Surgical treatment of Degenerative Disk Diseases (DDD) of the lumbar spine at various contiguous level from L2 to S1 Surgery
Conditions
Interventions
The SCARLET®AL-T system is implanted via an open or a minimally invasive anterior approach (ALIF).
All the data will be collected per the sites’ standard of care and based on their availability as r
Sponsors
Spineart (Switzerland)
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Patients who received at least one Scarlet® AL-T Hyperlordotic 3. Informed Consent Form signed
Exclusion criteria
Exclusion criteria: 1. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship 2. Subject who does not speak/understand French
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Interbody fusion rate of the treated level(s), evaluated on radiological images by the surgeon within the study FU period as Solid fusion, Fibrous union, or Non-union. The performance of Scarlet® AL-T Hyperlordotic will be demonstrated if >90% of the patients have a “solid fusion” acquired within the study on all level(s) treated with Scarlet® AL-T Hyperlordotic evaluated on radiological images at 20 months (V7) PO. | — |
Secondary
| Measure | Time frame |
|---|---|
| The performance of Scarlet® AL-T Hyperlordotic will be measured or confirmed by: 1. The time to fusion (in months) of the treated level (s) based on the fusion status (solid fusion confirmed) on radiological images at 20 months (V7) 2. The lumbar lordosis restoration on radiological images, by measuring the Cobb angle (°) between the superior sacral plate and the superior surface of the L-1 vertebra, at discharge (V3) and 20 months (V7) postoperation (PO), compared to the preoperative visit. 3. The sagittal balance (positive, neutral or negative) restoration on radiological images, by measuring the C7 plumb line, at discharge (V3) and 20 months (V7) PO, compared to the preoperative visit 4. The clinical benefit, by assessing low back disability and change in disability using the Oswestry Disability Index (ODI) questionnaire at 20 months (V7) PO compared to preop (V1) 5. The patient’s pain (back and leg) using the Visual Analogue Scale (VAS) at 20 months (V7) PO compared to preop (V1) 5. The clinical benefit with the clinical and neurological examination (low back pain, motor/sensory deficit) assessed by the surgeon at discharge (V3), and 20 months (V7) PO compared to the preoperative visit. 6. The safety by assessing the subsidence rate and type (early or delayed and cranial or caudal) assessed on radiological images at treated level(s) at 20 months (V7) PO. 7. The safety by assessing the osteolysis rate around Scarlet® AL-T Hyperlordotic and its screws, assessed on radiological images as lucency at the cage margins or around screws, at 20 months (V7) PO. A lucency suggests device movement at the operated level and loosening of the device. 8. The Scarlet® AL-T Hyperlordotic safety throughout the study to the last post-operative FU by reporting the incidence and time to resolution of all adverse device effects (ADEs) and all serious adverse events (SAEs) including all surgical revisions. | — |
Countries
France
Outcome results
None listed