Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures

NCT05096689 | Unknown

• 1 other identifier: H-21017621
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fracture Humerus; Physeal Fracture

Outcome Measures

Primary Outcomes (1)

• Mayo Elbow Performance Score (MEPS)

  MEPS consists of three domains; pain, elbow range of motion (ROM) and stability. The total score ranges from 0-100 with higher scores indicating better function. If the total score ranges between 75 and 100, the result is good (satisfactory); 50-74, fair (acceptable); \<50, poor (unsatisfactory).

  2 years

Secondary Outcomes (6)

• MRI results

  2 weeks

• Radiographic results

  2 years

• Secondary fracture displacement

  2 years

• Pain scale (age <5 years)

  2 years

• Pain scale (age >4 years)

  2 years

Study Arms (1)

Non-operative

EXPERIMENTAL

Non-operative treatment of lateral humeral condyle fractures

Other: MRI

Interventions

MRI OTHER

Magnetic Resonance Imaging

Non-operative

Eligibility Criteria

• Age: 2 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Fractures Interest Group, Denmark: lead

Study Sites (1)

Copenhagen University Hospital - Herlev and Gentofte

Herlev, Capital Region, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Humeral Fractures

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Morten J Andersen, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morten J Andersen, MD

CONTACT

004538681479; mortenjonandersen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Orthopedic Surgeon

Model Details: Prospective, Cohort, Single center

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 27, 2021
• Study Start: November 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2024
• Last Updated: November 11, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)