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

NCT05744349 | Unknown

• 1 other identifier: Soh-Med-23-02-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fracture Fixation, Intramedullary; Fracture Forearm

Outcome Measures

Primary Outcomes (3)

• Union of fractures

  1 month

• Degree of flexion and extension at wrist joint

  3 months

• Degree of supination and pronation

  3 months

Study Arms (1)

Study group

EXPERIMENTAL

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

Interventions

K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures PROCEDURE

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 group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

• 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.

  PMID: 30237611 BACKGROUND

• 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.

  PMID: 29049268 BACKGROUND

• 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.

  PMID: 26198018 BACKGROUND

• 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.

  PMID: 22154046 BACKGROUND

Central Study Contacts

Mahmoud H Abdelmajeed, Resident

CONTACT

01201605995; Mahmood-h-2010@outlook.com

Ahmad I Addosooki, Professor

CONTACT

01011110232

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at the department of Orthopedic surgery and Traumatology Sohag University Hospital

Model Details: 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 Record Dates

• First Submitted: February 15, 2023
• First Posted: February 27, 2023
• Study Start: February 28, 2023
• Primary Completion: February 28, 2024
• Study Completion: April 1, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

EG (1)