MDT-0123 Japan Study

NCT07414745 | Not Yet Recruiting FDA Device

• 1 other identifier: MDT23037
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Disc Degeneration; Spinal Deformity

Outcome Measures

Primary Outcomes (2)

• Primary endpoints of efficacy

  Bone fusion status 12 months visit after index procedure The success rate of bone fusion at the 12-month visit after the index procedure will be evaluated. Imaging evaluations will be performed at baseline, after the index procedure (to discharge), at 3, 6, and 12 months (CT scan will be performed at baseline, 6, and 12 months only), and imaging evaluation for the primary efficacy endpoint will be performed by the core laboratory at the 12-month visit. Primary endpoints

  12 months

• Primary endpoints of safety

  Incidence of Adverse Device Effects in both groups up to 12 months post index procedure. To evaluate the rate of subjects experiencing any adverse device effects in both groups that occurring up to 12-month visit after the index procedure.

  12months

Secondary Outcomes (6)

• Change in disc height at the 12-month visit compared to the measurements taken within 14 days after the index procedure.

  From 14 days after the index procedure to 12months

• Change of General health condition at follow-ups from baseline at 12months.

  From baseline to 12months

• Change of OSWESTRY DISABILITY INDEX (ODI) at follow-ups from baseline at month 12.

  From baseline to 12Months

• Change of Lower back pain at follow-ups from baseline at 12months

  From baseline to 12months

• Change of Pain in lower extremities (leg pain) at follow-ups from baseline at 12months

  From baseline to12months

Study Arms (2)

MDT-0123

ACTIVE COMPARATOR

Combination Product: MDT-0123

Iliac bone graft (ICBG)

PLACEBO COMPARATOR

Device: ICBG

Interventions

MDT-0123 COMBINATION_PRODUCT

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

MDT-0123

ICBG DEVICE

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

Iliac bone graft (ICBG)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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.
• 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
• 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.

You may not qualify if:

• 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.
• Subjects who cannot complete the implantation of the investigational device and the posterior fixation procedure in one procedure.
• Those whose total rhBMP-2 implantation is expected to exceed 12 mg.
• Subjects for whom use of an internal or external bone growth stimulator is planned.
• 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).
• Subjects with morbid obesity with a Body Mass Index (BMI) exceeding 40.
• Subjects with an active malignancy.
• Overt or active bacterial infection, either local to surgical space or systemic.
• Those who received bone formation promotion agents within 12 months prior to implantation of the investigational device.
• 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.
• All other patients taking warfarin must be washed out for at least 5 days prior to the procedure. Steroid inhalers can be used both before and after surgery.
• Use of short-term steroids before and after surgery is permissible. In this clinical trial, short term usage is defined as 2 weeks or less. Steroid use beyond 2 weeks postoperatively is prohibited until the follow-up examination 12 months later.
• Subjects with a medical history of autoimmune diseases known to affect bone metabolism or the spine. Examples include spondylotic arthropathy (e.g., ankylosing spondylitis, clonal disease, ulcerative colitis), juvenile arthritis, rheumatoid arthritis, Graves' disease, and Hashimoto's disease.
• Subjects with a medical history of endocrinological or metabolic diseases that are known to affect bone formation (e.g., Paget's disease, renal osteodystrophy, G.Danlos's syndrome, and bone dysplasia).
• Subjects who have been exposed to a combination of proteins used for bone formation.

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (13)

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

Location

Tokai University Hospital

Isehara, Kanagawa, 259-1193, Japan

Location

Wakakusa Daiichi Hospital

Higashiosaka, Osaka, 579-8056, Japan

Location

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama, 343-8555, Japan

Location

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, 430-8558, Japan

Location

Sonoda Medical Corporations Sonoda Third Hospital

Adachi-Ku, Tokyo, 121-0807, Japan

Location

Toranomon Hospital

Minato-Ku, Tokyo, 105-8470, Japan

Location

Shunyokai Medical Corporation Sangubashi Spine Surgery Hospital

Shibuya-Ku, Tokyo, 151-0053, Japan

Location

Keio University Hospital

Shinjuku-Ku, Tokyo, 160-8582, Japan

Location

Kyoto City Hospital

Kyoto, 604-8845, Japan

Location

Kitano Medical Research Institute Hospital

Osaka, 530-8480, Japan

Location

Osaka General Hospital of West Japan Railway Company

Osaka, 545-0053, Japan

Location

Japan Community Health care Organization Osaka Hospital

Osaka, 553-0003, Japan

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Takuya Sato

CONTACT

+818031720897; takuya.sato2@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

JP (13)