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

NCT04668430 | Unknown

• 1 other identifier: 2019-A02124-53
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Orthopedic Disorder

Keywords

computer simulation; orthopedic surgical procedures; Multimodal Imaging; gait analysis

Outcome Measures

Primary Outcomes (13)

• 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: * angles measured on pre operative imaging versus angles obtained on model 1 * angles measured on post operative imaging versus angles obtained on model 3

  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: * ROM measured on pre operative motion analysis versus ROM obtained on model 1 * ROM measured on post operative motion analysis versus ROM obtained on model 3

  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: * forces measured on pre operative motion analysis versus forces obtained on model 1 * forces measured on post operative motion analysis versus forces obtained on model 3

  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: * moment calculated on pre operative motion analysis versus moment obtained on model 1 * moment calculated on post operative motion analysis versus moment obtained on model 3

  18 months

• 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: * pressure measured on pre operative motion analysis versus pressure obtained on model 1 * pressure measured on post operative motion analysis versus pressure obtained on model 3

  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

Secondary Outcomes (12)

• correlation of clinical scores and changes in function

  18 months

• Comparison of post surgery models between real and simulated surgery regarding bone dimension

  18 months

• Comparison of post surgery models between real and simulated surgery regarding bone torsion

  18 months

• Comparison of post surgery models between real and simulated surgery regarding bone axis

  18 months

• Comparison of post surgery models between real and simulated surgery regarding bone volume

  18 months

Study Arms (1)

patients

OTHER

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

Other: imaging and motion analysis

Interventions

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.

patients

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre d'Investigation Clinique et Technologique 805: lead
• Fondation Garches: collaborator

MeSH Terms

Conditions

Musculoskeletal Diseases

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Antoine M PERRIER, PHD

  laboratoire TIMC CNRS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

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

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: December 16, 2020
• Study Start: December 15, 2020
• Primary Completion: October 15, 2022
• Study Completion: October 15, 2023
• Last Updated: December 16, 2020

Record last verified: 2020-04