Can an extra surgical step make bunion correction last longer?

NCT ID NCT06486753

What the study statuses mean

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial tests whether adding a lateral soft tissue release to standard chevron bunion surgery improves the correction of the big toe's angle and reduces the chance of the bunion returning. About 200 adults with mild to moderate bunions will be randomly assigned to receive either the standard surgery or the surgery with the extra release. Researchers will compare x-ray measurements and patient-reported outcomes over 12 months to see if the added step helps without increasing complications.

What this could mean

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

Active substance
Chevron osteotomy bunion surgery with lateral soft tissue release
What this could lead to
If adding lateral soft tissue release improves bunion correction and patient outcomes, it could become a standard part of chevron bunion surgery, reducing recurrence and the need for repeat procedures.
What could go wrong
This is a single trial, and the added release may not improve results or could raise the risk of complications like overcorrection or damage to the bone's blood supply. Results may not apply to severe or recurrent bunions.

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 200 people

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

Started

Jun 2021

Expected to finish

Dec 2028

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 years and older

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: * Over the age of 18 years old * Have mild to moderate bunions that are determined to benefit from Chevron osteotomies Exclusion Criteria: * Under the age of 18 * Connective tissue disease * Juvenile bunions * Severe bunions * Revision surgery

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Conditions

The condition(s) this trial relates to.

Bunion

As listed by the trial registrant

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

Contacts and locations

Locations

  • Houston Methodist Research Institute

    Houston, Texas, 77030, United States

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