NCT04188236已完成不适用
A Multi-center, Prospective Study to Evaluate the Safety and Performance of a Hernia Blocking System to Prevent Recurrent Lumbar Disc Herniation
NEOS Surgery9 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年10月23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
- 30
- 试验地点
- 9
- 主要终点
- Incidence of clinically symptomatic recurrent lumbar disc herniation
研究概览
简要总结
Prospective, multi-center, single-arm clinical study to assess the performance of an Hernia Blocking System in preventing clinically symptomatic recurrent lumbar disc herniation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is between 18 and 75 years of age.
- •Posterolateral disc herniation at one level between L4 and S1 with radiographic confirmation (CT and/or MRI) of neural compression.
- •At least six weeks of failed conservative treatment prior to surgery, including physical therapy, use of anti-inflammatory medications at maximum specified dosage and/or administration of epidural/facet injections.
- •Minimum posterior disc height of 5 mm at the index level.
- •Radiculopathy with positive straight leg raise test.
- •ODI score of at least 40/
- •Subjects who are able to give voluntary informed consent to participate in the clinical investigation and from whom consent has been obtained.
- •Subject is able and willing to comply with the protocol requirements.
排除标准
- •Spondylolisthesis and/or instability at the index level.
- •Foraminal, extra-foraminal or central disc herniation.
- •Subject has clinically compromised vertebral bodies in the lumbosacral region due to any traumatic, neoplastic, metabolic, or infectious pathology.
- •Subject has scoliosis of greater than 20 degrees (both angular and rotational).
- •Less than 20 mm of interpedicular distance in the spinal canal at the index level.
- •Grossly distorted anatomy due to congenital abnormalities.
- •Deformation that affect the posterior corners of the vertebra at the index level (e.g., osteophytes).
- •Endplate irregularities that, in the judgment of the surgeon, could affect the device implantation.
- •Prior surgery at the index lumbar vertebral level.
- •Radiological confirmation of severe facet joint disease or degeneration.
- •Patients diagnosed or at a high risk of osteoporosis (such as postmenopausal women and patients receiving long-term treatment with corticosteroids) who present a bone densitometry DXA T-score of less than -2.0 at the index level.
- •Cauda equina syndrome.
- •Fever, leucocytosis and/or systemic or localized active infection.
- •Systemic inflammation and/or inflammation at the implantation site.
- •Any metabolic bone disease.
- •Insulin-dependent diabetes mellitus.
- •Peripheral neuropathy.
- •Active hepatitis, AIDS or HIV.
- •Rheumatoid arthritis or other autoimmune disease.
- •Active or history of any invasive malignancy; patients with curatively-treated malignancies who have been disease-free for at least 5 years are eligible.
- •Active tuberculosis or history of tuberculosis in the past 3 years.
- •Immunologically suppressed patients.
- •Current anticoagulation therapy, unless anticoagulation therapy can be suspended for surgery.
- •Patients who have received medication (e.g., methotrexate, alendronate) that interferes with bone mineral metabolism within 4 weeks of the planned date of the index surgery.
- •Suspected or known allergies or intolerance to the implant materials.
- •Any condition that precludes the use of general anesthesia.
- •Any condition that precludes the surgical procedure.
- •Any contraindication for MRI or CT scan.
- •Class III obesity: Body mass index ≥
- •Current alcohol or recreational drug dependency.
- •Pregnant or interested in becoming pregnant in the following 24 months.
- •Breastfeeding.
- •Life expectancy less than 2 years.
- •Subject is currently participating or has participated in the previous 4 weeks in any other interventional clinical study.
结局指标
主要结局
Incidence of clinically symptomatic recurrent lumbar disc herniation
时间窗: 24 months
次要结局
- The change in the patient work status, compared to baseline(6 weeks, 6 months, 12 months, and 24 months)
- Change in Low back related disability according to the Oswestry Disability Index (ODI), related to baseline(6 weeks, 6 months, 12 months, and 24 months)
- The change in the disc degeneration (Pfirrmann scale), compared to baseline(6 months, 12 months, and 24 months)
- The incidence and type of all adverse events (AE) and serious adverse events (SAE).(6 weeks, 6 months, 12 months, and 24 months)
- Incidence of clinically asymptomatic recurrent disc herniation(6 months, 12 months, and 24 months)
- Disc height maintenance [mm] related to baseline(6 weeks, 6 months, 12 months, and 24 months)
- Change in leg and low back pain assessed by NRS (numeric rating scale), related to baseline(6 weeks, 6 months, 12 months, and 24 months)
- The change in quality of life according to EQ-5D-5L, compared to baseline(6 weeks, 6 months, 12 months, and 24 months)
- The change in patient neurological status: straight leg raise test, reflexes, motor muscle strength and sensory neurological evaluations, compared to baseline(6 weeks, 6 months, 12 months, and 24 months)
- The change in the endplate lesions (MODIC scale), compared to baseline(6 months, 12 months, and 24 months)
- The change in the kinematics of the intervertebral disc at the index level, compared to baseline(6 weeks, 6 months, 12 months, and 24 months)
研究者
研究点 (9)
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