Shoulder FracturesSFERNCT07564024
Clinical Decision Rule for Excluding Shoulder Fractures
An observational study of Shoulder Fractures, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Fractures
- What is being tested?
- The SFER clinical decision rule and X - ray
- How many people
- 1,216 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2026to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients aged 18 years or older presenting with acute shoulder trauma within 7 days of injury will be eligible for inclusion
Who cannot join
- Patients with polytrauma, previous shoulder surgery, open fractures, or inability to cooperate with clinical assessment will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
El - Helal Hospital
Cairo
Ahmed Samir, BPT, 201158440335, dr.ahmedsamer@icloud.com
About this study
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)
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.
Read the detailed description
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.
- Conditions
- Shoulder Fractures
- Being tested
- The SFER clinical decision rule, X - ray
- Keywords
- Validation, Clinical Decision Rule, Shoulder Fractures, Diagnostic Accurac, and Cost-Effectiveness
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The SFER clinical decision ruleDiagnostic 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
X - rayDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Decision Rule | All participants will undergo standardized assessment using the SFER clinical decision rule Receives: Diagnostic Test: The SFER clinical decision rule; Diagnostic Test: X - ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Measured: through study completion, an average of 6 months
Senstivity
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder FracturesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samir, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564024
- Sponsor's protocol ID
- SFERStudy
- Acronym
- SFER
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07564024
- Acronym / sponsor ID
- SFER / SFERStudy
- Conditions
- Shoulder Fractures
- Keywords
- Validation, Clinical Decision Rule, Shoulder Fractures, Diagnostic Accurac, and Cost-Effectiveness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,216 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical Decision Rule | – | Diagnostic Test: The SFER clinical decision rule, Diagnostic Test: X - rayAll participants will undergo standardized assessment using the SFER clinical decision rule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients aged 18 years or older presenting with acute shoulder trauma within 7 days of injury will be eligible for inclusion
Key exclusion criteria (1 listed)
- Patients with polytrauma, previous shoulder surgery, open fractures, or inability to cooperate with clinical assessment will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The SFER clinical decision ruleAll 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 | Clinical Decision Rule |
| X - rayRadiographic 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. | Diagnostic test | Clinical Decision Rule |
Primary outcome
Sensitivity
Time frame: through study completion, an average of 6 months
Senstivity
Time frame: through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
Related trials for Shoulder Fractures
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruitingObservational study
Outcomes of Arthroscopic Dynamic Anterior Stabilization With and Without Remplissage
Anterior Shoulder Instability
Not yet recruiting
Study on Outcomes of Proximal Humerus Fractures
Proximal Humerus Fracture
Recruiting
Comparison of Surgical Techniques for Anterior Shoulder Instability
Surgeons, Shoulder Instability
Enrolling by invitationObservational study
OsseoFit Stemless Shoulder System (Anatomic)
Shoulder Injuries, Shoulder Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Fractures, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Samir, BPT (+201158440335, dr.ahmedsamer@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: through study completion, an average of 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.