Kirschner Wires Fixation Versus Cannulated Screws Internal Fixation for Displaced Lateral Condyle Humeral Fracture in Children

Open Reduction and Kirschner Wires Fixation Versus Cannulated Screws Internal Fixation for Displaced Lateral Condyle Humeral Fracture in Children. Randomized Controlled Trial.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lateral Condyle Humerus Fracture in Children
• Intervention / Treatment: Procedure: open reduction; Other: Conservative management; Procedure: Closed reduction

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: bassam A abdalraheem, resident; Phone Number: 01099392948; Email: bssam011067@med.sohag.edu.eg
• Study Contact Backup: Name: El-shazly s mousa, professor

Study Locations

• Egypt
  • Sohag, Egypt
    • Sohag University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: screw fixation; lateral condyle humerus fracture open reduction and internal fixation by canullated screws	Procedure: open reduction; the displaced fractures will be treated with open reduction so as to achieve the near anatomical alignment
Active Comparator: k wire fixation; lateral condyle humerus fracture open reduction and internal fixation by K wire	Procedure: open reduction; the displaced fractures will be treated with open reduction so as to achieve the near anatomical alignment
Other: Conservative management; Undisplaced fractured treated conservatively by above elbow slab	Other: Conservative management; the non displaced fractures will be treated with closed reduction and castor slab
Other: Closed reduction and percutaneous pinning; Undisplaced fractured treated closed reduction and percutaneous pinning	Procedure: Closed reduction; the non displaced fractures will be treated with closed reduction and percutaneous pinning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures
• Other Study ID Numbers: soh-Med-22-03-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No