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Surgical nails beat traction for Kids' broken thighs?

NCT ID NCT07483944

Disease control Sponsor: Cairo University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared two treatments for broken thighbones in children aged 5 to 11: surgery with flexible nails (ESIN) versus a non-surgical traction splint (Thomas splint). The goal was to see which method led to faster healing and earlier walking. Forty-six children were randomly assigned to one of the two treatments and followed for recovery and complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Elastic Stable Intramedullary Nails (ESIN) and Thomas splint traction
What this could lead to
If ESIN proves better, it could become the preferred treatment for children's thighbone fractures, leading to faster recovery and less time in the hospital.
What could go wrong
This is a small, completed trial with only 46 children. Results may not apply to all fracture types or ages. Surgery carries risks like infection or implant issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

46 people

The number who actually took part.

Started

Jan 2021

Finished

Jun 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

5 to 11 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Femoral Fractures

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diaphyseal femur fracture

Contacts and locations

Locations

  • El Kasr El Aini Hospital

    Cairo, Egypt