1. Ethics approval and consent to participate
In the Clinic, the humeral supracondylar fractures with operative indication, unstable, were treated by fixation with two K-wires placed in “inverted V”, a procedure taken from Prof. Vereanu. The high rate of complications generated by the secondary displacements that occurred after the configuration of two pins passed through the two pillars (in "inverted V"), suggested changing this configuration to "X" or "double X" to ensure the best possible fixation. The newly implemented (experimental) protocol provided that the two pins be externalized through the opposite corticis to strengthen the fixation and, if necessary, for a better fixation, to place two more pins, one on each side, parallel to the first. All four pins were passed through the pillars of the humeral palette, two through the medial pillar and two through the lateral pillar, creating a "double X" configuration. This experimental protocol was approved by the Pediatric Orthopedics Commission of the Romanian Society of Pediatric Surgery (”Societatea Română de Chirurgie pediatrică” - SRCP). The Commission was formed by Prof. Alexandru Pesamosca, Assoc. Prof. Ștefan Puiu and Dr. Elvira Marin. All indications given in the study protocol have been made in accordance with the regulations mentioned in the experimental program.
All the parents of the patients operated in the period 2001-2020, to whom “Double X” fixation of the fracture was applied, were notified of this therapeutic eventuality and gave their consent on a special Consent Form attached to the Observation Sheet. Patients knew that two or three K-wires would be used in a variable configuration.
2. Consent for publication
All legally authorized representatives (parents, legal guardians, etc.) of the operated children agreed to participate in this study and for publication of the results, by signing an Informed Consent, attached to the observation sheets.
The images in Figure 3 are of a patient aged 3 years and 8 months. The mother gave her consent for publication on an Institutional Form (the Clinic’s Consent form for treatment, where the child was treated).
3. Availability of Data and Materials
a) The first paper on "double X" fixation of supracondylar fractures in children was communicated in 2011 at the Fourth Congress of the Romanian Association of Traumatologists and Pediatric Orthopedists (ARTOP): Burnei G, Georgescu I, Hodorogea D, Gavriliu Ș, Andreescu A, Breha A. Intricate double X osteosynthesis in supracondylar fractures of the humerus and femur (personal practice procedure), Al IV-lea ARTOP Congress, Bucharest, 6-8 October 2011 (Codex Aureus, Year II, no.2, October 2011, 47-8). The paper is published in the Congress Program.
b) In 2013, a paper (poster) was presented at the 32nd EPOS Congress in Greece: Burnei G. et al. Double X Osteosynthesis in Humeral Supracondylar Fractures with Malunion and Joint Stiffness Risks. 32nd EPOS Annual Meeting; 17-20 of April 2013; Athens, Greece.
c) In 2013 Georgescu I. et al. published an article in JML: Georgescu I, Gavriliu Ş, Pârvan A, Martiniuc A, Japie E, Ghiță R, Drăghici I, Hamei Ş, Ţiripa I, El Nayef T, Dan D. Burnei’s “double X” internal fixation technique for supracondylar humerus fractures in children: indications, technique, advantages and alternative interventions. Study and Research Group in Pediatric Orthopaedics-2012. Journal of Medicine and Life Vol. 6, Issue 2, April-June 2013.
This paper has been cited 7 times.
d) In 2013, Gomez VE reviews and updates treatment methods in supracondylar fractures in children: Gómez VE, Gil Albarova J, Herrera A. Revisión y actualización del tratamiento de las fracturas supracondíleas de húmero en la infancia. Rev Esp Cir Osteoar. 2013;48(255):110-22.
e) In 2014, Molina Mata M. mentions this technique in: Molina Mata M. Trabajo de fin de grado: Complicaciones de las fractura supracondileas del humero el la infancia. 2014-2015; 3-25 Curso Academico, Facultad Medicina Universidad Zaragoza. Tutor: Dr. Jorge Gil Albarova. Servicio de Cirugía Ortopédica y Traumatología Hospital Universitad de Zaragoza
f) In 2020, on January 27, an article is published in the Annals of Clinical and Medical Case Reports (ACMCR): Burnei G, Burnei C, Enache FD, Daraban AM and Raducan ID. “Double X” Cross Fixation in Paediatric Supracondylar Humerus Fractures: A 20-Year Expertise and 94 Surgical Interventions. Annals of Clinical and Medical Case Reports. 2020; V5(6): 1-12, and in the abstract is mentioned at Study Design the following: „1.3. Study Design: This is a retrospective study. The 94 cases referred in this paper have been subject to surgical interventions conducted from 2001 to 2020 and they all include data on the cas- es I have operated as well as essential details collected by Breha A (50 cases) and Moroi-Manea O (35 cases) who have also pre- pared bachelor's degree theses for the title of Bachelor of Science in Medicine (MD). In 2013, on the opportunity of the 32nd EPOS Annual Meeting, I presented 56 cases I had operated from 2001 to 2011; and starting from 2012 until the current year, 2020, I have successfully operated another 38 cases”.
Statistical data for 50 cases and 35 cases, respectively, were extracted from the observation sheets in the archives of the MS Curie Bucharest Children's Emergency Hospital. They were the subject of a bachelor's thesis to obtain the title of medical doctor and are deposited in the archives of UMF Bucharest.
The observation sheets of the other nine cases operated at Macta Clinic Constanța are stored in the Clinic's archive.
Dr. Breha Anca's paper is mentioned in the references of the paper from ACMCaseReports: Burnei G, Burnei C, Enache FD, Daraban AM and Raducan ID. “Double X” Cross Fixation in Paediatric Supracondylar Humerus Fractures: A 20-Year Expertise and 94 Surgical Interventions. Annals of Clinical and Medical Case Reports. 2020; V5(6): 1-12, as reference no. 64.
4. Competing interests
The authors declare that they have no competing interests.
THE GROUP FOR STUDIES AND RESEARCH IN TRAUMA AND PEDIATRIC ORTHOPAEDICS - CONSTANȚA 2021, with funds from the members' contribution.
6. Authors’ Contributions
BG – designed and wrote the article
RDI – analyzed and interpreted the data of 35 operated patients
EFD – followed nine patients operated in the Macta Constanța Clinic and analyzed and interpreted their data. He also translated the article into English.
DAM – analyzed and interpreted the data of 30 operated patients
ACR - analyzed and interpreted the data of 20 operated patients
BC – made drawings, prepared the images and wrote the legends of the four figures.
All authors read and approved the final manuscript.
We thank Dr. Anca Breha and Dr. Olesea Moroi-Manea for the statistical data and tables provided. We also thank Dr. Mihaela Bănculescu, an anesthesiologist who individualized a practical method for anesthesia and treatment in the first two days postoperatively. The method is set out in the text and represents the information provided by Dr. Bănculescu.