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Treatment of Displaced Medial Epicondyle Fractures In Children

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06454929
Enrollment
52
Registered
2024-06-12
Start date
2024-09-01
Completion date
2026-07-01
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fractures, Bone

Keywords

medial epicondyle fracture

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.

Interventions

PROCEDUREoperative

open reduction : fixation by k-wires or screws

PROCEDUREnon-operative

close reduction : by cast Immobilization

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Masking description

no masking

Intervention model description

operative by k-wires or screws or non-operative by cast immobilisation treatment (using randomization tables/software

Eligibility

Sex/Gender
ALL
Age
1 Years to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The disabilities of the arm, shoulder and hand (QuickDASH) scorebaselineQuickDASH uses 11 items to measure physical function and symptoms in people with any or multiple musculoskeletal disorders of the upper limb.

Contacts

Primary Contactahmed ezzat M eltaweel, Physician
ahmed.15235479@med.aun.edu.eg01068950894
Backup Contactmohamed K hassan, prof
Mohamedkhaled@aun.edu.eg01015636726

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026