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| Name | Class |
|---|---|
| Fondation Paul Bennetot | OTHER |
| Clinique les Maussins | UNKNOWN |
| Clinique Mutualiste de Lorient | UNKNOWN |
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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.
A observational, Prospective, non-randomized, multi-centric study. The main objective of this study will be to determine the diagnostic performance (sensitivity and specificity) of a functional score for the detection of a rupture of the knee ACL in the immediate post-traumatic period.
It will follow the methodology for the evaluation of a new diagnostic test according to the STARD (Standards for Reporting of Diagnostic Accuracy) checklist.
Phases of the study
For Phase 2, the workforce was calculated on sensitivity because it is important to detect LCA ruptures. To obtain a sensitivity of 98% with a 2% CI, and taking into account a 10% rate of incomplete records, 210 patients should be included.
For the inter-evaluative ancillary reproducibility study, to obtain a Pearson coefficient of 0.8 (strong correlation if coefficient greater than 0.5) with a confidence interval of 0.67 to 0.88 and a risk of first 60 patients should be included.
Statistical analysis
Phase 1:
Phase 2:
Inclusion procedure The study will target 380 patients seen in an emergency. After a knee sprain, patients usually go to hospital or a treatment center for medical consultation. For the study, patients will be recruited either in the emergency department if the investigating center has an emergency department or in the corresponding medical-surgical centers of the investigating center. Investigating surgeons at the centers should inform physicians of the initiation of the study and the modalities of implementation.
Usually, patients are received by an emergency physician, orthopedic surgeon on duty or a sports physician. A standard radiographic assessment will be performed to eliminate the presence of a bone fracture. If the patient meets the test selection criteria, he / she will be informed of the study and his / her right to oppose the collection of his / her medical data. The patient will ask all the questions necessary for his understanding before confirming his non-opposition. The questionnaire will then be completed by the physician with the patient. In the centers where the reproducibility study will be carried out, a second doctor will complete the questionnaire.
Once the consultation has been completed, the physician will issue prescriptions for the usual medical treatment, laximetry prescription (GNRB) to be performed between 3 to 6 weeks after the accident when the knee is indolent and the prescription of the MRI to be performed between 7 days and 1 month after the accident. 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 within 6 weeks of the accident.
During this delayed consultation, the orthopedic surgeon will realize in this patient the dynamic maneuvers of ligament testing. 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.
Ethical aspects Agreement will be sought from the local Ethics committee. All patients will be fully informed and will be provided with an information form. The data will be entered into an internet page and will be analysed anonymously.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| Between 7 days and 2 months after the accident. |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of differential laxity with GNRB | The GNRB will be performed when the knee is indolent | Between 3 to 8 weeks after the accident |
| Questionnaire of the score | This phase will quantify the weight of each item and sub-items of the questionnaire already conceived from a statistical analysis adapted and thus to give a value to each item then a maximum value to the score. |
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Inclusion Criteria:
Exclusion Criteria:
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The study will target patients seen in an emergency or hospital or a treatment center for medical consultation after a knee sprain.
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| Name | Affiliation | Role |
|---|---|---|
| Geoffroy NOURRISAT, PHD | Clinique des Maussins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pr François-Xavier GUNEPIN | Lorient | F-56100 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22210516 | Background | 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. | |
| 8881137 | 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. |
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In this study, the individual participant data (IPD) is not available to other researchers
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| ID | Term |
|---|---|
| D012421 | Rupture |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D005160 | Facility Design and Construction |
| ID | Term |
|---|---|
| D001108 | Architecture |
| D013676 | Technology, Industry, and Agriculture |
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |
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| At a day of patient inclusion |
| 37776951 | Derived | 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. |