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

NCT ID: NCT04361201

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2022-03-30

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.

Conditions

Ligament Plastic Surgery

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Ligament plastic surgery ankle

Patient treated priorly by ligament plastic surgery of lateral ankle plane under arthroscopy

Ligament plastic surgery

Intervention Type: PROCEDURE

Ligament plastic surgery of ankle under arthroscopy for recurrent instable ankle reason and failure of medical treatment.

RMI and ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Ligament plastic surgery

Intervention Type: PROCEDURE

Ligament plastic surgery of ankle under arthroscopy for recurrent instable ankle reason and failure of medical treatment.

RMI and ultrasound

Intervention Type: DIAGNOSTIC_TEST

RMI examination at 3 months on operated ankle, and 3 CT scan examinations with elastography module will be performed at planned timeframes.

Interventions

Ligament plastic surgery

Ligament plastic surgery of ankle under arthroscopy for recurrent instable ankle reason and failure of medical treatment.

Intervention Type: PROCEDURE

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre HARDY, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Surgery Department, Ambroise Paré hospital, APHP

Thomas BAUER, MD

Role: STUDY_DIRECTOR

Orthopaedic Surgery Department, Ambroise Paré hospital, APHP

Locations

Orthopaedic Surgery Department, Ambroise Paré hospital, APHP

Boulogne-Billancourt, , France

Countries

France

Other Identifiers

2020-A01317-32

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP200788

Identifier Type: -

Identifier Source: org_study_id