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

NCT04361201 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-03-16

No results posted yet for this study

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.

Conditions

  • Ligament Plastic Surgery

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Alexandre HARDY, MD · Orthopaedic Surgery Department, Ambroise Paré hospital, APHP

  • Thomas BAUER, MD · Orthopaedic Surgery Department, Ambroise Paré hospital, APHP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-03-30
Completion
2022-03-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04361201 on ClinicalTrials.gov