NCT07414745

MDT-0123 Japan Study

MDT-0123 Clinical Trial Targeting Patients Who Require Lumbar Vertebral Fusion in Japan

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Medtronic Spinal and Biologics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to compare the efficacy and safety of this investigational device with autologous iliac bone graft (ICBG) in patients who are deemed to require bone fusion through spinal fixation at two levels (ALIF or OLIF) due to disc degeneration or spinal deformity in the lumbosacral spine (L2-S1) for intervertebral support and correction with the aim of stabilizing the spine.

Detailed description

Prospective, multi-center, dual-arm, open-label, randomized, Pre-market, intervention pivotal clinical trial

Conditions

• Disc Degeneration
• Spinal Deformity

Interventions

Type	Name	Description
COMBINATION_PRODUCT	MDT-0123	Use a combination of the MDT-0123 spine cage and the MDT-0123 kit.
DEVICE	ICBG	Use a combination of the MDT-0123 spine cage and ICBG

Timeline

• Start date: 2026-02-28
• Primary completion: 2028-03-31
• Completion: 2028-03-31
• First posted: 2026-02-17
• Last updated: 2026-02-17

Locations

13 sites across 1 country: Japan

Regulatory

• FDA-regulated device study