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Percutaneous Intramedullary K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures

Primary Purpose

Fracture Fixation, Intramedullary, Fracture Forearm

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fracture Fixation, Intramedullary

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who are younger than the age of 10 years old from both genders and suffering from displaced fractures of shaft both bone of the forearm; Standard preoperative anteroposterior (AP) and lateral forearm radiographs; Complete clinical and radiographic data. Exclusion Criteria: Poly-traumatized patients with other associated fractures; Undisplaced fractures; Open fractures; Pathological fractures; Malignancy; Malnutrition; Chronic diseases as renal, hepatic, cardiac patients; Incomplete radiographic data.

Sites / Locations

  • Sohag university HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study group

Arm Description

Patients who are younger than the age of 10 years old from both genders and suffering from displaced fractures of shaft both bone of the forearm

Outcomes

Primary Outcome Measures

Union of fractures
Degree of flexion and extension at wrist joint
Degree of supination and pronation

Secondary Outcome Measures

Full Information

First Posted
February 15, 2023
Last Updated
April 17, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05744349
Brief Title
Percutaneous Intramedullary K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures
Official Title
Percutaneous Intramedullary K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 28, 2023 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is to improving outcome of pediatric both bone forearm fractures using minimally invasive procedure by intramedullary K-wires.
Detailed Description
Most shaft injuries present no unusual challenges and require nothing more than skillful closed reduction and cast immobilization due to the unique property of the growth potential of the immature skeleton. There is a relatively high incidence of re-displacement, malunion and consequent limitation of movement. Perfect anatomical reduction is not always necessary since remodeling of malunion may correct any residual deformity. Angulation has been shown to affect the range of pronation and supination of the forearm. The most common indications for surgery are failure of closed reduction, open fractures, and fracture instability. When operative intervention is indicated different techniques can be employed such as intramedullary nailing, osteosynthesis with plate and screws fixation and external fixators. Intramedullary nailing has been shown to produce excellent clinical results and in contrast to plate fixation is considered as a minimal invasive procedure. Surgical technique of K-wires : After administration of anesthesia, surgery will be performed with the patient supine on the operating table and fracture will be analyzed with an image intensifier. In radius, the wire will be inserted by surgical drilling through Lister's tubercle or the radial styloid while in ulna, the wire will be inserted through the tip of the olecranon.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Fixation, Intramedullary, Fracture Forearm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
After administration of anesthesia, surgery will be performed with the patient supine on the operating table and fracture will be analyzed with an image intensifier. In radius, the wire will be inserted by surgical drilling through Lister's tubercle or the radial styloid while in ulna, the wire will be inserted through the tip of the olecranon.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Patients who are younger than the age of 10 years old from both genders and suffering from displaced fractures of shaft both bone of the forearm
Intervention Type
Procedure
Intervention Name(s)
K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures
Intervention Description
After administration of anesthesia, surgery will be performed with the patient supine on the operating table and fracture will be analyzed with an image intensifier. In radius, the wire will be inserted by surgical drilling through Lister's tubercle or the radial styloid while in ulna, the wire will be inserted through the tip of the olecranon.
Primary Outcome Measure Information:
Title
Union of fractures
Time Frame
1 month
Title
Degree of flexion and extension at wrist joint
Time Frame
3 months
Title
Degree of supination and pronation
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are younger than the age of 10 years old from both genders and suffering from displaced fractures of shaft both bone of the forearm; Standard preoperative anteroposterior (AP) and lateral forearm radiographs; Complete clinical and radiographic data. Exclusion Criteria: Poly-traumatized patients with other associated fractures; Undisplaced fractures; Open fractures; Pathological fractures; Malignancy; Malnutrition; Chronic diseases as renal, hepatic, cardiac patients; Incomplete radiographic data.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud H Abdelmajeed, Resident
Phone
01201605995
Email
Mahmood-h-2010@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad I Addosooki, Professor
Phone
01011110232
Facility Information:
Facility Name
Sohag university Hospital
City
Sohag
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30237611
Citation
Yong B, Yuan Z, Li J, Li Y, Southern EP, Canavese F, Xu H. Single Bone Fixation versus Both Bone Fixation for Pediatric Unstable Forearm Fractures: A Systematic Review and Metaanalysis. Indian J Orthop. 2018 Sep-Oct;52(5):529-535. doi: 10.4103/ortho.IJOrtho_125_17.
Results Reference
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PubMed Identifier
29049268
Citation
Cruz AI Jr, DeFroda SF, Gil JA, Hansen H, Bolous A, Procaccini M, Zonfrillo MR. Patient and Parent Satisfaction With Sling Use After Pediatric Upper Extremity Fractures: A Randomized Controlled Trial of a Customized Cast-Sling Versus Standard Cast and Sling. J Pediatr Orthop. 2019 Feb;39(2):e120-e124. doi: 10.1097/BPO.0000000000001091.
Results Reference
background
PubMed Identifier
26198018
Citation
Pesenti S, Litzelmann E, Kahil M, Mallet C, Jehanno P, Mercier JC, Ilharreborde B, Mazda K. Feasibility of a reduction protocol in the emergency department for diaphyseal forearm fractures in children. Orthop Traumatol Surg Res. 2015 Sep;101(5):597-600. doi: 10.1016/j.otsr.2015.06.003. Epub 2015 Jul 18.
Results Reference
background
PubMed Identifier
22154046
Citation
Sinikumpu JJ, Lautamo A, Pokka T, Serlo W. The increasing incidence of paediatric diaphyseal both-bone forearm fractures and their internal fixation during the last decade. Injury. 2012 Mar;43(3):362-6. doi: 10.1016/j.injury.2011.11.006. Epub 2011 Dec 6.
Results Reference
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Percutaneous Intramedullary K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures

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