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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05744349
Other study ID # Soh-Med-23-02-01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 28, 2023
Est. completion date April 1, 2024

Study information

Verified date April 2023
Source Sohag University
Contact Mahmoud H Abdelmajeed, Resident
Phone 01201605995
Email Mahmood-h-2010@outlook.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date April 1, 2024
Est. primary completion date February 28, 2024
Accepts healthy volunteers No
Gender All
Age group 4 Years to 10 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Sohag university Hospital Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Union of fractures 1 month
Primary Degree of flexion and extension at wrist joint 3 months
Primary Degree of supination and pronation 3 months