Degenerative Lumbar Spinal StenosisBDYNCLINNCT04407338
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)
A study testing B-DYN and Conventional Bolted fusion (with or without cage) in people with Degenerative Lumbar Spinal Stenosis, run by Quanta Medical at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis
- What is being tested?
- B-DYN and Conventional Bolted fusion (with or without cage)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jun 2020to 1 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disease related criteria:
- Stenosis on 1, 2 or 3 disc levels (grade B or C or D according to Schizas classification or central stenosis of grade A according to Schizas classification with a lateral stenosis (postero-lateral overhang or disc protrusion)) on MRI (lumbar spine MRI )
- Spondylolisthesis grade 1 or no the upper surgical (treated) level
- Neurological impairment or neurogenic claudication on one or both legs (VAS score > 30)
- Subjects who have failed well-managed medical treatment that has not resulted in long-lasting symptom relief (duration of symptoms > 3 months);
- Subjects with no contraindication to fusion or the application of B-Dyn®.
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- Population-related criteria
- Subjects of both sexes, 40 years of age and older
- Subjects who have given free, informed and written consent to participate in the study;
- Subjects who are able to respond to questionnaires and who can communicate in the language of the study country ;
- Subjects affiliated to a social security scheme or entitled to a social security scheme.
Who cannot join
- Disease related criteria:
- Spondylolisthesis of grade > 1 on the upper surgical (treated) level
- Intervention required on more than 3 disc levels
- Degenerative Scoliosis (Cobb angle > 20°);
- Stenosis located only on the L5-S1 level
- History of instrumented lumbar surgery (cage, rod, etc.) on the upper or lower level, except in the case of instrumentation of the lower level with an intra-spinous device.
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- Stenosis not caused by from degenerative changes.
- Isolated disc herniation
- Other specific vertebral damage (for example: ankylosing spondylitis, cancer or neurological disorders)
- History of vertebral compression fractures at the instrumented level
- History of osteoporotic fractures
- Psychological disorders (e.g. dementia ….etc) or drug addiction that lead to an inability to participate in the study
- Chronic infection
- Population related criteria:
- Withdrawal of consent;
- Pregnant or Breastfeeding woman
- Participation in a clinical trial in the 3 months prior to the initial visit;
- Predicted unavailability during study. Patient deprived of liberty or under guardianship.
- Medical Device related criteria:
- 1. Allergy to any of the components of the medical device.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU [University Hospital Center]of Bordeaux - Le Tripode - GH Pellegrin/ Department of Orthopaedic and Trauma Surgery Spinal Surgery Unit
Bordeaux, 33000
Vincent POINTILLART, professor, +33 (0) 5 56 79 55 28, b.hill@quanta-medical.com
- Not yet recruiting
Clinique Des Cedres
Cornebarrieu, 31700
Bertrand debono, Doctor
About this study
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).
Read more
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).
Read the 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 level's 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 level's mobility when assembling.
First inclusion : May 2020
Inclusion period : 56 months
Follow up of the last patient: December 2029
Analysis and results: June 2030
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Being tested
- B-DYN, Conventional Bolted fusion (with or without cage)
- Keywords
- Spine, Arthrodesis, Dynamic stabilisation, BDYN
- Medical subject headings
- Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-DYNDevice
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.
Conventional Bolted fusion (with or without cage)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| B-DYN Device | Experimental | 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. Receives: Device: B-DYN |
| Conventional bolted fusion (with or without cage) | Active comparator | 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. Receives: Device: Conventional Bolted fusion (with or without cage) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The Oswestry questionnaire helps assess the symptoms and severity of back pain, as well as the impairment on daily life activities. The questionnaire contains 10 questions, concerning: pain, personal care, loads, walking ability, sitting position, standing position, sleep, sexual life, social life, travels. Each question offers 6 answers, with a score of 0 to 6 that the patient must choose; score 0 corresponds to a normal function, and score 6 to a very diminished function. The score obtained is multiplied by 2 to get a percentage of disability, with 0% for the absence of disability, and 100% for the most important disability. Completion of the test takes about 5 minutes
Measured: Baseline, 12 months
Secondary outcomes (16)
Measuring the mobility of the upper instrumented level and adjacent levels at inclusion, 2 months, 12 months and 60 months post intervention using dynamic X-rays of the lumbar spine:
Dynamic X-ray is a radiograph to measure the mobility of instrumented level and adjacent one. During this radiograph, the patient will be asked to bend down until he/she reaches the painful threshold in flexion and extension, and in lateral inclination. This image should focus on the instrumented level. The degree of mobility is calculated by subtracting the angle that is formed in flexure by the tangent of the upper layer of the upper vertebra, and the tangent of the lower layer to the angle formed by these extending tangents.
Measured: 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, 24 months and 60 months post-intervention;
The Oswestry questionnaire helps assess the symptoms and severity of back pain, as well as the impairment on daily life activities. The questionnaire contains 10 questions, concerning: pain, personal care, loads, walking ability, sitting position, standing position, sleep, sexual life, social life, travels. Each question offers 6 answers, with a score of 0 to 6 that the patient must choose; score 0 corresponds to a normal function, and score 6 to a very diminished function. The score obtained is multiplied by 2 to get a percentage of disability, with 0% for the absence of disability, and 100% for the most important disability. Completion of the test takes about 5 minutes
Measured: Inclusion, at 2 months, at 12 months, 24 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, 24 months and 60 months post-intervention;
The visual analogue scale is shaped as a graduated ruler: from 0 to 100; 0 means that the subject has no pain and 100 is the maximum pain he can bear. It's a self-assessment scale. It is sensitive, reproducible, reliable and validated in both acute and chronic pain situations.
Measured: Inclusion, at 2 months, at 12 months, 24 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, 24 months and 60 months post-intervention;
The Short Forum Health Survey (SF-12 test) is an abbreviated version of the Medical Outcomes Study Short-Form General Health Survey (SF-36) with only 12 of the 36 questions. The SF-12 provides two scores: a mental and social quality of life score and a physical quality of life score. The maximum value is 56 and the minimum value is 12. Higher Scores indicates better physcial and mental health
Measured: Inclusion, at 2 months, at 12 months, 24 months, and at 60 months
Measuring the anxiety using the Hospital Anxiety and Depression Scale (HAD) at inclusion, 2 months, 12 months, 24 months and 60 months post-intervention;
The HAD scale is a tool that detects anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. There are seven questions related to anxiety (total A) and seven others related to the depressive dimension (total D); this provides two scores (maximum score of each score = 21)
Measured: Inclusion, at 2 months, at 12 months, 24 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
MRC scale will be used to evaluate the motor function: 0 means no movement/contractions, 5 means normal muscle strength). The neurological status will be assessed at the L4, L5 and S1 levels (right and left)
Measured: 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
MRC scale for sensory assesment will be used to assess the sensation of touch and sting : 0 means Absent and 2 means Normal. The motor status will be assessed at the L4, L5 and S1 levels (right and left)
Measured: 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
Full spine radiograph (EOS) is a face and profil X-ray, on which the sagittal alignment parameters will be measured. An independent radiologist will be in charge of the centralized reading.
Measured: Inclusion, at 2 months, at 12 months and at 60 months
Evaluation of the maximum walking distance by self-paced test
Self-Paced Walking Test (SPWT) assesses walking capacity by measuring the total distance the patient can continuously walk on a flat surface at a self-selected pace, until experiencing symptoms of LSS or reaching a limit of 30 minutes.
Measured: 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
A re-operation during the study is defined as a secondary intervention at the instrumented level or adjacent level for any reason (infectious or mechanical): revision, implant removal (explantation), fusion, need for additional fixation. etc
Measured: During the whole study (up to 60 months)
Evaluation of radiological adjacent syndrome by simple and dynamic radiology and MRI.
Radiological adjacent syndrome is considered if in simple and dynamic radiology, we will detect the narrowing of the disc height (> 3 mm), posterior opening ( > 5°) and sliding progression (> 3 mm) compared to the pre-operative data of the lateral bending radiology.
Using MRI, we will follow postoperation progression of disc degeneration according to the Pfirrmann classification and the progression of spinal canal stenosis according to the classification of Imagama.
The 1 grade progression of disk degeneration or spinal canal stenosis on MRI is considered an adjacent radiological syndrome.
Measured: 60 months
Evaluation of symptomatic adjacent syndrome adjacent syndrome
Symptomatic adjacent syndrome is considered when clinical symptoms such as radicular pain of the segment adjacent to the treated level is confirmed by using the visual analogue scale (shaped as a graduated ruler: from 0 to 100; 0 means that the subject has no pain and 100 is the maximum pain he can bear) .
Measured: 60 months
Evaluation of surgical adjacent syndrome
Surgical adjacent syndrome is considered if additional operation to treat clinical symptoms such as radicular pain (assessed using the visual analogue scale graduated from 0 to 100; 0 means that the subject has no pain and 100 is the maximum pain he can bear) of the segment adjacent to the treated level is required.
Measured: 60 months
Assessing safety and tolerance
By evaluating Number of patients who experienced at least one adverse event during the follow-up period.
Measured: During the whole study (up to 60 months)
Assessing safety and tolerance
By evaluating Number of patients who experienced a serious adverse event during the follow-up period.
Measured: During the whole study (up to 60 months)
Assessing safety and tolerance
By evaluating Rate of short and long-term intraoperative and post-operative complications.
Measured: During the whole study (up to 60 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Jun 2020
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Degenerative Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, multicentric, comparative study of non-inferiority in parallel groups with an allocation ratio of 1:1, single-blind (the patient will be blinded from the arm of randomization), single blind (The patient will be blinded regarding randomization arm). The secondary objective of this study will be to assess the performance of the B-Dyn device compared to a simple fusion on dynamic parameters and the prevention of adjacent syndrome. Randomization, with a ratio of 1:1 will be stratified on the center and on the presence of spondylolisthesis (spondylolisthesis grade 1 on the upper instrumented (treated) level VS no spondylolisthesison the upper instrumented ( treated) level )
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quanta Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cousin Biotech
- Responsible party
- Sponsor
- Investigators
- Vincent POINTILLART, Professor, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04407338
- Sponsor's protocol ID
- 3001_BDYNCLIN
- Acronym
- BDYNCLIN
- Status last verified
- Jul 2024
- First submitted
- 15 May 2020
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.
PubMed 30560029Turner JA, Ersek M, Herron L, Deyo R. Surgery for lumbar spinal stenosis. Attempted meta-analysis of the literature. Spine (Phila Pa 1976). 1992 Jan;17(1):1-8. doi: 10.1097/00007632-199201000-00001.
PubMed 1531550Machado GC, Ferreira PH, Yoo RI, Harris IA, Pinheiro MB, Koes BW, van Tulder MW, Rzewuska M, Maher CG, Ferreira ML. Surgical options for lumbar spinal stenosis. Cochrane Database Syst Rev. 2016 Nov 1;11(11):CD012421. doi: 10.1002/14651858.CD012421.
PubMed 27801521Radcliff KE, Kepler CK, Jakoi A, Sidhu GS, Rihn J, Vaccaro AR, Albert TJ, Hilibrand AS. Adjacent segment disease in the lumbar spine following different treatment interventions. Spine J. 2013 Oct;13(10):1339-49. doi: 10.1016/j.spinee.2013.03.020. Epub 2013 Jun 15.
PubMed 23773433Morishita Y, Ohta H, Naito M, Matsumoto Y, Huang G, Tatsumi M, Takemitsu Y, Kida H. Kinematic evaluation of the adjacent segments after lumbar instrumented surgery: a comparison between rigid fusion and dynamic non-fusion stabilization. Eur Spine J. 2011 Sep;20(9):1480-5. doi: 10.1007/s00586-011-1701-1. Epub 2011 Feb 8.
PubMed 21301893
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04407338
- Acronym / sponsor ID
- BDYNCLIN / 3001_BDYNCLIN
- Conditions
- Degenerative Lumbar Spinal Stenosis
- Keywords
- Spine, Arthrodesis, Dynamic stabilisation, BDYN
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Quanta MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Cousin Biotech
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 level's 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 level's 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, multicentric, comparative study of non-inferiority in parallel groups with an allocation ratio of 1:1, single-blind (the patient will be blinded from the arm of randomization), single blind (The patient will be blinded regarding randomization arm). The secondary objective of this study will be to assess the performance of the B-Dyn device compared to a simple fusion on dynamic parameters and the prevention of adjacent syndrome. Randomization, with a ratio of 1:1 will be stratified on the center and on the presence of spondylolisthesis (spondylolisthesis grade 1 on the upper instrumented (treated) level VS no spondylolisthesison the upper instrumented ( treated) level )
| Arm | Type | Receives |
|---|---|---|
| B-DYN Device | Experimental | Device: B-DYNThe 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. |
| Conventional bolted fusion (with or without cage) | Active comparator | Device: Conventional 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Stenosis on 1, 2 or 3 disc levels (grade B or C or D according to Schizas classification or central stenosis of grade A according to Schizas classification with a lateral stenosis (postero-lateral overhang or disc protrusion)) on MRI (lumbar spine MRI )
- Spondylolisthesis grade 1 or no the upper surgical (treated) level
- Neurological impairment or neurogenic claudication on one or both legs (VAS score > 30)
- Subjects who have failed well-managed medical treatment that has not resulted in long-lasting symptom relief (duration of symptoms > 3 months);
- Subjects with no contraindication to fusion or the application of B-Dyn®.
Key exclusion criteria (20 listed)
- Spondylolisthesis of grade > 1 on the upper surgical (treated) level
- Intervention required on more than 3 disc levels
- Degenerative Scoliosis (Cobb angle > 20°);
- Stenosis located only on the L5-S1 level
- History of instrumented lumbar surgery (cage, rod, etc.) on the upper or lower level, except in the case of instrumentation of the lower level with an intra-spinous device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B-DYNThe 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. | Device | B-DYN Device |
| Conventional 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. | Device | Conventional bolted fusion (with or without cage) |
Primary outcome
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
Time frame: Baseline, 12 months
The Oswestry questionnaire helps assess the symptoms and severity of back pain, as well as the impairment on daily life activities. The questionnaire contains 10 questions, concerning: pain, personal care, loads, walking ability, sitting position, standing position, sleep, sexual life, social life, travels. Each question offers 6 answers, with a score of 0 to 6 that the patient must choose; score 0 corresponds to a normal function, and score 6 to a very diminished function. The score obtained is multiplied by 2 to get a percentage of disability, with 0% for the absence of disability, and 100% for the most important disability. Completion of the test takes about 5 minutes
16 secondary outcomes
Measuring the mobility of the upper instrumented level and adjacent levels at inclusion, 2 months, 12 months and 60 months post intervention using dynamic X-rays of the lumbar spine:
Time frame: 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, 24 months and 60 months post-intervention;
Time frame: Inclusion, at 2 months, at 12 months, 24 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, 24 months and 60 months post-intervention;
Time frame: Inclusion, at 2 months, at 12 months, 24 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, 24 months and 60 months post-intervention;
Time frame: Inclusion, at 2 months, at 12 months, 24 months, and at 60 months
Measuring the anxiety using the Hospital Anxiety and Depression Scale (HAD) at inclusion, 2 months, 12 months, 24 months and 60 months post-intervention;
Time frame: Inclusion, at 2 months, at 12 months, 24 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
Time frame: 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
Time frame: 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
Time frame: Inclusion, at 2 months, at 12 months and at 60 months
Evaluation of the maximum walking distance by self-paced test
Time frame: 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
Time frame: During the whole study (up to 60 months)
Evaluation of radiological adjacent syndrome by simple and dynamic radiology and MRI.
Time frame: 60 months
Evaluation of symptomatic adjacent syndrome adjacent syndrome
Time frame: 60 months
Evaluation of surgical adjacent syndrome
Time frame: 60 months
Assessing safety and tolerance
Time frame: During the whole study (up to 60 months)
Assessing safety and tolerance
Time frame: During the whole study (up to 60 months)
Assessing safety and tolerance
Time frame: During the whole study (up to 60 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Background: PubMed 30560029Ravindra VM, Senglaub SS, Rattani A, Dewan MC, Hartl R, Bisson E, Park KB, Shrime MG. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine J. 2018 Dec;8(8):784-794. doi: 10.1177/2192568218770769. Epub 2018 Apr 24.
- Background: PubMed 1531550Turner JA, Ersek M, Herron L, Deyo R. Surgery for lumbar spinal stenosis. Attempted meta-analysis of the literature. Spine (Phila Pa 1976). 1992 Jan;17(1):1-8. doi: 10.1097/00007632-199201000-00001.
- Background: PubMed 27801521Machado GC, Ferreira PH, Yoo RI, Harris IA, Pinheiro MB, Koes BW, van Tulder MW, Rzewuska M, Maher CG, Ferreira ML. Surgical options for lumbar spinal stenosis. Cochrane Database Syst Rev. 2016 Nov 1;11(11):CD012421. doi: 10.1002/14651858.CD012421.
- Background: PubMed 23773433Radcliff KE, Kepler CK, Jakoi A, Sidhu GS, Rihn J, Vaccaro AR, Albert TJ, Hilibrand AS. Adjacent segment disease in the lumbar spine following different treatment interventions. Spine J. 2013 Oct;13(10):1339-49. doi: 10.1016/j.spinee.2013.03.020. Epub 2013 Jun 15.
- Background: PubMed 21301893Morishita Y, Ohta H, Naito M, Matsumoto Y, Huang G, Tatsumi M, Takemitsu Y, Kida H. Kinematic evaluation of the adjacent segments after lumbar instrumented surgery: a comparison between rigid fusion and dynamic non-fusion stabilization. Eur Spine J. 2011 Sep;20(9):1480-5. doi: 10.1007/s00586-011-1701-1. Epub 2011 Feb 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vincent POINTILLART, Professor principal investigator
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-DYN and Conventional Bolted fusion (with or without cage) in people with Degenerative Lumbar Spinal Stenosis, run by Quanta Medical at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent POINTILLART, Professor (+33 (0) 1 47 08 63 41, b.hill@quanta-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04407338, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.