Degenerative Disc Disease
Conditions
Keywords
BDyn, Dynamic stabilization, Lumbar stabilization
Brief summary
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
DEVICEDynamic 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.
Sponsors
Cousin Biotech
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation rate at the upper adjacent segment | Through study completion, an average of 10 year | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Describe sagittal balance | Through study completion, an average of 10 year | To measure the angle of sagittal balance (the innate neutral standing position with C7 positioned over S1) in patients treated with BDyn dynamic stabilization for degenerative disc disease over long-term postoperative follow-up |
| Describe disc regeneration and degeneration of the stabilized segment, the upper and lower adjacent segment | Through study completion, an average of 10 year | Intervertebral disc degeneration assessed using the Pfirrmann grading system (grades I-V) on MRI for the stabilized segment and adjacent segments (upper and lower), evaluated at baseline and during long-term postoperative follow-up |
| Describe disability | Through study completion, an average of 10 year | Disability assessed using the Oswestry Disability Index (ODI), reported as a total score ranging from 0 to 100, evaluated at baseline and during long-term postoperative follow-up |
| Describe back pain | Through study completion, an average of 10 year | Change from baseline in back pain intensity measured using the Visual Analog Scale (VAS) (0-10), assessed during long-term postoperative follow-up |
| Describe leg pain | Through study completion, an average of 10 year | Change from baseline in leg pain intensity measured using the Visual Analog Scale (VAS) (0-10), assessed during long-term postoperative follow-up |
| Describe satisfaction | Through study completion, an average of 10 year | Patient satisfaction measured using a patient-reported outcome questionnaire, reported as a total score (range to be specified), assessed during long-term postoperative follow-up |
| Describe perioperative outcomes | Through study completion, an average of 10 year | Number of participants with perioperative complications within 30 days after surgery |
| Describe clinical safety | Through study completion, an average of 10 year | Number of participants requiring reoperation at the treated or adjacent segments during long-term postoperative follow-up |
| Reoperation rate at the instrumented segment | Through study completion, an average of 10 year | 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 | Through study completion, an average of 10 year | 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 disc height of the stabilized segment, the upper and lower adjacent segment | Through study completion, an average of 10 year | 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 |
| Describe segmental range of motion (ROM) of the stabilized segment, the upper and lower adjacent segment | Through study completion, an average of 10 year | 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 |
Outcome results
None listed