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
Sponsored by
About this trial
This is an interventional screening trial for Forearm Fracture
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.
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.
compare the rate of infection and malunion in participants who fixed by buried and exposed K-wire.
Full Information
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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
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
No
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
No
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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