Ultrasound Assesment Of Radial Nerve In Humeral Shaft Fracture Patients With Radial Palsy
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Istanbul Medeniyet University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Preoperative Ultrasound Accuracy in Detecting Radial Nerve Continuity
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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
- 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)
Investigators
Mahmut Gumus
Professor
Istanbul Medeniyet University