A Multicenter, Randomized, Controlled, Blinded Study of the Safety and Efficacy of Bone Healing Accelerant Versus Autologous Bone Grafting in Subjects Undergoing Hindfoot or Ankle Arthrodesis and Who Require Supplementary Grafting
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Successful Radiographic Fusion
研究概览
简要总结
This study is being conducted to demonstrate the safety and effectiveness of Bone Healing Accelerant (BHA) product when applied to the joint space of the ankle of hindfoot (the section of the foot immediately below the ankle joint) during fusion surgery. It is hypothesized that by 6 months, the number of subjects with successful bone fusion will be greater in the BHA-treated group compared to subjects treated with standard of care alone.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has pain with weight-bearing in the joint(s) below that, in the opinion of the Investigator, warrants arthrodesis:
- •Tibiotalar (ankle)
- •Talocalcaneal (subtalar)
- •Talonavicular
- •Calcaneocuboid
- •Double hindfoot (e.g., talonavicular and talocalcaneal joints)
- •Triple hindfoot (subtalar, talonavicular and calcaneocuboid joints
- •Joint space(s) can, in the opinion of the Investigator, be adequately filled with no more than 9 cc of graft material (BHA or ABG)
- •Each fused joint can be adequately compressed and rigidly stabilized with plates, screws, staples or a combination thereof. External fixation, percutaneous Kirschner wires or intramedullary rods may not be used.
- •Patient is willing and able to comply with all study requirements including all postoperative clinical and radiographic evaluations.
- •If patient is a woman of childbearing bearing potential (not post-menopausal for 12 months or surgically sterile), patient has a urine pregnancy test with a negative result at screening and on the day of surgery, prior to the procedure. These trial participants must commit to adequate birth control through the 52-week follow-up
排除标准
- •Skeletally immature patients (i.e., radiographic evidence of open physes), regardless of age
- •Bone deficit, defect or void requiring a structural graft
- •Condition requiring intramedullary nailing or external fixation for the arthrodesis
- •Condition requiring osteotomy or fusion of any midfoot joints.
- •Prior arthroplasty, arthrodesis, major surgical repair or reconstruction of the index ankle or hindfoot joints.
研究组 & 干预措施
BHA
Subjects treated with BHA + standard of care
干预措施: BHA (Combination Product)
Control
Subjects treated as per standard of care
结局指标
主要结局
Successful Radiographic Fusion
时间窗: 24 weeks
Greater than or equal to 50% bone bridging across joint space for the full complement of joints fused as determined by CT in the absence of secondary surgical or nonsurgical interventions intended to promote fusion.
次要结局
未报告次要终点