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Compares treatment options for Degenerative Lumbar Spinal Stenosis
Official 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)
ClinicalTrials.gov ID: NCT04407338
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join 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...
- Spondylolisthesis grade 1 or no the upper surgical (treated) level
- Neurological impairment or neurogenic claudication on one or both legs (VAS score \> 30)
- people who have failed well-managed medical treatment that has not resulted in long-lasting symptom relief (duration of symptoms \> 3 months);
You likely can't join 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...
See the full eligibility criteria
- 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...
- Spondylolisthesis grade 1 or no the upper surgical (treated) level
- Neurological impairment or neurogenic claudication on one or both legs (VAS score \> 30)
- people who have failed well-managed medical treatment that has not resulted in long-lasting symptom relief (duration of symptoms \> 3 months);
- people with no contraindication to fusion or the application of B-Dyn®. Population-related criteria
- people of both sexes, 40 years of age and older
- people who have given free, informed and written consent to participate in the study;
- people who are able to respond to questionnaires and who can communicate in the language of the study country ;
- people affiliated to a social security scheme or entitled to a social security scheme.
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Cornebarrieu, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Cornebarrieu, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.