Clinical Decision Rule for Excluding Shoulder Fractures
ConditionShoulder Fractures
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients aged 18 years or older presenting with acute shoulder trauma within 7 days of injury will be eligible for inclusion
Disqualifiers
None
Trial population
Adult patients aged 18 years or older presenting with acute shoulder trauma within 7 days of injury will be eligible for inclusion \- Patients with polytrauma, previous shoulder surgery, open fractures, or inability to cooperate with clinical assessment will be excluded.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
The SFER clinical decision rule
Diagnostic testAll 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
X - ray
Diagnostic testRadiographic 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.
Treatment groups
1,216 Participants
are divided into 1 treatment groupGroup A: Clinical Decision Rule2 interventions
Trial outcomes
Primary outcomes
1
Sensitivity
Time frame
through study completion, an average of 6 months2
Senstivity
Time frame
through study completion, an average of 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: