NCT03730207已完成不适用
A Prospective, 1: 1 Randomized, Single Blind, Multi-center Human Clinical Trial
Medtronic Spinal and Biologics3 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2018年12月18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
- 180
- 试验地点
- 3
- 主要终点
- The Change of Index Vertebral Body Angle From Baseline at 6 Months
研究概览
简要总结
The purpose of this clinical study is to confirm the efficacy and safety of the Kyphon®Xpede™ Bone Cement in human use in China.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject being diagnosed as having painful pathological vertebral body fracture, who is suitable for VP/BKP procedure (1-3 levels) according to clinic practice.
- •Subjects who are willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration.
- •Subjects are at least 18 and ≤80 years old .
排除标准
- •Subject has a local or systemic infection.
- •Subject has pains caused by other spine disease than painful pathological vertebral compression fracture.
- •Subject has a medical condition with less than 1 year of life expectancy.
- •Subject is grossly obese, i.e. BMI≥
- •Subject has medical conditions that represent contraindications for the use of bone cement by investigator's decision.
- •Subject has an allergy or an intolerance to bone cement component.
- •Subject has past spinal surgeries at the target level(s) for which the VP/BKP procedure is suitable.
- •Subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when document pre-approval is obtained from the Medtronic study manager and Medtronic Medical Advisor.
- •Pregnant women or breastfeeding women, or women of child bearing potential who are not on a reliable form of birth regulation method or abstinence.
- •Subjects with exclusion criteria required by local law (age or other).
- •Subjects with medical condition which precludes them from participation in the opinion of the Investigator.
结局指标
主要结局
The Change of Index Vertebral Body Angle From Baseline at 6 Months
时间窗: Baseline and 6 months
Vertebral body angle is defined the angle formed by lines drawn parallel to the superior endplate of the fractured vertebral body and the inferior endplate of the fractured vertebral body for each fractured vertebral body.
The Change of Numerical Rating Scale (NRS) Score From Baseline at 6 Months Postoperative
时间窗: Baseline and 6 months
NRS is used for rating patient pain intensity from 0-10, with a score of 0 representing "no pain" and a score of 10 representing "pain as bad as it could be."
次要结局
- The Change of NRS Score From Baseline at 1 Day and 3 Months(Baseline, 1 day, and 3 months)
- The Change of Oswestry Disability Index (ODI) Score From Baseline at 1 Day, 3 Months, and 6 Months(Baseline, 1 day, 3 months, and 6 months)
- The Change of SF-36 From Baseline at 1 Day, 3 Months, and 6 Months(Baseline, 1 day, 3 months, and 6 months)
- Change in Vertebral Body Angle From Baseline at 1 Day and 3 Months(Baseline, 1 day and 3 months)
- Number of Participants With Adverse Events Reported Through 6 Months(6 months)
- Change in Vertebral Body Height at 1 Day, 3 Months, and 6 Months(1 day, 3 months, and 6 months)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
A clinical study to evaluate the efficacy of bone-modyfying agent for the patients of prostate cancer.prostate cancerJPRN-UMIN000015126Department of Urology, Keio University School of Medicine
撤回
3 期
Bone Healing Accelerant Versus Standard of Care for Open Tibia FracturesTibial FracturesNCT03826784Carmell Therapeutics Corporation
撤回
2 期
Multiregion BHA in Open Tibia FracturesTibial FracturesNCT04056429Carmell Therapeutics Corporation
已完成
不适用
Histomorphometric and immunohistochemical evaluation of beta-tricalcium phosphate of different particles dimensions in maxillary sinus floor elevation: a randomized clinical studyStomatognathic diseasesMaxillary sinusBone substitutesBone resorptionA04.531.621.578D25.130.325C05.116.264RBR-63c3gnFaculdade de Odontologia de Araçatuba
终止
不适用
Localized Alveolar Ridge Augmentation With Space Maintenance DevicesAlveolar Bone LossNCT00991432Medtronic Spinal and Biologics10