Treatment of Displaced Medial Epicondyle Fractures In Children

NCT ID: NCT06454929

Last Updated: 2024-07-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-07-01

Brief 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.

Detailed 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.

Conditions

Fractures, Bone

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

operative group

fixation by k-wires or screws

Group Type: ACTIVE_COMPARATOR

operative

Intervention Type: PROCEDURE

open reduction : fixation by k-wires or screws

non operative group

fixation by cast immobilisation

Group Type: ACTIVE_COMPARATOR

non-operative

Intervention Type: PROCEDURE

close reduction : by cast Immobilization

Interventions

operative

open reduction : fixation by k-wires or screws

Intervention Type: PROCEDURE

non-operative

close reduction : by cast Immobilization

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed ezzat mohamed eltaweel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

ahmed ezzat M eltaweel, Physician

Role: CONTACT

ahmed.15235479@med.aun.edu.eg

01068950894 ext. +20

mohamed K hassan, prof

Role: CONTACT

Mohamedkhaled@aun.edu.eg

01015636726 ext. +20

References

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

Reference Type: BACKGROUND

PMID: 25564187 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27861213 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30277893 (View on PubMed)

Other Identifiers

Medial Epicondyle Fracture

Identifier Type: -

Identifier Source: org_study_id