Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures

Forearm Fracture Clinical Trial

Official title:

Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures: a Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03906929
• Other study ID #: fixation of forearm fracture
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: August 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparing the rate of complications between buried and exposed intramedullary implants after fixation of pediatric forearm fractures.

Description:

comparison between buried and exposed intramedullary k-wire in fixation of pediatric forearm fracture in rate of complications such as infection,malunion,nonunion and refracture.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

Inclusion Criteria:

1. Age: less than 10 years .

2. Diaphyseal forearm fracture.

3. closed fracture.

4. isolated or combined fracture of forearm.

Exclusion Criteria:

1. Patient age: more than 10 years old . 2-open fracture. 3- pathological fracture. 4-patient with medical history (immune compromized patient e.g D.M, cancer on chemotherapy and aplastic anemia). 5- neurovascular injury.

Related Conditions & MeSH terms

• Forearm Fracture
• Fractures, Bone

Intervention

Device:
• buried intramedullary K-wire
Using of buried kirschner wire in pediatric forearm fixation
• exposed intramedullary K-wire
Using of exposed kirschner wire in pediatric forearm fixation

Locations

Country	Name	City	State
Egypt	Assuit u. hospital	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Chan LW, Siow HM. Exposed versus buried wires for fixation of lateral humeral condyle fractures in children: a comparison of safety and efficacy. J Child Orthop. 2011 Oct;5(5):329-33. Epub 2011 Jul 28. — View Citation

Lascombes P, Haumont T, Journeau P. Use and abuse of flexible intramedullary nailing in children and adolescents. J Pediatr Orthop. 2006 Nov-Dec;26(6):827-34. Review. — View Citation

Tsukamoto N, Mae T, Yamashita A, Hamada T, Miura T, Iguchi T, Tokunaga M, Onizuka T, Momii K, Sadashima E, Nakashima Y. Refracture of pediatric both-bone diaphyseal forearm fracture following intramedullary fixation with Kirschner wires is likely to occur in the presence of immature radiographic healing. Eur J Orthop Surg Traumatol. 2020 Oct;30(7):1231-1241. doi: 10.1007/s00590-020-02689-0. Epub 2020 May 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare the rate of refracture in participants who fixed by buried and exposed K-wire.	comparison between the rate of refractures in participants who fixed by buried and exposed K-wire by follow up every month for six month.	6 months
Secondary	compare the rate of infection and malunion in participants who fixed by buried and exposed K-wire.	compare the rate of infection and malunion in participants who fixed by buried and exposed K-wire.	6 months