Knee Injury Decision

Bone Fracture Clinical Trial

— KID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02856945
• Other study ID #: 69HCL16_0518
• Status: Recruiting
• Phase: N/A
• First received: August 2, 2016
• Last updated: August 2, 2016
• Start date: December 2015
• Est. completion date: October 2016

Study information

• Verified date: August 2016
• Source: Hospices Civils de Lyon
• Contact: Karine CORREARD, MD
• Phone: (0)4 27 85 56 49
• Email: anne-karine.correard-darne[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 17 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bone Fracture
• Fractures, Bone
• Knee Trauma

Locations

Country	Name	City	State
France	Hospices Civils de Lyon, HFME. 32 Avenue Doyen Jean Lépine	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical criteria sensitivity	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.	when radiography results are available (day 1)	No
Secondary	criteria specificity	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	when radiography results are available, at inclusion day (day 1)	No
Secondary	Positive and negative predictive values		when radiography results are available, at inclusion day (day 1)	No
Secondary	Radiographic use reduction	The number of radiographic use will be measure to identify any variation in this procedure.	when radiography use is determined	No