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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07286734
Enrollment
20
Registered
2025-12-16
Start date
2024-01-01
Completion date
2026-02-28
Last updated
2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Humerus Shaft Fracture, Radial Nerve Palsy

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.

Interventions

DEVICEHigh-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.

Sponsors

Istanbul Medeniyet University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Preoperative Ultrasound Accuracy in Detecting Radial Nerve ContinuityBaseline (within 48 hours of admission); confirmation at surgeryThis 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

MeasureTime frameDescription
Correlation Between Ultrasound Classification and Intraoperative Radial Nerve FindingsBaseline (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
Functional Recovery of Radial Nerve Motor and Sensory Function1, 3, 6, and 12 months postoperativelyRecovery 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactMehmed Nuri Tutuncu, MD
mnuritutuncu@hotmail.com0090 531 265 33 79

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026