Comparing B-DYN and conventional fusion for treating lumbar stenosis

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

This study is testing if a new device called B-DYN can help people with severe back problems feel better and recover faster than traditional surgery methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Quanta Medical (Industry-sponsored)
• Locations: 2 sites (Bordeaux and 1 other locations)
• Trial ID: NCT04407338 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with degenerative lumbar spinal stenosis who have not found relief from medical treatments.

Not a fit: Patients with contraindications to fusion surgery or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less invasive surgical option that preserves mobility while effectively treating lumbar stenosis.

How similar studies have performed: Other studies have explored dynamic stabilization techniques, but this specific comparison with B-DYN is novel.

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.

Where this trial is running

Bordeaux and 1 other locations

• 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

Conditions Degenerative Lumbar Spinal Stenosis; Spine; Arthrodesis; Dynamic stabilisation; BDYN