Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 26
- 主要终点
- Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)
研究概览
简要总结
The objective of this study is to measure the effect that the scraping and scoring of vertebral cancellous bone using the Kyphon® Curette has on vertebral body anatomy height restoration and angular deformity correction during a balloon kyphoplasty procedure.
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
- None
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
- •One painful VCF meeting all of the following criteria:
- •Fracture due to diagnosed or suspected underlying primary or secondary osteoporosis
- •VCF is between T5 and L5
- •VCF shows hyperintense signal on STIR or T2 weighted MRI
- •VCF has at least 15% height loss as visualized on plain radiograph
- •Identified painful VCF has at least superior and one normal vertebrae within 2 levels inferior.
- •Either the immediate superior OR the immediate inferior vertebral body (but not both) may have a chronic fracture that does not need treatment.
- •Patient states availability for all study visits
- •Patient is able to understand the risks and benefits of participating in the study and is willing to provide written informed consent
排除标准
- •Patient is unable to undergo MRI
- •Patient shows evidence of edema in vertebral bodies other than index level on MRI
- •Patient is unable to stand for pre-operative and post-operative x-rays
- •Patient body mass index (BMI) is greater than 35 kg/m2
- •Patient is pregnant, or of child-bearing potential and not using contraception
- •Vertebral body (VB) morphology or configuration is such that balloon kyphoplasty is not technically feasible or clinically appropriate for the index VCF
- •Index fracture is result of high-energy trauma
- •Suspected or proven cancer inside any VB
- •Disabling back pain due to causes other than acute fracture
- •Spine stabilization beyond balloon kyphoplasty required for index VCF
- •Pre-existing conditions contrary to balloon kyphoplasty, such as:
- •Irreversible coagulopathy or bleeding disorder. Note that patients on Coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and re-initiation of anticoagulants.
- •Allergy to any device materials (e.g., bone cement) for balloon kyphoplasty. Note that in patients with allergy to iodine-based contrast, other marketed approved non-iodine contrast solutions may be used.
- •Any evidence of VB or systemic infection
研究组 & 干预措施
Curette-First
All of patients in the study were treated with Balloon Kyphoplasty. During Balloon Kyphoplasty, two inflatable bone tamps (IBTs) are placed into the vertebral body bilaterally via a transpedicular or extrapedicular approach under fluoroscopic guidance. In this arm, curettage was performed prior to use of inflatable bone tamps.
干预措施: Kyphon® Curette (Device)
IBT-First
All of patients in the study were treated with Balloon Kyphoplasty. During Balloon Kyphoplasty, two inflatable bone tamps (IBTs) are placed into the vertebral body bilaterally via a transpedicular or extrapedicular approach under fluoroscopic guidance. In this arm, inflatable bone tamps were used prior to curettage, then followed by a second inflation of the bone tamps.
干预措施: Kyphon® Curette (Device)
结局指标
主要结局
Absolute Vertebral Body Height Restoration as a Percent (Post-procedure Change From Baseline)
时间窗: Baseline and 48-hr post-procedure
次要结局
- Deformity Correction Assessed by Vertebral Body Kyphosis Angle (VBA)(Baseline and 48 hr post-procedure)
- Amount of Vertebral Body Height (VBH) Gained From IBTs Alone(Intra-operative measurement after postural reduction with Bolsters and intra-operative measurement after 1st round of IBT inflation.)
- Amount of Vertebra Body Height (VBH) Gained by Postural Reduction(baseline and intra-operative)
- Index Vertebral Body Height Restored in Millimeters.(Baseline and 48 hours after procedure)
- Change in Ambulatory Status(Baseline and 48 hrs post-procedure)
- Deformity Correction Assessed by Local Cobb Angle (LCA)(baseline and 48 hr post-procedure)
- Change in Back Pain.(Baseline and 48 hr post-procedure)