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This preprint describes a protocol for a two-phase study examining whether ultrasound can detect early callus formation in proximal humerus fractures before it becomes visible on conventional x-rays. The pilot phase will assess inter-rater reliability using ten patients scanned at 2 and 4 weeks post-injury, while the prospective cohort phase will recruit thirty additional patients to determine if early ultrasound-detected callus predicts successful healing at three and six months. The study aims to establish a standardized, radiation-free ultrasound protocol as a potential adjunct to radiographic monitoring of these common fractures.
Why it matters
If validated, this ultrasound protocol could enable earlier detection of healing problems in proximal humerus fractures without radiation exposure, potentially allowing clinicians to identify patients at risk for nonunion sooner and adjust treatment plans accordingly. The method could provide a cost-effective and repeatable way to monitor fracture healing progress in clinical practice.
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⚠️ Preprint – Noch nicht peer-reviewed
Dieser Artikel wurde noch nicht von unabhängigen Experten begutachtet. Die Ergebnisse sind vorläufig und sollten mit Vorsicht interpretiert werden.
Abstract Introduction: Proximal humerus fractures account for approximately 5-6% of all adult fractures and are primarily managed nonoperatively. Healing is conventionally monitored with radiographs, with radiopaque callus formation indicating healing. Visible radiographic callus appears weeks after biological union begins. Ultrasound provides a dynamic, radiation-free, and cost-effective method that can detect early callus formation before x-ray visibility. Although ultrasound has demonstrated utility for fracture healing in the clavicle and humeral shaft, its role in proximal humerus fractures remains unclear. Methods: This single-centre prospective study will be conducted in two phases. The pilot phase will measure inter-rater reliability for ultrasound detection of early callus formation at 2 and 4 weeks post-injury. Ten patients with proximal humerus fractures treated nonoperatively will undergo standardized anterior and lateral scans. Each patient will generate four saved images (short- and long-axis views), producing forty anonymized images independently reviewed by two raters. The prospective cohort phase will recruit approximately thirty additional patients. Results: Reliability will be quantified using Cohens kappa. A power calculation will be performed after pilot analysis. Results from the prospective cohort phase will help determine the association and predictive value of early ultrasound-detected bridging callus for radiographic and clinical union at three and six months. Patient reported outcome measures will be assessed using the Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) questionnaire. Discussion: This study will develop and validate a standardized ultrasound protocol for assessing early fracture healing in proximal humerus fractures. By establishing both inter-rater reliability and predictive value, the findings may support ultrasound as a reproducible, radiation-free adjunct to conventional imaging and enable earlier identification of union status.