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Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures

Primary Purpose

Forearm Fracture

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

buried intramedullary K-wire

exposed intramedullary K-wire

About this trial

This is an interventional screening trial for Forearm Fracture

Eligibility Criteria

5 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age: less than 10 years .
Diaphyseal forearm fracture.
closed fracture.
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.

Sites / Locations

Assuit u. hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pediatric forearm fracture fixed by buried or exposed intamedullary implant

Arm Description

compare complication of buried or exposed intamedullary implant

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

compare the rate of infection and malunion in participants who fixed by buried and exposed K-wire.

Full Information

NCT ID

NCT03906929

First Posted

April 3, 2019

Last Updated

August 8, 2022

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03906929

Brief Title

Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

September 1, 2019 (Actual)

Primary Completion Date

September 1, 2020 (Actual)

Study Completion Date

October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Forearm Fracture

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Using of buried and exposed intramedullary k-wire in pediatric forearm fixation.

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pediatric forearm fracture fixed by buried or exposed intamedullary implant

Arm Type

Experimental

Arm Description

compare complication of buried or exposed intamedullary implant

Intervention Type

Device

Intervention Name(s)

buried intramedullary K-wire

Other Intervention Name(s)

buried intramedullary kirschner wire

Intervention Description

Using of buried kirschner wire in pediatric forearm fixation

Intervention Type

Device

Intervention Name(s)

exposed intramedullary K-wire

Other Intervention Name(s)

exposed intramedullary kirschner wire

Intervention Description

Using of exposed kirschner wire in pediatric forearm fixation

Primary Outcome Measure Information:

Title

compare the rate of refracture in participants who fixed by buried and exposed K-wire.

Description

comparison between the rate of refractures in participants who fixed by buried and exposed K-wire by follow up every month for six month.

Time Frame

6 months

Secondary Outcome Measure Information:

Title

compare the rate of infection and malunion in participants who fixed by buried and exposed K-wire.

Description

compare the rate of infection and malunion in participants who fixed by buried and exposed K-wire.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age: less than 10 years . Diaphyseal forearm fracture. closed fracture. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamed K Hassan, professor

Organizational Affiliation

professor of orthopedic and traumatology Assuit university

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assuit u. hospital

City

Assuit

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23024723

Citation

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. doi: 10.1007/s11832-011-0358-y. Epub 2011 Jul 28.

Results Reference

background

PubMed Identifier

32372119

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.

Results Reference

background

PubMed Identifier

17065959

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. doi: 10.1097/01.bpo.0000235397.64783.d6.

Results Reference

background

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Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures

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