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

This study is to improving outcome of pediatric both bone forearm fractures using minimally invasive procedure by intramedullary K-wires.

Study Overview

• Status: Recruiting
• Conditions: Fracture Forearm; Fracture Fixation, Intramedullary
• Intervention / Treatment: Procedure: K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures

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.

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

Contacts and Locations

• Study Contact: Name: Mahmoud H Abdelmajeed, Resident; Phone Number: 01201605995; Email: Mahmood-h-2010@outlook.com
• Study Contact Backup: Name: Ahmad I Addosooki, Professor; Phone Number: 01011110232

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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;
2. Standard preoperative anteroposterior (AP) and lateral forearm radiographs;
3. Complete clinical and radiographic data.

Exclusion Criteria:

1. Poly-traumatized patients with other associated fractures;
2. Undisplaced fractures;
3. Open fractures;
4. Pathological fractures;
5. Malignancy;
6. Malnutrition;
7. Chronic diseases as renal, hepatic, cardiac patients;
8. Incomplete radiographic data.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study group; 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

Procedure: K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Union of fractures	1 month
Degree of flexion and extension at wrist joint	3 months
Degree of supination and pronation	3 months

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2023
• Primary Completion (Anticipated): February 28, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: February 15, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 27, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: Soh-Med-23-02-01

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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