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)

Launched by QUANTA MEDICAL · May 25, 2020

Keywords

ClinConnect Summary

This clinical trial, called BDYNCLIN, is studying two different surgical treatments for a common condition known as degenerative lumbar spinal stenosis (LSS), which causes pain and difficulty in movement due to narrowing of the spinal canal in the lower back. The trial compares a new device called B-DYN, which allows for some movement while stabilizing the spine, to traditional spinal fusion surgery, which is more rigid. Researchers want to find out if using the B-DYN device can help patients maintain better mobility and reduce functional disability after surgery compared to conventional methods.

To participate in this study, you need to be at least 40 years old and have specific issues related to lumbar stenosis, such as pain in the legs or lower back that hasn’t improved with other treatments. You also need to agree to take part in the study by signing a consent form. If you join, you can expect to be followed for five years to see how well the treatments work and if one is better than the other. It's important to note that there are some health conditions and situations that would exclude someone from participating, such as certain types of spinal issues or if you're pregnant.

Gender

ALL

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 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.