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) (BDYNCLIN)
Degenerative Lumbar Spinal Stenosis
About this trial
This is an interventional treatment trial for Degenerative Lumbar Spinal Stenosis
Eligibility Criteria
Inclusion Criteria:
- Stenosis on 1 to 3 vertebral levels (grade C or D according to Schizas classification) on MRI (lumbar spine MRI )
- Spondylolisthesis grade 1 or no spondylolisthesis
- Pseudoclamping on one or both legs and back pain (EVA score > 30)
- Subjects who have failed well-managed medical treatment that has not resulted in lasting symptom relief (duration of symptoms > 6 months).
- Subjects with no contraindications to fusion or the application of B-Dyn®.
- Subjects of both sexes, 40 years of age or older of.
- Patient who is able to respond to the questionnaires and who can communicate in the language of the study country.
- Patient who has given free, informed and written consent to participate in the study
- Subjects affiliated to or entitled to a social security scheme
Exclusion Criteria:
- Spondylolisthesis of grade > 1.
- Degenerative scoliosis (Cobb angle > 20°).
- History of fusion for spinal stenosis or instability.
- Stenosis not caused by degenerative changes.
- Isolated herniated disc.
- Other specific vertebral damage (e.g. ankylosing spondylitis, cancer or neurological disorders).
- History of vertebral compression fractures at the instrumented level.
- History of osteoporotic fractures.
- Psychological disorders (e.g., dementia or substance abuse) that lead to an inability to participate in the study.
- Intervention required on more than 3 vertebral levels.
- Chronic infection.
- Withdrawal of consent.
- Pregnant woman.
- Breastfeeding woman
- Participation in a clinical trial in the 3 months prior to the initial visit.
- Drug addiction.
- Predicted unavailability during the course of the study. Patient deprived of liberty or under guardianship.
- Allergy to any of the components of the medical device
Sites / Locations
- CHU [University Hospital Center]of Bordeaux - Le Tripode - GH Pellegrin/ Department of Orthopaedic and Trauma Surgery Spinal Surgery UnitRecruiting
- Clinique Des Cedres
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
B-DYN Device
Conventional bolted fusion (with or without cage)
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.
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.