Evaluation of outcomes after spinal fusion with a Scarlet® ALT Hyperlordotic titanium secured cage implant

Phase 4

• Conditions: Surgical treatment of Degenerative Disk Diseases (DDD) of the lumbar spine at various contiguous level from L2 to S1; Surgery

• Registration Number: ISRCTN80797849
• Lead Sponsor: Spineart (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-29
• Last Update Posted: 26 August 2024
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Age =18 years
2. Patients who received at least one Scarlet® AL-T Hyperlordotic
3. Informed Consent Form signed

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <4 months (V4), 4-9 months (V5), 9-20 months (V6), and >20 months (V7) PO.