Ultrasound Assesment Of Radial Nerve In Humeral Shaft Fracture Patients With Radial Palsy

Обзор

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.

Вмешательства

• Устройство High-Resolution Ultrasound Evaluation of the Radial Nerve
  High-resolution diagnostic ultrasound of the radial nerve is performed using a linear transducer (6-15 MHz) within 48 hours of admission in patients with humeral shaft fractures. The ultrasound systematically assesses the radial nerve's continuity, morphology, and relation to the fracture site. Based on established classification criteria (e.g., stretch neuropraxia, incarceration, partial/complete transection), the ultrasound findings guide intraoperative planning. All imaging is performed by bo

Первичные конечные точки

• Preoperative Ultrasound Accuracy in Detecting Radial Nerve Continuity [Срок оценки: Baseline (within 48 hours of admission); confirmation at surgery]

Вторичные конечные точки (2)

• Correlation Between Ultrasound Classification and Intraoperative Radial Nerve Findings [Срок оценки: Baseline (ultrasound), Intraoperative, and Postoperative (3, 6, and 12 months)]
• Functional Recovery of Radial Nerve Motor and Sensory Function [Срок оценки: 1, 3, 6, and 12 months postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul Medeniyet University — Istanbul

Идентификаторы

NCT: NCT07286734 · IstanbulMU_032025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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