NCT03761563已完成不适用
Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease (FORTE)
Xtant Medical14 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年2月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 14
- 主要终点
- Rate of lumbar fusion evaluated by radiographic evidence
研究概览
简要总结
This is a prospective, multi-center, non-randomized post-market evaluation designed to collect and evaluate data on the safety and performance of the Fortilink IBF System with TETRAfuse 3D Technology.
详细描述
This is a prospective, multi-center, non-randomized post-market evaluation designed to collect and evaluate data on the safety and performance of the Fortilink IBF System with TETRAfuse 3D Technology.
There will be 3 arms in the study, one for each configuration of the Fortilink IBF system (Fortilink-C, Fortilink-TS and Fortilink-L). Up to 50 subjects will be enrolled in each study arm for a total of up to 150 subjects at up to 20 sites in the United States (US) and European Union (EU).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is skeletally mature and at least 18 years of age.
- •The subject has degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptom at one or two contiguous levels (Fortilink-C), or the subject has DDD and ≤ Grade 1 spondylolisthesis of the lumbar spine at one or two contiguous levels (Fortilink-TS and Fortilink-L).
- •Subject plans to undergo one of the following procedures:
- •An anterior cervical interbody fusion at one to two continuous levels from C2-C3 to C7-T1 using autogenous or allogenic bone graft and supplemental fixation cleared and indicated for use at the proposed treatment level(s) (Fortilink-C), or
- •An interbody fusion in the lumbar spine at one to two continuous levels from L1-L2 to L5-S1 using autogenous or allogenic bone graft and supplemental fixation cleared and indicated for use at the proposed treatment level(s) (Fortilink-TS and Fortilink-L).
- •The subject has undergone non-operative treatment of at least six weeks (Fortilink-C) or at least six months (Fortilink-TS and Fortilink-L) prior to treatment with the IBF system.
- •The subject is willing and able to provide informed consent.
- •The subject is willing and able to attend the protocol required follow-up visits and examinations.
排除标准
- •The subject has an active infection
- •The subject has had prior fusion attempt(s) or is undergoing revision of a previously implanted system at the involved level(s).
- •The subject is a worker's compensation case, in active litigation related to the procedure or is a prisoner or ward of the state.
- •The subject meets one or more of the contraindications outlined in the IFU.
- •The subject is pregnant, nursing, or is planning to become pregnant in the next year.
- •The subject has documented evidence of current substance abuse.
- •The subject has other concurrent medical condition that, in the opinion of the investigator, does not make the subject a good candidate for the study.
结局指标
主要结局
Rate of lumbar fusion evaluated by radiographic evidence
时间窗: 24 months
Rate of cervical fusion evaluated by radiographic evidence
时间窗: 12 months
次要结局
- Incidence of serious device related adverse events(up to 24 months)
- Radiographic findings by CT evaluation(12 months and 24 months)
- Time to return to work(up to 24 months)
- Change in functional ability determined by Neck Disability Index (NDI) or Oswestry Disability Index (ODI)(3 months, 6 months, 12 months, and 24 months)
- Change in pain medication usage from baseline(1 month, 3 months, 6 months, 12 months, and 24 months)
- Change in pain from baseline evaluated by use of subject-reported 100mm Visual Analogue Scale (VAS)(1 month, 3 months, 6 months, 12 months, and 24 months)
- Incidence of serious procedure related adverse events(up to 24 months)
- Change in quality of life determined by SF-12 questionnaire(3 months, 6 months, 12 months, and 24 months)
研究者
研究点 (14)
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