NCT06605482招募中不适用
Early Fixation for Diaphyseal Humeral Shaft Fractures in the Elderly Patients: a Prospective Cohort Study
Fraser Orthopaedic Research Society1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2024年11月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- American Shoulder and Elbow Score
研究概览
简要总结
The study purpose is to evaluate whether early surgical fixation of upper arm fractures in elderly patients' age 65 years and older improves patient functional and psychological outcome scores compared to the standard of care with non-operative management.
详细描述
A prospective cohort study following patients that are 65 years or older after they have suffered a humeral shaft fracture. Follow up will continue until 1 year post treatment to see functional and psychological outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diaphyseal humeral shaft fracture (as defined as superior border of insertion of pectoralis major proximally, to the distal diaphysis)
- •Ambulatory (with or without the use of walking aides)
排除标准
- •Fractures with intra-articular extension
- •Ipsilateral upper extremity injury
- •Patients with vascular injury
- •Brachial plexus injury
- •Compartment syndrome
- •Pathological fractures
- •Open fractures
- •Periprosthetic fracture
- •BMI >40
- •Dementia or cognitive impairment that inhibits the collection of outcome measures
- •Likely problems, in the judgement of the investigator, with maintaining follow-up (i.e. patients with no fixed address, not mentally competent to give consent, intellectually challenged, patients without adequate support, etc.)
- •Inability to provide informed consent
结局指标
主要结局
American Shoulder and Elbow Score
时间窗: Enrolment to 12 months post treatment
Patient reported outcome measure for shoulder and elbow function. The score ranges from 0 to 100, with 0 the lowest level of function and 100 the highest level of function.
次要结局
- 12-Item Short Form Survey(Enrolment to 12 months post treatment)
- Range of Motion(3 months post treatment)
研究者
研究点 (1)
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