Disc DegenerationPhase 3NCT07414745
MDT-0123 Japan Study
A Phase 3 study testing MDT-0123 and ICBG in people with Disc Degeneration and Spinal Deformity, run by Medtronic Spinal and Biologics at 14 sites in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disc Degeneration, Spinal Deformity
- What is being tested?
- MDT-0123 and ICBG
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 14 sitesJapan
- Study dates
- 24 Apr 2026to 31 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
Japan14 sites, 14 recruiting
- Recruiting
Sonoda Medical Corporations Sonoda Third Hospital
Adachi-Ku, Tokyo, 121-0807
Masahiro Hoshino, +81358375111, mh-spine@mub.biglobe.ne.jp
- Recruiting
Seirei Hamamatsu General Hospital
Hamamatsu, Shizuoka, 430-8558
Kanji Sasaki, +81534742222, sasakan1@yahoo.co.jp
- Recruiting
Wakakusa Daiichi Hospital
Higashiosaka, Osaka, 579-8056
Yoshihisa Kotani, +81729881409, yoshi96k@gmail.com
- Recruiting
Tokai University Hospital
Isehara, Kanagawa, 259-1193
Daisuke Sakai, +81463931121, daisakai@tokai.ac.jp
- Recruiting
Kobe University Hospital
Kobe, Hyōgo, 650-0017
Takashi Yurube, +81783825111, takayuru@med.kobe-u.ac.jp
- Recruiting
Dokkyo Medical University Saitama Medical Center
Koshigaya, Saitama, 343-8555
Junya Katayanagi, +81489651111, junya@dokkyomed.ac.jp
- Recruiting
Kyoto City Hospital
Kyoto, 604-8845
Masashi Tanaka, +81753115311, masmasgoo@gmail.com
- Recruiting
Toranomon Hospital
Minato-Ku, Tokyo, 105-8470
Masayoshi Fukushima, +81335881111, masamasayoshi21@hotmail.co.jp
- Recruiting
Tokyo General Hospital
Nakano-Ku, Tokyo, 165-0022
Yasunobu Itoh, +81333875421, yasuitoh@mt.strins.or.jp
- Recruiting
Kitano Medical Research Institute Hospital
Osaka, 530-8480
Toshiyuki Kitaori, +81663121221, kitaorit0723@yahoo.co.jp
- Recruiting
Osaka General Hospital of West Japan Railway Company
Osaka, 545-0053
Sadahiko Konishi, +81666282221, konishi.sada@gmail.com
- Recruiting
Japan Community Health care Organization Osaka Hospital
Osaka, 553-0003
Shota Takenaka, +81664415451, show@yb3.so-net.ne.jp
- Recruiting
Shunyokai Medical Corporation Sangubashi Spine Surgery Hospital
Shibuya-Ku, Tokyo, 151-0053
Tomohisa Harada, +81353080511, t-harada@koto.kpu-m.ac.jp
- Recruiting
Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582
Kota Watanabe, +81333531211, takayuru@med.kobe-u.ac.jp
About this study
Official title: 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.
Read the detailed description
Prospective, multi-center, dual-arm, open-label, randomized, Pre-market, intervention pivotal clinical trial
- Conditions
- Disc Degeneration, Spinal Deformity
- Being tested
- MDT-0123, ICBG
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDT-0123Combination product
Use a combination of the MDT-0123 spine cage and the MDT-0123 kit.
ICBGDevice
Use a combination of the MDT-0123 spine cage and ICBG
| Study group | Role | What they receive |
|---|---|---|
| MDT-0123 | Active comparator | Not described Receives: Combination Product: MDT-0123 |
| Iliac bone graft (ICBG) | Placebo comparator | Not described Receives: Device: ICBG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
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-
Measured: 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).
Measured: 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.)
Measured: 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.
Measured: 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
Measured: From baseline to12months
Required time until bone fusion
Assess the time required for bone fusion through imaging evaluation (CT scan, X-ray examination)
Measured: From baseline to12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start24 Apr 2026
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disc DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Spinal and Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414745
- Sponsor's protocol ID
- MDT23037
- Status last verified
- Sep 2026
- First submitted
- 9 Feb 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MDT-0123 Clinical Trial Targeting Patients Who Require Lumbar Vertebral Fusion in Japan
- ClinicalTrials.gov ID
- NCT07414745
- Acronym / sponsor ID
- MDT23037
- Conditions
- Disc Degeneration, Spinal Deformity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Medtronic Spinal and BiologicsIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDT-0123 | Active comparator | Combination Product: MDT-0123 |
| Iliac bone graft (ICBG) | Placebo comparator | Device: ICBG |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDT-0123Use a combination of the MDT-0123 spine cage and the MDT-0123 kit. | Combination product | MDT-0123 |
| ICBGUse a combination of the MDT-0123 spine cage and ICBG | Device | Iliac bone graft (ICBG) |
Primary outcome
Primary endpoints of efficacy
Time frame: 12 months
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
Primary endpoints of safety
Time frame: 12months
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.
6 secondary outcomes
Change in disc height at the 12-month visit compared to the measurements taken within 14 days after the index procedure.
Time frame: From 14 days after the index procedure to 12months
Change of General health condition at follow-ups from baseline at 12months.
Time frame: From baseline to 12months
Change of OSWESTRY DISABILITY INDEX (ODI) at follow-ups from baseline at month 12.
Time frame: From baseline to 12Months
Change of Lower back pain at follow-ups from baseline at 12months
Time frame: From baseline to 12months
Change of Pain in lower extremities (leg pain) at follow-ups from baseline at 12months
Time frame: From baseline to12months
Required time until bone fusion
Time frame: From baseline to12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MDT-0123 and ICBG in people with Disc Degeneration and Spinal Deformity, run by Medtronic Spinal and Biologics at 14 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuta Sekiguchi (+818072088857, yuta.sekiguchi@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoints of efficacy (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.