RecruitingNot ApplicableNCT04407338

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


Sponsor

Quanta Medical

Enrollment

216 participants

Start Date

Jun 1, 2020

Study Type

INTERVENTIONAL

Conditions

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 56 months to recruit the necessary number of subjects for the study (a total of 216 patients is expected).


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study (BDYNCLIN) is comparing two surgical approaches for treating lumbar spinal stenosis — a narrowing of the spinal canal in the lower back that causes leg pain and difficulty walking. One approach is standard spinal fusion surgery, and the other uses a device called B-DYN that allows for dynamic stabilisation of the spine (some movement is preserved rather than fully fusing the vertebrae). Researchers want to know whether B-DYN results in less disability and better function compared to conventional fusion. Participants must have already tried non-surgical treatments. You may be eligible if... - You are 40 years of age or older - You have lumbar stenosis affecting 1–3 disc levels, confirmed on MRI, with Grade B, C, or D stenosis (or Grade A with lateral involvement) - You have neurological symptoms or neurogenic claudication (leg pain when walking) - You have already failed conservative treatment lasting at least 3 months - You have no contraindication to either fusion or the B-DYN device You may NOT be eligible if... - You have spondylolisthesis above Grade 1 at the surgical level - Surgery is needed at more than 3 disc levels - You have degenerative scoliosis with a Cobb angle greater than 20 degrees - Your stenosis is only at the L5-S1 level - You have had prior instrumented lumbar surgery (e.g., rods, cages) at adjacent levels - You have an allergy to any component of the B-DYN device - You are pregnant or breastfeeding - You have psychological disorders or drug addiction affecting study participation - You participated in another clinical trial within the past 3 months Talk to your spine surgeon about your MRI findings, prior treatment history, and eligibility for either surgical approach in this study.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEB-DYN

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.

DEVICEConventional Bolted fusion (with or without cage)

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.


Locations(2)

CHU [University Hospital Center]of Bordeaux - Le Tripode - GH Pellegrin/ Department of Orthopaedic and Trauma Surgery Spinal Surgery Unit

Bordeaux, France

Clinique Des Cedres

Cornebarrieu, France

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NCT04407338


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