NCT04631133招募中不适用
LISA Post Market Clinical Follow-Up Study:Post Marketing Prospective Documentation of Clinical Outcomes (Post-operative, Safety and Performance) After Lumbar Dynamic Stabilization Surgery With LISA Implant
BACKBONE5 个研究点 分布在 3 个国家目标入组 136 人开始时间: 2019年4月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 136
- 试验地点
- 5
- 主要终点
- LISA implant survival rate 2 years after surgery defined as successful LISA implantation without reoperation, revision, or removal/ ODI change between pre-operative assessment and 2 years follow-up (FU)/ 1ary endpoint will also be evaluated at 1-year FU
研究概览
简要总结
The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV (Pfirrmann MRI classification). "Post-market" means the device (i.e. the LISA implant) being used in this study has already obtained CE certification and is commercially available for use in the European market.
The LISA device consists of 3 components: A PEEK interspinous spacer, a polyester band, and a titanium blocker. The spacer is positioned between two adjacent spinous processes, the band is belted around the spinous processes and through the spacer, and the blocker is used to lock the band inside the spacer.
Medical Device manufacturers conduct "post-market" clinical studies in order to continuously evaluate the product scientifically and to comply with legal and ethical obligations. With these studies, the long-term safety as well as performance of their medical devices are assessed.
This study, which is initiated and sponsored by BACKBONE (LISA designer, developer, manufacturer and marketer), aims to evaluate the long-term safety and performance of the LISA implant for the treatment of lumbar degenerative disease and to evaluate the treatment.
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
- •Skeletally mature patients Patient ≥18 years of age
- •Patients with low-back pain caused by degenerative lesions of grade II, III and IV (Pfirrmann MRI classification)
- •Failed conservative treatment for low back pain conducted for at least 6 months
排除标准
- •Stage V degenerative disk lesions in Pfirrmann's MRI classification
- •Spondylolisthesis
- •Osteoporosis
- •Non-specific back pain
- •Modic 2 and Modic 3 changes
- •L5/S1 segments affected
- •Local or general infections that may compromise the surgical goals
- •Major local inflammatory phenomena
- •Pregnant and lactating Women
- •Immunosuppressive diseases
- •Bone immaturity
- •Severe mental illnesses
- •Bone metabolism diseases that may compromise the mechanical support expected from this type of implant
- •Patient with worker's compensation, under litigation or on disability benefits
- •Excessive physical activities
- •Patients deprived of their liberty in accordance with respective national regulations
- •Protected patients or patients not in a position to declare his or her consent in accordance with respective national regulations
结局指标
主要结局
LISA implant survival rate 2 years after surgery defined as successful LISA implantation without reoperation, revision, or removal/ ODI change between pre-operative assessment and 2 years follow-up (FU)/ 1ary endpoint will also be evaluated at 1-year FU
时间窗: 24-months post surgery; 12-months post surgery
次要结局
- Oswestry Disability Index (ODI) to assess limitations of various activities of daily living.(Pre-operative)
- Change from baseline in Oswestry Disability Index at 3 months(3-months post surgery)
- Duration of the implant placement(Perioperative)
- Change from baseline in Oswestry Disability Index at 72 months(72-months post surgery)
- Change from baseline in Oswestry Disability Index at 48 months(48-months post surgery)
- Number of hospitalization days(3-months post surgery)
- Number of patients with reoperations/ revision or removal at the operative level or on adjacent levels relating to the device and not the pathology/ implant breakage (polyester band rupture)(3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery)
- Number of patients with migration or rupture of any implant component (Polyester band loose)/ major unanticipated device related complications/ post-operative scapular pain/ recurrence of the initial symptoms/ degeneration of the adjacent segments(3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery)
- Change from baseline in Visual Analogue Scale (VAS) for back pain at 6 months(6-months post surgery)
- Change from baseline in Visual Analogue Scale (VAS) for back pain at 12 months(12-months post surgery)
- Change from baseline in Visual Analogue Scale (VAS) for back pain at 24 months(24-months post surgery)
- LISA implant survival rate defined as successful LISA implantation without reoperation, revision, or removal(3-months post surgery; 6-months post surgery; 48-months post surgery; 72-months post surgery)
- Duration of the surgery(Perioperative)
- Amount of blood loss(Perioperative)
- Scoring of the surgical technique assessed by a 14-items question(Perioperative)
- Time to return to normal activity (working) depending on the patient's profession (blue collar, white collar)(3-months post surgery)
- Number of patients with superficial infection/ dural injury/ bone fracture or bone erosion anywhere implant is in contact with the anatomy/ Any other procedure or device related adverse events(3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery)
- Change from baseline in Oswestry Disability Index at 6 months(6-months post surgery)
- Change from baseline in Visual Analogue Scale (VAS) for back pain at 3 months(3-months post surgery)
- Change from baseline in Visual Analogue Scale (VAS) for back pain at 48 months(48-months post surgery)
- Visual Analogue Scale (VAS) to assess right leg pain(Pre-operative)
- Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 3 months(3-months post surgery)
- Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 24 months(24-months post surgery)
- Visual Analogue Scale (VAS) to assess left leg pain(Pre-operative)
- Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 6 months(6-months post-surgery)
- Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 48 months(48-months post-surgery)
- Visual Analogue Scale (VAS) to assess back pain(Pre-operative)
- Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 12 months(12-months post surgery)
- Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 24 months(24-months post-surgery)
- Patient's recommendation for treatment assessed by a 4-items question(3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery)
- Change from baseline in foraminal compression at 72 months(72-months post-surgery)
- Change from baseline in Visual Analogue Scale (VAS) for back pain at 72 months(72-months post surgery)
- Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 6 months(6-months post surgery)
- Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 3 months(3-months post-surgery)
- Change from baseline in segmental joints condition at 6-months(6-months post surgery)
- Change from baseline in segmental joints condition at 72-months(72-months post surgery)
- Change from baseline in narrowness of the spinal canal at 12 months(12-months post surgery)
- Patient satisfaction with treatment assessed by a 4-items question(3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery)
- Segmental joints condition assessed thanks to radiological results (if available)(Pre-operative)
- Change from baseline in segmental joints condition at 24-months(24-months post surgery)
- Change from baseline in narrowness of the spinal canal at 3 months(3-months post surgery)
- Change from baseline in narrowness of the spinal canal at 48 months(48-months post surgery)
- Change from baseline in foraminal compression at 6 months(6-months post-surgery)
- Change from baseline in foraminal compression at 48 months(48-months post-surgery)
- Change from baseline in narrowness of the spinal canal at 72 months(72-months post surgery)
- Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 48 months(48-months post surgery)
- Change from baseline in Visual Analogue Scale (VAS) for right leg pain at 72 months(72-months post surgery)
- Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 12 months(12-months post-surgery)
- Change from baseline in Visual Analogue Scale (VAS) for left leg pain at 72 months(72-months post-surgery)
- Patient's opinion related to the treatment assessed by a 6-items question(3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery)
- Change from baseline in segmental joints condition at 3-months(3-months post surgery)
- Change from baseline in segmental joints condition at 12-months(12-months post surgery)
- Change from baseline in segmental joints condition at 48-months(48-months post surgery)
- Change from baseline in narrowness of the spinal canal at 6 months(6-months post surgery)
- Change from baseline in narrowness of the spinal canal at 24 months(24-months post surgery)
- Change from baseline in foraminal compression at 12 months(12-months post-surgery)
- Surgeon surgery outcome assessed by a 4-items question(3-months post surgery; 6-months post surgery; 12-months post surgery; 24-months post surgery; 48-months post surgery; 72-months post surgery)
- Narrowness of the spinal canal assessed thanks to radiological results (if available)(Pre-operative)
- Foraminal compression assessed thanks to radiological results (if available)(Pre-operative)
- Change from baseline in foraminal compression at 3 months(3-months post-surgery)
- Change from baseline in foraminal compression at 24 months(24-months post-surgery)
研究者
研究点 (5)
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