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Comparative Study Between Operative and Non-Operative Management of Femoral Shaft Fractures in Children

NCT07483944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-03-19

No results posted yet for this study

Summary

The goal of this clinical trial was to compare the management of pediatric femoral shaft fractures using either Thomas splint traction or Elastic Stable Intramedullary Nailing (ESIN).

The main questions it aimed to answer were:

Did ESIN provide faster fracture healing and earlier mobilization compared with Thomas splint traction?

Were there differences in complications and functional outcomes between the two treatment methods?

Researchers compared ESIN surgical fixation with Thomas splint traction to determine which treatment provided better clinical and functional outcomes in children with femoral shaft fractures.

Participants:

Were randomly assigned to receive either ESIN surgical fixation or Thomas splint traction.

Underwent regular clinical and radiographic follow-up to assess fracture healing, alignment, and recovery.

Were evaluated for complications, time to mobilization, functional outcomes, and treatment cost during the follow-up period.

Conditions

  • Diaphyseal Femur Fracture

Interventions

DEVICE

Thomas splint

Thomas splint is type of conservative treatment of different types of long bone fracture mostly lower limbs, it consists of traditional circular ring proximally

DEVICE

ESIN (Elastic Stable Intramedullary Nails)

ESIN is used in treatment of most of long bone fractures especially in pediatrics through minimally invasive incisions

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Hassan Magdy Elbarbary, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-03
Primary Completion
2024-06-29
Completion
2024-06-29

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07483944 on ClinicalTrials.gov