Evaluation of outcomes after spinal fusion surgery using a titanium-secured cage

Clinical and radiographic evaluation of the lumbar Scarlet AL-T cage outcomes within 24 months postoperatively

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN57950006

Enrollment

100

Registered

2023-03-09

Start date

2021-05-06

Completion date

Unknown

Last updated

2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical treatment of Degenerative Disk Diseases (DDD) Musculoskeletal Diseases

Interventions

The SCARLET®AL-T system may be implanted via an open or a minimally invasive anterior approach. As part of an observational study, the SCARLET®AL-T system should be implanted with an ALIF surgical app

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 years minimum 2. Treated by interbody fusion with SCARLET®AL-T system 3. Non opposition letter signed

Exclusion criteria

Exclusion criteria: 1. Patient lacking capacity to follow postoperative care instructions due to mental state (suffering from dementia and others) 2. Infection 3. Severely damaged bone structures that could prevent stable implantation of the cage 4. Neuromuscular or vascular disorders or illness 5. Inadequate activity 6. Pregnancy 7. Bone tumor in the region of implant 8. Fractures

Design outcomes

Primary

Measure	Time frame
Evaluate SCARLET®AL-T system performance by assessing interbody fusion by CT scan at 24 months post-operatively.	—

Secondary

Measure	Time frame
1. Assessment of fusion at 3, 6, and 12 months post-operatively by CT-scan. 2. Stability at 3, 6, 12 and 24 months post-operatively by assessing the subsidence, visible vertebrae endplate fracture and device mobility. 3. Safety assessment: Adverse Events. All perioperative and postoperative adverse events will be assessed for relationship to device and procedure, seriousness, incidence and time to resolution or re-operation. Incidence of re-intervention at the treated level will be assessed. 4. Disability and Change in Disability for low back pain. Obtaining improvement in Oswestry Disability Index (ODI) disease-specific questionnaire up to 24 months following the procedure, as compared to patient's baseline. Mean change in score of the ODI from baseline (the preoperative status) to 3-, 6-, 12- and 24-months postoperative values. 5. Pain and Change in Pain (Back and Leg): obtaining improvement in Visual Analogue Scale (VAS) Back and Leg pain scores up to 24 months following the treatment as compared to patient's baseline. Mean change in score of the VAS from baseline (the preoperative status) to 3-, 6-, 12- and 24-months postoperative values. 6. Patient satisfaction at 3-, 6-, 12- and 24-months postoperative based on the PRO (SF-12). 7. Evaluation of Spineart’s instrumentation supporting the surgery, enabling the implanted device to perform according to its intended use, in terms of safety and performance	—

Measure

Time frame

1. Assessment of fusion at 3, 6, and 12 months post-operatively by CT-scan. 2. Stability at 3, 6, 12 and 24 months post-operatively by assessing the subsidence, visible vertebrae endplate fracture and device mobility. 3. Safety assessment: Adverse Events. All perioperative and postoperative adverse events will be assessed for relationship to device and procedure, seriousness, incidence and time to resolution or re-operation. Incidence of re-intervention at the treated level will be assessed. 4. Disability and Change in Disability for low back pain. Obtaining improvement in Oswestry Disability Index (ODI) disease-specific questionnaire up to 24 months following the procedure, as compared to patient's baseline. Mean change in score of the ODI from baseline (the preoperative status) to 3-, 6-, 12- and 24-months postoperative values. 5. Pain and Change in Pain (Back and Leg): obtaining improvement in Visual Analogue Scale (VAS) Back and Leg pain scores up to 24 months following the treatment as compared to patient's baseline. Mean change in score of the VAS from baseline (the preoperative status) to 3-, 6-, 12- and 24-months postoperative values. 6. Patient satisfaction at 3-, 6-, 12- and 24-months postoperative based on the PRO (SF-12). 7. Evaluation of Spineart’s instrumentation supporting the surgery, enabling the implanted device to perform according to its intended use, in terms of safety and performance

—

Countries

France

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026