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Customized Biomechanical Models of the Musculoskeletal System Before and After Surgery (ORTHOSIMV1)

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ClinicalTrials.gov Identifier: NCT03835000
Recruitment Status : Not yet recruiting
First Posted : February 8, 2019
Last Update Posted : February 8, 2019
Sponsor:
Collaborators:
Fondation pour la Recherche Médicale
Fondation Garches
Technique de l'Imagerie Médicale et de la Complexité "TIMC" laboratory
Information provided by (Responsible Party):
Centre d'Investigation Clinique et Technologique 805

Brief Summary:
The objective of this study is to design a library of biomechanical musculoskeletal models of patients before and after surgery. These models will be evaluated to analyze the support they can provide for virtual surgical planning in orthopedics.

Condition or disease Intervention/treatment
Joint Disease Joint Instability Osteoarthritis Bone Malalignment Procedure: Orthopedic surgery

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Medical Imaging of the Musculoskeletal System Before and After Surgery for the Generation of Customized Biomechanical Models
Estimated Study Start Date : February 15, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pre operative patient
Patients who will require orthopedic surgery for corrective, replacement or repair
Procedure: Orthopedic surgery
before and after surgery, patient will need medical imaging to asses their conditions
Other Name: Medical imaging




Primary Outcome Measures :
  1. Bones volume assessment [ Time Frame: 20 days ]
    Comparison of volume of bone pieces in mm3

  2. Soft tissue volume assessment [ Time Frame: 20 days ]
    Volume comparison of soft tissue envelope in mm3

  3. Relative positions of bones [ Time Frame: 10 days ]
    Comparison of the relative positions of bones relative to each other in degrees


Secondary Outcome Measures :
  1. Biomechanical response [ Time Frame: 2 days ]

    the convergence of the numerical simulation performed from the reconstructed model.

    measurement of the Stress in Nm-2 and the strains (Strain has no units because it is a ratio of lengths)




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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 20 to 65 years who require orthopaedic surgery as described in the literature and for which 3D medical imaging will be performed before and after the surgical procedure.
Criteria

Inclusion criteria:

  • Men or women aged 20 to 65 years
  • Patients who have had orthopaedic surgery
  • Presence in the file of a preoperative CT scan and/or magnetic resonance imaging (MRI)
  • Presence in the file of a CT scan and/or MRI postoperatively at a distance from the operation (at least 4 weeks)
  • Presence in the file of an operating report describing the procedure in detail with access routes, operating times, type of equipment and possible complications.
  • Patient who has authorized the anonymous use of data from his pre and post surgical examinations
  • Patient who is a member of a social security organisation

Criteria for non-inclusion:

  • Patient who has expressed his refusal to use his medical data
  • Minor, patient under guardianship, inability to receive information and express consent
  • Pregnant women
  • Non-affiliation to a social security scheme (beneficiary or beneficiary)
  • Examinations of images that do not allow 3D reconstruction of structures (poor resolution or type of sequence)
  • Incomplete operating report not allowing the understanding of the steps of the surgery.
  • Surgical report describing surgery that does not represent the usual procedures performed.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835000


Contacts
Contact: Perrier Antoine, Dr +33 (1)44 74 10 19 perrier.antoine@gmail.com
Contact: Izedaren Fatima, CRA +33 (1)47 10 44 49 fatima.izedaren@aphp.fr

Locations
France
Laboratoire CNRS TIMC IMAG Not yet recruiting
La Tronche, Grenoble Alpes University - CNRS UMR, France, 38706
Contact: Perrier Antoine    + 33 (0)144741019    perrier.antoine@gmail.com   
Sponsors and Collaborators
Centre d'Investigation Clinique et Technologique 805
Fondation pour la Recherche Médicale
Fondation Garches
Technique de l'Imagerie Médicale et de la Complexité "TIMC" laboratory
Investigators
Principal Investigator: Perrier Antoine, Dr CIC 1429

Responsible Party: Centre d'Investigation Clinique et Technologique 805
ClinicalTrials.gov Identifier: NCT03835000     History of Changes
Other Study ID Numbers: CNIL 2168319 v 0
First Posted: February 8, 2019    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre d'Investigation Clinique et Technologique 805:
virtual patient
joint modeling
biomechanical simulation
surgery mechanical results

Additional relevant MeSH terms:
Osteoarthritis
Joint Diseases
Joint Instability
Bone Malalignment
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Bone Diseases