Status:
RECRUITING
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)
Lead Sponsor:
Quanta Medical
Collaborating Sponsors:
Cousin Biotech
Conditions:
Degenerative Lumbar Spinal Stenosis
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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 (...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04407338
Start Date
June 1 2020
End Date
November 1 2029
Last Update
March 19 2025
Active Locations (2)
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1
CHU [University Hospital Center]of Bordeaux - Le Tripode - GH Pellegrin/ Department of Orthopaedic and Trauma Surgery Spinal Surgery Unit
Bordeaux, France, 33000
2
Clinique Des Cedres
Cornebarrieu, France, 31700