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New spine cage aims to improve back surgery outcomes

NCT ID NCT07414745

Disease control Sponsor: Medtronic Spinal and Biologics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 4 times

Summary

This study compares a new spine cage device (MDT-0123) to a standard bone graft for patients needing two-level spinal fusion in the lower back. About 140 adults with disc degeneration or spinal deformity will be enrolled in Japan. The main goal is to see if the device leads to better bone fusion and fewer side effects after 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MDT-0123 spine cage and kit
What this could lead to
If successful, this device could offer a safer or more effective alternative to traditional bone graft for spinal fusion surgery.
What could go wrong
This is an early-stage trial with only 140 participants in Japan. The device may not prove superior to the standard bone graft, and risks include device-related side effects or failed fusion.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar disk degenerative disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Disc degeneration Spinal deformity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Dokkyo Medical University Saitama Medical Center

    RECRUITING

    Koshigaya, Saitama, 343-8555, Japan

  • Japan Community Health care Organization Osaka Hospital

    RECRUITING

    Osaka, 553-0003, Japan

  • Keio University Hospital

    RECRUITING

    Shinjuku-Ku, Tokyo, 160-8582, Japan

  • Kitano Medical Research Institute Hospital

    RECRUITING

    Osaka, 530-8480, Japan

  • Kobe University Hospital

    RECRUITING

    Kobe, Hyōgo, 650-0017, Japan

  • Kyoto City Hospital

    RECRUITING

    Kyoto, 604-8845, Japan

  • Osaka General Hospital of West Japan Railway Company

    RECRUITING

    Osaka, 545-0053, Japan

  • Seirei Hamamatsu General Hospital

    RECRUITING

    Hamamatsu, Shizuoka, 430-8558, Japan

  • Shunyokai Medical Corporation Sangubashi Spine Surgery Hospital

    RECRUITING

    Shibuya-Ku, Tokyo, 151-0053, Japan

  • Sonoda Medical Corporations Sonoda Third Hospital

    RECRUITING

    Adachi-Ku, Tokyo, 121-0807, Japan

  • Tokai University Hospital

    RECRUITING

    Isehara, Kanagawa, 259-1193, Japan

  • Tokyo General Hospital

    RECRUITING

    Nakano-Ku, Tokyo, 165-0022, Japan

  • Toranomon Hospital

    RECRUITING

    Minato-Ku, Tokyo, 105-8470, Japan

  • Wakakusa Daiichi Hospital

    RECRUITING

    Higashiosaka, Osaka, 579-8056, Japan

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