Clinical trial NCT02856945: Knee Injury Decision
Official title: Clinical Criteria for Decision Support Regarding Emergency Radiography for Knee Acute Traumatism in Order to Identify Bone Fracture Among Children.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Fracture
Knee Trauma
Keywords: fracture
children
knee
clinical criteria
decision making
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 25
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with Knee traumatism at HFME hospital

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.


Eligibility criteria: 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

Primary outcomes:
measure: clinical criteria sensitivity
timeFrame: when radiography results are available (day 1)
Secondary outcomes:
measure: criteria specificity
timeFrame: when radiography results are available, at inclusion day (day 1)
measure: Positive and negative predictive values
timeFrame: when radiography results are available, at inclusion day (day 1)
measure: Radiographic use reduction
timeFrame: when radiography use is determined
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon, HFME. 32 Avenue Doyen Jean Lépine
Study officials:
affiliation: Hospices Civils de Lyon, HFME
name: Karine CORREARD, MD
role: PRINCIPAL_INVESTIGATOR
References: