3D Reconstruction of the Knee Based on MRI

NCT ID: NCT05912777

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-13
• Study Completion Date: 2024-05-31

Brief Summary

ACL tear is a pathology of the knee quite common in athletes mainly caused by a twisting movement. The diagnosis of ACL tear can be confirmed by MRI (magnetic resonance imaging). This method makes it possible to visualize the inside of the knee and to diagnose lesions associated with rupture of the ACL (in particular meniscal lesions).

Obtaining a 3D model of patients' joints from a imaging is of growing interest to plan the gesture in preoperative but also to evaluate this gesture postoperatively. In orthopedic surgery, the baseline preoperative imaging is MRI. However, 3D models are generally obtained from a scanner-like imaging.

In this context, obtaining a 3D model from MRI imaging would make it possible to have a model that fits into the care pathway patients, without subjecting them to irradiation and visualizing anatomical structures not visible on CT.

However, the geometric precision and the reproducibility of the 3D reconstructions of joints reconstructed from an MRI remains unknown and must be evaluated to consider their clinical use.

Detailed Description

Rupture of the anterior cruciate ligament (ACL) is a pathology of the knee quite common in athletes. The main cause of an ACL tear is, in the majority of cases, an indirect trauma, caused by a twisting movement (example: the foot remains blocked on the ground while the knee rotates in or out).

Sometimes the clinical examination of the ACL tear may not be conclusive.This is usually the case when the patient's knee swelling is too large and that clinical tests are then difficult to carry out. The diagnosis of ACL tear can therefore be confirmed by MRI (magnetic resonance imaging). This method makes it possible to visualize the inside of the knee. In addition, the realization of the MRI will also help to diagnose lesions associated with rupture of the ACL and in particular meniscal lesions. This exam has become indispensable and is carried out in the vast majority of cases.

Obtaining a 3D model of patients' joints from a imaging is of growing interest. These 3D models allow particular to plan the gesture in preoperative but also to evaluate this gesture postoperatively. In orthopedic surgery, for patients suffering from an ACL tear, the baseline preoperative imaging is MRI. However, 3D models are generally obtained from a scanner-like imaging. This imagery has the advantage of presenting a very good definition of bone tissue but it is not part, for a large number of patients, routine preoperative imaging. It is irradiating and does not allow easy highlighting of other structures such as cartilage or menisci.

In this context, obtaining a 3D model from MRI imaging would make it possible to have a model that fits into the care pathway patients, without subjecting them to irradiation and visualizing anatomical structures not visible on CT.

However, the geometric precision and the reproducibility of the 3D reconstructions of joints reconstructed from an MRI remains unknown and must be evaluated to consider their clinical use. This is the purpose of this research.

Conditions

ACL Tear

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Scanner Arm

A scanner must be performed by Patients

Group Type: EXPERIMENTAL

Scanner

Intervention Type: RADIATION

Scanner to be performed by patients

Interventions

Scanner

Scanner to be performed by patients

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Patient, male or female, aged between ≥ 18 and ≤ 45 years old
• Patient eligible for ACL reconstruction
• Patient with an MRI performed at the SANTY orthopedic center or according to the protocol defined by the radiologists of the orthopedic center SANTY
• Patient with an MRI performed ≥ 3 weeks after ACL tear
• Affiliated patient or beneficiary of a social security scheme
• French-speaking patient who signed an informed consent

Exclusion Criteria

• Patient with a surgical history on the affected knee
• Patient with a multi-ligament lesion
• Patient already included in another study
• Protected patient: adult under guardianship, curatorship or other protection legal, deprived of liberty by judicial or administrative decision
• Patient hospitalized without consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bertrand SONNERY COTTET, MD

Role: PRINCIPAL_INVESTIGATOR

GCS RAMSAY SANTE

Locations

Hôpital Privé Jean Mermoz

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Bertrand SONNERY COTTET, MD

Role: CONTACT

sonnerycottet@aol.com

+ 33 4 37 53 00 22

Facility Contacts

Bertrand SONNERY COTTET, MD

Role: primary

sonnerycottet@aol.com

+33437530022

Other Identifiers

2023-A00531-44

Identifier Type: -

Identifier Source: org_study_id