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NOT YET RECRUITING
NCT07564024

Clinical Decision Rule for Excluding Shoulder Fractures

Sponsor: Cairo University

View on ClinicalTrials.gov

Summary

Many patients with shoulder injuries undergo X-rays even when fractures are unlikely, leading to unnecessary costs and delays in care. This study aims to develop a simple and reliable clinical tool to help healthcare providers determine when imaging is not required. By evaluating this tool in a large number of patients, we aim to improve patient care, reduce waiting times, and optimize the use of healthcare resources.

Official title: Development and External Validation of a Clinical Decision Rule for Excluding Shoulder Fractures: A Prospective Multicentre Diagnostic Accuracy and Cost-Effectiveness Study (SFER Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

1216

Start Date

2026-07-01

Completion Date

2026-12-01

Last Updated

2026-05-04

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

The SFER clinical decision rule

All participants will undergo assessment using a structured clinical decision framework designed to stratify patients with acute shoulder trauma into high- and low-risk categories for fracture. In the initial stage, patients will be screened for high-risk features based on demographic factors, symptom severity, and mechanism of injury. Individuals meeting any high-risk criteria will be referred for immediate radiographic evaluation. Patients not classified as high-risk will proceed to a secondary functional assessment stage. This stage incorporates a series of standardized clinical tests evaluating range of motion, localized tenderness, functional loading capacity, and soft tissue signs. Fracture will be considered unlikely only when all functional criteria are within normal limits. Radiographic imaging will be indicated if any abnormal finding is identified during assessment. All variables will be predefined and recorded using standardized criteria to ensure reproducibility and minim

DIAGNOSTIC_TEST

X - ray

Radiographic imaging (X-ray) will be performed for all participants and will serve as the reference standard for fracture diagnosis. Radiographs will be interpreted by qualified radiologists who will be blinded to the results of the clinical assessment to reduce diagnostic bias.

Locations (1)

El - Helal Hospital

Cairo, Egypt