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MDT-0123 Japan Study

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

NCT07414745•Medtronic Spinal and Biologics

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

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1\) Subjects who require bone fusion via consecutive 2-level spinal fusion due to disc degeneration or spinal deformity etc. in the lumbosacral vertebrae (L2-S1). 2) Subjects who satisfies any of the following.
•1. Image findings of symptomatic degenerative lesions from L2 to S1(MRI or myelography within 12 months prior to enrollment) and subjects who have been observed to have a neurological disorder by nerve root compression etc. as follows. A) Radiating pain in the lower limbs or buttocks, sensory disturbance, numbness, symptoms of weakness B) B. Nervous claudication
•2. Subjects with degenerative disc disease with disc-derived low back pain, with or without leg pain, and the subject's medical history confirms disc degeneration \[e.g., pain (symptoms of leg, back, or sciatic nerve distribution), functional deficits, and/or neurological defects)\] and one or more of the following on image examination (e.g., CT, MRI, X-ray, etc.): A) Instability (defined as an angle of motion \>greater than or equal to 5° and/or oscillation ≥4 mm, based on radiographs of anteroposterior flexion). B) Formation of osteophytes C) Decrease in the height of the intervertebral disc D) Thickening of ligamentous tissue E) Degeneration or herniation of the disc F) Degeneration of facet joints 3) Subjects with an ODI score of 35% or greater prior to the procedure. 4) Subjects with sufficiently mature skeletons. 5) Subjects who are 18 to 80 years of age or older at the time of surgery. 6) Subjects who has not responded to non-operative treatment (e.g., bed rest, physical therapy, medication, nerve block, manipulation, percutaneous electrical stimulation therapy (TENS)) for a period of 3 months. 7) Subjects who have received an adequate explanation of the details of this clinical trial and have given their written consent.

Exclusion Criteria

•1. Has undergone previous spinal surgery at the intervertebral level in question or at an Intervertebral level (e.g., spinal fusion / spinal surgery other than spinal fusion). Furthermore, the history of discectomy and/or discectomy surgery is acceptable.
•2. Subjects who cannot complete the implantation of the investigational device and the posterior fixation procedure in one procedure.
•3. Those whose total rhBMP-2 implantation is expected to exceed 12 mg.
•4. Subjects for whom use of an internal or external bone growth stimulator is planned.
•5. Subjects who have been diagnosed with osteoporosis with a T-score of -2.5 or lower within the past 12 months and who also present with fragility fractures at the time of informed consent.. If the subject has a history of fragility fracture and the T-score has not been assessed within the past 12 months, the subject must undergo a bone density test using Dual Energy X-ray Absorptiometry (DEXA).
•6. Subjects with morbid obesity with a Body Mass Index (BMI) exceeding 40.
•7. Subjects with an active malignancy.
•8. Overt or active bacterial infection, either local to surgical space or systemic.
•9. Those who received bone formation promotion agents within 12 months prior to implantation of the investigational device.
•10. Subjects who have been administered corticosteroids, anti-tumor drugs, immune stimulators, immunosuppressants, or systematic drugs that may interfere with the treatment of bone or soft tissue within 30 days prior to implantation of the investigational device.
+17 more criteria

Locations (13)

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

Shunyokai Medical Corporation Sangubashi Spine Surgery Hospital

Shibuya-Ku, Tokyo, Japan

Keio University Hospital

Shinjuku-Ku, Tokyo, Japan

Kyoto City Hospital

Kyoto, Japan

Key Dates

Start Date

February 28, 2026

Primary Completion Date

March 31, 2028

Completion Date

March 31, 2028

Last Updated

February 17, 2026

Enrollment

140

ESTIMATED participants

Conditions

Disc DegenerationSpinal Deformity

Interventions

MDT-0123

COMBINATION_PRODUCT

ICBG

DEVICE

Contacts

Takuya Sato

CONTACT

+818031720897 takuya.sato2@medtronic.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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MDT-0123 Japan Study

Inclusion Criteria

Exclusion Criteria

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Comparaison of Interbody Bone Fusion Between Two Osteoinductive Bioactive Bone Substitutes After Anterior Lumbar Interbody Arthrodesis in Degenerative Lumbar Disc Surgery in Adults

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