Clinical Screening of Acute Ruptures of the Anterior Cruciate Ligament of the Knee

NCT03113734 | Unknown

• 1 other identifier: SFA-ACL-TS 2015
• Study Type: observational
• Target: 355
• Locations: 1 country
• Sites: 1

Brief Summary

This study develops the construction and validation of a reliable functional screening score in LCA ruptures in the immediate post-traumatic period. This score, realizable in an emergency, would be an early warning signal requiring an emergency consultation with an orthopedic surgeon. It would be a tool for screening acute LCA ruptures at a time when ligament testing maneuvers are too painful to be contributory to the diagnosis. It would avoid a premature return to dangerous activity for the knee with a rupture of the LCA. The other impact would be economical since it would avoid the realization of unnecessary MRI. On the other hand, it will allow patients with LCA rupture to have faster access to MRI. The hypothesis of the study is that a validated functional score would make it possible to sort the patients in the emergencies and to prescribe the MRI only in the cases of effective rupture of the LCA.

Conditions

Orthopedic; Rupture

Outcome Measures

Primary Outcomes (1)

• Reference method or "gold standard"

  MRI will be used to determine whether the LCA is broken. The direct signs of complete LCA rupture are based on its morphological study, signal and spatial orientation. * In the acute phase, haemarthrosis secondary to rupture appears as a T1-weighted hyposignal and a proton-density and T2 -weight hyper-signal. In the subacute phase, the proximal and distal stump retract and remain separated by a proton density and T2-weighted signaling area. * AND / OR: Horizontalisation of the ACL, evaluated in relation to the plane of the tibial plateaus or the Blumensaat line, indicates the complete character of the ACL rupture with a sensitivity of 89% and a specificity of 100%. * AND / OR: The "sign of the empty notch" to be sought in the frontal and axial planes is pathognomonic of the complete rupture of the LCA at its high insertion. It is the most frequent form of rupture

  Between 7 days and 2 months after the accident.

Secondary Outcomes (2)

• Quantification of differential laxity with GNRB

  Between 3 to 8 weeks after the accident

• Questionnaire of the score

  At a day of patient inclusion

Interventions

Construction and validation of a functional score OTHER

All patients will be treated at the same way: Completion of questionnaire by the physician with him. Once the consultation has been completed, the physician will issue prescriptions for the usual medical treatment, laximetry prescription (GNRB) to be performed when the knee is indolent and the prescription of the MRI to be performed .The physician will inform the patient that they should consult with the investigator's orthopedic surgeon once the results of GNRB and MRI are available.The study will end there for the patient. The surgeon will then follow his usual diagnostic procedure to decide on the future care of the patient.

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study will target patients seen in an emergency or hospital or a treatment center for medical consultation after a knee sprain.

You may qualify if:

• Age of 18 to 55 years,
• Knee trauma occurred less than 9 days prior to hospital emergency visit or medical consultation,
• Absence of bone fractures on the standard radiographic assessment (face and profile),
• Patient affiliated to a social security scheme (beneficiary or beneficiary),
• Patient informed and confirmed his / her agreement to the study.

You may not qualify if:

• Severe knee trauma requiring immediate surgical management (fractures, dislocations)
• Traumatic history (including sprain) on the same or other knee
• Impossibility or refusal to do an MRI
• Inability to understand information delivered
• Patient's refusal
• Patients can not be tracked for geographical reasons

Sponsors & Collaborators

• French Arthroscopic Society: lead
• Fondation Paul Bennetot: collaborator
• Clinique les Maussins: collaborator
• Clinique Mutualiste de Lorient: collaborator

Study Sites (1)

Pr François-Xavier GUNEPIN

Lorient, F-56100, France

Location

Related Publications (3)

• Ahlden M, Hoshino Y, Samuelsson K, Araujo P, Musahl V, Karlsson J. Dynamic knee laxity measurement devices. Knee Surg Sports Traumatol Arthrosc. 2012 Apr;20(4):621-32. doi: 10.1007/s00167-011-1848-7. Epub 2011 Dec 31.

  PMID: 22210516 BACKGROUND

• Bollen SR, Scott BW. Rupture of the anterior cruciate ligament--a quiet epidemic? Injury. 1996 Jul;27(6):407-9. doi: 10.1016/0020-1383(96)00033-2.

  PMID: 8881137 BACKGROUND

• Gunepin FX, Letartre R, Mouton C, Guillemot P, Common H, Thoreux P, Di Francia R, Graveleau N; Francophone Arthroscopy Society (SFA). Construction and validation of a functional diagnostic score in anterior cruciate ligament ruptures of the knee in the immediate post-traumatic period. Preliminary results of a multicenter prospective study. Orthop Traumatol Surg Res. 2023 Dec;109(8S):103686. doi: 10.1016/j.otsr.2023.103686. Epub 2023 Sep 28.

  PMID: 37776951 DERIVED

MeSH Terms

Conditions

Rupture

Interventions

Facility Design and Construction

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Architecture; Technology, Industry, and Agriculture; Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Geoffroy NOURRISAT, PHD

  Clinique des Maussins

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2017
• First Posted: April 14, 2017
• Study Start: April 29, 2017
• Primary Completion: June 29, 2021
• Study Completion: August 29, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)