Clinical Decision Rule for Excluding Shoulder Fractures

NCT07564024 | Not Yet Recruiting DMC

• 1 other identifier: SFERStudy
• Study Type: observational
• Target: 1,216
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shoulder Fractures

Keywords

Validation; Clinical Decision Rule; Shoulder Fractures; Diagnostic Accurac; and Cost-Effectiveness

Outcome Measures

Primary Outcomes (2)

• Sensitivity

  through study completion, an average of 6 months

• Senstivity

  through study completion, an average of 6 months

Study Arms (1)

Clinical Decision Rule

All participants will undergo standardized assessment using the SFER clinical decision rule

Diagnostic Test: The SFER clinical decision rule; Diagnostic Test: X - ray

Interventions

The SFER clinical decision rule DIAGNOSTIC_TEST

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

Clinical Decision Rule

X - ray DIAGNOSTIC_TEST

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.

Clinical Decision Rule

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may not qualify if:

• \- Patients with polytrauma, previous shoulder surgery, open fractures, or inability to cooperate with clinical assessment will be excluded.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

El - Helal Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Shoulder Fractures

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Ahmed Samir, BPT

CONTACT

+201158440335; dr.ahmedsamer@icloud.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research Unit

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: May 4, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)