PROSPECTIVE OBSERVATIONAL SPINE FUSION REGISTRY FOR OssDsign® BONE GRAFT SUBSTITUTES IN REAL WORLD CLINICAL PRACTICE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 28
- 主要终点
- Rate of bone fusion
研究概览
简要总结
The purpose of this multi-center, prospective, observational registry is to gather information on the clinical outcomes and real-world use of commercially available bone graft substitutes manufactured by OssDsign® AB, in patients who require spine fusion.
详细描述
This multi-center study (up to 25 US study sites) is a post market, prospective, observational spine fusion registry. The outcomes of patients undergoing spine fusion with OssDsign® bone grafts will be documented and evaluated for the purposes of post market clinical follow up as part of OssDsign® post market surveillance activities. The length of study duration and number to be recruited is open-ended but initially a target of 750 subjects will be recruited and followed up for a period of 24 months ± 90 days after their index surgery in which an OssDsign® bone graft has been implanted.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has been diagnosed as a candidate for spinal fusion surgery for which the surgeon has decided an OssDsign® bone graft is appropriate.
- •The patient is ≥21 years old.
- •The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent
- •The patient is willing and able to participate in post- operative clinical and radiographic follow up evaluations for 2 years.
排除标准
- •Patients not meeting all of the inclusion criteria
结局指标
主要结局
Rate of bone fusion
时间窗: 12 months ± 60 days post-operative examination
Assessment of the rate of bone fusion via Computerized Tomography (CT)/x-ray based on evidence of continuous bone bridging from the superior to the inferior vertebral body at the target level.
次要结局
- Presence of bone fusion(6, 12 and 24 months)
- Quality of Life Questionnaire: Oswestry Disability Index(Up to 4 months, 6, 12 and 24 months)
- Quality of Life Questionnaire: Visual Analog Scale (VAS)(Up to 4 months, 6, 12 and 24 months)
- Quality of Life Questionnaire: Short Form 36 (SF-36)(Up to 4 months, 6, 12 and 24 months)
- Neurological Function(Up to 4 months, 6, 12 and 24 months)
- Quality of Life Questionnaire: Neck Disability Index (NDI)(Up to 4 months, 6, 12 and 24 months)
- Safety review of device related AE's(Throughout study, 24 months)