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

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.

Study Overview

• Status: Completed
• Conditions: Ligament Plastic Surgery
• Intervention / Treatment: Procedure: Ligament plastic surgery; Diagnostic test: RMI and ultrasound

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• France
  • Boulogne-Billancourt, France, 92100
    • Orthopaedic Surgery Department, Ambroise Paré hospital, APHP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients underwent a ligament plastic surgery of lateral ankle plane under arthroscopy.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Alexandre HARDY, MD, Orthopaedic Surgery Department, Ambroise Paré hospital, APHP; Study Director: Thomas BAUER, MD, Orthopaedic Surgery Department, Ambroise Paré hospital, APHP

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): March 30, 2022

Study Registration Dates

• First Submitted: April 20, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: ligament injury; ligamentization
• Other Study ID Numbers: APHP200788; 2020-A01317-32 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No