Degenerative Lumbar Spinal Stenosis Clinical Trial
Official title:
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
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).
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02592642 -
the Evaluation of Four Non-operative Treatments for Degenerative Lumbar Spinal Stenosis
|
N/A | |
Recruiting |
NCT05273346 -
TCM Conservative Treatment for the Degenerative Lumbar Spinal Stenosis
|
N/A | |
Recruiting |
NCT04469387 -
Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion
|
N/A | |
Completed |
NCT03302520 -
Comparison of Bioactive Glass Ceramics Spacer and PEEK Cages in Posterior Lumbar Interbody Fusion: A Prospective, RCT
|
N/A | |
Completed |
NCT03532945 -
A Follow-up Study to Evaluate the Efficacy and Safety of Novomax in Posterior Lumbar Interbody Fusion
|
N/A | |
Completed |
NCT03560401 -
Is Postoperative Bracing Necessary After Spine Surgery for Degenerative Conditions
|
N/A | |
Recruiting |
NCT06335511 -
Decompression Versus Instrumented Fusion for Lumbar Degenerative Disease. Clinical and Biomechanical Outcome Study
|
||
Not yet recruiting |
NCT06106061 -
Effectiveness and Safety of the Facet Fixation (FFX®) Implant in the Treatment of Degenerative Lumbar Spinal Stenosis
|
N/A | |
Completed |
NCT03302507 -
Biportal Endoscopy Spine Surgery (BESS )Versus Unilateral Laminotomy Bilateral Decompression (ULBD ): RCT, Non-inferiority Trial
|
N/A | |
Completed |
NCT02644746 -
Efficacy and Safety of Acupuncture for Degenerative Lumbar Spinal Stenosis
|
N/A | |
Completed |
NCT04406987 -
Instability in the Lumbar Spine of Patients With Age Related Changes and Narrowing of the Spinal Canal (Spinal Stenosis)
|
||
Recruiting |
NCT03553186 -
Tranexamic Acid in Adult Spinal Deformity Surgery
|
Phase 3 | |
Recruiting |
NCT05645497 -
Evaluation of the Efficacy and Safety of the FACET FIXation Implant.
|
||
Enrolling by invitation |
NCT04086784 -
3D-printed Porous Titanium Alloy Cages Versus PEEK Cages in Patients With Osteoporosis
|
||
Recruiting |
NCT05375201 -
Clinical Decision-Making and Virtual Reality Exercise
|
N/A | |
Completed |
NCT05203666 -
Clinical and Radiological Outcomes Following Insertion of a Novel Removable Percutaneous Interspinous Process Spacer: an Initial Experience.
|
||
Recruiting |
NCT04467944 -
Effect of Pre-existing Adjacent Segment Degeneration on Long-term Effectiveness After Lumbar Fusion Surgery
|
||
Active, not recruiting |
NCT03562936 -
The NORDSTEN Studies/The Observational Cohort Study
|
||
Terminated |
NCT00627497 -
DIAMâ„¢ Spinal Stabilization System vs. Decompression, Formerly vs. Posterolateral Fusion
|
Phase 3 | |
Completed |
NCT02121249 -
Clinical Trial of Minimally Invasive Robotic Spine Surgery
|
N/A |