Analysis of the Ligamentization Process in the Anatomical Ligamentoplasty of the Lateral Ankle Plane to the Hamstrings

Study Overview
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Brief Summary
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This is a prospective bi-centric study, which evaluate the evolution of RMI signal of transplant till 12 months after ligament plasty surgery. As the primary objective, the study aims to define the post-operative timeframe needed to obtain an optimal quality of repair, especially in their restarting of sportive activities, by analysis of RMI signal and biomechanic features modifications. As secondary objectives, the study aims to: study the correlation between the RMI signal of plasty and the Young's modulus; study the evolution of RMI of plasty at M3, M6 and M12; study the evolution of Young's modulus at M3, M6 and M12; evaluate the reproductibility between 2 lector of RMI measurements; evaluate the reproductibility between 2 lector of elastography measurements of LTFA; evaluate the optimal delay of return to sport after ligament plasty surgery of ankle; develope a score of type SNQ for ankle ligament plasty surgery; evolution of AOFAS and EVA scores.

Detailed Description
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The eligible patients will be enrolled in the department of orthopaedic surgery of Ambroise Paré hospital, each patient will undergo a 12-months follow-up in the department of orthopaedic surgery in Armand Trousseau hospital for the elastography evaluations.

Official Title
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Analysis of the Ligamentization Process in the Anatomical Ligamentoplasty of the Lateral Ankle Plane to the Hamstrings

Conditions
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Ligament Plastic Surgery

Intervention / Treatment
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* Procedure: Ligament plastic surgery
* Diagnostic Test: RMI and ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient treated priorly by ligament plastic surgery of lateral ankle plane under arthroscopy; Affiliated to or covered by the French social security - welfare system in France; Have provided written informed consent for the study; Be >/= 18 years of age on day of signing informed consent. Exclusion Criteria: Patients who undergo iterative surgery or have history of contralateral surgery; Patient under guardianship or curatorship; Unable to understand the proposed study or provide written informed consent for the study; Foreign patients under AME schema, a medical help from the state in France; Pregnant or breastfeeding woman; Patient refusal.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ligament plastic surgery ankle<br>Patient treated priorly by ligament plastic surgery of lateral ankle plane under arthroscopy | Procedure: Ligament plastic surgery<br>* Ligament plastic surgery of ankle under arthroscopy for recurrent instable ankle reason and failure of medical treatment.<br>Diagnostic Test: RMI and ultrasound<br>* RMI examination at 3 months on operated ankle, and 3 CT scan examinations with elastography module will be performed at planned timeframes.<br>|
| Control group<br>Controlateral ankle | Procedure: Ligament plastic surgery<br>* Ligament plastic surgery of ankle under arthroscopy for recurrent instable ankle reason and failure of medical treatment.<br>Diagnostic Test: RMI and ultrasound<br>* RMI examination at 3 months on operated ankle, and 3 CT scan examinations with elastography module will be performed at planned timeframes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Classification of RMI signal | The classification of RMI signal will be defined as: frank hyposignal: stage 1; intermediary signal (close to muscles of T2): stage 2; moderate hypersignal (close to cartilage of T2): stage 3; intensive hypersignal (close tointra-articular liquid of T2): stage 4. | At 3 months | 
| Classification of RMI signal | The classification of RMI signal will be defined as: frank hyposignal: stage 1; intermediary signal (close to muscles of T2): stage 2; moderate hypersignal (close to cartilage of T2): stage 3; intensive hypersignal (close tointra-articular liquid of T2): stage 4. | At 6 months | 
| Classification of RMI signal | The classification of RMI signal will be defined as: frank hyposignal: stage 1; intermediary signal (close to muscles of T2): stage 2; moderate hypersignal (close to cartilage of T2): stage 3; intensive hypersignal (close tointra-articular liquid of T2): stage 4. | At 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior talofibular ligament measurement | anterior talofibular ligament measurement will be performed by RMI | At 3, 6 and 12 months | 
| Calcaneofibular ligament measurement | calcaneofibular ligament measurement will be performed by RMI | At 3, 6 and 12 months | 
| Elastography | Elastography measurements: Young's Modulu | At 3, 6 and 12 months | 
| Pain evaluation | By the American Orthopedic Foot and Ankle Score (AOFAS) to evaluate the pain. | At baseline and 3, 6 and 12 months | 
| Pain evaluation | By the visual analog scale (VAS) to evaluate the pain. | At baseline and 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ligament injury, ligamentization