Casting vs Surgical Treatment of Children With Medial Epicondyle Fractures: A Randomized Clinical Trial
Grahn, Petra; Helenius, Ilkka; Hämäläinen, Tero; Kivisaari, Reetta; Nietosvaara, Yrjänä; Sinikumpu, Juha-Jaakko; Jalkanen, Jenni; Löyttyniemi, Eliisa; Ahonen, Matti; for the Finnish Pediatric Orthopedic Study Group Investigators (2025-03-06)
Grahn, Petra
Helenius, Ilkka
Hämäläinen, Tero
Kivisaari, Reetta
Nietosvaara, Yrjänä
Sinikumpu, Juha-Jaakko
Jalkanen, Jenni
Löyttyniemi, Eliisa
Ahonen, Matti
for the Finnish Pediatric Orthopedic Study Group Investigators
JAMA Network
06.03.2025
Grahn, P., Helenius, I., Hämäläinen, T., Kivisaari, R., Nietosvaara, Y., Sinikumpu, J.-J., Jalkanen, J., Löyttyniemi, E., Ahonen, M., Finnish Pediatric Orthopedic Study Group Investigators, Ahola, J.-A., Laaksonen, T., Zilliacus, K., Raitio, A., & Lastikka, M. (2025). Casting vs surgical treatment of children with medial epicondyle fractures: A randomized clinical trial. JAMA Network Open, 8(5), e258479. https://doi.org/10.1001/jamanetworkopen.2025.8479.
https://creativecommons.org/licenses/by/4.0/
© The Author(s) 2025. This is an open access article distributed under the terms of the CC-BY license, which permits unrestricted use, distribution, and reproduction in any medium. You are not required to obtain permission to reuse this article content, provided that you credit the author and journal.
https://creativecommons.org/licenses/by/4.0/
© The Author(s) 2025. This is an open access article distributed under the terms of the CC-BY license, which permits unrestricted use, distribution, and reproduction in any medium. You are not required to obtain permission to reuse this article content, provided that you credit the author and journal.
https://creativecommons.org/licenses/by/4.0/
Julkaisun pysyvä osoite on
https://urn.fi/URN:NBN:fi:oulu-202505073129
https://urn.fi/URN:NBN:fi:oulu-202505073129
Tiivistelmä
Abstract
Importance
Displaced pediatric medial humeral epicondyle fractures are traditionally treated nonoperatively with casting. However, the use of surgical treatment has increased despite limited high-level evidence supporting its benefits.
Objective
To determine whether open surgical reduction and internal fixation improve functional outcomes compared with long arm casting in children with displaced medial humeral epicondyle fractures at 12 months post injury.
Design, Setting, and Participants
This noninferiority randomized clinical trial was conducted in 4 university hospitals in Finland between August 30, 2019, and August 22, 2023, with a 12-month follow-up completed August 20, 2024. Participants included children (aged 7-16 years) with nonincarcerated medial humeral epicondyle fractures and more than 2 mm of displacement. Data analysis was based on intention to treat.
Interventions
Open reduction and fixation, followed by a long arm cast for 4 weeks, or long arm cast without reduction for 4 weeks.
Main Outcome and Measure
The primary outcome was the Quick Disabilities of the Arm, Shoulder, and Hand (QDASH) score at 12 months (range, 0-100 points, with 0 denoting no disability and 100 extreme disability; prespecified noninferiority margin was 6.8 points).
Results
Seventy-two patients were randomized (43 [59.7%] female; mean [SD] age, 12.1 [2.1] years; range, 7.9-15.9 years), with 37 (19 [51.4%] female) to the surgery group (mean [SD] age, 12.2 [2.3] years; range, 7.9-15.9 years) and 35 (24 [68.6%] female) to the cast group (mean [SD] age, 11.9 [2.0] years; range 7.9-15.9 years). At 12 months, the mean QDASH score was 1.73 (95% CI, 0.65-2.81) in the surgery group and 2.71 (95% CI, 0.52-4.90) in the cast group, showing noninferiority (mean difference, −0.98 [95% CI, −2.95 to 0.98] points). The cosmetic visual analog scale favored the cast group, with a statistically significant between-group difference of −8.9 points (95% CI, −16.6 to −1.2 points; P < .001). Nonunion occurred in 1 of 37 surgically treated patients (2.7%) and 24 of 35 cast-treated patients (68.6%). No crossovers from casting to surgery occurred.
Conclusions and Relevance
In this randomized clinical trial of displaced medial epicondyle fractures, treatment with casting alone was noninferior at 12 months to surgical reduction and internal fixation followed by casting. Findings support nonoperative care as effective at 1 year; longer-term outcomes remain to be studied.
Trial Registration
ClinicalTrials.gov Identifier: NCT04531085
Importance
Displaced pediatric medial humeral epicondyle fractures are traditionally treated nonoperatively with casting. However, the use of surgical treatment has increased despite limited high-level evidence supporting its benefits.
Objective
To determine whether open surgical reduction and internal fixation improve functional outcomes compared with long arm casting in children with displaced medial humeral epicondyle fractures at 12 months post injury.
Design, Setting, and Participants
This noninferiority randomized clinical trial was conducted in 4 university hospitals in Finland between August 30, 2019, and August 22, 2023, with a 12-month follow-up completed August 20, 2024. Participants included children (aged 7-16 years) with nonincarcerated medial humeral epicondyle fractures and more than 2 mm of displacement. Data analysis was based on intention to treat.
Interventions
Open reduction and fixation, followed by a long arm cast for 4 weeks, or long arm cast without reduction for 4 weeks.
Main Outcome and Measure
The primary outcome was the Quick Disabilities of the Arm, Shoulder, and Hand (QDASH) score at 12 months (range, 0-100 points, with 0 denoting no disability and 100 extreme disability; prespecified noninferiority margin was 6.8 points).
Results
Seventy-two patients were randomized (43 [59.7%] female; mean [SD] age, 12.1 [2.1] years; range, 7.9-15.9 years), with 37 (19 [51.4%] female) to the surgery group (mean [SD] age, 12.2 [2.3] years; range, 7.9-15.9 years) and 35 (24 [68.6%] female) to the cast group (mean [SD] age, 11.9 [2.0] years; range 7.9-15.9 years). At 12 months, the mean QDASH score was 1.73 (95% CI, 0.65-2.81) in the surgery group and 2.71 (95% CI, 0.52-4.90) in the cast group, showing noninferiority (mean difference, −0.98 [95% CI, −2.95 to 0.98] points). The cosmetic visual analog scale favored the cast group, with a statistically significant between-group difference of −8.9 points (95% CI, −16.6 to −1.2 points; P < .001). Nonunion occurred in 1 of 37 surgically treated patients (2.7%) and 24 of 35 cast-treated patients (68.6%). No crossovers from casting to surgery occurred.
Conclusions and Relevance
In this randomized clinical trial of displaced medial epicondyle fractures, treatment with casting alone was noninferior at 12 months to surgical reduction and internal fixation followed by casting. Findings support nonoperative care as effective at 1 year; longer-term outcomes remain to be studied.
Trial Registration
ClinicalTrials.gov Identifier: NCT04531085
Kokoelmat
- Avoin saatavuus [37920]