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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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.
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)
Time frame: Through study completion, an average of 10 year
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
Time frame: Through study completion, an average of 10 year
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
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
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
Time frame: Through study completion, an average of 10 year
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
Time frame: Through study completion, an average of 10 year
Describe sagittal balance
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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
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
Time frame: Through study completion, an average of 10 year
Describe disability
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
Time frame: Through study completion, an average of 10 year
Describe back pain
Change from baseline in back pain intensity measured using the Visual Analog Scale (VAS) (0-10), assessed during long-term postoperative follow-up
Time frame: Through study completion, an average of 10 year
Describe leg pain
Change from baseline in leg pain intensity measured using the Visual Analog Scale (VAS) (0-10), assessed during long-term postoperative follow-up
Time frame: Through study completion, an average of 10 year
Describe satisfaction
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
Time frame: Through study completion, an average of 10 year
Describe perioperative outcomes
Number of participants with perioperative complications within 30 days after surgery
Time frame: Through study completion, an average of 10 year
Describe clinical safety
Number of participants requiring reoperation at the treated or adjacent segments during long-term postoperative follow-up
Time frame: Through study completion, an average of 10 year