KID: Knee Injury Decision

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Unknown status
CT.gov ID
NCT02856945
Collaborator
(none)
25
1
10
2.5

Study Details

Study Description

Brief Summary

At this time, there is no standardization for knee trauma care in children. Each physician is free to resort or not to radiography to verify or dispel bone fracture, depending on radiographic device availability. This decision is based on trauma severity, clinical features, and physician experience.

Knee traumatisms are a common reason of consultation. In emergency departments, radiographic use is widespread for those traumatisms, but not in private practice.

Most of those knee traumatisms includes soft tissue lesion, for which radiography gives no details. Yet, radiography exposes bone fracture which may require a specific orthopaedic care. Then, it seems beneficial to highlight simple and reproducible clinical criteria in order to identify severe knee traumatisms, requiring radiography to assess bone fracture.

Those criteria should have a sensibility close to 1, and the highest specificity. Such criteria could significantly decrease the number of radiography thus irradiation, emergencies waiting time, and consultation expenses without missing bone fracture.

Ottawa knee rules for adults are: age 55 years older, tenderness at head of fibula, isolated tenderness of patella inability to flex to 90°, inability to bear weight on 4 steps both immediately and in the emergency department. Presence of one of those criteria required front and profile radiography to assess bone fracture.

However, few studies have been conducted among children, and they do not confirm the use of those criteria targeting fracture screening. Data are contradictory and they do not allow concluding that such criteria could be of benefit for children. Moreover, studies only consider adults clinical criteria. This study would be the first to implement specific paediatric criteria, which make this study original.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    25 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Criteria for Decision Support Regarding Emergency Radiography for Knee Acute Traumatism in Order to Identify Bone Fracture Among Children.
    Study Start Date :
    Dec 1, 2015
    Anticipated Primary Completion Date :
    Aug 1, 2016
    Anticipated Study Completion Date :
    Oct 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. clinical criteria sensitivity [when radiography results are available (day 1)]

      sensitivity will be evaluated for each clinical criterion, with the radiographic gold standard. Sensitivity will be compared by Mc Nemar paired test, or by Fischer exact test if Mc Nemar test conditions are not fulfilled.

    Secondary Outcome Measures

    1. criteria specificity [when radiography results are available, at inclusion day (day 1)]

      specificity will be evaluated for each clinical criterion, with the radiographic gold standard. Specificity will be compared by Mc Nemar paired test, or by Fischer exact test if Mc Nemar test conditions are not fulfilled

    2. Positive and negative predictive values [when radiography results are available, at inclusion day (day 1)]

    3. Radiographic use reduction [when radiography use is determined]

      The number of radiographic use will be measure to identify any variation in this procedure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age range from 1 to 17 years old included

    • Knee traumatism (distal third of femur and proximal third of tibia/fibula)

    • Traumatism not older than 7 days

    Exclusion Criteria:
    • Isolated knee wound

    • Loss of awareness

    • Paraplegia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospices Civils de Lyon, HFME. 32 Avenue Doyen Jean Lépine Bron France 69500

    Sponsors and Collaborators

    • Hospices Civils de Lyon

    Investigators

    • Principal Investigator: Karine CORREARD, MD, Hospices Civils de Lyon, HFME

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospices Civils de Lyon
    ClinicalTrials.gov Identifier:
    NCT02856945
    Other Study ID Numbers:
    • 69HCL16_0518
    First Posted:
    Aug 5, 2016
    Last Update Posted:
    Aug 5, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by Hospices Civils de Lyon
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 5, 2016