Study of the Efficacy and Tolerance of the B-Dyn Medical Device Compared to a Conventional Bolted Fusion With or Without Cage in the Treatment of Degenerative Lumbar Stenosis, With or Without Grade I Spondylolisthesis on the Degree of Postoperative Functional Disability, Preservation of Mobility and Prevention of the Adjacent Syndrome". Interventional, Prospective, Comparative, Randomized, Non-inferiority, Single Blind, International, Multicenter Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 216
- 试验地点
- 4
- 主要终点
- Evaluation of change from baseline degree of functional disability, related to low back pain, by using the Oswestry Disability Index (ODI) at 12th month post-surgery
研究概览
简要总结
Degenerative Lumbar Spinal Stenosis (LSS) is an extremely common condition affecting more than 102 million people each year. It is a narrowing of the spinal canal in the lower back. It causes pain and even disorders of the lower limbs. When the symptoms get worse and the individual feels functional discomfort despite medical treatment, surgical intervention is recommended. Two surgical options are available: Rigid Stabilization Devices as conventional fusion with or without cage, or dynamic stabilization system as B-DYN device, this system is called "dynamic" because it allows the stabilization of the operated part while preserving a certain mobility.
The main objective of this study is to evaluate the efficacy and tolerance of B-Dyn versus conventional bolted fusion (with or without cage) in the treatment of degenerative lumbar stenosis (DLS) on the degree of postoperative functional incapacity. So the investigator's hypothesis is that the use of the B-DYN device in the treatment of DLS could lead to the maintenance of functional disability related to low back pain (maintenance of walking and mobility).
Another important point to be demonstrated in this study is the preservation of the mobility of the stage overlying the assembly performed by B-Dyn. Indeed, the continued degeneration of segments adjacent to lumbar vertebral fusions is a concern for surgeons For B-Dyn, which is a dynamic stabilization, the combination of rigid and flexible parts allows the mobility of the overlying stage to be preserved and could also lead to a decrease in adjacent syndrome in the long-term compared to the use of conventional fusion.
The duration of patient follow-up is 60 months. The inclusion period is 56 months to recruit the necessary number of subjects for the study (a total of 216 patients is expected).
详细描述
The Lumbar Spinal Stenosis: LSS is an extremely common pathology that affects more than 102 million people worldwide every year.
It is most often linked to the combination of a disk space narrowing (loss of height and bulging within the canal), a hypertrophy of the yellow ligament and of the joint capsules and also a bone overgrowth by the posterior vertebral joints. This may be associated with Grade I spondylolisthesis.
This pathology often extends over several levels, frequently two (L5S1, L4L5 or L4L5, L3L4) sometimes more. A relatively homogeneous group of patients falls within the group of stenosis, from S1 to L2, without significant deviation (scoliosis or cyphosis type).
A wide variety of different surgical techniques are used to treat patients with LSS and patients who have symptoms despite well-conducted medical treatment. Decompressive laminectomy may prove to be insufficient when several levels are affected and also due to the fears of instability induced by the gesture itself (the joint hypertrophy responsible for nerve root compression is also a stabilizing element). Therefore, the scientific community usually associates a gesture of stabilization with the gesture of decompression.
The choice of stabilizing means is discussed without any conclusive answer provided by any controlled study. This question accounts for the subject of this study.
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 from the randomizing arm. As the procedure is performed under general anaesthesia, the patient will not be informed whether or not the B-Dyn® device has been implanted as a result of the procedure. The primary endpoint (the ODI being a reported outcome patient) will therefore be assessed blind to the randomizing arm. Other secondary endpoints such as quality of life or pain intensity will also be assessed blindly from the randomizing arm (patient assessment). Blinding of the surgeon is not possible. The device cannot be blinded from the surgeon's view.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease related criteria:
- •Stenosis on 1, 2 or 3 disc levels (grade B or C or D according to Schizas classification or central stenosis of grade A according to Schizas classification with a lateral stenosis (postero-lateral overhang or disc protrusion)) on MRI (lumbar spine MRI )
- •Spondylolisthesis grade 1 or no the upper surgical (treated) level
- •Neurological impairment or neurogenic claudication on one or both legs (VAS score > 30)
- •Subjects who have failed well-managed medical treatment that has not resulted in long-lasting symptom relief (duration of symptoms > 3 months);
- •Subjects with no contraindication to fusion or the application of B-Dyn®.
- •Population-related criteria
- •Subjects of both sexes, 40 years of age and older
- •Subjects who have given free, informed and written consent to participate in the study;
- •Subjects who are able to respond to questionnaires and who can communicate in the language of the study country ;
- •Subjects affiliated to a social security scheme or entitled to a social security scheme.
排除标准
- •Disease related criteria:
- •Spondylolisthesis of grade > 1 on the upper surgical (treated) level
- •Intervention required on more than 3 disc levels
- •Degenerative Scoliosis (Cobb angle > 20°);
- •Stenosis located only on the L5-S1 level
- •History of instrumented lumbar surgery (cage, rod, etc.) on the upper or lower level, except in the case of instrumentation of the lower level with an intra-spinous device.
- •Stenosis not caused by from degenerative changes.
- •Isolated disc herniation
- •Other specific vertebral damage (for example: ankylosing spondylitis, cancer or neurological disorders)
- •History of vertebral compression fractures at the instrumented level
- •History of osteoporotic fractures
- •Psychological disorders (e.g. dementia ….etc) or drug addiction that lead to an inability to participate in the study
- •Chronic infection
- •Population related criteria:
- •Withdrawal of consent;
- •Pregnant or Breastfeeding woman
- •Participation in a clinical trial in the 3 months prior to the initial visit;
- •Predicted unavailability during study. Patient deprived of liberty or under guardianship.
- •Medical Device related criteria:
- •1. Allergy to any of the components of the medical device.
结局指标
主要结局
Evaluation of change from baseline degree of functional disability, related to low back pain, by using the Oswestry Disability Index (ODI) at 12th month post-surgery
时间窗: Baseline, 12 months
The Oswestry questionnaire helps assess the symptoms and severity of back pain, as well as the impairment on daily life activities. The questionnaire contains 10 questions, concerning: pain, personal care, loads, walking ability, sitting position, standing position, sleep, sexual life, social life, travels. Each question offers 6 answers, with a score of 0 to 6 that the patient must choose; score 0 corresponds to a normal function, and score 6 to a very diminished function. The score obtained is multiplied by 2 to get a percentage of disability, with 0% for the absence of disability, and 100% for the most important disability. Completion of the test takes about 5 minutes
次要结局
- Assessing the intensity of radicular and lumbar pain by the VAS scale (0-100) at inclusion, 2 months, 12 months, 24 months and 60 months post-intervention;(Inclusion, at 2 months, at 12 months, 24 months, and at 60 months)
- Assessing safety and tolerance(During the whole study (up to 60 months))
- Measuring the mobility of the upper instrumented level and adjacent levels at inclusion, 2 months, 12 months and 60 months post intervention using dynamic X-rays of the lumbar spine:(Inclusion, at 2 months, at 12 months and at 60 months)
- Measuring the evolution of the degree of functional disability related to lumbar and radicular pain by the Oswestry Disability Index (ODI) at inclusion, 2 months, 12 months, 24 months and 60 months post-intervention;(Inclusion, at 2 months, at 12 months, 24 months, and at 60 months)
- Assessing the quality of life by the Short Forum Health Survey(SF-12 score) at inclusion, 2 months, 12 months, 24 months and 60 months post-intervention;(Inclusion, at 2 months, at 12 months, 24 months, and at 60 months)
- Measuring the anxiety using the Hospital Anxiety and Depression Scale (HAD) at inclusion, 2 months, 12 months, 24 months and 60 months post-intervention;(Inclusion, at 2 months, at 12 months, 24 months, and at 60 months)
- Assessing the motion status at the instrumented level and adjacent levels (right and left), by measuring motor skills at inclusion, 2 months, 12 months and 60 months post-intervention(Inclusion, at 2 months, at 12 months and at 60 months)
- Assessing the sensory status at the instrumented level and adjacent levels (right and left), by measuring feeling of touch and stinging sensation at inclusion, 2 months, 12 months and 60 months post-intervention(Inclusion, at 2 months, at 12 months and at 60 months)
- Evaluation of surgical adjacent syndrome(60 months)
- Measuring different radiological parameters as lumbar lordosis (LL), instrumented level segmental lordosis, disk height, pelvic parameters by full spine radiograph(Inclusion, at 2 months, at 12 months and at 60 months)
- Evaluation of radiological adjacent syndrome by simple and dynamic radiology and MRI.(60 months)
- Evaluation of the maximum walking distance by self-paced test(Inclusion, at 2 months, at 12 months and at 60 months)
- The rate of re-intervention on the instrumented level or adjacent level during the study(During the whole study (up to 60 months))
- Evaluation of symptomatic adjacent syndrome adjacent syndrome(60 months)