Comparative Study Between Operative and Non-Operative Management of Femoral Shaft Fractures in Children (ESIN-THOMAS)

Comparative Study Between Operative Fixation With Elastic Stable Intramedullary Nails and Non-Operative Thomas Splint Traction in Pediatric Femoral Shaft Fractures

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.

Study Overview

• Status: Completed
• Conditions: Diaphyseal Femur Fracture
• Intervention / Treatment: Device: Thomas splint; Device: ESIN (Elastic Stable Intramedullary Nails)

Detailed Description

Femoral shaft fractures are among the most common major injuries in the pediatric population. The optimal method of treatment in children between 5 to 16 years remains a subject of ongoing debate, particularly in settings where surgical resources may be limited. Traditionally, conservative treatment using traction and immobilization methods such as the Thomas splint has been widely used. However, surgical fixation with Elastic Stable Intramedullary Nailing (ESIN) has gained popularity because it allows for stable fixation, earlier mobilization, and shorter hospital stay.

This randomized clinical trial was conducted at a single center, and the data were registered retrospectively after completion of patient enrollment and follow-up which aimed to compare the clinical and radiological outcomes of Elastic Stable Intramedullary Nailing (ESIN) versus Thomas splint traction in the treatment of pediatric femoral shaft fractures.

Eligible pediatric patients presenting with femoral shaft fractures were randomly assigned to one of two treatment groups. The first group was managed conservatively using Thomas splint traction according to standard protocols, while the second group underwent surgical fixation using ESIN.

Participants were followed clinically and radiographically at scheduled intervals to assess fracture healing, alignment, time to mobilization, and complications. Functional outcomes and adverse events were also documented and compared between the two groups.

The results of this study may help determine whether ESIN offers significant advantages over traditional conservative treatment with the Thomas splint in the management of pediatric femoral shaft fractures, particularly in healthcare settings where resources may vary.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • El Kasr El Aini Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• children aged 5 to 11 years
• patients diagnosed with acute, closed and stable femoral shaft fractures (transverse, oblique or spiral patterns)
• patients less than 45 kg in body weight.
• Written informed consent obtained from parents or legal guardians.

Exclusion Criteria:

• patients with open or pathological fractures.
• patients with unstable (segmental or comminuted) fractures.
• patient with proximal or distal physeal involvement.
• patients with associated polytrauma, multiple fractures or neurovascular injury requiring urgent surgical intervention.
• patients with neuromuscular or cognitive disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Thomas splint treatment; Pediatric patients with fracture shaft femur were managed conservatively using Thomas splint, followed by standard post-splint care and follow-up.	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
Experimental: Elastic Stable Intramedullary Nail (ESIN) Surgical Treatment.; Pediatric patients with fracture shaft femur were managed surgically using ESIN with standard pediatric orthopedic techniques.	Device: ESIN (Elastic Stable Intramedullary Nails); ESIN is used in treatment of most of long bone fractures especially in pediatrics through minimally invasive incisions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achieve fracture bone union radiologically	Time required for fracture healing as confirmed by radiographic evidence of bridging callus across the fracture site on follow-up radiographs.	From treatment initiation to radiographic union, up to 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achieve full weight bearing	Time from initiation of treatment until the patient is able to bear full weight on the affected limb without assistance.	From treatment initiation to full weight bearing, up to 12 weeks.
Incidence of complications	Incidence of treatment-related complications such as infection, malunion, limb length discrepancy, or implant-related problems.	From treatment initiation up to 12 months.
Cost of treatment	Total direct medical cost associated with treatment, including surgical procedure, hospital stay, implants, medications, and other related hospital expenses.	From treatment initiation to hospital discharge (up to 7 days)
Functional outcome according to Flynn's criteria	Clinical outcome assessment based on Flynn's criteria, which evaluates limb length discrepancy, malalignment, pain, and complications. Results are categorized as excellent, satisfactory, or poor.	At 6 months,12 months, 2 years and 3 years.
Duration of hospital stay	Number of days the patient remains hospitalized from admission until discharge.	From admission to discharge (up to 7 days)

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Hassan Magdy Elbarbary, MD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2021
• Primary Completion (Actual): June 29, 2024
• Study Completion (Actual): June 29, 2024

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: treatment outcomes; orthotic devices; femoral fractures; Bone nails; school age
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Fractures, Bone; Femoral Fractures
• Other Study ID Numbers: MD-275-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected throughout the trial including baseline characteristics, intervention details, follow-up data, and primary and secondary outcome measures will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No