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Illizarov Fixation in Open Type III (A&B) Pediatric and Adolescent Tibial Shaft Fractures

Primary Purpose

Open Type III (A&B)Pediatric and Adolescent Tibial Shaft Fractures, Ilizarov Fixation

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ilizarov
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Type III (A&B)Pediatric and Adolescent Tibial Shaft Fractures

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged 8-16 years old.
  • Diagnosed to have open grade IIIA and IIIB tibial fracture according to Gustilo-Anderson fracture classification system.
  • Fractures of the shaft of the tibia or distal tibial fractures involving the ankle joint and were complicated by bone and/or soft-tissue loss of more than 3 cm.
  • An external fixator could be placed in the proximal lower extremity, distal lower extremity, or foot, and normal bone segments available for osteotomy.
  • Admitted in the duration between 1st of January 2022 until end of December 2023.

Exclusion Criteria:

  • Patients requiring free flap or local flap transfer to close the wound.
  • Open grade IIIC tibial fractures (with vascular injury).
  • Loss to follow-up.

Sites / Locations

  • Assiut universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ilizarov device

Arm Description

Ilizarov fixation in open type III pediatric tibial shaft fractures

Outcomes

Primary Outcome Measures

Union of tibial fracture
Assess Union of the fracture using radiographic union scale in tibial fracture(RUST)

Secondary Outcome Measures

Determine alignment
Determine alignment using slit scanogram for both Lower limbs
Patient reported outcome measures
Patient reported outcome measures using Stanmore limb reconstruction score (SLRS)

Full Information

First Posted
February 9, 2022
Last Updated
July 2, 2022
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05448053
Brief Title
Illizarov Fixation in Open Type III (A&B) Pediatric and Adolescent Tibial Shaft Fractures
Official Title
Clinical and Radiographic Evaluation of Illizarov Fixation in Open Type III (A&B) Pediatric and Adolescent Tibial Shaft Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The Ilizarov method is our usual treatment of choice for open, complex, physeal or unstable fractures and for patients in whom non-operative or other treatments have failed .
Detailed Description
Tibial fractures are the third most common injury involving a long bone in children. Most occur in the distal third, and approximately 10% are open.High-energy injuries with soft tissue compromise or segmental bone loss, present specific challenges. There is a significant risk of nonunion (7.5%),malunion (17%),infection (10%),and loss of reduction (32%).Many forms of treatment are available including a cast, elastic nailing, and external fixation using either a monolateral fixator, or a circular frame . In complex adult tibial fractures, evidence for the effectiveness of definitive external fixation using a circular frame continues to emerge.Fixators may be used for the correction of tibial deformities in children.Currently, only relatively small case series have been published describing their use for trauma in children and adolescents, albeit with good results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Type III (A&B)Pediatric and Adolescent Tibial Shaft Fractures, Ilizarov Fixation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ilizarov device
Arm Type
Experimental
Arm Description
Ilizarov fixation in open type III pediatric tibial shaft fractures
Intervention Type
Procedure
Intervention Name(s)
Ilizarov
Other Intervention Name(s)
ORIF with broad DCP
Intervention Description
Ilizarov fixation in open type III pediatric and adolescent tibial shaft fractures
Primary Outcome Measure Information:
Title
Union of tibial fracture
Description
Assess Union of the fracture using radiographic union scale in tibial fracture(RUST)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Determine alignment
Description
Determine alignment using slit scanogram for both Lower limbs
Time Frame
1 year
Title
Patient reported outcome measures
Description
Patient reported outcome measures using Stanmore limb reconstruction score (SLRS)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged 8-16 years old. Diagnosed to have open grade IIIA and IIIB tibial fracture according to Gustilo-Anderson fracture classification system. Fractures of the shaft of the tibia or distal tibial fractures involving the ankle joint and were complicated by bone and/or soft-tissue loss of more than 3 cm. An external fixator could be placed in the proximal lower extremity, distal lower extremity, or foot, and normal bone segments available for osteotomy. Admitted in the duration between 1st of January 2022 until end of December 2023. Exclusion Criteria: Patients requiring free flap or local flap transfer to close the wound. Open grade IIIC tibial fractures (with vascular injury). Loss to follow-up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled Gamal
Phone
01141110942
Email
Khaledalamir@yahoo.com
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71511
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khaled Gamal
Phone
01141110942
Email
khaledalamir@yahoo.com

12. IPD Sharing Statement

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Illizarov Fixation in Open Type III (A&B) Pediatric and Adolescent Tibial Shaft Fractures

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