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)

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

Sponsors

Lead Sponsor: Quanta Medical

Collaborator: Cousin Biotech

Source Quanta Medical
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 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 24 months to recruit the necessary number of subjects for the study (a total of 216 patients is expected).

Overall Status Not yet recruiting
Start Date June 1, 2020
Completion Date June 1, 2027
Primary Completion Date June 1, 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Evaluation of change from baseline degree of functional disability, related to low back pain, by using the Oswestry Disability Index (ODI) at 12th month post-surgery Baseline, 12 months
Secondary Outcome
Measure Time Frame
Measuring the mobility of the instrumented level and adjacent levels at inclusion, 2 months, 12 months and 60 months post intervention using dynamic X-rays of the lumbar spine: Inclusion, at 2 months, at 12 months and at 60 months
Measuring the evolution of the degree of functional disability related to lumbar and radicular pain by the Oswestry Disability Index (ODI) at inclusion, 2 months, 12 months and 60 months post-intervention; Inclusion, at 2 months, at 12 months and at 60 months
Assessing the intensity of radicular and lumbar pain by the VAS scale (0-100) at inclusion, 2 months, 12 months and 60 months post-intervention Inclusion, at 2 months, at 12 months and at 60 months
Assessing the quality of life by the Short Forum Health Survey(SF-12 score) at inclusion, 2 months, 12 months and 60 months post-intervention. Inclusion, at 2 months, at 12 months and at 60 months
Measuring the anxiety using the Hospital Anxiety and Depression Scale (HAD) at inclusion, 2 months, 12 months and 60 months post intervention; Inclusion, at 2 months, at 12 months and at 60 months
Assessing the motion status at the instrumented level and adjacent levels (right and left), by measuring motor skills at inclusion, 2 months, 12 months and 60 months post-intervention Inclusion, at 2 months, at 12 months and at 60 months
Assessing the sensory status at the instrumented level and adjacent levels (right and left), by measuring feeling of touch and stinging sensation at inclusion, 2 months, 12 months and 60 months post-intervention Inclusion, at 2 months, at 12 months and at 60 months
Measuring different radiological parameters as lumbar lordosis (LL), instrumented level segmental lordosis, disk height, pelvic parameters by full spine radiograph Inclusion, at 2 months, at 12 months and at 60 months
Evaluation of the maximum walking distance by self-paced test Inclusion, at 2 months, at 12 months and at 60 months
The rate of re-intervention on the instrumented level or adjacent level during the study During the whole study (up to 60 months)
Evaluation of radiological adjacent syndrome by simple and dynamic radiology and MRI. 60 months
Evaluation of symptomatic adjacent syndrome adjacent syndrome 60 months
Evaluation of surgical adjacent syndrome 60 months
Assessing safety and tolerance During the whole study (up to 60 months)
Assessing safety and tolerance During the whole study (up to 60 months)
Assessing safety and tolerance During the whole study (up to 60 months)
Enrollment 216
Condition
Intervention

Intervention Type: Device

Intervention Name: B-DYN

Description: The surgical technique for placement of the B-Dyn device is performed under general anaesthesia. The procedure begins with the insertion of the first upper polyaxial screw which is screwed in with the polyaxial screwdriver. The use of the phantom (Trial 10) is necessary in order to position the second screw. Once the screws are positioned, the B-Dyn is taken between the jaws of the gripping forceps in order to insert it into the heads of the polyaxial screws. The movable rod of the B-Dyn is then placed in the head of the upper screw. The positioning mark of the fixed rod must be placed facing the operator and in the center of the lower screw head. Finally the cap of the lower polyaxial pedicle screw is tightened. A final tightening of the two plugs on the polyaxial pedicle screw heads is performed to fix the assembly.

Arm Group Label: B-DYN Device

Intervention Type: Device

Intervention Name: Conventional Bolted fusion (with or without cage)

Description: The surgeon will complete his gesture by placing 2 screws in the upper vertebra and 2 screws in the lower vertebra; the screws will be connected to each other to stabilize the assembly. This type of surgery is done via posterior approach and under general anaesthesia.

Arm Group Label: Conventional bolted fusion (with or without cage)

Eligibility

Criteria:

Inclusion Criteria:

1. Stenosis on 1 to 3 vertebral levels (grade C or D according to Schizas classification) on MRI (lumbar spine MRI )

2. Spondylolisthesis grade 1 or no spondylolisthesis

3. Pseudoclamping on one or both legs and back pain (EVA score > 30)

4. Subjects who have failed well-managed medical treatment that has not resulted in lasting symptom relief (duration of symptoms > 6 months).

5. Subjects with no contraindications to fusion or the application of B-Dyn®.

6. Subjects of both sexes, 40 years of age or older of.

7. Patient who is able to respond to the questionnaires and who can communicate in the language of the study country.

8. Patient who has given free, informed and written consent to participate in the study

9. Subjects affiliated to or entitled to a social security scheme

Exclusion Criteria:

1. Spondylolisthesis of grade > 1.

2. Degenerative scoliosis (Cobb angle > 20°).

3. History of fusion for spinal stenosis or instability.

4. Stenosis not caused by degenerative changes.

5. Isolated herniated disc.

6. Other specific vertebral damage (e.g. ankylosing spondylitis, cancer or neurological disorders).

7. History of vertebral compression fractures at the instrumented level.

8. History of osteoporotic fractures.

9. Psychological disorders (e.g., dementia or substance abuse) that lead to an inability to participate in the study.

10. Intervention required on more than 3 vertebral levels.

11. Chronic infection.

12. Withdrawal of consent.

13. Pregnant woman.

14. Breastfeeding woman

15. Participation in a clinical trial in the 3 months prior to the initial visit.

16. Drug addiction.

17. Predicted unavailability during the course of the study. Patient deprived of liberty or under guardianship.

18. Allergy to any of the components of the medical device

Gender: All

Minimum Age: 40 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Vincent POINTILLART, Professor

Phone: +33 (0) 1 47 08 63 41

Email: [email protected]

Location
Facility: Contact:
CHU [University Hospital Center]of Bordeaux - Le Tripode - GH Pellegrin/ Department of Orthopaedic and Trauma Surgery Spinal Surgery Unit | Bordeaux, 33000, France Vincent POINTILLART, professor +33 (0) 5 56 79 55 28 [email protected]
Clinique Des Cedres | Cornebarrieu, 31700, France Bertrand debono, Doctor
Location Countries

France

Verification Date

May 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: B-DYN Device

Type: Experimental

Description: The surgical technique for placement of the B-Dyn device is performed under general anaesthesia. The procedure begins with the insertion of the first upper polyaxial screw which is screwed in with the polyaxial screwdriver. The use of the phantom (Trial 10) is necessary in order to position the second screw. Once the screws are positioned, the B-Dyn is taken between the jaws of the gripping forceps in order to insert it into the heads of the polyaxial screws. The movable rod of the B-Dyn is then placed in the head of the upper screw. The positioning mark of the fixed rod must be placed facing the operator and in the center of the lower screw head. Finally the cap of the lower polyaxial pedicle screw is tightened. A final tightening of the two plugs on the polyaxial pedicle screw heads is performed to fix the assembly.

Label: Conventional bolted fusion (with or without cage)

Type: Active Comparator

Description: The surgeon will complete his gesture by placing 2 screws in the upper vertebra and 2 screws in the lower vertebra; the screws will be connected to each other to stabilize the assembly. This type of surgery is done via posterior approach and under general anaesthesia.

Acronym BDYNCLIN
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Masking Description: The patient will be blinded from the randomizing arm. As the procedure is performed under general anaesthesia, the patient will not be informed whether or not the B-Dyn® device has been implanted as a result of the procedure. The primary endpoint (the ODI being a reported outcome patient) will therefore be assessed blind to the randomizing arm. Other secondary endpoints such as quality of life or pain intensity will also be assessed blindly from the randomizing arm (patient assessment). Blinding of the surgeon is not possible. The device cannot be blinded from the surgeon's view.

Source: ClinicalTrials.gov