Ignite Creation Date:
2024-05-06 @ 2:44 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04407338
Status:
RECRUITING
Last Update Posted:
2020-09-16
First Post:
2020-05-15
Brief Title:
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
Sponsor:
Quanta Medical
Organization:
Quanta Medical
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BDYNCLIN
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 investigators 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
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 investigators 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
Detailed Description:
The Lumbar Spinal Stenosis LSS is an extremely common pathology that affects more than 102 million people worldwide every year
It is most often linked to the combination of a disk space narrowing loss of height and bulging within the canal a hypertrophy of the yellow ligament and of the joint capsules and also a bone overgrowth by the posterior vertebral joints This may be associated with Grade I spondylolisthesis
This pathology often extends over several levels frequently two L5S1 L4L5 or L4L5 L3L4 sometimes more A relatively homogeneous group of patients falls within the group of stenosis from S1 to L2 without significant deviation scoliosis or cyphosis type
A wide variety of different surgical techniques are used to treat patients with LSS and patients who have symptoms despite well-conducted medical treatment Decompressive laminectomy may prove to be insufficient when several levels are affected and also due to the fears of instability induced by the gesture itself the joint hypertrophy responsible for nerve root compression is also a stabilizing element Therefore the scientific community usually associates a gesture of stabilization with the gesture of decompression
The choice of stabilizing means is discussed without any conclusive answer provided by any controlled study This question accounts for the subject of this study
Two alternatives are discussed
The current gold standard is to practice rigid stabilization through bolted fusion with or without inter somatic cage despite the fact that it causes an excessive rigidification of the mobile segment therefore responsible for the acceleration of the degeneration of the upper level
Soft stabilization system with pedicular screwing B-Dyn type It stabilizes the arthrodesis while maintaining some mobility This partial preservation of mobility could slow down or prevent the upper levels degradation
Based on the judgment from the dynamic profile images the devices some of which are approved in the USA claim to favor fusion while providing no information on the mobility of the upper level in their studies
The aim of this randomized and prospective comparative study would not only be to establish the non-inferiority of the procedure under study versus conventional fusion with or without cage on the degree of functional disability after surgery but also to demonstrate the significantly higher preservation of the upper levels mobility when assembling
First inclusion May 2020
Inclusion period 56 months
Follow up of the last patient December 2029
Analysis and results June 2030
It is most often linked to the combination of a disk space narrowing loss of height and bulging within the canal a hypertrophy of the yellow ligament and of the joint capsules and also a bone overgrowth by the posterior vertebral joints This may be associated with Grade I spondylolisthesis
This pathology often extends over several levels frequently two L5S1 L4L5 or L4L5 L3L4 sometimes more A relatively homogeneous group of patients falls within the group of stenosis from S1 to L2 without significant deviation scoliosis or cyphosis type
A wide variety of different surgical techniques are used to treat patients with LSS and patients who have symptoms despite well-conducted medical treatment Decompressive laminectomy may prove to be insufficient when several levels are affected and also due to the fears of instability induced by the gesture itself the joint hypertrophy responsible for nerve root compression is also a stabilizing element Therefore the scientific community usually associates a gesture of stabilization with the gesture of decompression
The choice of stabilizing means is discussed without any conclusive answer provided by any controlled study This question accounts for the subject of this study
Two alternatives are discussed
The current gold standard is to practice rigid stabilization through bolted fusion with or without inter somatic cage despite the fact that it causes an excessive rigidification of the mobile segment therefore responsible for the acceleration of the degeneration of the upper level
Soft stabilization system with pedicular screwing B-Dyn type It stabilizes the arthrodesis while maintaining some mobility This partial preservation of mobility could slow down or prevent the upper levels degradation
Based on the judgment from the dynamic profile images the devices some of which are approved in the USA claim to favor fusion while providing no information on the mobility of the upper level in their studies
The aim of this randomized and prospective comparative study would not only be to establish the non-inferiority of the procedure under study versus conventional fusion with or without cage on the degree of functional disability after surgery but also to demonstrate the significantly higher preservation of the upper levels mobility when assembling
First inclusion May 2020
Inclusion period 56 months
Follow up of the last patient December 2029
Analysis and results June 2030
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None