Reliability in the Detection of ACL Injuries in Emergency DepartmentsSCORESFANCT06960681
Evaluation of the External Validity of the Knee SFA Score
An observational study of Reliability in the Detection of ACL Injuries in Emergency Departments, run by University Hospital, Rouen at 3 sites in France.
Trial summary
A screening score for ACL (anterior cruciate ligament) injuries based on questioning has been developed by the Société Francophone d'Arthroscopie to provide better guidance for post-trauma patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Reliability in the Detection of ACL Injuries in Emergency Departments
- What is being tested?
- External validity of the SFA score
- How many people
- 150 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Feb 2024to 1 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patient with a rupture of the anterior cruciate ligament (ACL) diagnosed during a follow-up visit to the emergency department (diagnosed on clinical examination and/or MRI) and with a score ≥ 8.
Who may be able to join
- All patients presenting to adult emergency departments with knee trauma less than 9 days old;
- All patients aged between 18 and 55;
- All patients without an X-ray fracture (with the exception of indirect signs of injury to the central pivot: Segond's fracture and avulsion of the tibial spines);
- All patients affiliated to or benefiting from a social security scheme;
- All patients who have given their and who have received a study information sheet.
Who cannot join
- Trauma requiring immediate surgical treatment (fracture, dislocation);
- Previous osteoarticular trauma to the knee;
- Pregnant women;
- Impossible to carry out an MRI (contraindication, refusal, claustrophobia);
- Impossible to provide follow-up in the same centre;
- Protected patients: adults under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Groupe Hospitalier du Havre J. Monod
Montivilliers, 76290
University Rouen Hospital
Rouen, 76100
University Hospital of Toulouse
Toulouse, 31300
About this study
Official title: Evaluation of the External Validity of the Knee SFA Score for the Detection of LCA Lesions in Emergency Departments
A screening score for ACL (anterior cruciate ligament) injuries based on questioning has been developed by the Société Francophone d'Arthroscopie to provide better guidance for post-trauma patients. The score differentiates between 3 groups of patients: mild trauma (score 1 to 4), intermediate trauma (score 5 to 7) and severe trauma (score 8 to 12).
The main hypothesis of this study is that it is a reliable score for detecting ACL injuries in emergency departments.
Read the detailed description
Injury to the anterior cruciate ligament is a serious and not uncommon event, which can affect the functional future of the knee. The result is instability, leading to meniscal and osteo-cartilaginous damage in the medium and long term. Early diagnosis would limit the occurrence of these complications.
The average annual incidence of ACL rupture in the French population is estimated at around population can be estimated at around 0.03%, or approximately 20,000 cases per year. Diagnosis is currently based on clinical examination and dynamic ligament testing. However, these may be difficult to perform in the immediate post-trauma period, leading to a delay in diagnosis. Magnetic resonance imaging (MRI) is a good diagnostic tool, with a sensitivity of 83-95% and a specificity of 95-100%. However, access to MRI is still limited in emergencies, with an average appointment time (all indications combined) of 32.3 days. It is therefore to better target the indications for this examination.
The Société Francophone d'Arthroscopie has developed a screening score for ACL lesions, based on questioning, to help guide post-trauma patients.
- Being tested
- External validity of the SFA score
- Keywords
- ACL (anterior cruciate ligament)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External validity of the SFA scoreDiagnostic test
Testing the external validity of the SFA score for the detection of in adult emergency departments
What is being measured
The primary outcome is the main question the study is designed to answer.
External validity of the SFA score
Testing the external validity of the SFA score for the detection of in adult emergency departments
Measured: At enrollment visit, Month 1
Secondary outcomes (10)
Sensitivity of the different score items (EVA > 6)
Analyse the sensitivity of the EVA score for screening for ACL injuries (EVA > 6)
Measured: At enrollment visit, Month 1
Sensitivity of the different score items (functional impotence > 1)
Analyse the sensitivity of the functional impotence score for screening for ACL injuries (functional impotence > 1)
Measured: At enrollment visit, Month 1
Sensitivity of the different score items (Cracking ≥ 1)
Analyse the sensitivity of the Cracking score for screening for ACL injuries (Cracking ≥ 1)
Measured: At enrollment visit, Month 1
Sensitivity of the different score items (Instability ≥ 1)
Analyse the sensitivity of the Instability score for screening for ACL injuries (Instability ≥ 1)
Measured: At enrollment visit, Month 1
Sensitivity of the different score items (Presence of an effusion)
Analyse the sensitivity of the effusion score for screening for ACL injuries (Presence of an effusion)
Measured: At enrollment visit, Month 1
Specificity of the different score items (EVA > 6)
Analyse the Specificity of the EVA score for screening for ACL injuries (EVA > 6)
Measured: At enrollment visit, Month 1
Specificity of the different score items (functional impotence > 1)
Analyse the Specificity of the functional impotence score for screening for ACL injuries (functional impotence > 1)
Measured: At enrollment visit, Month 1
Specificity of the different score items (Cracking ≥ 1)
Analyse the Specificity of the Cracking score for screening for ACL injuries (Cracking ≥ 1)
Measured: At enrollment visit, Month 1
Specificity of the different score items (Instability ≥ 1)
Analyse the Specificity of the Instability score for screening for ACL injuries (Instability ≥ 1)
Measured: At enrollment visit, Month 1
Specificity of the different score items (Presence of an effusion)
Analyse the Specificity of the effusion score for screening for ACL injuries (Presence of an effusion)
Measured: At enrollment visit, Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start20 Feb 2024
- Primary completion20 Mar 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reliability in the Detection of ACL Injuries in Emergency DepartmentsStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan JC CURADO, Doctor, Study director, Service de Chirurgie Orthopédique et Traumatologie, UH Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960681
- Sponsor's protocol ID
- 2024/0102/OB
- Other IDs
- IDRCB 2023-A02760-45
- Acronym
- SCORESFA
- Status last verified
- Jan 2025
- First submitted
- 28 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the External Validity of the Knee SFA Score for the Detection of LCA Lesions in Emergency Departments
- ClinicalTrials.gov ID
- NCT06960681
- Acronym / sponsor ID
- SCORESFA / 2024/0102/OB
- Keywords
- ACL (anterior cruciate ligament)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 7 May 2025 (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.
A screening score for ACL (anterior cruciate ligament) injuries based on questioning has been developed by the Société Francophone d'Arthroscopie to provide better guidance for post-trauma patients. The score differentiates between 3 groups of patients: mild trauma (score 1 to 4), intermediate trauma (score 5 to 7) and severe trauma (score 8 to 12).
The main hypothesis of this study is that it is a reliable score for detecting ACL injuries in emergency departments.
Detailed description
Injury to the anterior cruciate ligament is a serious and not uncommon event, which can affect the functional future of the knee. The result is instability, leading to meniscal and osteo-cartilaginous damage in the medium and long term. Early diagnosis would limit the occurrence of these complications.
The average annual incidence of ACL rupture in the French population is estimated at around population can be estimated at around 0.03%, or approximately 20,000 cases per year. Diagnosis is currently based on clinical examination and dynamic ligament testing. However, these may be difficult to perform in the immediate post-trauma period, leading to a delay in diagnosis. Magnetic resonance imaging (MRI) is a good diagnostic tool, with a sensitivity of 83-95% and a specificity of 95-100%. However, access to MRI is still limited in emergencies, with an average appointment time (all indications combined) of 32.3 days. It is therefore to better target the indications for this examination.
The Société Francophone d'Arthroscopie has developed a screening score for ACL lesions, based on questioning, to help guide post-trauma patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient with a rupture of the anterior cruciate ligament (ACL) diagnosed during a follow-up visit to the emergency department (diagnosed on clinical examination and/or MRI) and with a score ≥ 8.
Key inclusion criteria (5 listed)
- All patients presenting to adult emergency departments with knee trauma less than 9 days old;
- All patients aged between 18 and 55;
- All patients without an X-ray fracture (with the exception of indirect signs of injury to the central pivot: Segond's fracture and avulsion of the tibial spines);
- All patients affiliated to or benefiting from a social security scheme;
- All patients who have given their and who have received a study information sheet.
Key exclusion criteria (6 listed)
- Trauma requiring immediate surgical treatment (fracture, dislocation);
- Previous osteoarticular trauma to the knee;
- Pregnant women;
- Impossible to carry out an MRI (contraindication, refusal, claustrophobia);
- Impossible to provide follow-up in the same centre;
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 |
|---|---|---|
| External validity of the SFA scoreTesting the external validity of the SFA score for the detection of in adult emergency departments | Diagnostic test | – |
Primary outcome
External validity of the SFA score
Time frame: At enrollment visit, Month 1
Testing the external validity of the SFA score for the detection of in adult emergency departments
10 secondary outcomes
Sensitivity of the different score items (EVA > 6)
Time frame: At enrollment visit, Month 1
Sensitivity of the different score items (functional impotence > 1)
Time frame: At enrollment visit, Month 1
Sensitivity of the different score items (Cracking ≥ 1)
Time frame: At enrollment visit, Month 1
Sensitivity of the different score items (Instability ≥ 1)
Time frame: At enrollment visit, Month 1
Sensitivity of the different score items (Presence of an effusion)
Time frame: At enrollment visit, Month 1
Specificity of the different score items (EVA > 6)
Time frame: At enrollment visit, Month 1
Specificity of the different score items (functional impotence > 1)
Time frame: At enrollment visit, Month 1
Specificity of the different score items (Cracking ≥ 1)
Time frame: At enrollment visit, Month 1
Specificity of the different score items (Instability ≥ 1)
Time frame: At enrollment visit, Month 1
Specificity of the different score items (Presence of an effusion)
Time frame: At enrollment visit, Month 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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. This study is not recruiting at the moment.
Jonathan JC CURADO, Doctor study director
Service de Chirurgie Orthopédique et Traumatologie, UH Rouen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reliability in the Detection of ACL Injuries in Emergency Departments, run by University Hospital, Rouen at 3 sites in France.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
External validity of the SFA score (time frame: At enrollment visit, Month 1). 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 13 May 2025.