Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures

Not Applicable

Completed

• Conditions: Forearm Fracture
• Interventions: Device: buried intramedullary K-wire; Device: exposed intramedullary K-wire

• Registration Number: NCT03906929
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-04-03
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-08
• Study Start: 2019-09-01
• Primary Completion: 2020-09-01
• Study Completion: 2020-10-01
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric forearm fracture fixed by buried or exposed intamedullary implant	buried intramedullary K-wire	compare complication of buried or exposed intamedullary implant
Pediatric forearm fracture fixed by buried or exposed intamedullary implant	exposed intramedullary K-wire	compare complication of buried or exposed intamedullary implant

Primary Outcome Measures

Name	Time	Method
compare the rate of refracture in participants who fixed by buried and exposed K-wire.	6 months	comparison between the rate of refractures in participants who fixed by buried and exposed K-wire by follow up every month for six month.

Secondary Outcome Measures

Name	Time	Method
compare the rate of infection and malunion in participants who fixed by buried and exposed K-wire.	6 months	compare the rate of infection and malunion in participants who fixed by buried and exposed K-wire.

Trial Locations

Locations (1)

Assuit u. hospital; 🇪🇬 Assuit, Egypt