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

Ligament Plastic Surgery Clinical Trial

— LIGANALYS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04361201
• Other study ID #: APHP200788
• Secondary ID: 2020-A01317-32
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: March 30, 2022

Study information

• Verified date: April 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ligament Plastic Surgery

Intervention

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.

Locations

Country	Name	City	State
France	Orthopaedic Surgery Department, Ambroise Paré hospital, APHP	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

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