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

Primary Purpose

Lateral Condyle Humerus Fracture in Children

Status

Not yet recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

open reduction

Closed reduction

Conservative management

About this trial

This is an interventional other trial for Lateral Condyle Humerus Fracture in Children

Eligibility Criteria

2 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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 .

Sites / Locations

Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Other

Arm Label

screw fixation

k wire fixation

Conservative management

Closed reduction and percutaneous pinning

Arm Description

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

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

Undisplaced fractured treated conservatively by above elbow slab

Undisplaced fractured treated closed reduction and percutaneous pinning

Outcomes

Primary Outcome Measures

Time of union

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05409053

First Posted

March 16, 2022

Last Updated

June 2, 2022

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT05409053

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 2022 (Anticipated)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lateral Condyle Humerus Fracture in Children

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

screw fixation

Arm Type

Active Comparator

Arm Description

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

Arm Title

k wire fixation

Arm Type

Active Comparator

Arm Description

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

Arm Title

Conservative management

Arm Type

Other

Arm Description

Undisplaced fractured treated conservatively by above elbow slab

Arm Title

Closed reduction and percutaneous pinning

Arm Type

Other

Arm Description

Undisplaced fractured treated closed reduction and percutaneous pinning

Intervention Type

Procedure

Intervention Name(s)

open reduction

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Closed reduction

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Conservative management

Intervention Description

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

Primary Outcome Measure Information:

Title

Time of union

Description

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

Time Frame

6 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 .

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

bassam A abdalraheem, resident

Phone

01099392948

bssam011067@med.sohag.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

El-shazly s mousa, professor

Facility Information:

Facility Name

Sohag University Hospital

City

Sohag

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Osama R ElSherif, professor

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

29456751

Citation

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.

Results Reference

background

PubMed Identifier

28852352

Citation

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.

Results Reference

background

PubMed Identifier

11856929

Citation

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.

Results Reference

background

PubMed Identifier

14569766

Citation

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.

Results Reference

background

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

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