NCT05409053

Brief Summary

Lateral condyle fracture of the distal humerus is the second most common injury around the elbow and accounts for 20% of all the elbow fractures in children.The average age for the fracture involving the lateral condyle is around six years. There are different treatment options of the lateral condyle fractures include

  • non-operative management with plaster cast immobilization for undisplaced or minimally displaced fractures.
  • Whereas the fractures displaced \>2 mm need operative management. The objective of treatment in the displaced fracture is to obtain and maintain the articular congruity. In the operative management, the reduction technique includes open or closed methods.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

March 16, 2022

Last Update Submit

June 2, 2022

Conditions

Lateral Condyle Humerus Fracture in Children

Outcome Measures

Primary Outcomes (1)

  • Time of union

    Follow up radiographs will be requested at immediate postoperative 2, 4, 6, 12 and 24 weeks postoperative to assess healing

    6 Months

Study Arms (4)

screw fixation

ACTIVE COMPARATOR

lateral condyle humerus fracture open reduction and internal fixation by canullated screws

Procedure: open reduction

k wire fixation

ACTIVE COMPARATOR

lateral condyle humerus fracture open reduction and internal fixation by K wire

Procedure: open reduction

Conservative management

OTHER

Undisplaced fractured treated conservatively by above elbow slab

Other: Conservative management

Closed reduction and percutaneous pinning

OTHER

Undisplaced fractured treated closed reduction and percutaneous pinning

Procedure: Closed reduction

Interventions

open reductionPROCEDURE

the displaced fractures will be treated with open reduction so as to achieve the near anatomical alignment

k wire fixationscrew fixation
Closed reductionPROCEDURE

the non displaced fractures will be treated with closed reduction and percutaneous pinning

Closed reduction and percutaneous pinning
Conservative managementOTHER

the non displaced fractures will be treated with closed reduction and castor slab

Conservative management

Eligibility Criteria

Age2 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children up to 14 years.
  • closed lateral condylar fracture.
  • displacement more than 2mm .
  • fracture Less than two weeks of injury.

You may not qualify if:

  • Patients with open fractures.
  • otherassociated injury in the same elbow .
  • elbow with preexisting anatomical deformity .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

  • Franks D, Shatrov J, Symes M, Little DG, Cheng TL. Cannulated screw versus Kirschner-wire fixation for Milch II lateral condyle fractures in a paediatric sawbone model: a biomechanical comparison. J Child Orthop. 2018 Feb 1;12(1):29-35. doi: 10.1302/1863-2548.12.170090.

    PMID: 29456751BACKGROUND

  • Justus C, Haruno LS, Riordan MK, Wilsford L, Smith T, Antekeier S, McKay SD. Closed and Open Reduction of Displaced Pediatric Lateral Condyle Humeral Fractures, a Study of Short-Term Complications and Postoperative Protocols. Iowa Orthop J. 2017;37:163-169.

    PMID: 28852352BACKGROUND

  • Cardona JI, Riddle E, Kumar SJ. Displaced fractures of the lateral humeral condyle: criteria for implant removal. J Pediatr Orthop. 2002 Mar-Apr;22(2):194-7.

    PMID: 11856929BACKGROUND

  • Baharuddin M, Sharaf I. Screw osteosynthesis in the treatment of fracture lateral humeral condyle in children. Med J Malaysia. 2001 Dec;56 Suppl D:45-7.

    PMID: 14569766BACKGROUND

MeSH Terms

Interventions

Open Fracture ReductionClosed Fracture ReductionConservative Treatment

Intervention Hierarchy (Ancestors)

Fracture FixationOrthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Central Study Contacts

bassam A abdalraheem, resident

CONTACT

01099392948bssam011067@med.sohag.edu.eg

El-shazly s mousa, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor at orthopaedic department sohag university hospital

Study Record Dates

First Submitted

March 16, 2022

First Posted

June 8, 2022

Study Start

June 1, 2022

Primary Completion

June 1, 2023

Study Completion

November 1, 2023

Last Updated

June 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

Locations

EG(1)