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)

NCT04407338 | Recruiting

• 1 other identifier: 3001_BDYNCLIN
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 2

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 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).

Conditions

Degenerative Lumbar Spinal Stenosis

Keywords

Spine; Arthrodesis; Dynamic stabilisation; BDYN

Outcome Measures

Primary Outcomes (1)

• 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

  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:

  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;

  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;

  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;

  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;

  Inclusion, at 2 months, at 12 months, 24 months, and at 60 months

Study Arms (2)

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.

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.

Device: Conventional Bolted fusion (with or without cage)

Interventions

B-DYN DEVICE

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.

B-DYN Device

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.

Conventional bolted fusion (with or without cage)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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®.
• 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.

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• Quanta Medical: lead
• Cousin Biotech: collaborator

Study Sites (2)

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

Bordeaux, 33000, France

RECRUITING

Clinique Des Cedres

Cornebarrieu, 31700, France

NOT YET RECRUITING

Related Publications (5)

• 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.

  PMID: 30560029 BACKGROUND

• Turner 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.

  PMID: 1531550 BACKGROUND

• Machado 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.

  PMID: 27801521 BACKGROUND

• Radcliff 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.

  PMID: 23773433 BACKGROUND

• Morishita 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.

  PMID: 21301893 BACKGROUND

MeSH Terms

Conditions

Ankylosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Vincent POINTILLART, Professor

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent POINTILLART, Professor

CONTACT

+33 (0) 1 47 08 63 41; b.hill@quanta-medical.com

Bertrand DEBONO, Doctor

CONTACT

+33 (0) 1 47 08 63 41; b.hill@quanta-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will be blinded from the randomizing arm. As the procedure is performed under general anaesthesia, the patient will not be informed whether or not the B-Dyn® device has been implanted as a result of the procedure. The primary endpoint (the ODI being a reported outcome patient) will therefore be assessed blind to the randomizing arm. Other secondary endpoints such as quality of life or pain intensity will also be assessed blindly from the randomizing arm (patient assessment). Blinding of the surgeon is not possible. The device cannot be blinded from the surgeon's view.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 )

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 29, 2020
• Study Start: June 1, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): November 1, 2029
• Last Updated: March 19, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)