NCT03835000

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 19, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 8, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 18, 2019

Status Verified

October 1, 2019

Enrollment Period

2.1 years

First QC Date

November 5, 2018

Last Update Submit

November 15, 2019

Conditions

Joint DiseaseJoint InstabilityOsteoarthritisBone Malalignment

Keywords

virtual patientjoint modelingbiomechanical simulationsurgery mechanical results

Outcome Measures

Primary Outcomes (3)

  • Bones volume assessment

    Comparison of volume of bone pieces in mm3

    20 days

  • Soft tissue volume assessment

    Volume comparison of soft tissue envelope in mm3

    20 days

  • Relative positions of bones

    Comparison of the relative positions of bones relative to each other in degrees

    10 days

Secondary Outcomes (1)

  • Biomechanical response

    2 days

Study Arms (1)

Pre operative patient

Patients who will require orthopedic surgery for corrective, replacement or repair

Procedure: Orthopedic surgery

Interventions

Orthopedic surgeryPROCEDURE

before and after surgery, patient will need medical imaging to asses their conditions

Also known as: Medical imaging
Pre operative patient

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire CNRS TIMC IMAG

La Tronche, Grenoble Alpes University - CNRS UMR, 38706, France

RECRUITING

MeSH Terms

Conditions

Joint DiseasesJoint InstabilityOsteoarthritisBone Malalignment

Interventions

Orthopedic ProceduresX-Rays

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesArthritisRheumatic DiseasesBone Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsSurgical Procedures, OperativeElectromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Perrier Antoine, Dr

    CIC 1429

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Perrier Antoine, Dr

CONTACT

+33 (1)44 74 10 19perrier.antoine@gmail.com

Izedaren Fatima, CRA

CONTACT

+33 (1)47 10 44 49fatima.izedaren@aphp.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2018

First Posted

February 8, 2019

Study Start

January 19, 2019

Primary Completion

March 1, 2021

Study Completion

October 1, 2021

Last Updated

November 18, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)