Long-term Assessment of BDyn Dynamic Stabilization Device in Patients With Lumbar Degenerative Disc Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dynamic Lumbar Stabilization Device.
- Who it may be relevant to
- Registry conditions: Degenerative Disc Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this clinical trial is to estimate the cumulative reoperation rate at upper adjacent segment level in patients treated with BDyn dynamix stabilization for lumbar degenerative disc diseases over long-term follow-up. Patients will provide baseline socio-demographic and surgical data, complete patient-reported outcome measures (ODI, pain NRS, satisfaction), undergo imaging assessments (dynamic X-rays, EOS, MRI), and participate in safety evaluations including adverse event monitoring throughout follow-up.
Interventions
- Device Dynamic Lumbar Stabilization Device
BDyn is intended for spine surgery with a posterio approach. The sterile spinal dynamic posterior stabilization devices BDyn is intended to restore the stabilization of the spine segment from T10 to S1 by preserving the anatomical lordosis and the deadening of the intervertebral joint.
Primary outcome measures
- Reoperation rate at the upper adjacent segment [Time frame: Through study completion, an average of 10 year]
Secondary outcome measures (12)
- Reoperation rate at the instrumented segment [Time frame: Through study completion, an average of 10 year]
- Describe upper adjacent segment integrity [Time frame: Through study completion, an average of 10 year]
- Describe segmental range of motion (ROM) of the stabilized segment, the upper and lower adjacent segment [Time frame: Through study completion, an average of 10 year]
- Describe disc height of the stabilized segment, the upper and lower adjacent segment [Time frame: Through study completion, an average of 10 year]
- Describe sagittal balance [Time frame: Through study completion, an average of 10 year]
- Describe disc regeneration and degeneration of the stabilized segment, the upper and lower adjacent segment [Time frame: Through study completion, an average of 10 year]
- Describe disability [Time frame: Through study completion, an average of 10 year]
- Describe back pain [Time frame: Through study completion, an average of 10 year]
- Describe leg pain [Time frame: Through study completion, an average of 10 year]
- Describe satisfaction [Time frame: Through study completion, an average of 10 year]
- Describe perioperative outcomes [Time frame: Through study completion, an average of 10 year]
- Describe clinical safety [Time frame: Through study completion, an average of 10 year]
Eligibility criteria
Inclusion criteria
- Patient, male or female, aged ≥ 18 years old
- Patient treated with BDyn device until end of December 2021, with between one and four fused level(s) maximum for the following indications: Degenerative intervertebral disc disease and/or articular facets confirmed by further examinations, Spinal canal stenosis, Degenerative spondylolisthesis grade 1, Segmental instability
- Patient who signed the informed consent form
- Patient affiliated with a social security scheme
Exclusion criteria
- Patients who are unable to provide informed consent due to cognitive impairment, language barrier, or any other condition that limits their ability to understand the nature, objectives, or potential risks of the study
- Patient that is pregnant or breastfeeding;
- Patient with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code;
- Patient who cannot comply with the protocol requirements based on the investigator's judgment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07580664 · 2026-A00343-48