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| Name | Class |
|---|---|
| Fondation Garches | OTHER |
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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.
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 :
Patients will have a pre and post operative assessment
Thus, it allows creating 3 digital models for the same patient:
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.
Evaluation the surgery simulation procedure:
Comparison of model 2 (angle, forces, geometry) versus model 3
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients | Other | Patients for whom orthopedic surgery is indicated and planned among :
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imaging and motion analysis | Other | performing a set of imaging and motion analysis tests before and after orthopedic surgery without modifying the operative indication or the pre- and post-operative management. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of simulated models regarding relative position of bones in static condition | comparison between real data (from imaging) vs simulated data regarding relative position of bones defining a joint: angles between mechanical bone axis in degree in two situations:
| 18 months |
| Evaluation of simulated models regarding relative position of bones in dynamic condition: range of motion (ROM) | comparison between real data (from motion analysis) vs simulated data regarding relative position of bones defining a joint: total joint range of motion (ROM) projected in anatomical planes : degree of freedom of the joint (flexion, extension, abduction, adduction, medial and lateral rotation) (Kinematic parameters) in two situations:
| 18 months |
| Evaluation of simulated models regarding forces | comparison between real data (from motion analysis) vs simulated data regarding kinetic parameters as forces (ground reaction forces) in Newton (N) in two situations:
| 18 months |
| Evaluation of simulated models regarding moment | comparison between real data (from motion analysis) vs simulated data regarding kinetic parameters as joint moment in Newton-metre (N.m) in two situations:
| 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| correlation of clinical scores and changes in function | changes in clinical scores (percentage) compared to the variation in the range of motion of joints studied | 18 months |
| Comparison of post surgery models between real and simulated surgery regarding bone dimension |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine MR PERRIER, PHD | Contact | +33 (1) 44 74 10 19 | perrier.antoine@gmail.com | |
| Yohan MR PAYAN, PHD | Contact | +33 (4) 45 56 20 01 | Yohan.Payan@univ-grenoble-alpes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Antoine M PERRIER, PHD | laboratoire TIMC CNRS | Principal Investigator |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D014965 | X-Rays |
| ID | Term |
|---|---|
| D060733 | Electromagnetic Radiation |
| D055590 | Electromagnetic Phenomena |
| D060328 | Magnetic Phenomena |
| D055585 | Physical Phenomena |
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| Evaluation of simulated models regarding pressure |
comparison between real data (from motion analysis) vs simulated data regarding kinetic parameters as pressure (baropodometric analysis) in Newton per square centimeter (N/cm2) in two situations:
|
| 18 months |
| comparison of post surgery changes in real and simulated results regarding bone dimension | comparison between real bone dimension's changes (from imaging) vs bone dimension's changes on simulated data difference calculated in mm in one situation: - bone dimension's difference calculated on CT scan (difference between pre and post operative bone dimensions) versus bone dimension's difference calculated on models (difference between bone dimensions obtained on model 1 and model 3) | 18 months |
| comparison of post surgery changes in real and simulated results regarding bone torsion | comparison between real bone torsion's changes (from imaging) vs bone torsion's changes on simulated data, difference calculated in degree in one situation: - bone torsion's difference calculated on CT scan (difference between pre and post operative bone torsions) versus bone torsion's difference calculated on models (difference between bone torsions obtained on model 1 and model 3) | 18 months |
| comparison of post surgery changes in real and simulated results regarding bone axis | comparison between real bone axis changes (from imaging) vs bone axis changes on simulated data : anatomical bone axis (corresponding mainly to the diaphyseal axis)) difference calculated in degree in one situation: - bone axis difference calculated on imaging (difference between pre and post operative bone torsion) versus bone torsion's difference calculated on models (difference between bone torsions obtained on model 1 and model 3) | 18 months |
| comparison of post surgery changes in real and simulated results regarding bone volume | comparison between real bone volume changes (from imaging) vs bone volume changes on simulated data difference calculated in mm3 in one situation: - bone volume difference calculated on CT scan (difference between pre and post operative bone volumes) versus bone volume difference calculated on models (difference between bone volumes obtained on model 1 and model 3) | 18 months |
| comparison of post surgery changes in real and simulated results regarding relative position of bones in static condition | comparison between real mechanical angle changes (from imaging) vs mechanical angle changes on simulated data difference between angles (obtained from mechanical bone axis) calculated in degree in one situation: - mechanical angle difference calculated on imaging (difference between pre and post operative mechanical angles) versus mechanical angle difference calculated on models (difference between mechanical angles obtained on model 1 and model 3) | 18 months |
| comparison of post surgery changes in real and simulated results regarding ROM's changes | comparison between real ROM'S changes (from motion analysis) vs ROM's changes on simulated data joint range of motion's difference calculated in degree in one situation: - ROM's difference calculated on motion analysis (difference between pre and post operative ROM) versus ROM's difference calculated on models (difference between ROM obtained on model 1 and model 3) | 18 months |
| comparison of post surgery changes in real and simulated results regarding moment changes | comparison between real moment changes (from motion analysis) vs moment changes on simulated data moment difference calculated in N.m in one situation: - moment difference calculated on motion analysis (difference between pre and post operative moments) versus moment difference calculated on models (difference between moments obtained on model 1 and model 3) | 18 months |
| comparison of post surgery changes in real and simulated results regarding pressure changes | comparison between real pressure changes (from motion analysis) vs pressure changes on simulated data pressure difference calculated in N/cm2 in one situation: - pressure difference calculated on motion analysis (difference between pre and post operative pressures) versus pressure difference calculated on models (difference between pressures obtained on model 1 and model 3) | 18 months |
comparison between bone dimension in simulated surgery (model 2) and bone dimension in real surgery model (model 3) difference calculated in mm |
| 18 months |
| Comparison of post surgery models between real and simulated surgery regarding bone torsion | comparison between bone torsion in simulated surgery (model 2) and bone torsion in real surgery model (model 3) difference calculated in degree | 18 months |
| Comparison of post surgery models between real and simulated surgery regarding bone axis | comparison between bone axis in simulated surgery (model 2) and bone axis in real surgery model (model 3) : anatomical bone axis (corresponding mainly to the diaphyseal axis)) difference calculated in degree | 18 months |
| Comparison of post surgery models between real and simulated surgery regarding bone volume | comparison between bone volume in simulated surgery (model 2) and bone volume in real surgery model (model 3) difference calculated in mm3 | 18 months |
| Comparison of post surgery models between real and simulated surgery regarding point-to-surface distance of bone | comparison of point-to-surface distance between two pairs of bones model 1/ model 2 and model 1/model 3 difference calculated in mm | 18 months |
| Comparison of post surgery models between real and simulated surgery regarding relative position of bones in static condition | comparison between mechanical angle in simulated surgery (model 2) and mechanical angle in real surgery model (model 3) difference between angles (obtained from mechanical bone axis) calculated in degree | 18 months |
| Comparison of post surgery models between real and simulated surgery regarding ROM's changes | comparison between ROM in simulated surgery (model 2) and ROM in real surgery model (model 3) joint range of motion's difference calculated in degree | 18 months |
| Comparison of post surgery models between real and simulated surgery regarding ground reaction forces changes | comparison between forces in simulated surgery (model 2) and forces in real surgery model (model 3) ground reaction forces difference calculated in Newton | 18 months |
| Comparison of post surgery models between real and simulated surgery regarding moment changes | comparison between moment in simulated surgery (model 2) and moment in real surgery model (model 3) moment difference calculated in N.m | 18 months |
| Comparison of post surgery models between real and simulated surgery regarding pressure changes | comparison between pressure in simulated surgery (model 2) and pressure in real surgery model (model 3) pressure difference calculated in N/cm2 | 18 months |
| comparison of simulated joint force changes between Pre and post surgery models | comparison between simulated joint forces (from model 1) vs simulated joint forces (from model 2 and 3) joint normal contact forces difference calculated in Newton | 18 months |
| D011827 | Radiation |
| D011839 | Radiation, Ionizing |