Clinical trial NCT06960681: Evaluation of the External Validity of the Knee SFA Score
Official title: Evaluation of the External Validity of the Knee SFA Score for the Detection of LCA Lesions in Emergency Departments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reliability in the Detection of ACL Injuries in Emergency Departments
Keywords: ACL (anterior cruciate ligament)
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: External validity of the SFA score
timeFrame: At enrollment visit, Month 1
Secondary outcomes:
measure: Sensitivity of the different score items (EVA > 6)
timeFrame: At enrollment visit, Month 1
measure: Sensitivity of the different score items (functional impotence > 1)
timeFrame: At enrollment visit, Month 1
measure: Sensitivity of the different score items (Cracking ≥ 1)
timeFrame: At enrollment visit, Month 1
measure: Sensitivity of the different score items (Instability ≥ 1)
timeFrame: At enrollment visit, Month 1
measure: Sensitivity of the different score items (Presence of an effusion)
timeFrame: At enrollment visit, Month 1
measure: Specificity of the different score items (EVA > 6)
timeFrame: At enrollment visit, Month 1
measure: Specificity of the different score items (functional impotence > 1)
timeFrame: At enrollment visit, Month 1
measure: Specificity of the different score items (Cracking ≥ 1)
timeFrame: At enrollment visit, Month 1
measure: Specificity of the different score items (Instability ≥ 1)
timeFrame: At enrollment visit, Month 1
measure: Specificity of the different score items (Presence of an effusion)
timeFrame: At enrollment visit, Month 1
Other outcomes:
Locations:
city: Montivilliers
country: France
facility: Groupe Hospitalier du Havre J. Monod
city: Rouen
country: France
facility: University Rouen Hospital
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: Service de Chirurgie Orthopédique et Traumatologie, UH Rouen
name: Jonathan JC CURADO, Doctor
role: STUDY_DIRECTOR
References: