NCT05144126Unknown不适用
Safety, Radiological and Patient Reported Outcomes of i-FACTOR+ Matrix Bone Graft Device - A Canadian, Multicenter, Post-Market Clinical Investigation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- index segment revision
研究概览
简要总结
The study intends tracking the usage patterns of a Bonegraft device within spine surgery in a multicenter setting in Canada.
详细描述
The study wil track the usage patterns of a bone graft by identifying and classifying spine surgery procedures by access and segment type within the spins and furthet, record and analyse safety and performance measures associated with each classification. This is a post-market surveillance study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult patient subjects not responding to conservative management of neck / arm or back/leg pain and requiring spinal fusion between levels C1 - T2 or L1 - S1
- •Informed Consent
排除标准
- •Hypersensitivity to i-FACTOR Bone Graft Devices
- •Adult Spinal deformity, Spinal Cord Injury
- •Infection
- •Compromised renal function
研究组 & 干预措施
i-Factor Arm
Experimental
All patients undergoing spine fusion surgery will be treated with i-FACTOR
干预措施: CT radioraphic assessment (Other)
结局指标
主要结局
index segment revision
时间窗: 12-months post-operative
Reintervention rate at index segment
次要结局
未报告次要终点
研究者
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