N/A
N=414
Augment® Bone Graft (Formerly GEM OS™1 Bone Graft) Compared to Autologous Bone Graft in Foot and Ankle Fusions
Foot Fusion
Bottom Line
View on ClinicalTrials.gov: NCT00583375 ↗Enrolled (actual)
414
Serious AEs
11.8%
Results posted
Feb 2018
Primary outcome: Primary: Subjects Fused at 24 Weeks (as Determined by CT Assessment) — 85; 159 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Augment® Bone Graft (Device); Standard of Care (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BioMimetic Therapeutics
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects Fused at 24 Weeks (as Determined by CT Assessment) |
85; 159 | — |
| SECONDARY Pain on Weight Bearing |
87; 167; 12; 14; 12; 25 | — |
| SECONDARY Pain at Fusion Site |
71; 144; 15; 20; 21; 39 | — |
| SECONDARY Foot Function Index (FFI) |
106; 190; 4; 19; 14; 16 | — |
| SECONDARY AOFAS Hindfoot and Ankle Score |
94; 180; 19; 27; 14; 35 | — |
| SECONDARY SF-12 Physical Component Score |
106; 203; 22; 38; 5; 8 | — |
Summary
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
Eligibility Criteria
Inclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT00583375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.