NCT01402167撤回不适用
Evaluating Transcutaneous Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures: a Randomized Pilot Study Using Catscan Volumetry
Centre Hospitalier Universitaire de Nīmes0 个研究点开始时间: 2014年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- The volume (cm^3) of injected ciment
研究概览
简要总结
The primary objective of this study is to compare the volume of injected ciment (polymethyl methacrylate) between a group of patients treated with vertebroplasty and a group of patients treated via kyphoplasty. Secondary evaluation will compare the restoration of vertebral height, volume and cyphotic angle between the two techniques, as well as extravation of ciment and functional and quality of life aspects related to these techniques.
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
- 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
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 3 months of follow-up
- •Fracture type according to Magerl Classification (1994) must be one of the following: A1, A2.1, A3.1, A3.2
- •Cyphose of >10°
- •Spinal pain
- •Vertebral fracture < 3 weeks old located between D5 and L5
- •If fragments in the canal, they must protrude less than 40%
- •Absence of other lesions, including cancer
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •Patient cannot read French
- •Patient is pregnant or breast feeding
- •Patient has a fracture on an adjacent vertebra
- •Patient has a contra-indication for a treatment used in this study
- •ASA class IV or V
- •Patient has a neurological deficit
- •Previous spinal surgery
研究组 & 干预措施
Kyphoplasty
Experimental
Patients randomized to this arm will be treated via balloon kyphoplasty.
干预措施: Kyphoplasty (Procedure)
Vertebroplasty
Active Comparator
Patients randomized to this arm will be treated via vertebroplasty.
干预措施: Vertebroplasty (Procedure)
结局指标
主要结局
The volume (cm^3) of injected ciment
时间窗: Baseline (Day 0)
The volume of injected ciment is measured by catscan extrapolated data.
次要结局
- The change in the ODI score before and after surgery(3 months)
- The % change in SF-36 quality of life score before and after surgery(3 months)
- Recovery of vertebral volume (%)(Day 1 to Day 7)
- Change from baseline of the cyphotic angle (°)(3 months)
- Change from baseline in vertebral height (mm)(3 months)
- Volume of ciment leakage (cm^3)(Day 1)
- % Change in FABQ score before and after surgery(3 months)
- Change in Visual Analog Scale (0 to 10) for pain before and after surgery(3 months)
- The % change in the ODI score before and after surgery(3 months)
- % Change in DPQ score before and after surgery(1 month)
- Presence / absence of post-operative complications(3 months)
- % Change in Visual Analog Scale (0 to 10) for pain before and after surgery(3 months)
- Change in SF-36 quality of life score before and after surgery(3 months)
- Presence / absence of per-operative complications(Day 0 (day of surgery))
- Change in FABQ score before and after surgery(3 months)
- Change in DPQ score before and after surgery(3 months)
- Duration of surgery (minutes)(Day 0 (day of surgery))
研究者
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