Assessing Safety and Effectiveness of the Hexanium TLIF Device for Adults With Degenerative Disc Disease

What this Trial Is About

Researchers are evaluating the safety and performance of the Hexanium TLIF system in treating adults with degenerative disc disease, a condition where spinal discs break down. This observational, international study includes patients who have already received or plan to receive the Hexanium TLIF implant. The study aims to follow participants for up to 24 months to collect important safety and effectiveness data. The treatment involves a Transforaminal Lumbar Interbody Fusion surgery, which fuses two vertebrae in the lower spine by removing the damaged disc and placing a cage to restore height, secured with screws and rods. Data will be collected from patients both retrospectively and prospectively at 2, 6, 12, and 24 months after the implant surgery to assess outcomes. Participants will be asked about their back and leg pain levels, disability, and any adverse effects since surgery. Researchers will measure fusion success, pain scores using the Visual Analogue Score VAS, disability with the Oswestry Disability Index ODI, and record any revision surgeries. The primary focus is on serious device- or procedure-related adverse events and changes in disability over one year. Follow-up spans two years to monitor long-term safety and performance.

Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease