Post Market Non-Inferiority Study Comparing Triojection® to Discectomy for Lumbar Disc Herniation
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 49
- 试验地点
- 6
- 主要终点
- Leg pain NRS
研究概览
简要总结
The primary objective of this study is to compare the early clinical outcomes following non-surgical treatment with Triojection® to surgical discectomy. Early is defined as less than or equal to 6 months.
详细描述
The objective of this study is to compare clinical, economic and safety outcomes between Triojection and surgical discectomy. The study will include two follow-up phases: 1) an initial follow-up period during the first 6 months after treatment and (2) a long-term follow-up lasting an additional 18 months (2 years total).
The hypothesis is that over the first six months after treatment, Triojection® will be non-inferior to discectomy with respect to the improvement in leg pain. This will be demonstrated using a non-inferiority margin of 19.4 points on the difference between baseline leg pain score and the average leg pain score recorded at 1 week, 1, 3 and 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is willing to provide informed consent.
- •Clinical and radiographic evidence of one, and only one, symptomatic protruding or extruded disc between L1 and S
- •The herniated disc should have a disc height of at least 50% that of the normal adjacent disc levels, as determined by the investigator.
- •The signal intensity of the herniated disc material should be equal or greater than the nucleus pulposus of the herniated disc.
- •The patient must have pain in a dermatomal distribution consistent with their radiographic findings
- •Leg pain greater than or equal to 5 on the NRS scale
- •Symptoms for at least 6 weeks
- •Willingness to complete all follow-up evaluations
- •Patient aged 18-65 years
排除标准
- •Patients with a disc herniation extending past the facet joint
- •Presence of a non-contiguous disc fragment
- •Impairment of bladder/bowel function or motor impairment in the affected leg
- •An epidural steroid injection in the past 2 weeks
- •Previous discectomy, arthroplasty or fusion at any lumbar level
- •In patients with L5-S1 disc herniation, a congenital condition where the L5 vertebral body is either fused to the sacrum or the L5-S1 disc is not fully formed as a normal adult disc.
- •Symptomatic lumbar stenosis or listhesis
- •Symptomatic sacroiliac joint
- •Symptomatic foraminal stenosis due to severe degenerative disc disease
- •History of spinal tumor, fracture or infection
- •Females of childbearing age that are known to be pregnant or wishing to become pregnant during the study
- •Fibromyalgia
- •Active infection
- •Metastatic cancer within the past 5 years
- •Pending litigation against a health care provider
- •More than 3 months of continuous sick leave prior to enrollment.
- •Known drug or alcohol abuse
- •Diagnosed psychiatric disease or psychological distress caused by recent trauma like divorce, death of a member family or loss of a job
- •Patient known to be affected by favism (G6PD deficiency)
研究组 & 干预措施
Triojection System for ozone injection
Triojection is a system including a single-use sterile syringe cartridge and an accessory console. The console is interfaced to a supply of medical oxygen and uses this supply to fill the syringe with oxygen. Ozone is produced by applying a high voltage to electrodes physically located within the syringe. When a concentration of 35µg/ml is reached, the cartridge is removed from the console. The sterile syringe, containing the gas, is extracted from the protective housing and the gas is administered directly to the center of the herniated disc through a spinal needle.
干预措施: Triojection (Device)
Surgical discectomy
The surgical group will be receive a standard surgical discectomy to remove the herniated disc material.
干预措施: Surgical discectomy (Procedure)
结局指标
主要结局
Leg pain NRS
时间窗: Baseline, 1 week, 1, 3 and 6 months.
The primary outcome measure will be the amount of improvement in leg pain after treatment. This will be determined by taking the difference between the baseline score and the average of the post-treatment scores at 1 week, 1, 3 and 6 months.
次要结局
- Patient Satisfaction via a survey(Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.)
- Cost Diary(Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.)
- Leg pain NRS(Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.)
- Review of MRI images(Baseline and 6 and 24 months after treatment.)
- Back pain NRS(Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.)
- Functional Score measured by RMDI.(Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.)
- Quality of Life measured by EQ-5D(Baseline and 1 week, 1, 3, 6, 12, 18 and 24 months after treatment.)