NCT02461810已完成不适用
A Prospective, Multicenter, Randomized, Comparative Clinical Study to Compare the Safety and Effectiveness of Two Vertebral Compression Fracture (VCF) Reduction Techniques: the SpineJack® and the KyphX Xpander® Inflatable Bone Tamp
Vexim SA13 个研究点 分布在 5 个国家目标入组 152 人开始时间: 2015年4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
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 13
- 主要终点
- Proportion of Participants With Study Success
研究概览
简要总结
The purpose of this study is to compare the safety and effectiveness of the SpineJack® with the Kyphx Xpander® Inflatable Bone Tamp and support a non-inferiority finding for the use of SpineJack® VCF treatment system versus Balloon Kyphoplasty.
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
- •Male or Female with at least 50 years of age
- •1 painful VCF which at least meet all following criteria:
- •Fracture due to diagnosed or presumed underlying osteoporosis
- •VCF between T7 and L3
- •Fracture age <3 months
- •VCF shows loss of height in the anterior, mid or posterior third of the VB from estimated pre-fracture configuration of at least 15% but not more than 40% based on X-Ray at baseline
- •The Index fracture is acute or persistent (not healed), as demonstrated by T2 weighted STIR MRI (or bone scan if patient is contraindicated for MRI)
- •Patient has failed conservative medical therapy, defined as either having a VAS back pain score of ≥50 mm at 6 weeks after initiation of fracture care or a VAS back pain score of ≥70mm at 2 weeks after initiation of fracture care
- •Investigator believes target VB is suitable for SpineJack procedure and Balloon kyphoplasty (e.g., appropriate pedicle diameter) assessed on CT scan pre op
- •Patient has an Oswestry Disability Index (ODI) score of ≥ 30/100
- •Patient is mentally capable and willing to sign a study specific informed consent as documentation of the informed consent process prior to any study procedures
- •The patient is willing and able to comply with all study requirements including follow-up visits and radiographic assessments.
排除标准
- •Target VCF due to underlying or suspected tumor
- •Target VCF due to high-energy trauma
- •Target VCF is diagnosed as an osteonecrotic fracture
- •Segmental kyphosis of target VB of >30°
- •Any prior surgical treatment for a vertebral body compression fracture or other surgical procedure on target VB or adjacent level
- •The patient has uncontrolled diabetes
- •Pre-existing or clinically unstable neurologic deficit
- •The patient has spinal canal compromise causing clinical manifestations of cord, neural foramen, or nerve root compression at the level to be treated
- •Any physical exam evidence of myelopathy or radiculopathy
- •The patient has pain based on clinical diagnosis of herniated nucleus pulposus or severe spinal stenosis (progressive weakness or paralysis)
- •Patient not able to walk without assistance prior to fracture
- •Any radiographic evidence of pedicle fracture visible on CT scan pre op
- •Spondylolisthesis >Grade 1 at target VB
- •Any underlying systemic bone disease other than osteoporosis (e.g., osteomalacia, osteogenesis imperfect, Paget's disease, etc.)
- •A medical contraindication to spinal surgery and/or general anesthesia, such as coagulopathy and/or taking warfarin (Coumadin) or other anticoagulant on regular basis for coagulopathy (with a threshold for normal being INR≤1.5, PTT within lab normal range, and platelet count > 100,000)
- •Pain due to any other condition that requires daily narcotic medication
- •Disabling back pain due to causes other than acute fracture
- •History of intolerance or allergic reaction to titanium or acrylic compounds
- •Active systemic or local infection at baseline
- •Body mass index >40
- •Severe cardiopulmonary deficiencies
- •Any other medical illness or condition that, in the investigator's opinion, is likely to impair long-term follow-up (e.g., cancer) or greatly increase the risk of surgery including but not limited to patients with contraindications for general anesthesia (surgeon expertise)
- •Any evidence of alcohol or drug abuse
- •The patient has uncontrolled psychiatric illness or severe dementia
- •The patient is currently on anti-cancer therapy or anti-HIV therapy
- •Patient's life expectancy is less than the study duration or undergoing palliative care
- •Participating in any other investigational study
- •The patient is on long-term steroid therapy (steroid dose ≥ 30 mg /day for > 3 months)
- •The patient is known to be involved in medical litigation including Workmen's Compensation
- •Patient with contraindication for MRI
- •The patient is pregnant or considering getting pregnant during study participation.
研究组 & 干预措施
Balloon Kyphoplasty
Active Comparator
VCF treatment system Vertebral fracture surgery
干预措施: Balloon Kyphoplasty (Procedure)
SpineJack® system
Experimental
VCF treatment system Vertebral fracture surgery
干预措施: Vertebral fracture surgery SpineJack® (Device)
结局指标
主要结局
Proportion of Participants With Study Success
时间窗: 12 month post-op
The primary composite endpoint defines a successful subject if the following components are satisfied (safety and effectiveness): 1. Reduction in VCF fracture-related pain at 12 months from baseline as measured by a 100 mm VAS scale (reduction of pain at 12 months by \> 20 mm) AND, 2. Maintenance or improvement in function at 12 months from baseline as measured by the 100 point Oswestry Disability Index (ODI) AND, 3. Absence of device-related serious adverse events, defined as device-related adverse events (device migration, recollapse, protrusion) or symptomatic cement extravasation requiring surgical re-intervention or retreatment at the index level, including revision, removal, reoperation, and/or supplemental fixation.
次要结局
未报告次要终点
研究者
研究点 (13)
Loading locations...
相似试验
已完成
不适用
Incidence of Proximal Junctional Kyphosis (PJK) in Long Posterior Spinal Fusion: A Study Comparing Traditional Open Surgery to Minimally Invasive Percutaneous Technique at the Proximal Fusion LevelsKyphosisScoliosisNCT00890227Johns Hopkins University48
已完成
不适用
Effectiveness and Safety of SpineCare Used in Conjunction With Spinal Realignment TherapyScoliosis IdiopathicNCT06519201REBOM CLINIC10
已完成
不适用
Xpede Clinical StudyPathological Fracture of Vertebra Due to Secondary Osteoporosis (Disorder)Pathological Fracture of Vertebra Due to Neoplastic Disease (Disorder)NCT03730207Medtronic Spinal and Biologics180
终止
不适用
Kineflex|C Artificial Disc System to Treat Cervical Degenerative Disc Disease (DDD)Degenerative Disc Disease (DDD)NCT00374413SpinalMotion343
终止
不适用
Kineflex Artificial Disc System to Treat Degenerative Disc Disease (DDD)Degenerative Disc DiseaseNCT00292292SpinalMotion514