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.
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
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
Single group
Dynamic Lumbar Stabilization Device
DeviceBDyn 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.
Reoperation rate at the upper adjacent segment
Cumulative reoperation rate at the upper adjacent segment will be defined as the occurrence of reoperation at this level over long-term postoperative follow-up (≥4 years)
Reoperation rate at the instrumented segment
The aim is to estimate the cumulative reoperation rate at the instrumented segment in patients treated with BDyn dynamic stabilization for degenerative disc disease over long-term postoperative follow-up
Describe upper adjacent segment integrity
To evaluate the upper adjacent segment integrity in patients treated with BDyn dynamic stabilization for lumbar degenerative disc disease over long-term postoperative follow-up
Describe segmental range of motion (ROM) of the stabilized segment, the upper and lower adjacent segment
To describe segmental range of motion (ROM) of the stabilized segment, the upper and lower adjacent segment in patients treated with BDyn dynamic stabilization for degenerative disc disease over long-term postoperative follow-up
Describe disc height of the stabilized segment, the upper and lower adjacent segment
Intervertebral disc height measured in millimeters on MRI at the stabilized segment and adjacent segments (upper and lower), assessed at baseline and during long-term postoperative follow-up
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This trial is not recruiting at the moment. You can still explore other options:
