Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures

NCT ID: NCT03906929

Last Updated: 2022-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-10-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Forearm Fracture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

SCREENING

Blinding Strategy

NONE

Study Groups

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Pediatric forearm fracture fixed by buried or exposed intamedullary implant

compare complication of buried or exposed intamedullary implant

Group Type EXPERIMENTAL

buried intramedullary K-wire

Intervention Type DEVICE

Using of buried kirschner wire in pediatric forearm fixation

exposed intramedullary K-wire

Intervention Type DEVICE

Using of exposed kirschner wire in pediatric forearm fixation

Interventions

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buried intramedullary K-wire

Using of buried kirschner wire in pediatric forearm fixation

Intervention Type DEVICE

exposed intramedullary K-wire

Using of exposed kirschner wire in pediatric forearm fixation

Intervention Type DEVICE

Other Intervention Names

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buried intramedullary kirschner wire exposed intramedullary kirschner wire

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Andrew Nabil Fouad Gergis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohamed K Hassan, professor

Role: PRINCIPAL_INVESTIGATOR

professor of orthopedic and traumatology Assuit university

Locations

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Assuit u. hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 23024723 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32372119 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17065959 (View on PubMed)

Khaled M, Fadle AA, Hassan AAA, Khalifa AA, Nabil A, Hafez A, Abol Oyoun N. To Bury or Not to Bury the K-wires After Fixation of Both Bone Forearm Fractures in Patients Younger Than 11 Years Old: A Randomized Controlled Trial. J Pediatr Orthop. 2023 Nov-Dec 01;43(10):e783-e789. doi: 10.1097/BPO.0000000000002516. Epub 2023 Sep 7.

Reference Type DERIVED
PMID: 37678342 (View on PubMed)

Other Identifiers

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fixation of forearm fracture

Identifier Type: -

Identifier Source: org_study_id

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