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Completed

NCT Number: NCT07483944

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

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.

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Key information

Age range

5 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

El Kasr El Aini Hospital

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Thomas splint

Device

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

ESIN (Elastic Stable Intramedullary Nails)

Device

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

Primary outcomes

  1. Time to achieve fracture bone union radiologically

    Time frame: From treatment initiation to radiographic union, up to 12 weeks.

    Time required for fracture healing as confirmed by radiographic evidence of bridging callus across the fracture site on follow-up radiographs.

Secondary outcomes

  1. Time to achieve full weight bearing

    Time frame: From treatment initiation to full weight bearing, up to 12 weeks.

    Time from initiation of treatment until the patient is able to bear full weight on the affected limb without assistance.

  2. Incidence of complications

    Time frame: From treatment initiation up to 12 months.

    Incidence of treatment-related complications such as infection, malunion, limb length discrepancy, or implant-related problems.

  3. Cost of treatment

    Time frame: From treatment initiation to hospital discharge (up to 7 days)

    Total direct medical cost associated with treatment, including surgical procedure, hospital stay, implants, medications, and other related hospital expenses.

  4. Functional outcome according to Flynn's criteria

    Time frame: At 6 months,12 months, 2 years and 3 years.

    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.

  5. Duration of hospital stay

    Time frame: From admission to discharge (up to 7 days)

    Number of days the patient remains hospitalized from admission until discharge.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: ESIN-THOMAS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2026
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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