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Clinical Trial NCT07414745 for Disc Degeneration, Spinal Deformity is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
MDT-0123 Japan Study 140
MDT-0123 Clinical Trial Targeting Patients Who Require Lumbar Vertebral Fusion in Japan
- MDT23037
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorMDT-0123 | MDT-0123 Use a combination of the MDT-0123 spine cage and the MDT-0123 kit. |
Placebo ComparatorIliac bone graft (ICBG) | ICBG Use a combination of the MDT-0123 spine cage and ICBG |
| 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 |
| 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 |
1) Subjects who require bone fusion via consecutive 2-level spinal fusion due to disc degeneration or spinal deformity etc. in the lumbosacral vertebrae (L2-S1). 2) Subjects who satisfies any of the following.
- Image findings of symptomatic degenerative lesions from L2 to S1(MRI or myelography within 12 months prior to enrollment) and subjects who have been observed to have a neurological disorder by nerve root compression etc. as follows. A) Radiating pain in the lower limbs or buttocks, sensory disturbance, numbness, symptoms of weakness B) B. Nervous claudication
- Subjects with degenerative disc disease with disc-derived low back pain, with or without leg pain, and the subject's medical history confirms disc degeneration \[e.g., pain (symptoms of leg, back, or sciatic nerve distribution), functional deficits, and/or neurological defects)\] and one or more of the following on image examination (e.g., CT, MRI, X-ray, etc.): A) Instability (defined as an angle of motion >greater than or equal to 5° and/or oscillation ≥4 mm, based on radiographs of anteroposterior flexion). B) Formation of osteophytes C) Decrease in the height of the intervertebral disc D) Thickening of ligamentous tissue E) Degeneration or herniation of the disc F) Degeneration of facet joints 3) Subjects with an ODI score of 35% or greater prior to the procedure. 4) Subjects with sufficiently mature skeletons. 5) Subjects who are 18 to 80 years of age or older at the time of surgery. 6) Subjects who has not responded to non-operative treatment (e.g., bed rest, physical therapy, medication, nerve block, manipulation, percutaneous electrical stimulation therapy (TENS)) for a period of 3 months. 7) Subjects who have received an adequate explanation of the details of this clinical trial and have given their written consent.
Has undergone previous spinal surgery at the intervertebral level in question or at an Intervertebral level (e.g., spinal fusion / spinal surgery other than spinal fusion). Furthermore, the history of discectomy and/or discectomy surgery is acceptable.
Subjects who cannot complete the implantation of the investigational device and the posterior fixation procedure in one procedure.
Those whose total rhBMP-2 implantation is expected to exceed 12 mg.
Subjects for whom use of an internal or external bone growth stimulator is planned.
Subjects who have been diagnosed with osteoporosis with a T-score of -2.5 or lower within the past 12 months and who also present with fragility fractures at the time of informed consent.. If the subject has a history of fragility fracture and the T-score has not been assessed within the past 12 months, the subject must undergo a bone density test using Dual Energy X-ray Absorptiometry (DEXA).
Subjects with morbid obesity with a Body Mass Index (BMI) exceeding 40.
Subjects with an active malignancy.
Overt or active bacterial infection, either local to surgical space or systemic.
Those who received bone formation promotion agents within 12 months prior to implantation of the investigational device.
Subjects who have been administered corticosteroids, anti-tumor drugs, immune stimulators, immunosuppressants, or systematic drugs that may interfere with the treatment of bone or soft tissue within 30 days prior to implantation of the investigational device.
- All other patients taking warfarin must be washed out for at least 5 days prior to the procedure. Steroid inhalers can be used both before and after surgery.
- Use of short-term steroids before and after surgery is permissible. In this clinical trial, short term usage is defined as 2 weeks or less. Steroid use beyond 2 weeks postoperatively is prohibited until the follow-up examination 12 months later.
Subjects with a medical history of autoimmune diseases known to affect bone metabolism or the spine. Examples include spondylotic arthropathy (e.g., ankylosing spondylitis, clonal disease, ulcerative colitis), juvenile arthritis, rheumatoid arthritis, Graves' disease, and Hashimoto's disease.
Subjects with a medical history of endocrinological or metabolic diseases that are known to affect bone formation (e.g., Paget's disease, renal osteodystrophy, G.Danlos's syndrome, and bone dysplasia).
Subjects who have been exposed to a combination of proteins used for bone formation.
Subjects who have a history of hypersensitivity, allergy, or intolerance to bone morphogenic proteins (BMPs) (BMPs used for dental treatment), injectable collagen, protein drugs (such as monoclonal antibodies or gamma globulins), bovine collagen products, and/or instrument materials (titanium alloy).
Subjects with a medical history of allergy that may cause anaphylaxis.
Subjects who have a mental disorder and have been judged by the investigator to be of an inappropriate level for enrollment into this clinical trial.
Subjects who have received treatment in other clinical trials targeting spinal diseases within 3 months prior to the index procedure (drugs, devices, and/or biological products), subjects who have received treatment in other clinical trials within 28 days prior to the index procedure, or subjects who are scheduled to receive treatment in other clinical trials during the clinical trial period. Simultaneous enrollment into a clinical trial that is being conducted in parallel is permissible only if a prior approval document has been obtained from the clinical trial manager of Medtronic Sofamor Danek.
Women of childbearing potential or men whose partners wish to become pregnant who are unable to agree to use appropriate contraception (ex: Barrier methods using condoms, intrauterine devices, oral contraceptives, vasectomy/tubal ligation, etc.) or abstain from sexual intercourse during the trial period and for 12 months after implantation of the investigational device. "Women of childbearing potential" refers to those who have not undergone permanent sterilization or entered menopause. Menopause refers to the absence of menstruation for 12 consecutive months or longer without any other underlying medical cause.
Subjects with a spinal tumor in the upper or lower adjacent vertebral body between the vertebrae to which the investigational device is implanted.
Subjects who have stainless steel implants or implants from other companies implanted in the lumbosacral vertebrae, or subjects who may be implanted during the study period.
Subjects with other medical diseases or conditions that may interfere with the accurate clinical evaluation of the safety and efficacy of the treatment in this clinical trial (e.g.: Subjects with a neuromuscular disease or marked anatomical abnormality in the vasculature, have a considerably narrow right and left common iliac arteriovenous space, have a fragile vasculature, have difficulty performing angiography, have a history of surgery that expects advanced adhesions, etc.).
Subjects with diseases or conditions contraindicated for MRI examination.
Subjects who smoke within 12 weeks prior to implantation of the investigational device (including electronic cigarettes) and may smoke during the study period.
A documented diagnoses of alcohol abuse and/or substance abuse.
Subjects who are judged by the investigator to be unsuitable for inclusion in the clinical trial.
Medtronic Spinal and BiologicsHyōgo
Kanagawa
Osaka
Saitama
Shizuoka
Tokyo