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A surgical showdown for teen shinbone fractures: which fix heals faster?

NCT ID NCT07783529

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This trial compares two surgical techniques for fixing a specific type of shinbone fracture in adolescents aged 10 to 16. Half the participants will receive elastic nails with small wires, and the other half will get a metal plate and screws. The study tracks how quickly the bone heals, how straight it stays, time to full weight-bearing, and any complications, with follow-ups over six months.

What this could mean

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

Active substance
Two surgical procedures: elastic stable intramedullary nailing with Kirschner wires versus plate fixation
What this could lead to
If one method proves better, it could lead to faster healing, fewer complications, and quicker return to full activity for teens with this fracture.
What could go wrong
This is a small, single-center trial, and results may not apply to all patients. Both surgeries carry risks like infection, nerve damage, 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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

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

10 to 16 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: * Age 10-16 years. * Patients diagnosed with distal tibial metaphyseal-diaphyseal junction (DTDMJ) fractures. * Closed fractures or Gustilo-Anderson type I open fractures. * Acute fractures presenting within two weeks of injury. * Displaced or unstable fractures requiring surgical fixation. * Open or partially open physis, as assessed on preoperative radiographs. Exclusion Criteria: * Patients younger than 10 years or older than 16 years. * Fractures involving the distal tibial physis (Salter-Harris fractures). * Intra-articular distal tibial fractures. * Gustilo-Anderson type II and III open fractures. * Pathological fractures. * Fractures associated with metabolic bone disease or congenital skeletal disorders. * Polytrauma patients requiring alternative treatment priorities. * Previous fracture, deformity, or surgical intervention involving the affected tibia. * Neurovascular injury requiring repair.

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Conditions

The condition(s) this trial relates to.

tibia fracture

As listed by the trial registrant

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

Adolescents Bone plates Distal tibial fracture Fracture fixation, internal Fracture fixation, intramedullary Tibial fracture

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Sohag University Hospital

    RECRUITING

    Sohag, Sohag Governorate, 82749, Egypt

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