ClinicalTrials.gg
CompletedNCT06960681SCORESFAUpdated May 13, 2025

Evaluation of the External Validity of the Knee SFA Score

An observational study in Reliability in the Detection of ACL Injuries in Emergency Departments, sponsored by University Hospital, Rouen. Completed at 3 sites in France. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-05-13.

Sponsored by University Hospital, Rouen · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
150
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Reliability in the Detection of ACL Injuries in Emergency Departments

Keywords

  • ACL (anterior cruciate ligament)
03

In context

Lead sponsor

University Hospital, Rouen is the lead sponsor of 417 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
150 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testExternal validity of the SFA score

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

06

What researchers measure

Primary outcomes

  1. External validity of the SFA score

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

    Time frame: At enrollment visit, Month 1

Secondary outcomes

  1. Sensitivity of the different score items (EVA > 6)

    Analyse the sensitivity of the EVA score for screening for ACL injuries (EVA \> 6)

    Time frame: At enrollment visit, Month 1

  2. 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)

    Time frame: At enrollment visit, Month 1

  3. Sensitivity of the different score items (Cracking ≥ 1)

    Analyse the sensitivity of the Cracking score for screening for ACL injuries (Cracking ≥ 1)

    Time frame: At enrollment visit, Month 1

  4. Sensitivity of the different score items (Instability ≥ 1)

    Analyse the sensitivity of the Instability score for screening for ACL injuries (Instability ≥ 1)

    Time frame: At enrollment visit, Month 1

  5. 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)

    Time frame: At enrollment visit, Month 1

  6. Specificity of the different score items (EVA > 6)

    Analyse the Specificity of the EVA score for screening for ACL injuries (EVA \> 6)

    Time frame: At enrollment visit, Month 1

  7. 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)

    Time frame: At enrollment visit, Month 1

  8. Specificity of the different score items (Cracking ≥ 1)

    Analyse the Specificity of the Cracking score for screening for ACL injuries (Cracking ≥ 1)

    Time frame: At enrollment visit, Month 1

  9. Specificity of the different score items (Instability ≥ 1)

    Analyse the Specificity of the Instability score for screening for ACL injuries (Instability ≥ 1)

    Time frame: At enrollment visit, Month 1

  10. 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)

    Time frame: At enrollment visit, Month 1

07

Study locations

3 sites
  • Groupe Hospitalier du Havre J. Monod
    Montivilliers, 76290, France
  • University Rouen Hospital
    Rouen, 76100, France
  • University Hospital of Toulouse
    Toulouse, 31300, France
08

References and documents

Individual participant data

Plan to share: No — The data provided will be the property of the sponsor and will be used solely for its own research activities.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2024 to primary completion in Mar 2024, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2025
First posted
May 7, 2025
StartActual
Feb 20, 2024
Primary completionActual
Mar 20, 2024
CompletionActual
Jul 1, 2024
Last update
May 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06960681
Responsible party
Sponsor
First posted
May 7, 2025
Start date
Feb 20, 2024
Primary completion
Mar 20, 2024
Completion
Jul 1, 2024
Last update
May 13, 2025

Study contacts

Jonathan JC CURADO, Doctor
study director · Service de Chirurgie Orthopédique et Traumatologie, UH Rouen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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