Percutaneous Kyphoplasty Assisted With/Without Mixed Reality Technology in Treatment of OVCF With IVC: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
To prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC.
详细描述
The study is to prospectively assess the outcome of PKP assisted with and without MR technology in treatment of OVCF with IVC. Forty cases of OVCF with IVC undergoing PKP were randomized into a MR technology assisted group (group A) and a traditional C-arm fluoroscopy group (group B). Both groups were performed PKP and evaluated by VAS scores, ODI scores, radiological evidence of vertebral body height and kyphotic angle(KA) at pre-operation and post-operation. The volume of injected cement and Operation time was recorded. And whether cement touching both endplates or not(non-PMMA-endplates-contact, NPEC) in radiological evidence were also recorded postoperatively. The clinical outcomes and complications were evaluated afterwards. All patients received 10 to 14 months' follow-up, with an average of 12 months.
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
- 50 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Single level OVCF in the thoracic and lumbar levels (T10-L4), suffering with severe back pain.;
- •OVCF without damaged vertebral posterior wall and nerve lesion;
- •The patient was over 50 years old and , the diagnosis of osteopenia or osteoporosis was confirmed by bone densitometry ;
- •All patients underwent（received） plain radiography, computed tomography (CT) and MRI before surgery, and with IVC presented in MRI.
排除标准
- 未提供
研究组 & 干预措施
PKP of traditional procedure
traditional method of PKP
干预措施: Mixed Reality technology (Device)
结局指标
主要结局
Oswestry Disability Index
时间窗: 1 year
Oswestry Disability Index is for movement function, Questionnaire examines perceived level of disability in everyday activities of daily living. The ODI score (index) is calculated as: For example: If all 10 sections are completed, the score is calculated as follows: if 16 (total scored) out of 50 (total possible score) x 100 = 32%; If one section is missed (or not applicable), the score is calculated: If 16 (total scored) / 45 (total possible score) x 100 = 35.5%.
visual analog scale
时间窗: 1 year
visual analog scale(0-10 scores) is for pain, 0 represent no pain, 10 score represent the severe pain.
Vertebral height
时间窗: 1 year
Vertebral height in X-ray is for recontruction of the vertebra.
Kyphotic angle
时间窗: 1 year
kyphotic angle in X-ray is also for recontruction of the vertebra.
次要结局
未报告次要终点