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)

  • STATUS
    Recruiting
  • End date
    Jun 1, 2027
  • participants needed
    216
  • sponsor
    Quanta Medical
Updated on 26 January 2021

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

Details
Condition Degenerative Lumbar Spinal Stenosis
Treatment B-DYN, Conventional Bolted fusion (with or without cage)
Clinical Study IdentifierNCT04407338
SponsorQuanta Medical
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Stenosis on 1 to 3 vertebral levels (grade C or D according to Schizas classification) on MRI (lumbar spine MRI )
Spondylolisthesis grade 1 or no spondylolisthesis
Pseudoclamping on one or both legs and back pain (EVA score > 30)
Subjects who have failed well-managed medical treatment that has not resulted in lasting symptom relief (duration of symptoms > 6 months)
Subjects with no contraindications to fusion or the application of B-Dyn
Subjects of both sexes, 40 years of age or older of
Patient who is able to respond to the questionnaires and who can communicate in the language of the study country
Patient who has given free, informed and written consent to participate in the study
Subjects affiliated to or entitled to a social security scheme

Exclusion Criteria

Spondylolisthesis of grade > 1\
Degenerative scoliosis (Cobb angle > 20)
History of fusion for spinal stenosis or instability
Stenosis not caused by degenerative changes
Isolated herniated disc
Other specific vertebral damage (e.g. ankylosing spondylitis, cancer or neurological disorders)
History of vertebral compression fractures at the instrumented level
History of osteoporotic fractures
Psychological disorders (e.g., dementia or substance abuse) that lead to an inability to participate in the study
Intervention required on more than 3 vertebral levels
Chronic infection
Withdrawal of consent
Pregnant woman
Breastfeeding woman
Participation in a clinical trial in the 3 months prior to the initial visit
Drug addiction
Predicted unavailability during the course of the study. Patient deprived of liberty or under guardianship
Allergy to any of the components of the medical device
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note