NCT03617094已完成不适用
Early Percutaneous Vertebroplasty Versus Standard Conservative Treatment in Thoracolumbar Vertebral Fractures. Monocentric, Prospective, Randomised and Compared Clinical Study
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2018年7月5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
- 42
- 试验地点
- 2
- 主要终点
- Vertebral kyphosis change between fracture diagnosis and after 3 months of treatment, in the two groups
研究概览
简要总结
The aim of this study is to evaluate the efficacy of carrying out early vertebroplasty procedure, compared to the standard conservative treatment (corset), in order to prevent residual deformations that could occur in complications of vertebral fractures that are medically treated using a corset.
This is a monocentric, randomized, parallel group, prospective and open-label study.
详细描述
In this study, 58 patients with a vertebral fracture no more than 10 days old (with a max of 15 days old) will be enrolled. Treatment will be randomly allocated in 2 groups: Early percutaneous vertebroplasty (EPV group) or standard conservative treatment (corset, CT group). Patients will be followed up during 3 months after treatment. They will receive standard care for a vertebral fracture at the Grenoble-Alpes University Hospital.
Evaluated criteria: Vertebral kyphosis evolution, Pain, Efficacy and Quality of vertebroplasty procedure, Tolerance and observance of the standard treatment, Safety, Physical performance, Quality of life, Autonomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years
- •Fracture localisation : vertebrae from T8 to L5
- •Recent fracture (< 10 days, maximum 15 days)
- •CT scan showing a fracture of the superior endplate and of the anterior cortex of the vertebral body of type A1 according to the Magerl classification AND vertebral kyphosis deformation < 30°
- •Patient affiliated to the French social security system or an equivalent system
- •Patient who has signed consent form
排除标准
- •Multiple level fracture
- •Repeated fracture at the same level
- •Others peripheral fractures
- •Contraindication for percutaneous procedure
- •Contraindication for vertebroplasty procedure (pathology with risk of decompensation, coagulation problems, deformation considered by the surgeon to be inaccessible by vertebroplasty procedure, presence of an infected site)
- •Contraindication for anasthesia
- •Methylmethacrylate (MMA) allergy known
- •Impossibility to plan the start of the treatment (set up of treatment or carrying out of a vertebroplasty gesture) within a maximum deadline of 15 days after the fracture
- •Body Mass Index (BMI) > 31,5
- •Progressive local infection
- •Progressive local cancer
- •Patient presenting cognitive disorder with behavioural disorder which could disturb the treatment
- •Non-cooperative patient
- •Patient who can not be followed up at Grenoble hospital during the 3 months of the study
- •Patient concerned by articles L1121-5, L1121-6, L1121-8 of the French public health code
结局指标
主要结局
Vertebral kyphosis change between fracture diagnosis and after 3 months of treatment, in the two groups
时间窗: Diagnosis, and after 3 months of treatment
Difference in the kyphotic angle measured at the fracture diagnosis and after 3 months of treatment
次要结局
- Compare the pain evolution between fracture diagnosis and after 3 months of treatment, in the two groups(diagnosis, after 24 hours, 45 days and 3 months of treatment)
- Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Kyphotic Angle(Diagnosis, immediat post-op, after 45 days and 3 months of treatment)
- Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Anterior vertebral height(Diagnosis, immediat post-op, after 45 days and 3 months of treatment)
- Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Vertebral Compression Ratio(Diagnosis, immediat post-op, after 45 days and 3 months of treatment)
- Evaluation of the efficacy of early vertebroplasty procedure (EPV arm) - Regional kyphotic angle(Diagnosis, immediat post-op, after 45 days and 3 months of treatment)
- Quality of the early vertebroplasty procedure (EPV arm) assessed as the quality of cement filling(Immediately post-op)
- Tolerability of the treatment by corset (CT arm) assessed using the number of thoracolumbar corset readjustments during treatment(3 months)
- Evaluation of the observance of the treatment by corset (CT arm)(3 months)
- Comparison of the adverse events during the study between the two groups(3 months)
- Comparison of physical performance evolution between 24h and 3 months after treatment, between the two groups(24 hours and 3 months after treatment)
- Comparison of the evolution in the autonomy of the patients using ADL questionnaire (before and after vertebral fracture, and 3 months after treatment), between the two groups(Diagnosis (before / after fracture), and 3 months after treatment)
- Comparison of the evolution in the autonomy of the patients using IADL questionnaire (before and after vertebral fracture, and 3 months after treatment), between the two groups(Diagnosis (before / after fracture), and 3 months after treatment)
- Comparison of the evolution of quality of life using SF-36 questionnaire score (before and after vertebral fracture, and 3 months after treatment) between the two groups(Diagnosis (before / after fracture), and 3 months after treatment)
- Comparison of the evolution of quality of life using QUALEFFO questionnaire (before and after vertebral fracture, and 3 months after treatment) between the two groups(Diagnosis (before / after fracture), and 3 months after treatment)
- Comparison of the number of days of hospitalization between the two groups(3 months)
研究者
研究点 (2)
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