Clinical Trial

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

Study acronym: ESIN-THOMAS
Completed
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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.
Trial Details
NCT Number NCT07483944
Lead Sponsor Cairo University
Conditions Diaphyseal Femur Fracture
Enrollment 46 participants
Start Date 2021-01-03
Primary Completion 2024-06-29 (estimated)
Study Completion 2024-06-29 (estimated)
Updated on ClinicalTrials.gov 2026-03-19