About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dynamic Lumbar Stabilization Device