Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures (NOTICE)

Children's Fractures Interest Group, Denmark

Status: Enrolling

Conditions: Physeal Fracture; Fracture Humerus

Treatments: Other: MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT05096689

H-21017621

Details and patient eligibility

About

The diagnosis of LHCF is complicated by radiographic inability to show the full extent of the injury into the chondral (unossified) epiphysis. MRI gives a perfect view of these fractures. The safety and feasibility of non-operative treatment based on MRI findings in children with elbow fractures has not been investigated in a Danish setting. If safe and feasible, the use of MRI could dramatically lower the need for surgery in children with LHCF.

Full description

The treatment of LHCF has historically most often been surgical with open reduction and fixation. The diagnosis of LHCF is complicated by radiographic inability to show the full extent of the injury into the unossified chondral epiphysis and therefore physicians often opt for open surgical treatment. MRI; however, gives a perfect view of these fractures. This project investigates the safety and feasibility of non-operative treatment of LHCF based on MRI performed without sedation or anesthesia and seeks to dramatically lower the need for surgery. Objectives are to describe functional outcome, radiological healing, secondary fracture displacement and any complications after two years. The investigators hypothesize that undisplaced and minimally displaced LHCF can be treated non-operatively based on MRI findings with good functional outcomes after two years. A cohort study design is used to follow 50 children with LHCF.

Enrollment: 50 estimated patients

Sex: All

Ages: 2 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of acute Lateral humeral condyle fracture
• Fracture <5 days old
• Fracture with <5 mm of displacement on plain radiographs
• Parental informed consent obtained

Exclusion criteria

• Contraindication(s) to performing an MRI
• Unable to participate in follow-up
• Existing bone pathology
• Previous ipsilateral elbow fracture

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Non-operative

Experimental group

Description:

Non-operative treatment of lateral humeral condyle fractures

Treatment:

Other: MRI