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.

Study Overview

• Status: Recruiting
• Conditions: Radial Nerve Palsy; Humerus Shaft Fracture
• Intervention / Treatment: Device: High-Resolution Ultrasound Evaluation of the Radial Nerve

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Mehmed Nuri Tutuncu, MD; Phone Number: 0090 531 265 33 79; Email: mnuritutuncu@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Kars
    • Istanbul, Kars, Turkey (Türkiye), 34722
      • Recruiting
      • Istanbul Medeniyet University
      • Contact: Tolga Onay, Associate Professor; Phone Number: 00905054418123; Email: tolgaonay.md@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting with acute traumatic humeral shaft fractures at a tertiary care orthopedic center. Patients are assigned to cohorts based on the presence or absence of clinical radial nerve palsy. All participants undergo standard diagnostic and therapeutic procedures, with targeted ultrasound used for nerve assessment in the radial palsy group.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radial Nerve Palsy Group; Patients with humeral shaft facture and Radial Nerve Palsy	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 board-certified musculoskeletal radiologists following a standardized protocol.
No radial Nerve Palsy; Patients with humeral shaft fracture but no radial nerve palsy	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 board-certified musculoskeletal radiologists following a standardized protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative Ultrasound Accuracy in Detecting Radial Nerve Continuity	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.	Baseline (within 48 hours of admission); confirmation at surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Between Ultrasound Classification and Intraoperative Radial Nerve Findings	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	Baseline (ultrasound), Intraoperative, and Postoperative (3, 6, and 12 months)
Functional Recovery of Radial Nerve Motor and Sensory Function	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.	1, 3, 6, and 12 months postoperatively

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Mononeuropathies; Radial Neuropathy
• Other Study ID Numbers: IstanbulMU_032025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No