MDT-0123 Clinical Trial Targeting Patients Who Require Lumbar Vertebral Fusion in Japan
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 23
- 主要终点
- Primary endpoints of efficacy
研究概览
简要总结
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.
详细描述
Prospective, multi-center, dual-arm, open-label, randomized, Pre-market, intervention pivotal clinical trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
MDT-0123
干预措施: MDT-0123 (Combination Product)
Iliac bone graft (ICBG)
干预措施: ICBG (Device)
结局指标
主要结局
Primary endpoints of efficacy
时间窗: 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
时间窗: 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.
次要结局
- Change in disc height at the 12-month visit compared to the measurements taken within 14 days after the index procedure.(From 14 days after the index procedure to 12months)
- Change of General health condition at follow-ups from baseline at 12months.(From baseline to 12months)
- Change of OSWESTRY DISABILITY INDEX (ODI) at follow-ups from baseline at month 12.(From baseline to 12Months)
- Change of Lower back pain at follow-ups from baseline at 12months(From baseline to 12months)
- Change of Pain in lower extremities (leg pain) at follow-ups from baseline at 12months(From baseline to12months)
- Required time until bone fusion(From baseline to12 months)