Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions

Study Overview
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Brief Summary
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STUDY OBJECTIVES: Demonstrate equivalent clinical and radiologic outcomes to the gold standard (ABG) in a representative clinical model (hindfoot and ankle fusions) STUDY HYPOTHESIS: Augment® Bone Graft is an equivalent bone grafting substitute to autologous bone graft in applications as shown by non-inferiority analysis STUDY RATIONALE: Evaluate a fully synthetic growth-factor enhanced bone graft substitute to facilitate fusion in conditions or injuries requiring bone graft in a representative clinical fusion model and thus the opportunity to provide equivalent union rates as ABG without necessitating an additional invasive procedure to harvest the graft REGULATORY PHASE: Investigational Device Exemption (IDE) for Premarket Approval (PMA) Application as a bone regeneration system, pivotal phase

Official Title
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A Prospective, Randomized, Controlled, Multi-Center, Pivotal Human Clinical Trial to Evaluate the Safety and Effectiveness of Augment® Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions

Conditions
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Foot Fusion

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Bone defect in the hindfoot or ankle requiring fusion using open surgical technique with supplemental bone graft/substitute, requiring one of the following procedures: Ankle joint fusion Subtalar fusion Calcaneocuboid fusion Talonavicular fusion Triple arthrodesis (subtalar, talonavicular and calcaneocuboid joints) Double fusions (talonavicular and calcaneocuboid joints) Exclusion Criteria: Previous fusion surgery of the proposed fusion site. The patient uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage > 10mg/day). Pregnant or a female intending to become pregnant during this study period. Morbidly obese (BMI > 45 kg/m2)

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>Standard Rigid Fixation plus autograft Standard of Care: Autologous Bone Graft | Procedure: Standard of Care<br>* Autologous Bone Graft<br>|
| Experimental: Group 2<br>Standard Rigid Fixation plus Augment® Bone Graft | Device: Augment® Bone Graft<br>* Augment® Bone Graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects Fused at 24 Weeks (as Determined by CT Assessment) | An independent radiologist examined CT images for all patients' joints and determined whether or not the joint had at least 50% osseous bridging. If a patient demonstrated all joints having at least 50% osseous bridging, this patient was classified as fused. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on Weight Bearing | 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). Clinically significant improvement: ≥20mm decrease from baseline Detectable improvement: 10-20mm decrease from baseline Maintained: <10mm decrease from baseline and <10mm increase from baseline Deteriorated: >10mm increase from baseline | 24 and 52 Weeks | 
| Pain at Fusion Site | Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable). Clinically significant improvement: ≥20mm decrease from baseline Detectable improvement: 10-20mm decrease from baseline Maintained: <10mm decrease from baseline and <10mm increase from baseline Deteriorated: >10mm increase from baseline | 24 and 52 weeks | 
| 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. 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. Lower scores are indicative of better outcomes whereas higher scores indicate greater impairment. Clinically significant improvement: ≥10 point decrease from baseline Improved: 5-10 point decrease from baseline Maintained: <5 point decrease from baseline and <5 point increase from baseline Deteriorated: >5 point increase from baseline | 24 and 52 weeks | 
| AOFAS 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. Clinically significant improvement: ≥20 point increase from baseline Improved: 10-20 point increase from baseline Maintained: <10 point increase from baseline and <10 point decrease from baseline Deteriorated: >10 point decrease from baseline | 24 and 52 weeks | 
| SF-12 Physical Component Score | The SF-12 Physical Component Score is a validated quality of life metric with a minimum of zero and a maximum of 100, with higher scores denoting higher quality of life. Maintenance or improvement: ≥0 point increase from baseline Slight Decline: 0-10 point decrease from baseline Deteriorated: >10 point decrease from baseline | 24 and 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hindfoot fracture, arthritis, ankle pain, foot pain, ankle fracture