Comparing B-DYN and conventional fusion for treating lumbar stenosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the efficacy and tolerance of the B-DYN dynamic stabilization device compared to conventional bolted fusion techniques in patients with degenerative lumbar spinal stenosis. The research focuses on patients who experience significant functional incapacity despite medical treatment and require surgical intervention. Participants will be assessed for postoperative outcomes, including pain relief and functional improvement. The study aims to determine whether the B-DYN device offers advantages over traditional methods in terms of mobility and recovery.

Why it matters

Who can join: the full rules

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.

Where it's running

• CHU [University Hospital Center]of Bordeaux - Le Tripode - GH Pellegrin/ Department of Orthopaedic and Trauma Surgery Spinal Surgery Unit
  Bordeaux, France Recruiting
• Clinique Des Cedres
  Cornebarrieu, France Not yet recruiting

Study contacts

• Principal investigator: Vincent POINTILLART, Professor — University Hospital, Bordeaux
• Study coordinator: Vincent POINTILLART, Professor
• Email: b.hill@quanta-medical.com
• Phone: +33 (0) 1 47 08 63 41

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.