Clariance Idys™ TLIF 3DTi Device Prospective Post Market Clinical Follow-up
试验速览
- 阶段
- 不适用
- 发起方
- Clariance
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Evolution of the Fusion rate
研究概览
简要总结
The aim of this observational post-marketing study is to provide additional information on the safety and effectiveness of Idys™ TLIF 3DTi at up to 24 months post transforaminal lumbar fusion in usual surgical practice.
详细描述
The primary endpoint is to evaluate the effectiveness of the Idys™ TLIF (Transforaminal Lumbar Interbody Fusion) 3DTi (Porous Titanium additive manufacturing) by measuring the evolution of the rate of fusion during the postoperative period.
The secondary endpoints are to analyze the safety and the patient's benefit of the Idys™ TLIF 3DTi by evaluating several point of view:
- The adverse events related to the surgery;
- The functional improvement between preoperative state and the different follow-up time points using the Oswestry Disability Index (ODI);
- The improvement of back pain between preoperative state and the different follow-up time points using the Visual Analog Scale (VAS) (legs and back);
- The evolution of several radiologic lumbar parameters to assess the correction and its stability.
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
- •English Speaking patients
- •Patient with skeletal maturity
- •Patient with
- •degenerative disc disease at one or two levels from L2 to S1 and/or
- •grade 1 spondylolisthesis
- •Surgical treatment with Idys TLIF 3DTi interbody fusion device used in conjunction with a posterior fixation system (pedicle screws and rod).
排除标准
- •Off-label indications.
- •Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery.
- •Any patient having a prior fusion at the level to be treated.
- •Any patient being vulnerable
- •Non-English speakers
结局指标
主要结局
Evolution of the Fusion rate
时间窗: 6 months, 12 months, 24 months postoperatively
Evolution of the radiological assessment of bony fusion at 3 different time point
次要结局
- Evolution of the Patient Pain(Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively)
- Radiologic Outcomes - Stability of the Idys TLIF 3DTi Device(6 weeks, 6 months, 12 months and 24 months postoperatively)
- Radiologic Outcomes - Evolution of the lordosis angles (degree)(Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively)
- Adverse events(Up to 24 months postoperatively)
- Evolution of the Patient Disability(Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively)
- Radiologic Outcomes - Evolution of the Intervertebral Height (mm)(Preoperatively and then 6 weeks, 6 months, 12 months and 24 months postoperatively)