Clinical trial NCT04668430: Evaluation of Personalized Biomechanical Models of the Musculoskeletal System Before and After Orthopedic Surgeries
Official title: Imaging for the Generation of Personalized Biomechanical Models of the Musculoskeletal System Before and After Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthopedic Disorder
Keywords: computer simulation
orthopedic surgical procedures
Multimodal Imaging
gait analysis
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
Collaborators: name: Fondation Garches
First posted: 2020-12-16
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed 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

Eligibility criteria: 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)

Primary outcomes:
measure: Evaluation of simulated models regarding relative position of bones in static condition
timeFrame: 18 months
measure: Evaluation of simulated models regarding relative position of bones in dynamic condition: range of motion (ROM)
timeFrame: 18 months
measure: Evaluation of simulated models regarding forces
timeFrame: 18 months
measure: Evaluation of simulated models regarding moment
timeFrame: 18 months
measure: Evaluation of simulated models regarding pressure
timeFrame: 18 months
measure: comparison of post surgery changes in real and simulated results regarding bone dimension
timeFrame: 18 months
measure: comparison of post surgery changes in real and simulated results regarding bone torsion
timeFrame: 18 months
measure: comparison of post surgery changes in real and simulated results regarding bone axis
timeFrame: 18 months
measure: comparison of post surgery changes in real and simulated results regarding bone volume
timeFrame: 18 months
measure: comparison of post surgery changes in real and simulated results regarding relative position of bones in static condition
timeFrame: 18 months
measure: comparison of post surgery changes in real and simulated results regarding ROM's changes
timeFrame: 18 months
measure: comparison of post surgery changes in real and simulated results regarding moment changes
timeFrame: 18 months
measure: comparison of post surgery changes in real and simulated results regarding pressure changes
timeFrame: 18 months
Secondary outcomes:
measure: correlation of clinical scores and changes in function
timeFrame: 18 months
measure: Comparison of post surgery models between real and simulated surgery regarding bone dimension
timeFrame: 18 months
measure: Comparison of post surgery models between real and simulated surgery regarding bone torsion
timeFrame: 18 months
measure: Comparison of post surgery models between real and simulated surgery regarding bone axis
timeFrame: 18 months
measure: Comparison of post surgery models between real and simulated surgery regarding bone volume
timeFrame: 18 months
measure: Comparison of post surgery models between real and simulated surgery regarding point-to-surface distance of bone
timeFrame: 18 months
measure: Comparison of post surgery models between real and simulated surgery regarding relative position of bones in static condition
timeFrame: 18 months
measure: Comparison of post surgery models between real and simulated surgery regarding ROM's changes
timeFrame: 18 months
measure: Comparison of post surgery models between real and simulated surgery regarding ground reaction forces changes
timeFrame: 18 months
measure: Comparison of post surgery models between real and simulated surgery regarding moment changes
timeFrame: 18 months
measure: Comparison of post surgery models between real and simulated surgery regarding pressure changes
timeFrame: 18 months
measure: comparison of simulated joint force changes between Pre and post surgery models
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: laboratoire TIMC CNRS
name: Antoine M PERRIER, PHD
role: PRINCIPAL_INVESTIGATOR
References: