Observational Study to Evaluate the STALIF® C FLX, STALIF® M FLX, STALIF® L FLX Cages and FORTOS-C®

Launched by SILONY MEDICAL GMBH · Mar 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of certain medical devices used to treat problems with the cervical (neck) and lumbar (lower back) spine. Specifically, it focuses on implants called STALIF® C FLX, STALIF® M FLX, STALIF® L FLX, and FORTOS-C®, which are used during surgeries to help relieve pain and improve function for people suffering from degenerative disc diseases. The trial collects information from patients after their surgery to see how well these devices are performing and to ensure they are safe for use.

To be eligible for this study, participants must be 21 years or older and have had surgery using one of the specified devices for certain levels of their spine. They should also be able to complete questionnaires about their neck or back pain before surgery and at least 12 months after. It’s important to note that while the study is currently active, it is not accepting new participants at this time. Overall, this trial aims to gather valuable information that can help improve treatment options for patients with spinal issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • - Indications according to IFU
• Surgical implantation of STALIF® C or M FLX device for 1 or 2 levels between:
• • STALIF® C FLX: C2-T1 (cervical)
• • STALIF® M FLX: L2-S1 (lumbar)
• • STALIF® L FLX: L2-L5 (lumbar)
• Surgical implantation of FORTOS-C® for the fusion of up to 3 levels between:
• • FORTOS-C®: C2 - T1 (cervical)
• • Age: ≥ 21 years
• • For the evaluation of the questionnaires (NDI or ODI, VAS neck and VAS arm or VAS leg and VAS back), only patients with the questionnaire available at the time of admission (pre-op) and at least at 12-months FU will be included
• Exclusion Criteria:
• • Relative and absolute contraindications according to IFU