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Knee Injury Decision

Clinical Criteria for Decision Support Regarding Emergency Radiography for Knee Acute Traumatism in Order to Identify Bone Fracture Among Children.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02856945
Acronym
KID
Enrollment
25
Registered
2016-08-05
Start date
2015-12-31
Completion date
2016-10-31
Last updated
2016-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Fracture, Knee Trauma

Keywords

fracture, children, knee, clinical criteria, decision making

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.

Interventions

None listed

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 17 Years
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

Design outcomes

Primary

MeasureTime frameDescription
clinical criteria sensitivitywhen 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

MeasureTime frameDescription
criteria specificitywhen 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
Positive and negative predictive valueswhen radiography results are available, at inclusion day (day 1)
Radiographic use reductionwhen radiography use is determinedThe number of radiographic use will be measure to identify any variation in this procedure.

Countries

France

Contacts

Primary ContactKarine CORREARD, MD
anne-karine.correard-darne@chu-lyon.fr(0)4 27 85 56 49
Backup ContactJulien BERTHILLER, Clinical project manager
julien.bertheiller@chu-lyon.fr(0)4 27 85 63 01

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026