MDT-0123 Japan Study

Exclusion Criteria

• •1. 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.
• •2. Subjects who cannot complete the implantation of the investigational device and the posterior fixation procedure in one procedure.
• •3. Those whose total rhBMP-2 implantation is expected to exceed 12 mg.
• •4. Subjects for whom use of an internal or external bone growth stimulator is planned.
• •5. 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).
• •6. Subjects with morbid obesity with a Body Mass Index (BMI) exceeding 40.
• •7. Subjects with an active malignancy.
• •8. Overt or active bacterial infection, either local to surgical space or systemic.
• •9. Those who received bone formation promotion agents within 12 months prior to implantation of the investigational device.
• •10. 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.
• •11. 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.
• •12. 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).
• •13. Subjects who have been exposed to a combination of proteins used for bone formation.
• •14. 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).
• •15. Subjects with a medical history of allergy that may cause anaphylaxis.
• •16. 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.
• •17. 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.
• •18. 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.
• •19. Subjects with a spinal tumor in the upper or lower adjacent vertebral body between the vertebrae to which the investigational device is implanted.
• •20. 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.
• •21. 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.).
• •22. Subjects with diseases or conditions contraindicated for MRI examination.
• •23. Subjects who smoke within 12 weeks prior to implantation of the investigational device (including electronic cigarettes) and may smoke during the study period.
• •24. A documented diagnoses of alcohol abuse and/or substance abuse.
• •25. Subjects who are judged by the investigator to be unsuitable for inclusion in the clinical trial.