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

• Sponsor: Sohag University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05744349
• Collaborator: (none)
• Enrollment: 20
• Arm: 1
• Anticipated Duration (Months): 13

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Fracture Fixation, Intramedullary; Fracture Forearm	Procedure: K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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.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)
• Primary Purpose: Treatment
• Official Title: Percutaneous Intramedullary K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Union of fractures [1 month]

2. Degree of flexion and extension at wrist joint [3 months]

3. Degree of supination and pronation [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 10 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Mahmoud Hamdy Abdelmajeed, Resident at the department of Orthopedic surgery and Traumatology Sohag University Hospital, Sohag University
• ClinicalTrials.gov Identifier: NCT05744349
• Other Study ID Numbers: Soh-Med-23-02-01
• First Posted: Feb 27, 2023
• Last Update Posted: Mar 3, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fractures, Bone

Study Results

No Results Posted as of Mar 3, 2023