MDT-0123 Japan Study

NCT07414745 | Recruiting Phase 3 FDA Device

• 1 other identifier: MDT23037
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 14

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:

• Requirement for bone fusion via consecutive 2-level spinal fusion due to disc degeneration or spinal deformity in the lumbosacral spine (L2-S1)
• Symptomatic degenerative lesions from L2 to S1 confirmed by imaging (MRI or myelography within 12 months prior to enrollment) with neurological symptoms due to nerve root compression, including radiating pain, sensory disturbance, numbness, weakness, or neurogenic claudication
• Degenerative disc disease with discogenic back pain, with or without leg pain, supported by clinical history and radiographic findings (e.g., CT, MRI, X-ray), with at least one of the following: instability (angular motion ≥5° and/or translation ≥4 mm), osteophyte formation, decreased intervertebral disc height, ligamentous thickening, disc degeneration or herniation, or facet joint degeneration
• Preoperative Oswestry Disability Index (ODI) score ≥35%
• Skeletally mature
• Age 18 to 80 years at the time of surgery
• Failure to respond to at least 3 months of non-operative treatment (e.g., bed rest, physical therapy, medication, nerve block, manipulation, or transcutaneous electrical nerve stimulation)
• Ability to provide written informed consent after receiving adequate explanation of the study

You may not qualify if:

• Prior spinal surgery at the target or adjacent intervertebral level, except for decompression procedures such as discectomy
• Inability to complete both investigational device implantation and posterior fixation in a single procedure
• Expected total rhBMP-2 dose greater than 12 mg
• Planned use of an internal or external bone growth stimulator
• Osteoporosis defined as T-score ≤ -2.5 within 12 months with fragility fracture
• Body mass index (BMI) \>40
• Active malignancy
• Active local or systemic infection
• Use of bone formation promoting agents within 12 months prior to implantation
• Use of medications that may interfere with bone or soft tissue healing within 30 days prior to implantation, including corticosteroids, antitumor agents, or immunosuppressants
• History of autoimmune diseases affecting bone metabolism or the spine, including ankylosing spondylitis, inflammatory bowel disease, or rheumatoid arthritis
• History of endocrine or metabolic disorders affecting bone formation, including Paget's disease or osteodystrophy
• Prior exposure to modified proteins used for bone formation
• Known hypersensitivity or allergy to device materials or related substances, including titanium, collagen, or protein-based products
• History of severe allergic reactions such as anaphylaxis

Sponsors & Collaborators

• Medtronic Spinal and Biologics: lead

Study Sites (14)

Kobe University Hospital

Kobe, Hyōgo, 650-0017, Japan

RECRUITING

Tokai University Hospital

Isehara, Kanagawa, 259-1193, Japan

NOT YET RECRUITING

Wakakusa Daiichi Hospital

Higashiosaka, Osaka, 579-8056, Japan

NOT YET RECRUITING

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama, 343-8555, Japan

NOT YET RECRUITING

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, 430-8558, Japan

NOT YET RECRUITING

Sonoda Medical Corporations Sonoda Third Hospital

Adachi-Ku, Tokyo, 121-0807, Japan

RECRUITING

Toranomon Hospital

Minato-Ku, Tokyo, 105-8470, Japan

NOT YET RECRUITING

Tokyo General Hospital

Nakano-Ku, Tokyo, 165-0022, Japan

NOT YET RECRUITING

Shunyokai Medical Corporation Sangubashi Spine Surgery Hospital

Shibuya-Ku, Tokyo, 151-0053, Japan

NOT YET RECRUITING

Keio University Hospital

Shinjuku-Ku, Tokyo, 160-8582, Japan

NOT YET RECRUITING

Kyoto City Hospital

Kyoto, 604-8845, Japan

RECRUITING

Kitano Medical Research Institute Hospital

Osaka, 530-8480, Japan

RECRUITING

Osaka General Hospital of West Japan Railway Company

Osaka, 545-0053, Japan

NOT YET RECRUITING

Japan Community Health care Organization Osaka Hospital

Osaka, 553-0003, Japan

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Central Study Contacts

Aki Shiomitsu

CONTACT

+8108070920518; aki.shiomitsu@medtronic.com

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: April 24, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-07

Locations

JP (14)