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New screw technique aims to mend stubborn ankle breaks

NCT ID NCT07539922

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a surgical procedure using two compression screws to fix ankle fractures that have not healed after at least 6 months. Ten adults aged 18 to 65 with a specific type of non-union will be treated and followed for 12 weeks to see if the bone heals and pain improves. The goal is to find a better way to treat these difficult fractures.

What this could mean

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

Active substance
Double compression screw fixation procedure
What this could lead to
If successful, this could provide a reliable surgical option to heal non-union ankle fractures, restoring function and reducing pain.
What could go wrong
This is a very small, early study with only 10 participants, so results may not apply to everyone. Surgery carries risks like infection or nerve damage.

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 10 people

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

Started

Feb 2026

Expected to finish

Feb 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

18 to 65 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: 1. Age from 18 to 65 years. 2. Both sexes. 3. Transvers, non-united Weber type A Lateral Malleolar ankle fracture classification 4. Non-union classified as atrophic, oligotrophic, or hypertrophic 5. Radiologically confirmed non-union of distal fibular fracture (failure to unite after ≥ 6 months post-injury). 6. Adequate bone stock on radiographs/CT suitable for screw fixation. Exclusion Criteria: 1. Active or previous osteomyelitis or local infection at the fracture site. 2. Pathological fractures. 3. Non-union with gross deformity or significant bone loss requiring complex reconstruction or bone transport

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Conditions

The condition(s) this trial relates to.

Ankle Fractures

As listed by the trial registrant

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

Lateral malleolus fractures

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sohag University Hospital

    RECRUITING

    Sohag, Sohag Governorate, 82511, Egypt