Analysis of the Ligamentization Process in the Anatomical Ligamentoplasty of the Lateral Ankle Plane to the Hamstrings
- Conditions
- Ligament Plastic Surgery
- Interventions
- Procedure: Ligament plastic surgeryDiagnostic Test: RMI and ultrasound
- Registration Number
- NCT04361201
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control group Ligament plastic surgery Controlateral ankle Ligament plastic surgery ankle Ligament plastic surgery Patient treated priorly by ligament plastic surgery of lateral ankle plane under arthroscopy Control group RMI and ultrasound Controlateral ankle Ligament plastic surgery ankle RMI and ultrasound Patient treated priorly by ligament plastic surgery of lateral ankle plane under arthroscopy
- Primary Outcome Measures
Name Time Method Classification of RMI signal At 12 months 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.
- Secondary Outcome Measures
Name Time Method Anterior talofibular ligament measurement At 3, 6 and 12 months anterior talofibular ligament measurement will be performed by RMI
Elastography At 3, 6 and 12 months Elastography measurements: Young's Modulu
Calcaneofibular ligament measurement At 3, 6 and 12 months calcaneofibular ligament measurement will be performed by RMI
Pain evaluation At baseline and 3, 6 and 12 months By the visual analog scale (VAS) to evaluate the pain.
Trial Locations
- Locations (1)
Orthopaedic Surgery Department, Ambroise Paré hospital, APHP
🇫🇷Boulogne-Billancourt, France