Study Comparing MDT-0123 Spine Cage and Iliac Bone Graft for Two-Level Lumbar Spinal Fusion Treatment for Disc Degeneration and Spinal Deformity in Adults 18 to 80 Years Old in Japan

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a new investigational device compared to the standard autologous iliac bone graft ICBG for patients needing bone fusion through spinal fixation at two levels in the lower spine L2-S1. This study focuses on individuals with disc degeneration or spinal deformity requiring intervertebral support and spine stabilization. It is a prospective, multi-center, open-label, randomized clinical trial aiming to assess treatment outcomes in this patient group. Participants will be randomly assigned to receive either the investigational device MDT-0123, which includes a spine cage and a kit, or the standard treatment using the MDT-0123 spine cage combined with ICBG. The goal is to compare these two approaches for lumbar vertebral fusion over a treatment period. The study is conducted before the market release of the device and follows a parallel group design. During the trial, participants will undergo assessments over 12 months to measure success and safety, including changes in disc height, general health condition, disability index, and pain levels in the lower back and legs. Researchers will also track the time required for bone fusion. Participants will have regular follow-ups to monitor outcomes and safety. The total study period extends up to 12 months after the procedure, with detailed evaluations to understand the effectiveness of the treatments.

MDT-0123 Japan Study