Clinical Decision Rule for Excluding Shoulder Fractures

Официальное название

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

Обзор

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.

Подробное описание

Abstract Shoulder trauma is a common presentation in orthopedic and emergency settings and frequently leads to routine radiographic imaging despite a relatively low prevalence of fractures. This practice contributes to increased healthcare costs, unnecessary radiation exposure, and inefficiencies in patient flow. Currently, no validated clinical decision rule exists to safely exclude shoulder fractures. We will conduct a prospective, multicentre diagnostic accuracy study in a high-volume orthopedic setting, enrolling approximately 1200 adult patients presenting with acute shoulder trauma. The study will include derivation and external validation cohorts. All participants will undergo standardized clinical assessment using the SFER clinical decision rule, followed by radiographic imaging as the reference standard. The primary outcome is sensitivity for fracture detection, with secondary outcomes including specificity, negative predictive value, reduction in imaging rates, missed fracture rate, inter-rater reliability, and cost-effectiveness. We hypothesize that the SFER rule will achieve sensitivity ≥95% with a missed fracture rate \<1%, enabling safe reduction of unnecessary imaging and improving clinical efficiency.

Вмешательства

• Диагностический тест 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 second
• Диагностический тест 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.

Первичные конечные точки

• Sensitivity [Срок оценки: through study completion, an average of 6 months]
• Senstivity [Срок оценки: through study completion, an average of 6 months]

Критерии участия

Критерии включения

• Adult patients aged 18 years or older presenting with acute shoulder trauma within 7 days of injury will be eligible for inclusion

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Египет · 1 центр

• El - Helal Hospital — Cairo

Идентификаторы

NCT: NCT07564024 · SFERStudy

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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