Prospective, Observational Clinical Investigation of the Exos® Reformable Brace for Conservatively Managed Distal Radius Fractures: An Evaluation of Time to Union, Satisfaction, and Convenience
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- bony union
研究概览
简要总结
This is a prospective observational single cohort trial quantifying time to radiographic union (primary endpoint) and convenience, satisfaction, pain and resource requirements (secondary) for patients with non-operatively treated distal radius fractures managed with a thermoformable Exos short-arm brace.
详细描述
The trial will be a prospective trial of a convenience sample of skeletally mature patients with radiographically-confirmed distal radius fractures that can be managed without ORIF. The study population will be defined as all adult patients (>18 years) with stable, non-displaced distal radius fractures. All patients will be independent in activities of daily living. Patients will be screened as candidates for enrollment into the study and if the patient satisfies the inclusion/exclusion criteria, a clinical research coordinator or the study PI/coPI will explain all essential elements of the clinical trial. If the patient agrees to participate, the study coordinator or PI/coPI will obtain informed consent. The patient will still be followed clinically per the PI/coPI's standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- 是
入选标准
- •Age > 18 years;
- •Unilateral fracture of distal radius without misalignment (dorsal angulation <10°, axial radial shortening <5mm), <2mm intraarticular stepoff;
- •Independent in activities of daily living;
- •Capable and willing of signing informed consent.
- •Children under the age of 18;
- •Fracture of the contralateral arm;
- •Other fractures of the ipsilateral arm;
- •Open fractures;
- •Fractures that require reduction.
排除标准
- 未提供
研究组 & 干预措施
Brace Arm
All subjects in this study received the reformable brace
干预措施: molded brace (Other)
结局指标
主要结局
bony union
时间窗: 2-12 weeks
radiographic time to union
次要结局
- Patient Reported Outcomes(2-12 weeks)
- Patient Reported Disability Scale- Quick-DASH(2-12 weeks)
- Patient rated Wrist Evaluation(2-12 weeks)