NCT02657265已完成不适用
Prospective Multicenter Randomized Study Comparing Two Standard Treatments: SpineJack® System and Conservative Orthopedic Management in Acute Traumatic Vertebral Fractures Types A1 and A3.1 According to the Magerl Classification
Vexim SA9 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年1月13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
- 100
- 试验地点
- 9
- 主要终点
- VAS
研究概览
简要总结
This study will compare two standard treatments in acute stable traumatic vertebral fractures (types A1 and A3.1 by Magerl Classification). The two treatments are as follows:
- SpineJack® system
- Conservative Orthopedic Management consisting of brace and pain medication.
详细描述
100 subjects (18 to 60 years old) will be enrolled (1:1) with one to two painful traumatic fractures, non-pathological (types A1 and A3.1 by Magerl Classification).
Subjects will be followed at admission, procedure, discharge, 1 month, 3 months, 12 months and 24 months post Vertebral Compression Fracture (VCF) reduction procedure or the set-up of the brace.
The estimated enrollment period is 12 months and each patient should perform a 24 months follow-up period. Therefore, the total study duration is estimated to be 36 months for the complete study.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must have signed the consent form
- •Male or Female between 18 and 60 years old
- •One to two painful traumatic fractures, non-pathological, traumatic vertebral fracture is less than 10 days, between T11 and L5, type A1 and A3.1 according to Magerl classification. All the fractures should meet the inclusion criteria (deformity, etiology, technical possibility of performing the procedure).
- •Vertebral kyphosis angle >10°
- •Patient is eligible to treatment with brace
- •Technical feasibility of a SpineJack® procedure and brace 1 to 5 days after screening/baseline
排除标准
- •Vertebral fracture more than 10 days old
- •Spontaneous osteoporotic vertebral fracture
- •Neurological signs or symptoms related to the vertebral fracture
- •Vertebral kyphosis angle >30°
- •Active systemic or local infection at baseline
- •Patient with substance abuse
- •History of intolerance or allergic reaction to titanium or acrylic compounds
- •Fracture geometry making the insertion of the implant impossible
- •Malignant lesions
- •Any other medical illness or condition that, in the investigator's opinion, is likely to impair long-term follow-up (e.g., cancer) or greatly increase the risk of surgery*
- •Patient on long-term steroid therapy (steroid dose ≥ 30 mg /day for > 3 months)
- •Patient presenting with a non-correctable spontaneous or therapeutic coagulation disorder.
- •Non-compliant patient: Impossibility to participate in the study and to be followed-up for 2 years.
- •Participating in any other investigational study
- •Female patients who are pregnant, breastfeeding, or planning to get pregnant during the course of the study
- •Patient not affiliated to social security *: including but not limited to patients with contraindications for general anesthesia (surgeon expertise)
结局指标
主要结局
VAS
时间窗: 1 and 12 months follow-up
Mean Visual Analogue Scale (VAS) back pain score at 1 and 12 months follow-up
次要结局
- Kyphotic angle(Screening/baseline, immediat post-op, 1, 3, 12 and 24 months)
- Regional Kyphotic Angle(Screening/baseline, immediat post-op, 1, 3, 12 and 24 months)
- Costs comparison of overall treatments(Screening/baseline, immediat post-op, 1, 3, 12 and 24 months)
- Oswestry Disability Index(Screening/baseline, immediat post-op, 1, 3, 12 and 24 months)
- EQ-5D(Screening/baseline, immediat post-op, 1, 3, 12 and 24 months)
- Evaluation of safety through evaluation of adverse events(Screening/baseline, immediat post-op, 1, 3, 12 and 24 months)
研究者
研究点 (9)
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