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Recruiting NCT07286734

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

Observational Humerus Shaft Fracture Radial Nerve Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High-Resolution Ultrasound Evaluation of the Radial Nerve.
Who it may be relevant to
Registry conditions: Humerus Shaft Fracture, Radial Nerve Palsy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device 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

Primary outcome measures

  • Preoperative Ultrasound Accuracy in Detecting Radial Nerve Continuity [Time frame: Baseline (within 48 hours of admission); confirmation at surgery]
Secondary outcome measures (2)
  • Correlation Between Ultrasound Classification and Intraoperative Radial Nerve Findings [Time frame: Baseline (ultrasound), Intraoperative, and Postoperative (3, 6, and 12 months)]
  • Functional Recovery of Radial Nerve Motor and Sensory Function [Time frame: 1, 3, 6, and 12 months postoperatively]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Istanbul Medeniyet University — Istanbul

Identifiers

NCT: NCT07286734 · IstanbulMU_032025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗