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

NCT07286734 | Recruiting

• 1 other identifier: IstanbulMU_032025
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Humerus Shaft Fracture; Radial Nerve Palsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Radial Nerve Palsy Group

Patients with humeral shaft facture and Radial Nerve Palsy

Device: High-Resolution Ultrasound Evaluation of the Radial Nerve

No radial Nerve Palsy

Patients with humeral shaft fracture but no radial nerve palsy

Device: High-Resolution Ultrasound Evaluation of the Radial Nerve

Interventions

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.

No radial Nerve Palsy; Radial Nerve Palsy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Kars, 34722, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Radial Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Mehmed Nuri Tutuncu, MD

CONTACT

0090 531 265 33 79; mnuritutuncu@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)