Treatment of Displaced Medial Epicondyle Fractures In Children

Fractures, Bone Clinical Trial

Official title:

Comparison Between Operative And Non-operative Treatment of Displaced Medial Epicondyle Fractures In Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06454929
• Other study ID #: Medial Epicondyle Fracture
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: July 1, 2026

Study information

• Verified date: June 2024
• Source: Assiut University
• Contact: ahmed ezzat M eltaweel, Physician
• Phone: 01068950894
• Email: ahmed.15235479[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compare the outcome of the operative and non-operative treatment; for fractures of the medial epicondyle of humerus in children as regards union, alignment and complications.

Description:

On the distal humerus, posteromedially, is where the medial epicondyle apophysis is situated. It serves as the starting point for the flexor-pronator muscle and the ulnar collateral ligament. 12-20% of pediatric elbow fractures have been reported to be caused by fractures of the medial humeral epicondyle. Thirty to fifty percent of these fractures result in elbow dislocation, and eighteen to twenty percent of the fracture fragments become lodged in the elbow joint. The medial epicondyle fractures typically happen between the ages of 9 and 14 due to the insufficient ossification of the bone, which makes it more prone to failure early than the stronger soft-tissue attachments.

Optimal treatment for pediatric medial epicondyle fractures continues to be a topic of debate.

In the face of technical advancements, evolving surgical indications, and societal pressures, there is little concrete data demonstrating the superiority of either operative or non-operative treatment.

When a child's medial humeral epicondyle fracture is minimally displaced (less than 2 mm), non-operative therapy is recommended. The PedsQL Pediatric discomfort Questionnaire revealed that children who received non-operative treatment experienced reduced discomfort (3 vs. 15, p = 0.01) and had superior cosmetic results. There is a great deal of disagreement about how to treat displaced fractures (3-15 mm), with some surgeons supporting internal fixation as the non-union rate drops significantly. For upper-extremity athletes who need elbow stability to play their sport, surgery is also advised. Furthermore, it has been proposed that there are no statistically significant variations in outcomes between surgical and non-operative groups.

Fractures of the medial humeral epicondyle in children heal well with 3-4 weeks' immobilization. There is no common consensus in treatment of closed medial epicondyle fractures with >2 mm displacement (without incarceration of the fragment inside the joint or ulnar nerve dysfunction) that Open reduction and screw fixation improve outcome.

The purpose of our study is to compare the treatment outcomes and complications between operatively and non-operatively treated displaced medial epicondyle fractures. We aim to improve our understanding of the outcomes of these fractures to make treatment recommendations. We hypothesise that there is no difference in treatment outcomes between non-operative and operative treatment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: July 1, 2026
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

Inclusion Criteria:

• Patients Age < 16 years presenting with a =2 mm displaced non-incarcerated medial epicondyle fracture with or without concomitant elbow dislocation and normal ulnar nerve function.

• Acute fractures were defined as less than7 days between the date of injury and initiation of treatment

Exclusion Criteria:

• systemic bone disease

• concomitant fracture or injury of the same upper limb requiring operative intervention

• Open fractures, incarceration of the fragment inside the joint or ulnar nerve dysfunction require surgery

Related Conditions & MeSH terms

• Fractures, Bone

Intervention

Procedure:
• operative
open reduction : fixation by k-wires or screws
• non-operative
close reduction : by cast Immobilization

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Axibal DP, Carry P, Skelton A, Mayer SW. No Difference in Return to Sport and Other Outcomes Between Operative and Nonoperative Treatment of Medial Epicondyle Fractures in Pediatric Upper-Extremity Athletes. Clin J Sport Med. 2020 Nov;30(6):e214-e218. doi: 10.1097/JSM.0000000000000666. — View Citation

Beck JJ, Bowen RE, Silva M. What's New in Pediatric Medial Epicondyle Fractures? J Pediatr Orthop. 2018 Apr;38(4):e202-e206. doi: 10.1097/BPO.0000000000000902. — View Citation

Pathy R, Dodwell ER. Medial epicondyle fractures in children. Curr Opin Pediatr. 2015 Feb;27(1):58-66. doi: 10.1097/MOP.0000000000000181. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The disabilities of the arm, shoulder and hand (QuickDASH) score	QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.	baseline