MDT-0123 Japan Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Disc Degeneration; Spinal Deformity
• Intervention / Treatment: Combination product: MDT-0123; Device: ICBG

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Aki Shiomitsu; Phone Number: +8108070920518; Email: aki.shiomitsu@medtronic.com

Study Locations

• Japan
  • Kyoto, Japan, 604-8845
    • Recruiting
    • Kyoto City Hospital
    • Contact: Masashi Tanaka; Phone Number: +81753115311; Email: masmasgoo@gmail.com
  • Osaka, Japan, 553-0003
    • Recruiting
    • Japan Community Health care Organization Osaka Hospital
    • Contact: Shota Takenaka; Phone Number: +81664415451; Email: show@yb3.so-net.ne.jp
  • Osaka, Japan, 530-8480
    • Recruiting
    • Kitano Medical Research Institute Hospital
    • Contact: Toshiyuki Kitaori; Phone Number: +81663121221; Email: kitaorit0723@yahoo.co.jp
  • Osaka, Japan, 545-0053
    • Not yet recruiting
    • Osaka General Hospital of West Japan Railway Company
    • Contact: Sadahiko Konishi; Phone Number: +81666282221; Email: konishi.sada@gmail.com
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0017
      • Recruiting
      • Kobe University Hospital
      • Contact: Takashi Yurube; Phone Number: +81783825111
  • Kanagawa
    • Isehara, Kanagawa, Japan, 259-1193
      • Not yet recruiting
      • Tokai University Hospital
      • Contact: Daisuke Sakai; Phone Number: +81463931121; Email: daisakai@tokai.ac.jp
  • Osaka
    • Higashiosaka, Osaka, Japan, 579-8056
      • Not yet recruiting
      • Wakakusa Daiichi Hospital
      • Contact: Yoshihisa Kotani; Phone Number: +81729881409; Email: yoshi96k@gmail.com
  • Saitama
    • Koshigaya, Saitama, Japan, 343-8555
      • Not yet recruiting
      • Dokkyo Medical University Saitama Medical Center
      • Contact: Junya Katayanagi; Phone Number: +81489651111; Email: junya@dokkyomed.ac.jp
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 430-8558
      • Not yet recruiting
      • Seirei Hamamatsu General Hospital
      • Contact: Kanji Sasaki; Phone Number: +81534742222; Email: sasakan1@yahoo.co.jp
  • Tokyo
    • Adachi-Ku, Tokyo, Japan, 121-0807
      • Recruiting
      • Sonoda Medical Corporations Sonoda Third Hospital
      • Contact: Masahiro Hoshino; Phone Number: +81358375111; Email: mh-spine@mub.biglobe.ne.jp
    • Minato-Ku, Tokyo, Japan, 105-8470
      • Not yet recruiting
      • Toranomon Hospital
      • Contact: Masayoshi Fukushima; Phone Number: +81335881111; Email: masamasayoshi21@hotmail.co.jp
    • Nakano-Ku, Tokyo, Japan, 165-0022
      • Not yet recruiting
      • Tokyo General Hospital
      • Contact: Yasunobu Itoh; Phone Number: +81333875421; Email: yasuitoh@mt.strins.or.jp
    • Shibuya-Ku, Tokyo, Japan, 151-0053
      • Not yet recruiting
      • Shunyokai Medical Corporation Sangubashi Spine Surgery Hospital
      • Contact: Tomohisa Harada; Phone Number: +81353080511; Email: t-harada@koto.kpu-m.ac.jp
    • Shinjuku-Ku, Tokyo, Japan, 160-8582
      • Not yet recruiting
      • Keio university hospital
      • Contact: Kota Watanabe; Phone Number: +81333531211; Email: takayuru@med.kobe-u.ac.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Mental or psychiatric conditions that may interfere with study participation
• Participation in another clinical study within 3 months or planned participation during this study period
• Inability or unwillingness to use appropriate contraception during the study period and for 12 months after implantation
• Presence of spinal tumors in adjacent vertebrae
• Existing or planned implantation of non-study implants in the lumbosacral spine
• Medical conditions that could interfere with evaluation of safety or effectiveness, including significant vascular or anatomical abnormalities
• Contraindications to MRI
• Smoking within 12 weeks prior to implantation or unwillingness to abstain during the study period
• Alcohol or substance abuse
• Any condition that, in the investigator's judgment, makes the subject unsuitable for the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MDT-0123	Combination product: MDT-0123; Use a combination of the MDT-0123 spine cage and the MDT-0123 kit.
Placebo Comparator: Iliac bone graft (ICBG)	Device: ICBG; Use a combination of the MDT-0123 spine cage and ICBG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in disc height at the 12-month visit compared to the measurements taken within 14 days after the index procedure.	The height of the intervertebral disc measured by x-ray in the standing position. The calculation method uses (anterior disc height + central disc height + posterior disc height) divided by the anteroposterior diameter of the vertebral body. Preoperative measurements are conducted to understand the subject's pathological condition. 2） Change of General health condition at follow-	From 14 days after the index procedure to 12months
Change of General health condition at follow-ups from baseline at 12months.	Medical Outcomes Study 36-ltem Short Form Health Survey (SF-36) was used to assess the general health status of the subjects. The results of SF-36 can be summarized into two components: physical element summary (PCS) and mental element summary (MCS).	From baseline to 12months
Change of OSWESTRY DISABILITY INDEX (ODI) at follow-ups from baseline at month 12.	Using the ODI, calculate and evaluate each score for the 10 sections (pain intensity, self-care, raising the object, etc.)	From baseline to 12Months
Change of Lower back pain at follow-ups from baseline at 12months	The numerical rating scale (Numerical Rating Scale (NRS)) used to evaluate lower back pain using a score of 0-10.	From baseline to 12months
Change of Pain in lower extremities (leg pain) at follow-ups from baseline at 12months	The numerical rating scale (Numerical Rating Scale (NRS)) used to evaluate leg pain using a score of 0-10	From baseline to12months
Required time until bone fusion	Assess the time required for bone fusion through imaging evaluation (CT scan, X-ray examination)	From baseline to12 months

Collaborators and Investigators

• Sponsor: Medtronic Spinal and Biologics

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: MDT23037

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes