MDT-0123 clinical trial targeting patients who require lumbar vertebral fusion in Japan

未提供0 个研究点目标入组 140 人开始时间: 待定

适应症

试验速览

阶段: 不适用
状态: 招募中
入组人数: 140

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized

入排标准

年龄范围: 18age old over 至 80age old under（—）
性别: All

入选标准

•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).
•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 any of the neurological disorders by nerve root compression etc. as follows.
•A) Radiating pain in the lower limbs or buttocks, sensory disturbance, numbness, symptoms of weakness
•B) Nervous claudication
•If the subject has not had an MRI or contrast-enhanced imaging study in the past 12 months, the subject must have an MRI or contrast-enhanced imaging study.
•Has degenerative disc disease as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc conformed by subject history (e.g., pain [leg, back, or symptoms in the sciatic nerve distribution ], function deflect and/or neurological deficit and radiographic studies (e.g., CT, MRI, X-Ray, etc.) to include one or more of the following:
•A) Instability (defined as angular motion >=5 and/or translation >=4mm, 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
•Subjects with a preoperative ODI score of 35% or greater.
•Subjects with sufficiently mature skeletons.
•Subjects who are 18 to 80 years of age at the time of surgery.
•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.
•Subjects who have received an adequate explanation of the details of this clinical trial and have given their written consent.

排除标准

•Has undergone previous spinal surgery at the intervertebral level in question or at an adjacent spinal level. (e.g., spinal surgery other than spinal fusion or spinal fusion). Furthermore, the history of surgeries aimed for decompression or relief, such as 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 receive undergo a bone density test using Dual Energy X-ray Absorptiometry (DEXA).
•Subjects with morbid obesity with a Body Mass Index (BMI) exceeding
•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 who are taking Warfarin must have a washout for at least 5 days prior to the index procedure.
•Steroid inhalers and topical steroids can be used before and after surgery.
•Use of short-term steroids before and after surgery is permissible. In this clinical trial, short-term use is defined as 2 weeks or less. Steroid use that exceeds consecutive 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, Crohns disease, ulcerative colitis), juvenile arthritis, rheumatism, Graves' disease, and Hashimoto's disease.
•Subjects with a medical history of endocrinological or metabolic diseases known to affect bone formation (e.g., Paget disease, nephrogenic osteodystrophy, Glas-Danlos syndrome, and osteogenic dysplasia).
•Subjects who have a history of exposure to a modified protein used for bone formation.
•Bone morphogenic proteins (BMPs) (BMP agents were used for dental treatment, etc.), injection collagen, protein drugs (monoclonal antibodies, gamma globulin, etc.), bovine collagen Subjects who have a medical history of hypersensitivity, allergy, or intolerance to the device 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 or the investigator to be of an inappropriate level for enrollment into this clinical trial.
•Subjects who have received treatment in other clinical trials for spinal disease within 3 months prior to the index procedure (drugs, equipment, 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 in 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 at 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 vertebrae between the vertebrae to which the trial 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 conditions 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 a great blood vessel, have a history of surgery where the space between the left and right common iliac arteries and veins is considerably narrow, the great blood vessel is fragile, angiography is difficult, or a high degree of adhesion is expected).
•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 and/or substance abuse.
•Other subjects who are judged by the investigator or the investigator to be unsuitable for inclusion in the clinical trial.

研究者

发起方

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