Study #91-01 - A Randomized Study of the Stryker OP Device vs. Bone Autograft for the Treatment of Tibial Nonunions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 18
- 主要终点
- No further retreatment of the surgical site, function and pain at the site of the nonunion, evidence of bridging.
研究概览
简要总结
This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the healing rates of the OP Device to that of autograft.
详细描述
This study is to evaluate the safety and effectiveness of the OP device for the treatment of nonunion bone fractures and to compare the clinical safety and effectiveness (healing rates) of the OP Device to that of traditional bone autografts to repair nonunions.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must show radiographic skeletal maturity
- •Documented evidence of previous fracture management
- •Nonunion in the tibia and candidate to receive bone autografts and intramedullary (IM) Nail fixation
- •Nonunion gap must not exceed half the diameter of the bone at the site of fracture, as assessed radiographically prior to study treatment
排除标准
- •Patients who do not have adequate vascularity to permit healing
- •Patients with inadequate skin coverage
- •Patients with chronic use of steroidal medications
- •Patients with active infection systemically or at the site of nonunion.
研究组 & 干预措施
1
Surgical implantation of OP-1
干预措施: Surgical implantation of OP-1 device or autograft bone graft material (Device)
2
Surgical implantation of bone graft material
干预措施: Surgical implantation of OP-1 device or autograft bone graft material (Device)
结局指标
主要结局
No further retreatment of the surgical site, function and pain at the site of the nonunion, evidence of bridging.
时间窗: 3, 6, 9, 12, 24 months
次要结局
- Medical events, treatment related events, laboratory tests, medication use.(3, 6, 9, 12, 24 months)