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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 414
- 试验地点
- 37
- 主要终点
- Subjects Fused at 24 Weeks (as Determined by CT Assessment)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Group 1
Standard Rigid Fixation plus autograft
Standard of Care: Autologous Bone Graft
干预措施: Standard of Care (Procedure)
Group 2
Standard Rigid Fixation plus Augment® Bone Graft
干预措施: Augment® Bone Graft (Device)
结局指标
主要结局
Subjects Fused at 24 Weeks (as Determined by CT Assessment)
时间窗: 24 weeks
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.
次要结局
- SF-12 Physical Component Score(24 and 52 weeks)
- Pain on Weight Bearing(24 and 52 Weeks)
- AOFAS Hindfoot and Ankle Score(24 and 52 weeks)
- Pain at Fusion Site(24 and 52 weeks)
- Foot Function Index (FFI)(24 and 52 weeks)