Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures (NOTICE)
Primary Purpose
Fracture Humerus, Physeal Fracture
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional treatment trial for Fracture Humerus
Eligibility Criteria
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
Sites / Locations
- Copenhagen University Hospital - Herlev and GentofteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Non-operative
Arm Description
Non-operative treatment of lateral humeral condyle fractures
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Radiographic results
Injury radiographs and subsequent radiographs during FU will be read and described by a senior orthopedic surgeon.
Secondary fracture displacement
Any secondary displacement and amount of radiographic displacement (mm) is recorded.
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.
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.
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.
Full Information
NCT ID
NCT05096689
First Posted
October 12, 2021
Last Updated
November 5, 2021
Sponsor
Children's Fractures Interest Group, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT05096689
Brief Title
Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures
Acronym
NOTICE
Official Title
Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures: a Cohort Study of 50 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Fractures Interest Group, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Humerus, Physeal Fracture
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, Cohort, Single center
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-operative
Arm Type
Experimental
Arm Description
Non-operative treatment of lateral humeral condyle fractures
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
Magnetic Resonance Imaging
Primary Outcome Measure Information:
Title
Mayo Elbow Performance Score (MEPS)
Description
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).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
MRI results
Description
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.
Time Frame
2 weeks
Title
Radiographic results
Description
Injury radiographs and subsequent radiographs during FU will be read and described by a senior orthopedic surgeon.
Time Frame
2 years
Title
Secondary fracture displacement
Description
Any secondary displacement and amount of radiographic displacement (mm) is recorded.
Time Frame
2 years
Title
Pain scale (age <5 years)
Description
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.
Time Frame
2 years
Title
Pain scale (age >4 years)
Description
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.
Time Frame
2 years
Title
Pain scale (age >8 years)
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Morten J Andersen, MD
Phone
004538681479
Email
mortenjonandersen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Morten J Andersen, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen University Hospital - Herlev and Gentofte
City
Herlev
State/Province
Capital Region
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten J Andersen, MD
Phone
004538681479
Email
morten.jon.andersen@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures
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