A Phase 3 interventional study of MDT-0123 and ICBG in Disc Degeneration and Spinal Deformity, sponsored by Medtronic Spinal and Biologics. Recruiting at 14 sites in Japan. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Medtronic Spinal and Biologics (part of Medtronic) · Phase 3, Interventional, and Treatment
Among 23 studies in Intervertebral Disc Degeneration by Medtronic Spinal and Biologics — 2 open to participants now, 2 under way, 1 of them phase 3. Intervertebral Disc Degeneration · Medtronic Spinal and Biologics.
Among the 23 studies in Intervertebral Disc Degeneration by Medtronic Spinal and Biologics, this one is the 7th largest by planned enrollment of the 18 interventional ones, is the only one that started in 2026, is one of 3 in phase 3, and was the 23rd registered.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's planned enrollment of 140 is above the median of 60 across 256 interventional studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →2 of the 23 studies in Intervertebral Disc Degeneration by Medtronic Spinal and Biologics are open now, in 2 countries. Each count lists the studies.
Of the 60 Intervertebral Disc Degeneration studies recruiting now, 29 (48%) set no upper age limit and 16 (27%) stop at 75 or younger; 7 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →23 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 1 started in 2026.
Median enrollment 76 across the 18 interventional studies, 168 across the 5 observational. Of the 21 that completed or were terminated, 5 (24%) have results posted.
Medtronic Spinal and Biologics is the lead sponsor of 57 studies on the registry; 3 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 23 studies in Intervertebral Disc Degeneration by Medtronic Spinal and Biologics, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Prospective, multi-center, dual-arm, open-label, randomized, Pre-market, intervention pivotal clinical trial
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combination Product: MDT-0123
Device: ICBG
Use a combination of the MDT-0123 spine cage and the MDT-0123 kit.
Use a combination of the MDT-0123 spine cage and ICBG
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
Time frame: 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.
Time frame: 12months
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-
Time frame: 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).
Time frame: 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.)
Time frame: 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.
Time frame: 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
Time frame: From baseline to12months
Required time until bone fusion
Assess the time required for bone fusion through imaging evaluation (CT scan, X-ray examination)
Time frame: From baseline to12 months
Started Apr 2026 (actual). Primary completion is estimated for Mar 2028, 23 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Intervertebral Disc Degeneration →
Medtronic Spinal and Biologics →