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Non-operative Treatment of Pediatric Lateral Humeral Condyle Fractures

NCT ID: NCT05096689

Last Updated: 2021-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2024-10-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Fracture Humerus Physeal Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, Cohort, Single center
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non-operative

Non-operative treatment of lateral humeral condyle fractures

Group Type EXPERIMENTAL

MRI

Intervention Type OTHER

Magnetic Resonance Imaging

Interventions

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MRI

Magnetic Resonance Imaging

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Fractures Interest Group, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Morten Jon Andersen

Consultant Orthopedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Morten J Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Copenhagen University Hospital - Herlev and Gentofte

Herlev, Capital Region, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Morten J Andersen, MD

Role: CONTACT

Phone: 004538681479

Email: [email protected]

Facility Contacts

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Morten J Andersen, MD

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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H-21017621

Identifier Type: -

Identifier Source: org_study_id