Evaluation of Personalized Biomechanical Models of the Musculoskeletal System Before and After Orthopedic Surgeries (OrthosimPro)

Centre d'Investigation Clinique et Technologique 805

Status: Unknown

Conditions: Orthopedic Disorder

Treatments: Other: imaging and motion analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT04668430

2019-A02124-53

Details and patient eligibility

About

Advances in biomechanical modeling of musculoskeletal systems make it possible to consider the use of a digital clone of a patient to test surgical procedure before carrying it out on the patient himself.

The study aims at evaluating the design and simulation procedure of anatomical and functional pre and post surgical patient-specific numerical models.

Full description

The general research framework is focused on predicting the functional outcome of orthopaedic surgery for a given patient.

Since surgery is an invasive and irreversible procedure, it may be useful to carry out surgical simulations on a digital clone before performing them on the real patient.

This simulation would therefore be a tool for optimized surgical planning, based on a realistic functional objective.

The investigators' work in the design and evaluation of biomechanical models is now applicable to orthopedic surgery.

So, it is necessary to verify that the digital procedures allowing the realization of virtual surgical gestures are comparable to the procedures actually applied to the patient.

Thus, a first retrospective study (Imaging for the generation of personalized biomechanical models of the musculoskeletal system before and after surgery - ORTHOSIM Retrospective) Clinical Trial N° NCT03835000, is in progress in order to validate the possibility of creating pre- and post-operative anatomical digital clones. The aim of this prospective study is to integrate the functional characteristics of the patient before and after surgery with the objective of dynamic validation of the biomechanical models created.

OrthosimPro is a bi-centric, longitudinal and prospective study.

10 patients needing orthopedic surgery will be enrolled after being informed about the study and potential risks. They will give written informed consent.

This study will not modify :

• the operative indication
• the surgical procedure
• the management before and after the surgery

Patients will have a pre and post operative assessment

• Anatomical by sectional imaging
• Functional by motion analysis

Thus, it allows creating 3 digital models for the same patient:

1. Creation of Model 1: preoperative dynamic model obtained from the anatomical and functional preoperative assessment.
2. Creation of Model 2: Model 1 to which the surgery is applied according to the criteria indicated by the surgeon.
3. Creation of Model 3: a dynamic postoperative model independent of Models 1 and 2 obtained from the anatomical and functional postoperative assessment.

Validation of each model:

Each model will be compared with the patient data used to build the model, there is no comparison of patients regarding each other or models belonging to different patients. This study therefore aims to validate an individual's model on his or her own data.

• Comparison of model 1 (angle, forces, geometry) versus morphological and functional assessment before surgery
• Comparison of model 3 (angle, forces, geometry) versus morphological and functional assessment after surgery

Evaluation the surgery simulation procedure:

Comparison of model 2 (angle, forces, geometry) versus model 3

Enrollment: 10 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• If women, menopausal or on contraception if of childbearing age
• Patients who will benefit from one of the orthopedic surgical procedures corresponding to the surgeries studied
• Patient who is a member of a social security organization
• Patient who has signed a written informed consent form

Exclusion criteria

• Patient refusal to participate in the study
• Minor,
• Patient under guardianship and / or curators,
• Patient unable to receive information and express consent
• Pregnant and/or breastfeeding women
• Contraindication to MRI (presence of ferromagnetic materials, neurosurgical clips, vascular, pacemaker).
• Non-affiliation to a social security scheme (beneficiary or entitled person)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

patients

Other group

Description:

Patients for whom orthopedic surgery is indicated and planned among : * Tibial valgus osteotomy * Supra-malleolar osteotomy * Hallux osteotomy for hallux valgus * Total knee arthroplasty * Total ankle arthroplasty * Ankle arthrodesis * Hallux arthrodesis * Rear foot torque arthrodesis * Inverted shoulder prosthesis * Anterior lumbar interbody arthrodesis

Treatment:

Other: imaging and motion analysis