Ultrasound Assesment Of Radial Nerve In Humeral Shaft Fracture Patients With Radial Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Preoperative Ultrasound Accuracy in Detecting Radial Nerve Continuity
研究概览
简要总结
This study investigates how well ultrasound imaging can identify damage to the radial nerve in patients with a broken upper arm bone (humeral shaft fracture). Some of these patients also have weakness or paralysis in their hand and wrist due to injury to the radial nerve. The study compares patients with and without radial nerve problems to see if early ultrasound scans can accurately detect nerve damage before surgery.
All patients will receive standard care, including surgery to fix the fracture. Those with nerve problems will also have the nerve explored during surgery. The results of the ultrasound will be compared to what is found during the operation. Patients will be followed closely over 12 months to monitor nerve recovery, healing of the bone, and any complications.
The goal is to improve the early diagnosis and management of nerve injuries in arm fractures, using a safe, non-invasive ultrasound scan that could help guide treatment decisions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Adult patients aged 18 years or older.
- •Diagnosed with traumatic humeral shaft fracture.
- •Admitted and followed according to the local clinical protocol with a confirmed diagnosis.
- •Underwent required investigations, including high-resolution ultrasonography and/or electromyography (EMG).
- •Provided written informed consent to participate in the study.
排除标准
- •Pathological fractures due to malignancy or metabolic disorder.
- •History of previous humeral fracture or pre-traumatic radial nerve deficit.
- •Clinically detected vascular injury or major soft tissue loss accompanying the fracture.
- •Incomplete diagnostic workup (absence of ultrasound or EMG examination).
- •Declined participation or were lost to follow-up.
- •Persons under 18 years of age.
结局指标
主要结局
Preoperative Ultrasound Accuracy in Detecting Radial Nerve Continuity
时间窗: Baseline (within 48 hours of admission); confirmation at surgery
This outcome assesses how accurately high-resolution ultrasonography identifies whether the radial nerve is intact in patients with humeral shaft fractures and radial nerve palsy. The ultrasound findings will be compared to surgical exploration results (reference standard). Diagnostic accuracy metrics include sensitivity, specificity, positive predictive value, and negative predictive value.
次要结局
- Correlation Between Ultrasound Classification and Intraoperative Radial Nerve Findings(Baseline (ultrasound), Intraoperative, and Postoperative (3, 6, and 12 months))
- Functional Recovery of Radial Nerve Motor and Sensory Function(1, 3, 6, and 12 months postoperatively)
研究者
Mahmut Gumus
Professor
Istanbul Medeniyet University