Knee Injury Decision

• Conditions: Bone Fracture; Knee Trauma

• Registration Number: NCT02856945
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-02
• Last Update Submitted: 2016-08-02
• Study First Posted: 2016-08-05
• Last Update Posted: 2016-08-05
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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

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Exclusion Criteria

• Isolated knee wound
• Loss of awareness
• Paraplegia

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Positive and negative predictive values	when radiography results are available, at inclusion day (day 1)
Radiographic use reduction	when radiography use is determined	The number of radiographic use will be measure to identify any variation in this procedure.

Trial Locations

Locations (1)

Hospices Civils de Lyon, HFME. 32 Avenue Doyen Jean Lépine; 🇫🇷 Bron, France