Evaluation of the External Validity of the Knee SFA Score

NCT ID: NCT06960681

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2024-07-01

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.

Conditions

Reliability in the Detection of ACL Injuries in Emergency Departments

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

External validity of the SFA score

Testing the external validity of the SFA score for the detection of in adult emergency departments

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan JC CURADO, Doctor

Role: STUDY_DIRECTOR

Service de Chirurgie Orthopédique et Traumatologie, UH Rouen

Locations

Groupe Hospitalier du Havre J. Monod

Montivilliers, , France

University Rouen Hospital

Rouen, , France

University Hospital of Toulouse

Toulouse, , France

Countries

France

Other Identifiers

IDRCB 2023-A02760-45

Identifier Type: OTHER

Identifier Source: secondary_id

2024/0102/OB

Identifier Type: -

Identifier Source: org_study_id