Efficacy and Safety of the Inter-laminar Device IntraSPINE® Associated with Discectomy in the Treatment of Lumbar Disc Herniation. a Single-blind, Randomised, Comparative, Multicentre Clinical Trial Vs. Discectomy Alone.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Change from Baseline to 12 months of the degree of functional disability associated with lumbar pain will be measured using the Oswestry Disability Index
研究概览
简要总结
IntraSPINE® is a novel device that, unlike interspinous positioned implants, is unique in being placed more anteriorly in an interlaminar position, closer to the normal center of rotation of the motion segment. Mechanical advantages are thus conferred over more posteriorly positioned devices through the possibility of more physiological 'rocking' type movements in flexion and extension . This enables IntraSPINE® to off-load the facet joints in extension without blocking movement. Having a more anteriorly placed fulcrum also helps control excessive flexion movements by virtue of an improved lever arm in conjunction with an intact posterior tension band.
The underlying hypothesis of this work is that a clinical gain is achieved by adding an IntraSPINE® interlaminar device to discectomy in patients suffering from a lumbar disc herniation. This should result in an improvement in incapacity level and a reduction in pain.
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 (Participant)
盲法说明
The patient will be blinded to the randomisation arm. As the procedure is conducted under general anaesthesia, the patient will not be informed whether the procedure which was performed on him/her did or did not result in the implantation of the IntraSPINE® device (which is not visible on radiographs)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease-related criteria:
- •single segment L4-L5 or L5-S1 lumbar disc hernia identified on imaging (lumbar spine MRI)
- •median or posterolateral disc hernia.
- •failure of correct medical treatment which has not provided lasting symptom relief absence of contraindications to surgical discectomy and implantation of the IntraSPINE®.
- •Population related criteria:
- •subjects of either sex and over 18 years old
- •who have given their free informed signed consent to participate in the study
- •patients who are able to respond to the questionnaires and who can communicate in the language of the study country
- •and who are affiliated to a social security system or have rights from a social security system.
排除标准
- •Disease-related criteria:
- •recurrent disc hernia post-discectomy at any level
- •foraminal and extra-foraminal disc hernia
- •paralysing disc hernia (score of 3/5 or less) and cauda equina syndrome
- •any grade of spondylolisthesis
- •degenerative scoliosis ≥ 15°
- •osteoporosis or Paget's disease
- •BMI > 30
- •procedure required on more than one vertebral level
- •endoscopic microdiscectomy prohibiting insertion of the IntraSPINE®
- •chronic infection
- •systemic or metabolic disorders
- •active ongoing malignant disease (liable to prevent the study being conducted and does not carry a risk of vertebral lysis)
- •occupational disorder responsible for the disease Treatment or device-related criteria
- •allergy to any of the constituents of the medical device
- •Population-related criteria:
- •past history of spinal procedure.
- •withdrawal of consent
- •pregnant women
- •breast-feeding women
- •participation in a clinical study within 3 months before the initial visit.
- •drug addiction
- •predictable lack of availability during the study. Patients deprived of their freedom or under legal guardianship.
研究组 & 干预措施
the IntraSPINE® device associated with discectomy
干预措施: Insertion of INTRASPINE device (Device)
the IntraSPINE® device associated with discectomy
干预措施: Discectomy (Procedure)
discectomy alone
干预措施: Discectomy (Procedure)
结局指标
主要结局
Change from Baseline to 12 months of the degree of functional disability associated with lumbar pain will be measured using the Oswestry Disability Index
时间窗: Baseline and 12 months
The Oswestry questionnaire provides an assessment of the symptoms and severity of the back pain and repercussions on activities of daily living. The questionnaire contains 10 questions concerning: pain, personal care, carrying loads, walking, seated position, standing position, sleep, sex life, social life and travel. Each question offers six answers with a score of 0 to 6 which the patient must select: a score of 0 represents normal function and a score of 6 represents greatly reduced function. The score obtained is multiplied by 2 in order to obtain a percentage handicap, with 0% for no handicap and 100% for the greatest handicap. It takes approximately 5 minutes to complete the test.
次要结局
- The effect of the IntraSPINE® device associated with discectomy versus discectomy alone in the treatment of lumbar disc herniation with regard to recurrence of disc herniation during the study(All study period (24 months))
- Evolution between inclusion, 1, 6,12 and 24 months post-surgery of the degree of functional disability like symptoms and severity of back pain and repercussions on activities of daily living associated with lumbar pain using the Oswestry Disability Index(inclusion, 1 month, 6 months, 12 months and 24 months post-surgery)
- Evolution between inclusion, 1 month, 6 months, 12 months and 24 months post-surgery in the two groups with regard to lumbar and radicular pain using a Visual Analogic Scale(inclusion, 1 month, 6 months, 12 months and 24 months post-surgery)
- Evolution between inclusion, 1month, 6 months, 12 months and 24 months post-surgery in the two groups with regard to quality of life(inclusion, 1 month, 6 months, 12 months and 24 months post-surgery)
- Evolution between inclusion, 12 months and 24 months post-surgery in the two groups with regard to sagittal alignement(inclusion, 12 months and 24 months post-surgery)
- Evolution between inclusion, 12 months and 24 months post-surgery in the two groups with regard to disc height(inclusion, 12 months and 24 months post-surgery)
- Evolution between inclusion, 1 month, 6 months, 12 months and 24 months in the two groups with regard to neurological and motor status(inclusion, 1 month, 6 months, 12 months and 24 months)
- Time to resumption of work post-surgery(1 month, 6 months, 12 months and 24 months post-surgery)
- Rates of further surgery at the level of the implant during the study(All study period (24 months))
- The number of adverse events (AE) reported, classified by type and organ.(All study period (24 months))
- The number of serious adverse events (SAE) reported, classified by type and organ.(All study period (24 months))
- Integrity of the implant: migration or wear(All study period (24 months))
- The peroperative complication rate.(All study period (24 months))
- The short and long term postoperative complication rate.(All study period (24 months))