Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures: a Cohort Study of 50 Patients
Phase: NA
Conditions: Fracture Humerus, Physeal Fracture
Sponsor: Children's Fractures Interest Group, Denmark

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
1/31 
Non-operative treatment of pediatric lateral humeral condyle fractures:  
1 
a cohort study of 50 patients 
2 
 
3 
 
4 
 
5 
Clinical Investigation Plan 
6 
 
7 
 
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9 
File name: Study Protocol - Non-OP treatment of LHCF - H-21017621.pdf 
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11 
Version and date: Version 3.0, 30 July 2021 
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Principal Coordinating Investigator 
Morten Jon Andersen 
MD 
Department of Orthopedic Surgery 
Copenhagen University Hospital –  
Herlev and Gentofte,  
Copenhagen, Denmark 
Phone +45 38 68 14 79 
Mobile +45 26 14 86 24 
E-mail morten.jon.andersen@regionh.dk 
Sponsor 
Department of Orthopedic Surgery and 
Department of Radiology and Scanning 
Copenhagen University Hospital 
Herlev and Gentofte 
Copenhagen, Denmark 
The Danish Data Protection Agency ID:  
P-2020-1197 
The Danish National Committee On Health 
Research Ethics ID: H-21017621 
 
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Confidentiality statement 
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The information provided in this document is strictly confidential and is available for review to 
24 
investigators, potential investigators and appropriate Ethics Committees (EC). No disclosure should 
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take place without written authorization from the sponsor, except to the extent necessary to obtain 
26 
informed consent from potential patients. 
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Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
2/31 
Content 
29 
Clinical Investigation Plan ....................................................................................................................... 1 
30 
Principal Coordinating Investigator .................................................................................................... 1 
31 
Sponsor .............................................................................................................................................. 1 
32 
Confidentiality statement .................................................................................................................... 1 
33 
Abbreviations/glossary ............................................................................................................................ 4 
34 
Definitions ................................................................................................................................................ 4 
35 
1 Synopsis ............................................................................................................................................. 5 
36 
2 Rationale and purpose of the study ................................................................................................... 8 
37 
3 General information/responsibilities ................................................................................................... 8 
38 
3.1 Responsibilities........................................................................................................................... 8 
39 
4 Background and literature review ...................................................................................................... 9 
40 
4.1 Definition and epidemiology ....................................................................................................... 9 
41 
4.2 Diagnosis .................................................................................................................................... 9 
42 
4.3 Outcome ..................................................................................................................................... 9 
43 
4.4 Current status of research in this area ....................................................................................... 9 
44 
5 Primary and secondary objectives ................................................................................................... 11 
45 
5.1 Primary objective ...................................................................................................................... 11 
46 
5.2 Secondary objective(s) ............................................................................................................. 11 
47 
5.3 Hypothesis ................................................................................................................................ 11 
48 
6 Study design..................................................................................................................................... 11 
49 
6.1 Study population and patient enrollment .................................................................................. 11 
50 
6.2 Study procedures ..................................................................................................................... 13 
51 
6.3 Study treatments ...................................................................................................................... 15 
52 
7 Definitions of outcome measures and study variables .................................................................... 18 
53 
7.1 Primary outcome ...................................................................................................................... 18 
54 
7.2 Secondary outcomes ................................................................................................................ 19 
55 
8 Statistical planning ........................................................................................................................... 21 
56 
8.1 Hypotheses ............................................................................................................................... 21 
57 
8.2 Sample size considerations...................................................................................................... 21 
58 
8.3 Statistical analysis .................................................................................................................... 21 
59 
9 Bias .................................................................................................................................................. 21 
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10 Benefits ............................................................................................................................................ 22 
61 
11 Risk analysis .................................................................................................................................... 22 
62 
11.1 Treatment-related risks ............................................................................................................ 22 
63 
11.2 Study disadvantages ................................................................................................................ 22 
64 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
3/31 
11.3 Study-related risks .................................................................................................................... 22 
65 
11.4 Actions to minimize increased risks ......................................................................................... 23 
66 
12 Informed consent process ................................................................................................................ 23 
67 
12.1 Special considerations to consent pediatric patients ............................................................... 23 
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13 Adverse event reporting ................................................................................................................... 24 
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14 Data management ............................................................................................................................ 24 
70 
14.1 Data collection, source data, storage and archiving ................................................................ 24 
71 
14.2 Imaging data ............................................................................................................................. 25 
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14.3 Confidentiality ........................................................................................................................... 25 
73 
15 Regulatory affairs ............................................................................................................................. 25 
74 
16 Disclosures and economy ................................................................................................................ 25 
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17 Patient insurance ............................................................................................................................. 25 
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18 Study report and publication policy .................................................................................................. 25 
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18.1 Final Study Report .................................................................................................................... 25 
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18.2 Publication ................................................................................................................................ 26 
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19 Termination criteria .......................................................................................................................... 26 
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19.1 Stopping rules........................................................................................................................... 26 
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20 Deviations from the Clinical Investigation Plan ................................................................................ 26 
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21 Amendments to the Clinical Investigation Plan................................................................................ 26 
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22 Time schedule .................................................................................................................................. 27 
84 
23 Authors ............................................................................................................................................. 27 
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24 Reference list ................................................................................................................................... 28 
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Appendix 1 - Diagnosis and Treatment Protocol .................................................................................. 31 
87 
 
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89 
 
 
90 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
4/31 
Abbreviations/glossary 
91 
AE/SAE 
Adverse Event(s)/Serious Adverse Event(s) 
ADE/SADE 
Adverse Device Event(s)/Serious Adverse Device Event(s) 
AO 
Arbeitsgemeinschaft für Osteosynthesefragen = Association for the 
Study of Internal Fixation (ASIF) 
CIP 
Clinical Investigation Plan 
CRF 
Case Report Form 
CRO 
Contract Research Organization = Clinical Research Organization 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
FSR 
Final Study Report 
FU(s) 
Follow-up(s), eg follow-up visit(s), follow-up procedure(s) 
GA 
General Anesthesia 
GCP 
Good Clinical Practice 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization of Technical Requirements 
for Registration of Pharmaceuticals for Human Use 
ISF 
Investigator Site File 
ISO 
International Organization for Standardization 
LHCF 
Lateral Humeral Condyle Fracture 
MeSH 
Medical Subject Heading 
MRI 
Magnetic Resonance Imaging 
PCI 
Principal Coordinating Investigator (= Principal Clinical Investigator) 
PI 
Principal Investigator 
SD 
Standard Deviation 
U(S)ADE 
Unanticipated (Serious) Adverse Device Effect 
 
92 
Definitions 
93 
Baseline 
Status post injury but pretreatment 
Enrolled 
Patients with written informed consent who commenced treatment within 
the study 
Follow-up visit 
FU; visit at predefined times after the treatment day 
Follow-up 
population 
Patients intended to be followed-up (i.e. enrolled population) 
Injury day 
"Day 0"; day of injury 
Written informed 
consent 
Legally binding signature on the informed consent form (ICF) (i.e. the 
patient’s parents or legal guardians) 
 
 
94 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
5/31 
1 
Synopsis 
95 
Official title 
Non-operative treatment of pediatric lateral humeral condyle fractures:  
a cohort study of 50 patients 
Short title 
Non-operative treatment of pediatric lateral humeral condyle fractures 
Sponsor 
Department of Orthopedic Surgery 
Copenhagen University Hospital – Herlev and Gentofte 
Registration 
The study will be registered with ClinicalTrials.gov 
Background and 
purpose 
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. 
Condition 
Pediatric lateral humeral condyle fracture 
Intervention/procedure 
investigated 
Non-operative treatment of LHCF based on MRI findings 
Comparison 
None 
Study type 
Interventional 
Study design 
Prospective, Cohort, Single center 
Short description 
Cohort study of 50 patients aged 2-15 with acute LHCF. Intervention with 
non-operative treatment based on MRI performed without sedation or 
anesthesia. Objectives are to describe functional outcome, radiological 
healing, secondary fracture displacement and any complications after two 
years. Patients are seen for follow-up 1, 2 and 4 weeks and 3, 6, 12 and 
24 months after injury. 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. 
Primary objective 
Describe the functional outcome two years after non-operative treatment 
of undisplaced and minimally displaced LHCF in children. 
Secondary objectives 
 Describe the feasibility of performing a subacute MRI of the elbow in children 
with LHCF within 2-7 days after the injury without sedation or anesthesia 
 Report MRI findings and classify fractures according to Song classification 
based on MRI 
 Report the number and proportion of fractures that displace secondarily and 
their treatment 
 Report final treatment; non-operative or operative 
 Describe radiographic results and compare with MRI 
 Report any early or late complications 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
6/31 
Hypothesis 
Children with minimally displaced LHCF (Song stage 1, 2 and 3) can be 
treated non-operatively based on MRI findings with good functional 
outcome after two years. 
Primary outcome 
measure 
Mayo Elbow Performance Score (MEPS) two years after injury 
Secondary outcome 
measures 
 Pain 
 Radiographic results 
 MRI results 
 Alteration in treatment regime based on MRI 
 Number and proportion of fractures with secondary displacement 
 Any early or late complications 
Statistical 
considerations and 
estimated enrollment 
Sample size is estimated from previous studies which included less than 
30 participants. The investigators of this study suspect that by enrolling 
50 participants the age distribution and variation in fracture pattern will be 
representative of the background population. 
 
Baseline characteristics and outcomes recorded at scheduled FU 
assessments will be presented using simple summary statistics. 
Start of enrollment 
October 2021 (estimated) 
Last patient/last visit 
October 2025 (estimated) 
Eligibility inclusion 
criteria 
Inclusion criteria: 
 Children age 2-15 years 
 Diagnosis of acute LHCF (<5 days) with <5 mm of displacement on plain 
radiographs 
 Parental informed consent obtained 
Eligibility exclusion 
criteria 
Exclusion criteria: 
 Contraindication(s) to performing an MRI 
 Unable to participate in follow-up 
 Existing bone pathology 
 Previous ipsilateral elbow fracture 
Principal Coordinating 
Investigator 
Morten Jon Andersen, MD 
Department of Orthopedic Surgery 
Copenhagen University Hospital – Herlev and Gentofte 
Copenhagen, Denmark 
 
Phone +45 38 68 14 79 
Mobile +45 26 14 86 24 
E-Mail morten.jon.andersen@regionh.dk 
Study site 
Department of Orthopedic Surgery 
Copenhagen University Hospital – Herlev and Gentofte 
Copenhagen, Denmark 
Health authority 
The Danish Data Protection Agency 
The Danish National Committee On Health Research Ethics 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
7/31 
Pubmed Medical 
Subject Heading 
[MeSH] terms and 
keywords 
 
Child [MeSH] 
Casts, Surgical [MeSH] 
Fracture Fixation [MeSH] 
Humeral Fractures [MeSH] 
Imaging review 
All images collected will be analyzed by independent radiologists during 
the study 
 
96 
 
 
97 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
8/31 
2 
Rationale and purpose of the study 
98 
The treatment of LHCF is most often surgical with open reduction and fixation [1]. The diagnosis of 
99 
LHCF is complicated by radiographic inability to show the full extent of the injury into the unossified 
100 
chondral epiphysis and therefore physicians often opt for open surgical treatment. MRI; however, gives 
101 
a perfect view of these fractures [2–5]. This project investigates the safety and feasibility of non-
102 
operative treatment of LHCF based on MRI performed without sedation or anesthesia and seeks to 
103 
dramatically lower the need for surgery. Objectives are to describe functional outcome, radiological 
104 
healing, secondary fracture displacement and any complications after two years. The investigators 
105 
hypothesize that undisplaced and minimally displaced LHCF can be treated non-operatively based on 
106 
MRI findings with good functional outcomes after two years. A cohort study design is used to follow 50 
107 
children with LHCF. 
108 
3 
General information/responsibilities 
109 
The International Conference on Harmonization for Good Clinical Practice (ICH-GCP) and ISO 14155 
110 
guidelines define the responsibilities of the sponsor and investigators in the context of the study. 
111 
Specific topics, such as the permission from the responsible EC, are defined separately in the CIP. The 
112 
study site undertakes to guarantee correct and prompt implementation, documentation, and 
113 
transmission of the study data. 
114 
 
115 
In the context of the study, the participating study site will return the completely documented cases. 
116 
Completely documented means that all FU visits have been carried out for the cases included in the 
117 
study and that these assessments are recorded on the electronic Case Report Forms (eCRFs) specially 
118 
designed for this study. Furthermore, the necessary radiological investigations must be performed at the 
119 
FU visits. 
120 
3.1 
Responsibilities 
121 
Principal Coordinating Investigator 
Morten Jon Andersen 
MD 
Department of Orthopedic Surgery Copenhagen 
University Hospital - Herlev 
and Gentofte, Copenhagen, Denmark 
Phone 
+45 38 68 14 79 
Mobile 
+45 26 14 86 24 
E-Mail 
morten.jon.andersen@regionh.dk 
Sponsor 
Copenhagen University Hospital 
Herlev and Gentofte 
Department of Orthopedic Surgery and  
Department of Radiology and Scanning 
Copenhagen University Hospital 
Herlev and Gentofte 
Copenhagen, Denmark 
 
122 
 
123 
 
124 
 
125 
 
126 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
9/31 
4 
Background and literature review 
127 
4.1 
Definition and epidemiology 
128 
 
129 
Fractures of the distal humerus account for 5-10% of all pediatric fractures but constitute up to 30% in 
130 
children aged 4-9 years of age [6–10]. Fractures of the lateral humeral condyle account for 10-20% of 
131 
all elbow fractures in children making it the second most frequent after supracondylar fractures 
132 
[3,11,12]. 
133 
 
134 
LHCF are usually the result of a fall on an outstretched arm with either the extensor-supinator mass 
135 
pulling or the radial head pushing off the lateral condyle [13]. The diagnosis is suspected by the history 
136 
of a fall, usually a swollen and painful elbow with tenderness over the lateral aspect. In more severe 
137 
cases a hematoma can present early. 
138 
 
139 
A LHCF is a Salter-Harris type II or IV physeal fracture which can appear as everything from a hairline 
140 
fracture to grossly displaced intraarticular injuries. 
141 
4.2 
Diagnosis 
142 
 
143 
Fractures are usually diagnosed on plain radiographs with antero-posterior (AP), medial-lateral (ML) 
144 
and internal oblique (IO) radiographs. Especially the IO is important in appreciating the amount of 
145 
displacement [14]. The distal humerus, especially in younger children, is largely composed of cartilage 
146 
and is termed the chondroepiphysis [7]. Four secondary ossification centers arise with growth at 
147 
different ages making interpretation of elbow radiographs in children a challenge [15]. A study showed 
148 
that emergency department (ED) physicians only made the right radiographic diagnosis in 53% (16/30) 
149 
of cases concerning pediatric elbow injuries [16]. 
150 
4.3 
Outcome 
151 
 
152 
Neglecting to treat displaced LHCF can lead to painful nonunion, malunion and growth disturbances e.g. 
153 
fishtail deformity. Complications such as tardy ulnar nerve palsy and varus or valgus deformity can 
154 
develop years after an untreated injury [13]. 
155 
4.4 
Current status of research in this area 
156 
 
157 
Undisplaced and minimally displaced LHCF found on radiographs compose a specific challenge in 
158 
choosing between non-operative or operative treatment [13]. The risk of secondary displacement of an 
159 
initially undisplaced fracture varies from 4% to more than 40% depending on the initial stability and 
160 
displacement [12]. 
161 
 
162 
Historically these fractures where classified according to Milch [17] however this system neither 
163 
describes fracture stability nor focusses on fractures in children and has no prognostic value [1].  
164 
 
165 
Song’s classification (figure 1) [18] discerns incomplete from complete and undisplaced from displaced 
166 
fractures clearly describing fracture stability.  
167 
 
168 
Song stage 1 fractures only involve the bony metaphysis. Stage 2 fractures pass into the 
169 
chondroepiphysis, but not through, leaving the articular cartilage intact and functioning as a hinge [4]. 
170 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
10/31 
Stage 1 and 2 fractures are considered stable and can be treated non-operatively. Stage 3 fractures are 
171 
complete and traverse the entire course of the metaphysis, chondroepiphysis and the articular cartilage 
172 
leaving the fragment without any attachment. These fractures can be undisplaced but are always 
173 
considered unstable. Treatment controversy arises from the inability to distinguishing stage 1 and 2 
174 
from stage 3 on plain radiographs. 
175 
 
176 
 
177 
 
178 
Figure 1 - Song classification. 
179 
Because of the risk of secondary displacement, operative treatment is often conducted with many 
180 
surgeons choosing open reduction and fixation in all cases [19,20]. Operative fixation imposes the risk 
181 
of minor complications such as superficial infection, ulcers and granulomas but also major complications 
182 
such as deep infection, osteomyelitis, malunion, non-union, growth disturbance and osteonecrosis [21]. 
183 
 
184 
MRI with specific cartilage sequences (figure 2) can clearly show the chondroepiphysis and studies 
185 
have shown that MRI is capable of precisely showing the fracture pattern [2,3,5,22]. Using simple 
186 
techniques and advances in technology to prepare the child, MRI has been shown to be feasible in 
187 
younger children without sedation or anesthesia in whom this was previously thought necessary [23–
188 
30]. 
189 
 
190 
 
191 
 
192 
Figure 2 - MRI showing LHCF. Left: Stage 1, confined to metaphysis. Center: Stage 2, fracture line stops in the 
193 
chondroepiphysis. Right: Stage 3, traverses the joint cartilage. 
194 
 
 
195 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
11/31 
5 
Primary and secondary objectives 
196 
5.1 
Primary objective 
197 
 
198 
To describe the functional outcome two years after non-operative treatment of undisplaced and 
199 
minimally displaced LHCF in children. 
200 
5.2 
Secondary objective(s) 
201 
 
202 
 Describe the feasibility of performing a subacute MRI of the elbow in children with LHCF within 2-7 
203 
days after the injury without sedation or anesthesia 
204 
 Report MRI findings and classify fractures according to Song classification based on MRI 
205 
 Report the number and proportion of fractures that displace secondarily and their treatment 
206 
 Report final treatment; non-operative or operative 
207 
 Describe radiographic results and compare with MRI 
208 
 Report any early or late complications 
209 
5.3 
Hypothesis 
210 
 
211 
Children with minimally displaced LHCF (Song stage 1, 2 and 3) can be treated non-operatively based 
212 
on MRI findings with good functional outcome after two years. 
213 
6 
Study design 
214 
This project uses a cohort study design conformed to the STROBE Statement [31]. The investigators 
215 
aim to prospectively and consecutively recruit all children with undisplaced or minimally displaced LHCF 
216 
(cohort) which based on MRI are treated non-operatively (exposure). We report functional and 
217 
radiological outcome two years after the injury (outcome). This study design is relevant in reporting the 
218 
primary and secondary outcomes based on the exposure in our cohort. 
219 
6.1 
Study population and patient enrollment 
220 
 
221 
This study investigates the treatment of pediatric LHCF; therefore, this study cannot be conducted in 
222 
consenting adults. LHCF occur predominantly in 4-9 year olds and thus it is not possible to select only 
223 
older children for inclusion. 
224 
 
225 
This study is believed to have great positive implications for the participants and successive patients 
226 
with the same condition. 
227 
6.1.1 
Setting 
228 
The study will be performed in the Capitol Region of Denmark. Patients in the catchment area of 
229 
Copenhagen University Hospital – Herlev and Gentofte are eligible for recruitment (population 700.000 
230 
of which 80.000 are children). 
231 
 
 
232 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
12/31 
6.1.2 
Inclusion criteria 
233 
 Children aged 2-13 years 
234 
 Diagnosis of acute LHCF 
235 
– Fracture <5 days old 
236 
– Fracture with <5 mm of displacement on plain radiographs (AP, ML and IO views) 
237 
 
238 
 Parental informed consent obtained: 
239 
– Ability of all legal guardians to understand the content of the patient information and ICF 
240 
– Willingness and ability to let the child participate in the clinical investigation according to the 
241 
Clinical Investigation Plan (CIP) 
242 
– Signed and dated EC-approved written parental informed consent sheet 
243 
6.1.3 
Exclusion criteria 
244 
 Contraindication(s) to performing an MRI [32] without the use of sedation or anesthesia: 
245 
– Ferromagnetic implants or foreign bodies 
246 
– Pacemaker 
247 
– Ear implant  
248 
– Severe claustrophobia 
249 
 Unable to participate in follow-up 
250 
 Existing bone pathology 
251 
– Tumor 
252 
– Osteogenesis imperfecta 
253 
– Degenerative disease 
254 
 Previous ipsilateral elbow fracture 
255 
6.1.4 
Enrollment of participants 
256 
A member of the research team will identify all eligible patients (i.e., who meet all of the inclusion and 
257 
none of the exclusion criteria). 
258 
 
259 
The identification of eligible patients is done during the daily routine review of radiographs taken in the 
260 
ED of Copenhagen University Hospital - Herlev and Gentofte. 
261 
 
262 
Electronic letters for FU cannot be sent to minors; therefore all parents are routinely approached by 
263 
phone. During this standard approach we ask permission from the EC to inquire the parents about their 
264 
interest and their child’s eligibility in participating in this study. This inquiry will include a short 
265 
prescreening with questions to confirm eligibility as well as a short description of the study and 
266 
responsibilities for participating. None of the data of the pre-screening process will be documented 
267 
study specifically. 
268 
 
269 
If interested in participating, the parents and the patient are invited to the outpatient clinic. Parents are 
270 
informed of the possibility of bringing an assessor. At the visit, a member of the research team will go 
271 
through the informed consent process, and explain the purpose of the study, the procedures, the 
272 
risk/benefits, alternatives to participation, and data protection. 
273 
 
274 
For each patient participating the parents will sign and date an ICF. A copy of the signed ICF will be 
275 
placed into the ISF and one copy will be handed over to the parents. A more detailed description of the 
276 
informed consent process is provided in section 12. 
277 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
13/31 
All patients with written informed consent will be allocated to a unique patient trial number. The date of 
278 
informed consent and the recruitment information is entered in the study database. 
279 
 
280 
The recruitment period will be up to 24 months, during which 50 patients are planned to be enrolled. 
281 
6.2 
Study procedures 
282 
 
283 
The schedule of all FU visits including imaging procedures as well as the data to be collected at each 
284 
visit is shown in Table 1. All FU visits with the defined time windows are calculated from the day of injury 
285 
(i.e. day 0). 
286 
 
287 
All participants live in the catchment area of Herlev and Gentofte Hospital within short transportation 
288 
time. Information about the time and place for the follow-up examination is sent physically by mail to the 
289 
current address registered in the Civil Registration System and via the electronic health record (EHR) 
290 
system. Parents are usually very keen to take their children for follow-up appointments making the risk 
291 
of missing an appointment low. Any participants who miss an appointment will be contacted by phone to 
292 
reschedule. 
293 
 
294 
Table 1: Study schedule 
295 
 
296 
Assessment parameters 
 
Out-patient clinic visits and imaging procedures * 
 
Visit 
1** 
Visit 
2 
Visit 
3 
Visit 
4 
Visit 
5 
Visit 
6 
Visit 
7 
Visit 
8 
Visit 
9 
Visit 
10 
 
Injury (day 0) 
Screening 
Information visit 
Enrollment and 
consent 
5 (± 3) days 
12 (± 3) days 
4 weeks 
3 months 
6 months 
12 months 
24 months 
Eligibility 
 
X 
 
 
 
 
 
 
 
 
 
 
Patient information 
 
 
X 
 
 
 
 
 
 
 
 
 
Consent 
 
 
 
X 
 
 
 
 
 
 
 
 
Demographics 
 
 
 
X 
 
 
 
 
 
 
 
 
MRI 
 
 
 
 
X 
 
 
 
 
 
 
 
If applicable - Control-MRI 
 
 
 
 
 
(X) 
 
 
 
 
 
 
Cast removal*** 
 
 
 
 
 
 
X 
 
 
 
 
 
Radiographs and clinical 
exam 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
 
 
297 
* All FU visits with the defined time windows are calculated from the day of injury (i.e. day 0). 
298 
** Telephone interview. 
299 
*** Casting may be prolonged two weeks in case of lack of callus formation at four weeks. 
300 
 
 
301 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
14/31 
6.2.1 
Visit 1: Screening (by phone) 
302 
 As described in section 6.1.4, the parents of potential study patients are informed about the study 
303 
over telephone by the PI. 
304 
6.2.2 
Visit 2: Information visit 
305 
 All inclusion and exclusion criteria are checked to decide if the patient can participate in the study. 
306 
 Specific procedures for enrollment of pediatric patients are undertaken. A more detailed description 
307 
of the enrolment of participants and informed consent process is provided in section 6.1.4 and 10. 
308 
 Before any study-specific examinations are performed, the patient’s parents give written informed 
309 
consent to participate in the study according to the CIP. 
310 
6.2.3 
Visit 3: Enrolment, consent and preparation for MRI 
311 
 Obtain baseline demographics 
312 
 Book MRI 
313 
 Prepare child for MRI using the Child Centered Care model described in section 6.3 
314 
 Data verification and entry into the eCRF 
315 
6.2.4 
Visit 4: MRI (5 (± 3) days) 
316 
 The MRI is performed according to the Child Centered Care model described in section 6.3 
317 
 Results of the MRI are given to the parents by phone 
318 
 Any necessary adjustments to the treatment plan is made 
319 
 Entry into the eCRF 
320 
6.2.5 
ONLY if applicable: Control-MRI (12 (± 3) days) 
321 
 If an unstable Song stage 3 fracture is diagnosed based on the initial MRI an additional control MRI 
322 
is performed during this visit 
323 
 Results of the MRI are given to the parents by phone 
324 
 Any necessary adjustments to the treatment plan is made 
325 
 Entry into the eCRF 
326 
6.2.6 
Visit 5: Radiographs and clinical examination (12 (± 3) days) 
327 
 Plain radiographs of injured elbow without cast (AP, ML and IO) 
328 
 Clinical examination 
329 
– Cast condition 
330 
– Assessment of pain and use of pain medication 
331 
– Neurovascular status of the hand 
332 
 Entry into the eCRF 
333 
6.2.7 
Visit 6, 7, 8, 9 and 10: Radiographs and clinical examination (4 weeks and 3, 6, 12 and 24 
334 
months). 
335 
 Plain radiographs of injured elbow without cast (AP, ML and IO) 
336 
 Clinical examination 
337 
– Assessment of pain and use of pain medication 
338 
– Neurovascular status of the hand 
339 
– Bilateral elbow assessment according to Mayo Elbow Performance Score (MEPS) 
340 
– Bilateral carrying angle of the elbow measured in degrees by goniometer 
341 
 Entry into the eCRF 
342 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
15/31 
6.2.8 
Unscheduled visits 
343 
Unscheduled visits can take place at any time during the study if a need occurs or if the investigator 
344 
considers this to be appropriate for patient care. Information collected between study visits are to be 
345 
documented at the next regular study visit with the following exceptions: 
346 
 If a patient drops out of the study, a dropout form is completed at the time of dropout 
347 
6.2.9 
Premature study termination 
348 
Patient participation in the study may end prematurely for one of the following reasons: 
349 
 Patient withdrew informed consent 
350 
 Protocol violation 
351 
 Investigator's discretion (e.g. patient noncompliance with CIP) 
352 
 Unknown/lost to FU 
353 
 
354 
For each case of premature termination detailed information will be obtained explaining the 
355 
circumstances leading to the termination. This will be recorded on a dropout form in the eCRF. 
356 
 
357 
If patients are withdrawn from the study, any collected data will be censored. Censoring allows this 
358 
collection of data to be accounted for in the analysis. 
359 
6.3 
Study treatments 
360 
 
361 
This study is not investigating any medical device. All devices in this study will be used per standard of 
362 
care at the participating institutions. 
363 
6.3.1 
Emergency treatment 
364 
All patients who sustain a LHCF are initially treated in the ED with an above elbow splint. Parents and, 
365 
when applicable, the patient are informed of the injury, cast management and use of pain medicine. 
366 
6.3.2 
MRI in children without sedation or anesthesia 
367 
Child Centered Care (CCC) (figure 3 and 4) consists of: 
368 
 Oral and written information about MRI together with a demonstration of the process using a toy 
369 
scanner is given by a member of the research team to parents and patient. 
370 
 Movies from the hospital’s radiology department that prepare the child for the experience. 
371 
 An interactive app (Rumble in M I
R , free in App Store and Google Play Store) that prepares and 
372 
motivates the child. The troll character Rumble and 3D animations of rooms increase recognisability. 
373 
 A pediatric team of radiographers focus on the child feeling safe and secure. 
374 
 A child-friendly environment in the MRI room with lights and movies coordinated in themes known 
375 
from the app projected on the wall (“Philips Ambient Experience”, Philips Electronics, Koninklijke, 
376 
Netherlands). 
377 
 
378 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
16/31 
 
379 
 
380 
Figure 3 - Left) Rumble in MRI app. Right) Toy scanner from Playmobil® used to show children the procedure. 
381 
To further better the child’s experience, all MRIs are performed during daytime hours, preferably before 
382 
noon. Parents are asked to give the child pain medicine according to age and weight before leaving 
383 
home. Scans are performed with an above elbow splint on. 
384 
6.3.3 
MRI protocol 
385 
MRI examination (figure 4) of the elbow is performed using Philips dStream S flex coils on 3 Tesla MRI 
386 
scanners (Philips Ingenia Elition X 3T and Philips Ingenia 3T). Patients undergoing the examination will 
387 
have a splint on with the elbow flexed to 90 degrees. The splinted elbow is lowered beside the patient, 
388 
removing the respiratory artifact. The dStream S flex coils include two flexible coils which can obtain 10 
389 
cm coverage with a maximum of four channels. These coils are placed around the patients elbow 
390 
parallel to each other, and perpendicular to the static magnetization field. 
391 
 
392 
 
393 
 
394 
Figure 4 – A pediatric team of radiographers focus on the child feeling safe and secure. 
395 
The MRI protocol consists of three sequences with breaks in between; 3D WATS - 2 minutes and 32 
396 
seconds, T1 coronal – 2 minutes and 16 seconds and STIR coronal 3 minutes and 53 seconds. Total 
397 
scan time is less than 9 minutes. The most important information comes from the 3D WATS sequence 
398 
and in most cases the derived images will be sufficient to choose between non-operative or operative 
399 
treatment. 
400 
 
401 
In total, 45 minutes is set aside for receiving and briefing patient and parents, positioning the child and 
402 
completing the scans. Parents are invited to sit next to the child during the scan. The radiographers 
403 
involve the children by dialog and each child can choose the color of the room. The child holds the stop 
404 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
17/31 
button in his or her hand, so that they can press stop along the way. Communication with radiographers 
405 
is possible throughout the procedure. The procedure is stopped at any request from the child or parents 
406 
or if deemed necessary by the radiographers. 
407 
 
408 
3D Water Selective Excitation (WATS) 
409 
3D WATS is a fast field echo T1 weighted pulse sequence [33]. 3D WATS utilizes the chemical shift 
410 
artifact to differentiate between the frequencies of fat and water. The sequence applies a technique 
411 
where the water protons are selectively excited to induce fat suppression in cartilage. WATS is a 3D 
412 
imagery so it can be reconstructed with various slices in the computer after the scan. The 3D WATS 
413 
sequence is usually used for evaluation of cartilage. 
414 
 
415 
T1 
416 
T1 weighted images results from the differences in the T1 recovery times of the tissues. In T1 
417 
sequences, fat and degeneration has a high signal, where cortical bone, infection and cysts has a low 
418 
signal. T1 weighted images are used to portray the anatomy. 
419 
 
420 
Short Tau Inversion Recovery (STIR) 
421 
STIR is a pulse sequence that suppresses the signal from fat [34]. STIR is an important sequence in 
422 
musculoskeletal imaging showing lesions inside of the bone. A normal bone contains fat bone marrow 
423 
and STIR suppresses fat which shows lesions with bone marrow edema. 
424 
 
425 
Table 2: Specific scan parameters and scan times 
426 
6.3.4 
MRI results 
427 
The results of the MRI are reconstructed and read by senior MRI radiologists together with the PI. 
428 
Patient and parents are informed of the MRI findings and the following treatment (operative or non-
429 
operative) by the PI. 
430 
6.3.5 
Operative treatment 
431 
If the MRI cannot be completed for any reason, the images are insufficient in establishing fracture 
432 
pattern or if the MRI shows an unstable fracture which is displaced more than 2 mm, we will suggest 
433 
operative treatment with Kirschner wire fixation. Further participation in this project will be terminated. 
434 
Parameter 
3D WATS 
T1 COR 
STIR COR 
TR 
20 
Range (450-750) 750 3536 
TE 
4.9 
9 
60 
FA 
15 
90 
Inversion Recovery: 220 msek. 
Refocusing angle: 90* 
Scan mode 
3D 
2D 
2D 
Technique 
FFE 
SE (TSE) 
IR (TSE) 
Slice thickness 
3 mm 
3 mm 
3 mm 
Interslice gap 
-1.5 mm 
0.3 mm 
0.3 mm 
FOV 
150 x 150 
140 x 140 
130 x 130 
Voxel 
0.493 x 0.493 
0.5 x 0.53 
0.6 x 0.74 
Time 
2.32 min 
2.16 min  
3.53 min 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
18/31 
6.3.6 
Non-operative treatment 
435 
Patients with undisplaced and minimally displaced LHCF as seen on MRI will follow a non-operative 
436 
treatment protocol (appendix 1). The treatment consists of an above elbow splint until radiographic 
437 
union. Radiographic union usually occurs after four weeks; however, treatment will be continued until 
438 
callus formation is seen at the cortex of the metaphysis. 
439 
 
440 
Fractures that are not complete (e.g., do not traverse both metaphysis, physis, epiphysis and joint 
441 
cartilage) are considered stable. Complete fractures displaced <2 mm are considered unstable but still 
442 
eligible for non-operative treatment. All patients will be seen for FU as outlined in section 6.2. 
443 
 
444 
Any patient with a fracture seen to displace more than 2 mm during FU will be suggested operative 
445 
treatment. 
446 
7 
Definitions of outcome measures and study variables 
447 
7.1 
Primary outcome 
448 
7.1.1 
Mayo Elbow Performance Score (MEPS) 
449 
MEPS consists of four domains; pain, elbow range of motion (ROM), stability and function [35]. We use 
450 
a modified MEPS which omits the functional domain because it is not relevant in smaller children. The 
451 
total score ranges from 0-100 with higher scores indicating better function (figure 5). If the total score 
452 
ranges between 75 and 100, the result is good (satisfactory); 50–74, fair (acceptable); <50, poor 
453 
(unsatisfactory) [36]. MEPS has been found to be accurate and reliable compared to other elbow 
454 
scoring systems [37]. 
455 
 
456 
Figure 5 - Modified Mayo Elbow Performance Score. 
457 
 
458 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
19/31 
7.2 
Secondary outcomes 
459 
7.2.1 
MRI results 
460 
 Proportion of successful MRIs defined as a completed scan with an image quality that is useful for 
461 
analysis by the radiologist. 
462 
 MRI findings. 
463 
 Song classification based on MRI. 
464 
 Scan length (minutes). 
465 
 Any discomforts for the child during the scan. 
466 
7.2.2 
Radiographic results 
467 
Injury radiographs and subsequent radiographs during FU will be read and described by a senior 
468 
orthopedic surgeon. 
469 
7.2.3 
Secondary displacement 
470 
Any secondary displacement and amount of radiographic displacement (mm) is recorded. 
471 
7.2.4 
Pain 
472 
To quantify pain in the patient, an age appropriate rating scale is applied:  
473 
 Age <5 years: Face, Legs, Activity, Cry, Consolability Scale (FLACC) 
474 
 Age >4 years: Faces Pain Scale – Revised (FPS-R) 
475 
 Age >8 years: Visual analogue scale 
476 
 
477 
Face, Legs, Activity, Cry, Consolability Scale (FLACC) 
478 
To quantify pain behaviors in children who may not be able to verbalize the presence or severity of pain  
479 
FLACC [38] provides a simple framework. The child is observed for at least 2-5 minutes. Legs and body 
480 
are observed uncovered. Activity is observed and body is assessed for tenseness and tone. 
481 
 
482 
Behavior 
0 
1 
2 
Face 
No particular expression or 
smile 
Occasional grimace or 
frown, withdrawn, 
disinterested 
Frequent to constant 
quivering chin, clenched 
jow 
Legs 
Normal position or relaxed 
Uneasy, restless, tense 
Kicking or legs drawn up 
Activity 
Lying quietly, normal 
position, moves easily 
Squirming, shifting, back 
and forth, tense 
Arched, rigid or jerking 
Cry 
No cry (awake or asleep) 
Moans or whimpers; 
occasional complaint 
Crying steadily, screams, 
sobs, frequent complaints 
Consolability 
Content, relaxed 
Reassured by touching, 
hugging or being talked to, 
distractible 
Difficult to console or 
comfort 
 
483 
Assessment of Behavioural Score: 
484 
 0 = Relaxed and comfortable 
485 
 1-3 = Mild discomfort 
486 
 4-6 = Moderate pain 
487 
 7-10 = Severe discomfort/pain 
488 
 
489 
 
490 
 
491 
 
492 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
20/31 
Faces Pain Scale – Revised (FPS-R) 
493 
The Faces Pain Scale – Revised (FPS-R) [39] is used to quantify pain in children above four years of 
494 
age. It is a self-report measure of pain intensity developed for children. It was adapted from the Faces 
495 
Pain Scale [40] to make it possible to score the sensation of pain on a 0-to-10 metric. The scale shows 
496 
a close linear relationship with visual analog pain scales (VAS) across the age range of 4-16 years. 
497 
 
498 
 
499 
Figure 6 - Faces of the FPS-R. The child is instructed to point to the faces that shows how much pain the child is in at 
500 
that moment. Faces are scored 0, 2, 4, 6, 8 or 10 from left to right. 
501 
 
502 
FPS-R is easy to administer and requires no equipment except for the photocopied faces (figure 6). The 
503 
child is asked to point to the face that shows how much pain the child is in at that moment. Faces are 
504 
scored 0-10 so 0 equals no pain and 10 equals very much pain. 
505 
 
506 
Visual analogue scale 
507 
A visual analogue scale (VAS) (Figure 7) is used to quantify pain in children age 8 and above. VAS has 
508 
been extensively investigated in quantifying pain in older children [41,42]. The child is asked to put a 
509 
mark on the line corresponding to the child’s pain at that moment. A mark to the far left equals no pain 
510 
and a mark to the far right equals worst possible pain. The line is 10 cm long and the child’s mark is 
511 
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 
512 
cooperate to using VAS, FPS-R is used instead. 
513 
 
514 
 
515 
 
516 
Figure 7 - Visual analogue scale (VAS) for quantifying pain in children age 8 and above. 
517 
 
518 
 
519 
 
520 
 
521 
 
522 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
21/31 
8 
Statistical planning 
523 
8.1 
Hypotheses 
524 
 
525 
Minimally displaced LHCF (Song stage 1, 2 and 3) can be treated non-operatively based on MRI 
526 
findings with good functional outcomes after two years. 
527 
8.2 
Sample size considerations 
528 
 
529 
Samples size is estimated from previous studies which included less than 30 participants [22,23]. The 
530 
investigators of this study suspect that by enrolling 50 participants the age distribution and fracture 
531 
pattern variation will be representative of the background population. By enrolling 50 patients the 
532 
investigators suspect that any frequent and serious complications will be found. 
533 
8.3 
Statistical analysis 
534 
 
535 
Baseline characteristics and outcomes recorded at scheduled FU assessments will be presented using 
536 
simple summary statistics.  
537 
 
538 
 Categorical variables will be summarized using the frequency and percentage for each category. 
539 
 Continuous variables will be summarized using the mean, standard deviation (SD), median, inter-
540 
quartile range, and minimum and maximum values and, if appropriate, according to clinically relevant 
541 
categories.  
542 
 
543 
In general, continuous variables with both baseline and FU measurements available will also be 
544 
summarized in terms of the individual patient-level changes between baseline and follow-up. 
545 
 
546 
A p-value of <0.05 is regarded as being significant. Data will be analyzed using SPSS (SPSS, Chicago, 
547 
IL, USA). 
548 
8.3.1 
Patient discontinuation 
549 
If a participant chooses to discontinue the follow-up examinations for any reason, the date and reason 
550 
for drop-out is recorded and the latest examination will be carried forward in the analysis. In case of 
551 
drop-out before the first follow-up visit the participant will be excluded from the analysis. Participants are 
552 
only removed from the study if they decline participation. 
553 
9 
Bias 
554 
We strive to minimize bias in our study. Minimally displaced fractures of the elbow can go unnoticed and 
555 
be missed by our project. However, Danish parents are usually not withholding in taking an injured child 
556 
to the ED. A strict protocol for referrals for treatment are in place in Denmark. All eligible patients 
557 
referred to Herlev and Gentofte University Hospital will be asked to participate in the study. We 
558 
speculate that by enrolling 50 participants the cohort will be representative of the background 
559 
population. We speculate that these efforts will limit selection bias. Efforts described in the follow-up 
560 
section reduce the risk of loss to follow-up. Overall, we find a low risk of bias in our study for the chosen 
561 
study design and size. 
562 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
22/31 
10 Benefits 
563 
Classifying lateral condyle fractures and establishing whether they are stable or not is the key to 
564 
choosing the right treatment strategy. MRI is the only feasible image modality that can make that 
565 
distinction. 
566 
 
567 
LHCF is currently a fracture that requires open surgery in most cases due to the radiographic inability to 
568 
distinguish stable injuries from unstable. This project seeks to use MRI without sedation or GA in order 
569 
to distinguish fracture patterns. MRI has been shown to be feasible in all age groups without the need 
570 
for sedation or GA [24].  
571 
 
572 
Thévenin-Lemoine et.al. found that 25 of 27 children could successfully complete an MRI without 
573 
sedation or GA [23]. Of the 25 children, 17 (68%) had incomplete stable fracture patterns and six (24%) 
574 
had complete but minimally displaced fractures. In all, 23 (92%) children could be treated non-
575 
operatively. Two children had unstable and displaced fractures and underwent surgery. 
576 
 
577 
If proven safe and feasible, non-operative treatment for undisplaced and minimally displaced LHCF 
578 
would relieve the child of hospital admission, anesthesia and surgery and reduce parent’s need for time 
579 
off work and reduce overall healthcare costs. 
580 
 
581 
The investigators suspect a significant decrease in the need for operative management based on the 
582 
results of this project. 
583 
11 Risk analysis 
584 
The risks that occur in this study are associated with the general risks of non-operative treatment for 
585 
LHCF. 
586 
11.1 Treatment-related risks 
587 
Discomforts/risks from casting: 
588 
 Heat injury 
589 
 Pressure sores and skin breakdown 
590 
 Dermatitis 
591 
 Joint stiffness 
592 
11.2 Study disadvantages 
593 
Extra visits to the outpatient clinic. We follow all patients with seven visits to the outpatient clinic. This is 
594 
four more than with standard treatment and might be viewed as a disadvantage. 
595 
11.3 Study-related risks 
596 
11.3.1 Secondary displacement 
597 
During non-operative treatment of fractures, the risk of secondary displacement is well known. The risk 
598 
of secondary displacement of an initially undisplaced LHCF varies from 4% to more than 40% 
599 
depending on the initial stability and displacement [12]. As the initial stability in this study is evaluated by 
600 
MRI the investigators suspect that the risk of secondary displacement will be close to 4%. 
601 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
23/31 
11.3.2 Radiation 
602 
In comparison with the standard follow up of LHCF there are four additional visits to the out-patient clinic 
603 
with radiographs of the elbow in AP, ML and IO view. Collectively, the effective dosage is 0.004 mSv - 
604 
far below 0.1 mSv and is considered insignificant. 
605 
11.3.3 Loss of privacy 
606 
Patients' private and confidential medical information may get disclosed and confidentiality broken. 
607 
 
608 
11.4 
Actions to minimize increased risks 
609 
General treatment-related risks will be present whether the patient participates in the study or not. Such 
610 
risks will be managed by use of standards of treatment, i.e. casting by trained physicians and nurses. 
611 
 
612 
Risk of unnoticed secondary displacement is lowered by an increased number of FUs with radiographs 
613 
and MRI in case of unstable injury. 
614 
 
615 
The risk of loss of privacy and confidentiality will be managed by strict adherence to data safety and 
616 
security procedures explained elsewhere in this CIP. 
617 
 
618 
The study will be implemented according to current valid international guidelines (ICH-GCP and ISO 
619 
14155). The ethical position is based on the Declaration of Helsinki, thus guaranteeing optimal 
620 
protection of patient interests. 
621 
12 Informed consent process 
622 
12.1 Special considerations to consent pediatric patients 
623 
In this pediatric study, the parent(s) or legal guardian(s) are informed face-to-face about the study and 
624 
provide informed consent using specific patient information and ICF. In any case, the child is informed 
625 
orally in an adequate way.  
626 
 
627 
Written informed consent needs to be obtained from the parent(s) or legal guardian(s). Assent is 
628 
obtained from any child considered to be able to understand the basic information provided.  
629 
 
630 
A member of the research team will, in an undisturbed environment, explain using a plain, 
631 
understandable language, movies and toys to each participant and parents the nature of the study, its 
632 
purpose, the procedures involved, the expected duration, the potential risks and benefits and any 
633 
discomfort it may entail. 
634 
 
635 
Parents and children will be informed that the participation in the study is completely voluntary and that 
636 
they may withdraw from the study at any time and that withdrawal of consent will not affect subsequent 
637 
medical assistance and treatment.  
638 
 
639 
The participant’s parents will be informed that their child’s medical records will be examined directly by 
640 
authorized individuals involved in the study. 
641 
 
642 
Consent will be obtained from every patient’s parents before any study-specific procedures or 
643 
assessments take place. 
644 
 
645 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
24/31 
Parents will be provided specific information and ICF describing the study and providing sufficient 
646 
information for the parents to make an informed decision about their child’s participation in the study 
647 
together with general information about participating in a research project from the Danish National 
648 
Committee on Health Research Ethics. 
649 
 
650 
Parents will in most cases have at least 24 hours to consider enrollment however, there might be factors 
651 
(e.g. late presentation to the ED) that dictate more emergent treatment requiring consent with less 
652 
consideration time. 
653 
 
654 
The parents will signify their willingness to let their child participate in the study by signing and dating a 
655 
personal copy of the approved ICF. The consent form must also be signed and dated by a member of 
656 
the research team and it will be retained as part of the study records. The investigator will keep the 
657 
original ICF in the ISF and provide the patient’s parents with a copy. 
658 
13 Adverse event reporting 
659 
In this clinical investigation no medical devices are used and based on the risk analyses, AEs or serious 
660 
AEs (SAEs) according to ISO 14155 are not collected. 
661 
14 Data management 
662 
This project complies with the EU’s General Data Protection Regulation (GDPR) according to the 
663 
Danish law on data protection Databeskyttelsesloven and Databeskyttelsesforordningen. 
664 
 
665 
In order to plan and conduct visits we ask that consent is given to access the patient’s EHR. We ask 
666 
permission to retrieve patient-related data and to read entries regarding visits. We ask permission to 
667 
access radiographs and MRIs. We ask that access the patient’s EHR is given until the conclusion of the 
668 
project. No access to the patient’s EHR regarding the study is made before informed consent to 
669 
participate is given. 
670 
 
671 
Consent gives the person responsible for the trial and the relevant authorities direct access to obtain 
672 
information in the patient's medical records for the purpose of carrying out the project as well as for 
673 
control purposes. 
674 
14.1 Data collection, source data, storage and archiving 
675 
Data management will be performed by the PI. Data handling and protection are conducted according to 
676 
the ISO 14155 guidelines and ICH-GCP and applicable regulations. 
677 
 
678 
The eCRF collects data from each participant. Specifically all data on each patient participating in the 
679 
study are documented in the eCRF. The eCRF contains data items as specified in this CIP. Modification 
680 
of the eCRF will be made only if deemed necessary and in accordance with any amendment to the CIP. 
681 
 
682 
The patient’s hospital records are stored securely in the hospital’s EHR (Epic Systems Corporation, 
683 
Verona, Wisconsin, USA). 
684 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
25/31 
14.1.1 Electronic CRF 
685 
For this study, an eCRF is designed to accommodate the specific features of the study design. Access 
686 
to the eCRF is password protected. The project’s eCRF is stored securely using Research Electronic 
687 
Data Capture (RedCAP, Vanderbilt University, USA). The eCRF is to be completed in a timely manner 
688 
after a patient’s visit (i.e. 14 days after occurrence of a documentable event). 
689 
14.2 Imaging data 
690 
Radiographs and MRIs are stored securely in the hospital’s Picture archiving and communication 
691 
system (PACS). 
692 
14.3 Confidentiality 
693 
Privacy and confidentiality of the patient's medical data will be maintained through the study. 
694 
 
695 
Fully identifiable information may be reviewed for the purpose of verifying data in the eCRF. This can be 
696 
carried out by the PI. Personal medical information will be treated as confidential at all times. The 
697 
informed consent document will contain information about the confidentiality of the medical information 
698 
and approval for the access. 
699 
15 Regulatory affairs 
700 
The CIP, associated documents, investigator’s financial disclosure, the patient information and ICFs will 
701 
be sent to a respective EC for evaluation and approval. The relevant EC will be kept informed about the 
702 
study progress and events according to their specific regulations and procedures. 
703 
16 Disclosures and economy 
704 
The initiative for this study has been taken solely by the investigators. The investigators and affiliated 
705 
colleagues have not received any financial payments or other benefits from any commercial entity 
706 
related to the subject of this project. The investigators declare that they have no conflict of interest. 
707 
 
708 
Participants do not receive any economic benefits or gifts from the participation in this project. 
709 
 
710 
All expenses are paid for by the sponsor. 
711 
17 Patient insurance 
712 
As with any treatment in the Danish healthcare system all patients are insured and covered by The 
713 
Patient Compensation Association (Patienterstatningen). 
714 
18 Study report and publication policy 
715 
18.1 Final Study Report 
716 
The results of the statistical evaluation will be summarized in a report, which forms the basis for the 
717 
comprehensive FSR. The comprehensive FSR forms the basis for all future publications. 
718 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
26/31 
18.2 Publication 
719 
The study protocol and the trial will be registered with Clinicaltrials.gov 
720 
 
721 
The results, both positive, negative and inconclusive, will be sent for submission in a peer reviewed 
722 
international orthopedic journal, and the results will be presented at national and international scientific 
723 
meetings. Reporting will adhere to the STROBE guidelines for cohort studies [31]. 
724 
19 Termination criteria 
725 
The progress of the study, in particular the enrollment and safety aspects, will be closely monitored 
726 
together with the sponsor. The sponsor may decide to terminate the. In case of an early study 
727 
termination, all patients already enrolled in the study will be followed up until the last FU visit as defined 
728 
in the CIP. 
729 
19.1 Stopping rules 
730 
The recruitment will be put on hold for safety reason if: 
731 
 
732 
 Secondary displacement of more than 2 mm during FU in > 75% of cases at interim analysis. 
733 
 
734 
In such a case, the reported complication will be discussed with the sponsor. The sponsor will decide 
735 
about the actions to be taken and if the study needs to be stopped or not. 
736 
20 Deviations from the Clinical Investigation Plan 
737 
Deviations from the procedures as described in this CIP or altering the CIP without following a defined 
738 
process are not permitted. 
739 
 
740 
A CIP deviation is any non-adherence to the protocol that does not involve the inclusion/exclusion 
741 
criteria, primary efficacy variable, and GCP guidelines. CIP deviations are minor and do not impact the 
742 
study in a major way. CIP deviations are to be reported to the sponsor within ten working days. 
743 
 
744 
A CIP violation is any significant divergence from the protocol on the part of the patient, investigator, 
745 
sponsor, or any other responsible party that affects e.g. the inclusion/exclusion criteria, primary efficacy 
746 
variable, or GCP guidelines. Violations will be recorded at the study site and in the eCRF. 
747 
21 Amendments to the Clinical Investigation Plan 
748 
No changes to the approved CIP are allowed, except when the change removes immediate threats for 
749 
the patient safety or is of a purely administrative or logistic nature. 
750 
 
751 
Should there be any need during the performance of the study to change this CIP, an amendment will 
752 
be developed, issued and approved by or notified to the required bodies. 
753 
 
754 
 
755 
 
756 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
27/31 
22 Time schedule 
757 
Ethics Committee approvals 
28.06.2021 
to 
01.09.2021 
First patient/first visit 
01.10.2021 
 
 
Last patient/first visit 
01.10.2023 
 
 
Last patient/last visit 
01.10.2025 
 
 
Data analysis 
01.11.2025 
to 
01.03.2026 
Final Study Report 
01.03.2026 
to 
01.06.2026 
23 Authors 
758 
CIP developed by 
759 
 
760 
PCI 
Department of Orthopedic Surgery 
Copenhagen University Hospital - Herlev 
and Gentofte, Copenhagen, Denmark 
Project Manager 
Morten Jon Andersen 
Additional author(s) 
Peter Søndergaard, MD 
Bo Sanderhoff Olsen, MD, ph.d., professor 
Jeppe Vejlgaard Rasmussen, MD, ph.d. 
 
761 
 
762 
CIP approval signatures 
763 
 
764 
Name 
Function 
Date 
Signature 
Morten Jon 
Andersen 
Principal Coordinating 
Investigator 
 
 
 
765 
Name 
Function 
Date 
Signature 
Bo Sanderhoff 
Olsen 
Director of institution 
 
 
 
766 
With signing this statement, I agree and confirm: 
767 
 To have read and understood this CIP and to have informed and to have supervised the appropriate 
768 
training of all research team members of this study site involved with the conduct of the study. 
769 
 To assume responsibility to conduct the study in compliance with this protocol and future 
770 
amendments at this study site. 
771 
 To obtain written approval the independent EC before initiating the clinical investigation at this study 
772 
site. 
773 
 To not implement any changes to the protocol or the corresponding procedures without written 
774 
agreement from the sponsor and the EC, except where necessary to eliminate immediate risk to the 
775 
study patients. 
776 
 That I and all team members involved in the conduct of this clinical investigation are aware and 
777 
trained in aspects of ICH-GCP and all applicable regulatory requirements. 
 
778 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
28/31 
24 Reference list 
779 
1.  
Rang M, Pring ME, Wenger DR. Rang’s Children’s Fractures. 3. udg. Lippincott Williams & 
780 
Wilkins; 2005. 
781 
2.  
Kamegaya M, Shinohara Y, Kurokawa M, et al. Assessment of stability in children’s minimally 
782 
displaced lateral humeral condyle fracture by magnetic resonance imaging. J Pediatr Orthop 
783 
1999;19:570–2. 
784 
3.  
Horn BD, Herman MJ, Crisci K, et al. Assessment of stability in children’s minimally displaced 
785 
lateral humeral condyle fracture by magnetic resonance imaging. J Pediatr Orthop 2020;90:30–
786 
5. 
787 
4.  
Horn BD, Herman MJ, Crisci K, et al. Fractures of the lateral humeral condyle: Role of the 
788 
cartilage hinge in fracture stability. J Pediatr Orthop 2002;22:8–11. 
789 
5.  
Beltran J, Rosenberg ZS, Kawelblum M, et al. Pediatric elbow fractures: MRI evaluation. Skelet 
790 
Radiol A J Radiol Pathol Orthop 1994;23:277–81. 
791 
6.  
Houshian S, Mehdi B, Larsen MS. The epidemiology of elbow fracture in children: Analysis of 
792 
355 fractures, with special reference to supracondylar humerus fractures. J Orthop Sci 2001; 
793 
7.  
Waters PM, Skaggs DL, Flynn JM (Jack), et al. Rockwood and Wilkins’ fractures in children. 9. 
794 
udg. Wolters Kluwer; 2019. 
795 
8.  
Naranje SM, Erali RA, Warner WC, et al. Epidemiology of Pediatric Fractures Presenting to 
796 
Emergency Departments in the United States. J Pediatr Orthop 2016;36:e45–8. 
797 
9.  
Hedström EM, Svensson O, Bergström U, et al. Epidemiology of fractures in children and 
798 
adolescents: Increased incidence over the past decade: A population-based study from northern 
799 
Sweden. Acta Orthop 2010;81:148–53. 
800 
10.  
Rennie L, Court-Brown CM, Mok JYQ, et al. The epidemiology of fractures in children. Injury 
801 
2007;38:913–22. 
802 
11.  
Landin LA, Danielsson LG. Elbow fractures in children: An epidemiological analysis of 589 
803 
cases. Acta Orthop 1986;57:309–12. 
804 
12.  
Pirker ME, Weinberg AM, Höllwarth ME, et al. Subsequent displacement of initially nondisplaced 
805 
and minimally displaced fractures of the lateral humeral condyle in children. J Trauma - Inj Infect 
806 
Crit Care 2005;58:1202–7. 
807 
13.  
Abzug JM, Dua K, Kozin SH, et al. Current Concepts in the Treatment of Lateral Condyle 
808 
Fractures in Children. J Am Acad Orthop Surg 2019;00:1. 
809 
14.  
Song KS, Kang CH, Min BW, et al. Internal oblique radiographs for diagnosis of nondisplaced or 
810 
minimally displaced lateral condylar fractures of the humerus in children. J Bone Jt Surg - Ser A 
811 
2007;89:58–63. 
812 
15.  
Goodwin SJ, Irwin LJ, Irwin GJ. Gender differences in the order of appearance of elbow 
813 
ossification centres. Scott Med J 2019;64:2–9. 
814 
16.  
Shrader W, Campbell M, Jacofsky D. Accuracy of emergency room physicians’ interpretation of 
815 
elbow fractures in children. Orthopedics Orthopedics; 2008;31:1177. 
816 
17.  
Milch H. Fractures and fracture dislocations of the humeral condyles. J Trauma - Inj Infect Crit 
817 
Care 1964;4:592–607. 
818 
18.  
Song KS, Chul HCK, Byung WM, et al. Closed reduction and internal fixation of displaced 
819 
unstable lateral condylar fractures of the humerus in children. J Bone Jt Surg - Ser A 
820 
2008;90:2673–81. 
821 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
29/31 
19.  
Song KS, Waters PM. Lateral condylar humerus fractures: Which ones should we fix? J Pediatr 
822 
Orthop 2012;32:5–9. 
823 
20.  
Bast SC, Hoffer MM, Aval S. Nonoperative treatment for minimally and nondisplaced lateral 
824 
humeral condyle fractures in children. J Pediatr Orthop 1998;18:448–50. 
825 
21.  
Weiss JM, Graves S, Yang S, et al. A new classification system predictive of complications in 
826 
surgically treated pediatric humeral lateral condyle fractures. J Pediatr Orthop 2009;29:602–5. 
827 
22.  
Haillotte G, Bachy M, Delpont M, et al. The Use of Magnetic Resonance Imaging in Management 
828 
of Minimally Displaced or Nondisplaced Lateral Humeral Condyle Fractures in Children. Pediatr 
829 
Emerg Care 2017;33:21–5. 
830 
23.  
Thévenin-Lemoine C, Salanne S, Pham T, et al. Relevance of MRI for management of non-
831 
displaced lateral humeral condyle fractures in children. Orthop Traumatol Surg Res 
832 
2017;103:777–81. 
833 
24.  
Runge SB, Christensen NL, Jensen K, et al. Children centered care: Minimizing the need for 
834 
anesthesia with a multi-faceted concept for MRI in children aged 4–6. Eur J Radiol Elsevier; 
835 
2018;107:183–7. 
836 
25.  
Hallowell LM, Stewart SE, De Amorim E Silva CT, et al. Reviewing the process of preparing 
837 
children for MRI. Pediatr Radiol Pediatr Radiol; 2008. s. 271–9. 
838 
26.  
Raschle NM, Lee M, Buechler R, et al. Making MR imaging child’s play - Pediatric neuroimaging 
839 
protocol, guidelines and procedure. J Vis Exp 2009;29:1–6. 
840 
27.  
De Bie HMA, Boersma M, Wattjes MP, et al. Preparing children with a mock scanner training 
841 
protocol results in high quality structural and functional MRI scans. Eur J Pediatr 
842 
2010;169:1079–85. 
843 
28.  
Cahoon GD, Davison TE. Prediction of compliance with MRI procedures among children of ages 
844 
3 years to 12 years. Pediatr Radiol 2014;44:1302–9. 
845 
29.  
Ahmad R, Hu HH, Krishnamurthy R, et al. Reducing sedation for pediatric body MRI using 
846 
accelerated and abbreviated imaging protocols. Pediatr Radiol Pediatr Radiol; 2018;48:37–49. 
847 
30.  
Barnea-Goraly N, Weinzimer SA, Ruedy KJ, et al. High success rates of sedation-free brain MRI 
848 
scanning in young children using simple subject preparation protocols with and without a 
849 
commercial mock scanner-the Diabetes Research in Children Network (DirecNet) experience. 
850 
Pediatr Radiol 2014;44:181–6. 
851 
31.  
Vandenbroucke JP, Von Elm E, Altman DG, et al. Strengthening the Reporting of Observational 
852 
Studies in Epidemiology (STROBE): Explanation and elaboration. Epidemiology 2007;18:805–
853 
35. 
854 
32.  
Dill T. Contraindications to magnetic resonance imaging: non-invasive imaging. Heart England; 
855 
2008;94:943–8. 
856 
33.  
Tawfik AI, Kamr WH, Taman SE. Comparison of 2D Fat Suppressed Proton Density (FS-PD) 
857 
and 3D (WATS-c) MRI pulse sequences in evaluation of chondromalacia patellae. Egypt J 
858 
Radiol Nucl Med 2019;50:85. 
859 
34.  
Bitar R, Leung G, Perng R, et al. MR pulse sequences: What every radiologist wants to know but 
860 
is afraid to ask. Radiographics 2006. s. 513–37. 
861 
35.  
Morrey BF. The elbow and its disorders. Saunders; 2008. 
862 
36.  
Longo UG, Franceschi F, Loppini M, et al. Rating systems for evaluation of the elbow. Br Med 
863 
Bull 2008; 
864 
37.  
Cusick MC, Bonnaig NS, Azar FM, et al. Accuracy and reliability of the mayo elbow performance 
865 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
30/31 
score. J Hand Surg Am 2014; 
866 
38.  
Merkel, Voepel-Lewis, Shayevitz, et al. The FLACC: a behavioral scale for scoring postoperative 
867 
pain in young children. Pediatr Nurs 1997;23:293–7. 
868 
39.  
Hicks CL, Von Baeyer CL, Spafford PA, et al. The Faces Pain Scale - Revised: Toward a 
869 
common metric in pediatric pain measurement. Pain 2001;31:1177. 
870 
40.  
Bieri D, Reeve RA, Champion GD, et al. The faces pain scale for the self-assessment of the 
871 
severity of pain experienced by children: Development, initial validation, and preliminary 
872 
investigation for ratio scale properties. Pain 1990;41:139–50. 
873 
41.  
Huguet A, Stinson JN, McGrath PJ. Measurement of self-reported pain intensity in children and 
874 
adolescents. J Psychosom Res 2010;68:329–36. 
875 
42.  
Bailey B, Gravel J, Daoust R. Reliability of the visual analog scale in children with acute pain in 
876 
the emergency department. Pain 2012;153:839–42. 
877 
 
878 

Non-operative treatment of pediatric lateral humeral condyle fractures 
Protocol ID: H-21017621 
Version 3.0, July 30, 2021 
 
AO Foundation | AO Education Institute 
Stettbachstrasse 6 | 8600 Duebendorf | Switzerland 
Phone: +41 81 414 21 11 | E-mail: aopeer@aofoundation.org | www.aopeer.org 
31/31 
Appendix 1 - Diagnosis and Treatment Protocol 
879