Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07286734

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Humerus Shaft Fracture Mononeuropathies Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radial Nerve Palsy Radial Neuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Medeniyet University

Istanbul, Kars, 34722, Turkey (Türkiye)

Location status: Recruiting

Location contact

Tolga Onay, Associate Professor

CONTACT

[email protected]

00905054418123

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High-Resolution Ultrasound Evaluation of the Radial Nerve

Device

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 board-certified musculoskeletal radiologists following a standardized protocol.

Primary outcomes

  1. Preoperative Ultrasound Accuracy in Detecting Radial Nerve Continuity

    Time frame: 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.

Secondary outcomes

  1. Correlation Between Ultrasound Classification and Intraoperative Radial Nerve Findings

    Time frame: Baseline (ultrasound), Intraoperative, and Postoperative (3, 6, and 12 months)

    Ultrasound-based classification of radial nerve injury (e.g., stretch, incarceration, partial/complete transection) will be compared with intraoperative findings to assess diagnostic agreement. Additional analyses will evaluate the relationship between USG classification and postoperative functional outcomes

  2. Functional Recovery of Radial Nerve Motor and Sensory Function

    Time frame: 1, 3, 6, and 12 months postoperatively

    Recovery of motor function (wrist/finger/thumb extension) will be evaluated using the Medical Research Council (MRC) scale (0-5). Sensory recovery will be assessed via light touch and pinprick sensation in the radial nerve territory. Outcomes include proportion of patients with full, partial, or no recovery, and time to initial and full improvement.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmed Nuri Tutuncu, MD

CONTACT

[email protected]

0090 531 265 33 79

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.