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NCT Number: NCT06454929

Treatment of Displaced Medial Epicondyle Fractures In Children

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.

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Key information

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Operative

Procedure

open reduction : fixation by k-wires or screws

Non-operative

Procedure

close reduction : by cast Immobilization

Primary outcomes

  1. The disabilities of the arm, shoulder and hand (QuickDASH) score

    Time frame: baseline

    QuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.

Study contacts

Contact information is provided by the study sponsor or research team.

ahmed ezzat M eltaweel, Physician

CONTACT

[email protected]

01068950894 ext. +20

mohamed K hassan, prof

CONTACT

[email protected]

01015636726 ext. +20

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 12, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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