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New, Easy and Efficient Ways to CLassify AcetabulaR Fractures

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Completed
CT.gov ID
NCT03316235
Collaborator
(none)
35
Enrollment
1
Location
5.1
Actual Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Acetabular fractures are the resultant from high-energy trauma or low-energy trauma in the elder patients. Usually, surgeons use LETOURNEL's classification or/and JUDET's one.

Five elements are considered and associated to five type of fracture. Even more, for orthopaedic surgeons with less experience with these fractures, correct classification can be more difficult.

So the the aim of this study is:

  1. Evaluate the efficacy of four "special" 3D reconstruction: a 3D reconstruction of the pelvis with anterior view, posterior view, endopelvic view where the opposite hemipelvis removed and an exopelvic view where the femoral head is removed according to the initial teaching of E. Letournel.

  2. Evaluate the addition of teaching of non-experimented surgeon on the accuracy of classifying acetabular fractures.

  3. Evaluate the addition of a digital algorithm (mobile application) on the accuracy of classifying acetabular fractures.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    12 reviewers will be given the different imaging of each case and will be divided in 4 groups: novice (junior ER and ortho residents), intermediate (non-experimented orthopedic surgeons), intermediate with a formation on classifying acetabular fractures and finally experts (acetabular fracture expert surgeons) . For each patient, representative CT scans are provided for each assessment. The study will be divided into 3 phases separated by 4-6 weeks of time. In the first phase, for each patient, representative CT scans are provided for each assessment with 2D and multiplanar reconstruction (MPR) without 3D views. In the second phase, 3D views are added. In the third phase, the cases are evaluated using the "Acetabular Diagnosis Tool" To note, the evaluation of the cases is done twice in each phase separated by 4-6 weeks and the order of the cases is changed, both in order to minimize recall bias

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    35 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    New, Easy and Efficient Ways to CLassify AcetabulaR Fractures
    Actual Study Start Date :
    May 27, 2016
    Actual Primary Completion Date :
    Aug 31, 2016
    Actual Study Completion Date :
    Oct 30, 2016

    Outcome Measures

    Primary Outcome Measures

    1. 3D reconstruction of pelvis CT scan [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • acetabular fracture
    Exclusion Criteria:
    • no criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France France 75014

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT03316235
    Other Study ID Numbers:
    • CLARIFY
    First Posted:
    Oct 20, 2017
    Last Update Posted:
    Oct 20, 2017
    Last Verified:
    Oct 1, 2017
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Fractures, Bone

    Study Results

    No Results Posted as of Oct 20, 2017