Exposed Versus Buried Intramedullary K-wires for Pediatric Forearm Fractures

NCT03906929 | Completed DMC

• 1 other identifier: fixation of forearm fracture
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Forearm Fracture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  6 months

Study Arms (1)

Pediatric forearm fracture fixed by buried or exposed intamedullary implant

EXPERIMENTAL

compare complication of buried or exposed intamedullary implant

Device: buried intramedullary K-wire; Device: exposed intramedullary K-wire

Interventions

buried intramedullary K-wire DEVICE

Using of buried kirschner wire in pediatric forearm fixation

Also known as: buried intramedullary kirschner wire

Pediatric forearm fracture fixed by buried or exposed intamedullary implant

exposed intramedullary K-wire DEVICE

Using of exposed kirschner wire in pediatric forearm fixation

Also known as: exposed intramedullary kirschner wire

Pediatric forearm fracture fixed by buried or exposed intamedullary implant

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: less than 10 years .
• Diaphyseal forearm fracture.
• closed fracture.
• isolated or combined fracture of forearm.

You may not qualify if:

• \. 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).
• neurovascular injury.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assuit u. hospital

Asyut, Egypt

Location

Related Publications (4)

• 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.

  PMID: 23024723 BACKGROUND

• 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.

  PMID: 32372119 BACKGROUND

• 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.

  PMID: 17065959 BACKGROUND

• 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.

  PMID: 37678342 DERIVED

Study Officials

• Mohamed K Hassan, professor

  professor of orthopedic and traumatology Assuit university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 8, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: October 1, 2020
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)