NCT00969839Unknown4 期
A Study to Evaluate the Safety and Effectiveness of the NovaLign Intramedullary Fixation System for the Treatment of Humeral Diaphysis Fractures
NovaLign Orthopaedics, Inc4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Radiographic union and safety
研究概览
简要总结
This post-market clinical study is being done to evaluate the use of the NovaLign™ Intramedullary Fixation System in the treatment of humeral fractures.
详细描述
This is an observational, prospective, nonrandomized open label, post-market clinical study, designed to evaluate the use a flexible intramedullary fixation device used in the treatment of fractures of the humerus. This is a multicentre trial.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Humeral Fracture
- •Surgical intervention can be performed within 14 days of injury (injury being Day 0 for this particular criteria)
- •Fully functioning contralateral limb (e.g., hand, arm, shoulder)
- •Age 18 years or older and skeletally mature
排除标准
- •Intraarticular fractures or those involving shoulder or elbow of the index arm
- •Pathologic fracture (e.g., tumor involvement, osteomalacia, etc.; osteoporosis is not an exclusion)
- •Evidence of neurologic injury in the index arm, including compartment syndrome or radial nerve palsy
- •Additional upper body injuries (e.g., upper extremity, abdominal, thoracic, neck or head injury) that may affect or inhibit the evaluation of the index or contralateral arm, shoulder, elbow, etc or would not allow the patient to follow or comply with appropriate post-operative regimens
- •Any previous bodily injury or surgery that may interfere with function or evaluation of index or contralateral arm, shoulder, elbow, etc.
结局指标
主要结局
Radiographic union and safety
时间窗: 12 months
次要结局
- Function, pain, and quality of life assessments at regular intervals(12 months)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Effectiveness Of The Fibulock Intramedullary NailFibula FractureNCT02688296Arthrex, Inc.34
终止
不适用
IntErnational Long-term Follow-up Study of Patients With Uncontrolled HyperTensioNBlood PressureHypertensionNCT01705080Abbott Medical Devices276
已完成
不适用
Safety & Effectiveness of Wortie Freeze Plus in Common and Plantar WartsCommon WartPlantar WartNCT05115669Karo Pharma AB50
进行中（未招募）
不适用
Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic PainPeripheral NeuralgiaChronic PainNCT05287373Nalu Medical, Inc.89
进行中（未招募）
不适用
Clinical Study of a Micro-Implantable Pulse Generator for the Treatment of Peripheral Neuropathic Pain (COMFORT 2)Peripheral NeuralgiaChronic PainPeripheral NeuropathyNCT05870124Nalu Medical, Inc.185