RecruitingPhase 3NCT07414745

MDT-0123 Japan Study

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


Sponsor

Medtronic Spinal and Biologics

Enrollment

140 participants

Start Date

Apr 24, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called ICBG and MDT-0123 for people with disc degeneration and spinal deformity. The study is currently recruiting participants at 14 locations. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTMDT-0123

Use a combination of the MDT-0123 spine cage and the MDT-0123 kit.

DEVICEICBG

Use a combination of the MDT-0123 spine cage and ICBG


Locations(14)

Kobe University Hospital

Kobe, Hyōgo, Japan

Tokai University Hospital

Isehara, Kanagawa, Japan

Wakakusa Daiichi Hospital

Higashiosaka, Osaka, Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama, Japan

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, Japan

Sonoda Medical Corporations Sonoda Third Hospital

Adachi-Ku, Tokyo, Japan

Toranomon Hospital

Minato-Ku, Tokyo, Japan

Tokyo General Hospital

Nakano-Ku, Tokyo, Japan

Shunyokai Medical Corporation Sangubashi Spine Surgery Hospital

Shibuya-Ku, Tokyo, Japan

Keio University Hospital

Shinjuku-Ku, Tokyo, Japan

Kyoto City Hospital

Kyoto, Japan

Kitano Medical Research Institute Hospital

Osaka, Japan

Osaka General Hospital of West Japan Railway Company

Osaka, Japan

Japan Community Health care Organization Osaka Hospital

Osaka, Japan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07414745


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