NCT05906394已完成不适用
A Pre-market, Open-label, Single-arm Study to Evaluate b.Bone for Posterolateral Fusion Treatment of Degenerative Thoracolumbar, Lumbar or Lumbosacral Spinal Disease.
GreenBone Ortho S.p.A.2 个研究点 分布在 2 个国家目标入组 16 人开始时间: 2023年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Successful fusion rate by CT scan assessments after surgery.
研究概览
简要总结
Prospective, open-label, single-arm clinical investigation. The purpose of this clinical investigation is to evaluate the bone substitute b.Bone in posterolateral fusion treatment of degenerative thoracolumbar, lumbar or lumbosacral spinal conditions, in terms of performance and safety.
Subjects who meet the study selection will undergo up to a three-level posterolateral fusion using b.Bone in combination with autologous bone in a 1:1 ratio. Subjects will be followed up at discharge, week 6, Month 3, Month 6, and Month 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient ≥ 18 years old.
- •Patients requiring posterolateral fusion treatment for degenerative thoracolumbar, lumbar, or lumbosacral spinal conditions up to 8 levels.
- •Patients willing and able to attend the follow-up visits and procedures foreseen by the study protocol.
- •Patients who have provided written informed consent to participate in the study and the processing of personal data before any study procedure is performed.
排除标准
- •Any previous surgical attempt(s) for spinal fusion (revision surgery) of the intended segment(s).
- •Patients who have been treated with chemotherapy or radiotherapy within 12 months before the enrolment.
- •Indication for spinal fusion because of an acute traumatic reason, like a spinal fracture.
- •Bone infection.
- •Bone malignant tumor(s).
- •Concomitant infectious systemic diseases,
- •Inflammatory systemic diseases,
- •Concomitant myeloproliferative disorders,
- •Active autoimmune disease,
- •Known or suspected allergy or hypersensitivity to the b.Bone device components,
- •Calcium metabolism disorder (i.e. hypercalcemia),
- •Known hyperthyroidism or autonomous thyroid adenoma.
- •Patients currently treated with systemic immunosuppressive agents.
- •Patients who are currently enrolled in another clinical study that would directly interfere with the current study, except when the patient is participating in a purely observational registry with no associated treatments.
- •Body mass index (BMI) larger than 36 (morbidly obese).
- •Known severe osteoporosis.
- •Patients requiring instrumented fusion in the cervical spine.
- •Woman who is pregnant or breast-feeding.
结局指标
主要结局
Successful fusion rate by CT scan assessments after surgery.
时间窗: 12 months
次要结局
- Quality of life assessed by Health Questionnaire(Baseline, 6 weeks, 3, 6, and 12 months post-treatment.)
- Successful fusion rate by CT scan assessments after surgery.(6 months)
- Functional activity assessed by Oswestry Disability Index.(Baseline, 6 weeks, 3, 6, and 12 months post-treatment.)
- Back and Leg pain assessed by Visual Analog Scale.(Baseline, 6 weeks, 3, 6, and 12 months post-treatment.)
- Rate of Adverse Events through the clinical trial period.(Up to 12 months)
- Neurological function(Baseline, 3, 6, and 12 months post-treatment.)
研究者
研究点 (2)
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