bone Graft, Autologous Bone Graft, arthritis, ankle pain, foot pain, hindfoot fracture, ankle fracture