Efficacy and Tolerance Study of B-DYN Versus Conventional Fusion in the Treatment of Lumbar Stenosis on the Degree of Post-operative Functional Incapacity (BDYNCLIN)
Recruiting
N/AInterventional Study
Degenerative Lumbar Spinal Stenosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
40 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
216 (estimated)
Sponsor
Quanta Medical · Industry
Who this trial is looking for
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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…
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).
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Eligibility Criteria
Inclusion Criteria:
Disease related criteria:
1. 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 M…
Inclusion Criteria:
Disease related criteria:
1. 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 )
2. Spondylolisthesis grade 1 or no the upper surgical (treated) level
3. Neurological impairment or neurogenic claudication on one or both legs (VAS score \> 30)
4. Subjects who have failed well-managed medical treatment that has not resulted in long-lasting symptom relief (duration of symptoms \> 3 months);
5. Subjects with no contraindication to fusion or the application of B-Dyn®.
Population-related criteria
1. Subjects of both sexes, 40 years of age and older
2. Subjects who have given free, informed and written consent to participate in the study;
3. Subjects who are able to respond to questionnaires and who can communicate in the language of the study country ;
4. Subjects affiliated to a social security scheme or entitled to a social security scheme.
Exclusion Criteria:
Disease related criteria:
1. Spondylolisthesis of grade \> 1 on the upper surgical (treated) level
2. Intervention required on more than 3 disc levels
3. Degenerative Scoliosis (Cobb angle \> 20°);
4. Stenosis located only on the L5-S1 level
5. 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.
6. Stenosis not caused by from degenerative changes.
7. Isolated disc herniation
8. Other specific vertebral damage (for example: ankylosing spondylitis, cancer or neurological disorders)
9. History of vertebral compression fractures at the instrumented level
10. History of osteoporotic fractures
11. Psychological disorders (e.g. dementia ….etc) or drug addiction that lead to an inability to participate in the study
12. Chronic infection
Population related criteria:
1. Withdrawal of consent;
2. Pregnant or Breastfeeding woman
3. Participation in a clinical trial in the 3 months prior to the initial visit;
4. 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.
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