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

NCT ID: NCT05744349

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2024-04-01

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.

Conditions

Fracture Fixation, Intramedullary; Fracture Forearm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

K-wires Fixation of Pediatric Shaft Both Bone Forearm Fractures

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Hamdy Abdelmajeed

Resident at the department of Orthopedic surgery and Traumatology Sohag University Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag university Hospital

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mahmoud H Abdelmajeed, Resident

Role: CONTACT

Mahmood-h-2010@outlook.com

01201605995

Ahmad I Addosooki, Professor

Role: CONTACT

01011110232

References

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.

Reference Type: BACKGROUND

PMID: 30237611 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29049268 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26198018 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22154046 (View on PubMed)

Other Identifiers

Soh-Med-23-02-01

Identifier Type: -

Identifier Source: org_study_id