Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
TERMINATED
NCT04361201

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2021-02-01

Completion Date

2022-03-30

Last Updated

2026-07-16

Healthy Volunteers

No

Interventions

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 (1)

Orthopaedic Surgery Department, Ambroise Paré hospital, APHP

Boulogne-Billancourt, France