Percutaneous Injection of Strontium Containing Hydroxyapatite Versus Polymethacrylate Plus Short Segment Pedicle Screw Fixation for Traumatic A2 and A3 AO-type Fractures in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
The aim of this study was to examine the short- to medium-term efficacy of percutaneous vertebral body reconstruction by vertebral body augmentation with Sr-HA paste plus short-segment pedicle screw fixation in fresh fractures, as well as to evaluate Sr-HA resorption/substitution. The hypotheses tested in this study were as follows: 1) whether Sr-HA is equivalent to PMMA for restoring the fractured thoracolumbar vertebral body, 2) whether leakage of Sr-HA is less than that of PMMA, and 3) whether Sr-HA is completely resorbed and replaced by cancellous bone.
详细描述
Introduction Polymethacrylate (PMMA) is commonly used in vertebroplasty and balloon kyphoplasty, but its use has been associated with complications. This study tests three hypotheses: 1) whether strontium hydroxyapatite (Sr-HA) is equivalent to PMMA for restoring thoracolumbar vertebral body fractures, 2) if incidence of PMMA leakage is similar to that of Sr-HA leakage, and 3) whether Sr-HAis resorbed and substituted by new vertebral bone.
Materials and Methods Two age- and sex-matched groups received short percutaneous pedicle screw fixation plus PEEK implant (Kiva, VCF Treatment System, Benvenue Medical, Santa Clara, CA, USA) filled with either Sr-HA (Group A) or PMMA (Group B) after A2- and A3/AO-type thoracolumbar vertebral body fractures. Visual Analog Scale (VAS) score and imaging parameters, which included segmental kyphosis angle (SKA), vertebral body height ratios (VBHr), spinal canal encroachment (SCE), bone cement leakage, and Sr-HA resorption, were compared between the two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 38 Years 至 53 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •One single, severely (>40%) compressed A2 and A3/AO-type thoracolumbar (T10-L3) fracture
- •No other serious concomitant injuries
排除标准
- •Polytrauma
- •Neurologic impairment
- •Spinal deformity
- •Known malignancy
- •Previous fracture or surgery in the same or adjacent vertebrae
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: 33 months
Units on VAS scale (0-10)
次要结局
- Vertebral body height ratios (VBHr)(33 months)
- Segmental kyphosis angle (SKA)(33 months)
- Cement leakage(33 months)
- Spinal canal encroachment (SCE)(33 months)
- Sr-HA resorption(33 months)
研究者
Vasileios Syrimpeis
Orthopaedic Surgeon
University Hospital of Patras