Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures (NOTICE)

Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures: a Cohort Study of 50 Patients

The diagnosis of LHCF is complicated by radiographic inability to show the full extent of the injury into the chondral (unossified) epiphysis. MRI gives a perfect view of these fractures. The safety and feasibility of non-operative treatment based on MRI findings in children with elbow fractures has not been investigated in a Danish setting. If safe and feasible, the use of MRI could dramatically lower the need for surgery in children with LHCF.

Study Overview

• Status: Recruiting
• Conditions: Fracture Humerus; Physeal Fracture
• Intervention / Treatment: Other: MRI

Detailed Description

The treatment of LHCF has historically most often been surgical with open reduction and fixation. The diagnosis of LHCF is complicated by radiographic inability to show the full extent of the injury into the unossified chondral epiphysis and therefore physicians often opt for open surgical treatment. MRI; however, gives a perfect view of these fractures. This project investigates the safety and feasibility of non-operative treatment of LHCF based on MRI performed without sedation or anesthesia and seeks to dramatically lower the need for surgery. Objectives are to describe functional outcome, radiological healing, secondary fracture displacement and any complications after two years. The investigators hypothesize that undisplaced and minimally displaced LHCF can be treated non-operatively based on MRI findings with good functional outcomes after two years. A cohort study design is used to follow 50 children with LHCF.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Capital Region
    • Herlev, Capital Region, Denmark, 2730
      • Recruiting
      • Copenhagen University Hospital - Herlev and Gentofte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of acute Lateral humeral condyle fracture
• Fracture <5 days old
• Fracture with <5 mm of displacement on plain radiographs
• Parental informed consent obtained

Exclusion Criteria:

• Contraindication(s) to performing an MRI
• Unable to participate in follow-up
• Existing bone pathology
• Previous ipsilateral elbow fracture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Non-operative; Non-operative treatment of lateral humeral condyle fractures	Other: MRI; Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mayo Elbow Performance Score (MEPS)	MEPS consists of three domains; pain, elbow range of motion (ROM) and stability. The total score ranges from 0-100 with higher scores indicating better function. If the total score ranges between 75 and 100, the result is good (satisfactory); 50-74, fair (acceptable); <50, poor (unsatisfactory).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI results	Proportion of successful MRIs defined as a completed scan with an image quality that is useful for analysis by the radiologist. MRI findings. Song classification based on MRI. Scan length (minutes). Any discomforts for the child during the scan.	2 weeks
Radiographic results	Injury radiographs and subsequent radiographs during FU will be read and described by a senior orthopedic surgeon.	2 years
Secondary fracture displacement	Any secondary displacement and amount of radiographic displacement (mm) is recorded.	2 years
Pain scale (age <5 years)	To quantify pain in the patient age <5 years, the Face, Legs, Activity, Cry, Consolability Scale (FLACC). To quantify pain behaviors in children who may not be able to verbalize the presence or severity of pain FLACC provides a simple framework. The child is observed for at least 2-5 minutes. Legs and body are observed uncovered. Activity is observed and body is assessed for tenseness and tone. Assessment of Behavioural Score: 0 = Relaxed and comfortable. 1-3 = Mild discomfort. 4-6 = Moderate pain. 7-10 = Severe discomfort/pain.	2 years
Pain scale (age >4 years)	To quantify pain in the patient >4 years, Faces Pain Scale - Revised (FPS-R) is applied. The Faces Pain Scale - Revised (FPS-R) is used to quantify pain in children above four years of age. It is a self-report measure of pain intensity developed for children. It was adapted from the Faces Pain Scale to make it possible to score the sensation of pain on a 0-to-10 metric. The scale shows a close linear relationship with visual analog pain scales (VAS) across the age range of 4-16 years. FPS-R is easy to administer and requires no equipment except for the photocopied faces. The child is asked to point to the face that shows how much pain the child is in at that moment. Faces are scored 0-10 so 0 equals no pain and 10 equals very much pain.	2 years
Pain scale (age >8 years)	A visual analogue scale (VAS) is used to quantify pain in children age 8 and above. VAS has been extensively investigated in quantifying pain in older children. The child is asked to put a mark on the line corresponding to the child's pain at that moment. A mark to the far left equals no pain and a mark to the far right equals worst possible pain. The line is 10 cm long and the child's mark is measured from left to right in cm with one decimal e.g., 3.4 cm equaling a VAS of 3.4. If the child cannot cooperate to using VAS, FPS-R is used instead.	2 years

Collaborators and Investigators

• Sponsor: Children's Fractures Interest Group, Denmark

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2021
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): October 1, 2024

Study Registration Dates

• First Submitted: October 12, 2021
• First Submitted That Met QC Criteria: October 24, 2021
• First Posted (ACTUAL): October 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 11, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: H-21017621

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No