Study of Subtalar Arthrodesis Using AlloStem® Versus Autologous Bone Graft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AlloSource
- 入组人数
- 140
- 试验地点
- 10
- 主要终点
- Fusion Rate (%)(as determined by CT assessment)
研究概览
简要总结
The purpose of this clinical trial is to evaluate the outcome of implanting AlloStem® graft with appropriate rigid internal fixation hardware as an alternative to autograft bone graft with rigid fixation in subtalar arthrodesis procedures. The primary objective of this clinical trial is to compare the overall fusion rate of the investigational to the control treatment. Fusion will be determined by clinical findings, radiographs and computed tomography (CT) of the subtalar joint 24 weeks (6 months) after the trial surgery.
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
- None
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
- •Must be diagnosed with degenerative osteoarthritis, post-traumatic arthritis, inflammatory arthritis (ie: rheumatoid arthritis) or other conditions of the hindfoot requiring subtalar arthrodesis.
- •Patients must be able to attend follow-up examinations for the duration of the trial.
- •The patient is at least 18 years of age and skeletally mature, or less than 80 years of age at the time of surgery.
- •Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.
排除标准
- •Younger than 18 years old or older than 80 years old.
- •Has a condition that prevents ambulation or completion of any of the trial measurements.
- •Requires fusion of additional hindfoot or ankle joints simultaneously (i.e. a pantalar, tibiotalocalcaneal or triple arthrodesis). Concomitant midfoot or forefoot procedures, such as osteotomies, tendon or metatarsal procedures are not exclusionary.
- •Has treatment planned for the arthrodesis which does not require the use of screws.
- •Has any active infection of the hindfoot, a systemic infection or bacteremia.
- •Has received any treatment within the past 12 months which may interfere with bone metabolism [bisphosphonates (Fosamax, Actonel, Boniva, Reclast) and calcitonin (Miacalcin)].
- •Is scheduled to have any surgical procedure on the contralateral foot within 6 weeks before or after the study procedure.
研究组 & 干预措施
AlloStem Live Cellular Allograft
AlloStem is the combination of the Mesenchymal Stem Cells (MSC) derived from adipose with demineralized bone.
干预措施: Subtalar Arthrodesis (Procedure)
Control: Autologous Bone Marrow Aspirate
Autologous bone graft is recovered from the patient's own tibia or iliac crest, for transplantation in the subtalar joint.
干预措施: Subtalar Arthrodesis (Procedure)
结局指标
主要结局
Fusion Rate (%)(as determined by CT assessment)
时间窗: 6 months post-op
Fusion Rate (%)(as determined by CT assessment)
次要结局
- Functional outcome measurements(Pre-operatively, 3, 6, 12 and 24 months)
- Radiographic outcome assessments(Pre-operatively, 6 weeks, 3, 6, 12 and 24 months)