Evaluation of Personalized Biomechanical Models of the Musculoskeletal System Before and After Orthopedic Surgeries
NCT ID: NCT04668430
Last Updated: 2020-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
10 participants
INTERVENTIONAL
2020-12-15
2023-10-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study aims at evaluating the design and simulation procedure of anatomical and functional pre and post surgical patient-specific numerical models.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
patients
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
imaging and motion analysis
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
imaging and motion analysis
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
20 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondation Garches
OTHER
Centre d'Investigation Clinique et Technologique 805
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Antoine M PERRIER, PHD
Role: PRINCIPAL_INVESTIGATOR
laboratoire TIMC CNRS
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019-A02124-53
Identifier Type: -
Identifier Source: org_study_id