3D Reconstruction of the Knee Based on MRI

NCT05912777 | Unknown

• 1 other identifier: 2023-A00531-44
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

ACL Tear

Outcome Measures

Primary Outcomes (2)

• Manual 3D knee reconstruction from MRI and scanner

  Mean IoU (Intersection-Over-Union metric)

  1 day

• Manual 3D knee reconstruction from MRI and scanner

  DICE coefficient

  1 day

Secondary Outcomes (2)

• Manual and AI 3D knee reconstruction from MRI

  1 day

• Manual and AI 3D knee reconstruction from MRI

  1 day

Study Arms (1)

Scanner Arm

EXPERIMENTAL

A scanner must be performed by Patients

Radiation: Scanner

Interventions

Scanner RADIATION

Scanner to be performed by patients

Scanner Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Bertrand SONNERY COTTET, MD

  GCS RAMSAY SANTE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertrand SONNERY COTTET, MD

CONTACT

+ 33 4 37 53 00 22; sonnerycottet@aol.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: September 13, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)