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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with BDyn dynamic stabilization | Experimental | All enrolled patients undergo lumbar dynamic stabilization using the BDyn device. Clinical, radiological, and patient-reported outcomes are collected during long-term follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Lumbar Stabilization Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Through study completion, an average of 10 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion, an average of 10 year |
| Describe upper adjacent segment integrity |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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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 |
| 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 | 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 | Through study completion, an average of 10 year |
| Describe sagittal balance | 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 | 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 | 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 | 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 | 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 | 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 | Through study completion, an average of 10 year |
| Describe perioperative outcomes | Number of participants with perioperative complications within 30 days after surgery | 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 | Through study completion, an average of 10 year |