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Could bunion surgery patients walk right away? trial puts it to the test

NCT ID NCT05534724

Symptom relief Sponsor: Ente Ospedaliero Cantonale, Bellinzona 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing whether people can put full weight on the foot immediately after a modified Lapidus operation, a common bunion surgery that fuses bones in the midfoot. The trial assigns 122 adults to either walk fully in a special post-op shoe or limit weight to 10 to 15 kilograms for six weeks. Everyone wears the shoe for six weeks, and researchers track function with a 100-point ankle score and pain on a visual scale. The goal is to see whether early walking is safe and helps recovery compared with the standard partial weight-bearing approach.

What this could mean

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

Active substance
a rehabilitation plan of walking on the foot right after surgery versus putting only limited weight on it
What this could lead to
If walking on the foot right away proves safe, people recovering from Lapidus bunion surgery might return to daily activities sooner and spend less time on crutches.
What could go wrong
Putting full weight on a freshly fused joint could loosen the repair or delay healing, and this single trial in 122 people may not settle the question for everyone.

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 122 people

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

Started

Jan 2023

Expected to finish

Jul 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 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Patient who undergo modified Lapidus arthrodesis operation and associated with: * Additional surgical gestures such as e.g. interventions on the proximal phalanx of the first finger (Akin) or interventions on the 2nd and / or 3rd ray (Weil / Hohmann) \[23,24\]. * Willingness and ability to participate in the trial * Signed Informed Consent Exclusion Criteria: * Diabetes mellitus * Rheumatoid arthritis * Previous foot surgery * Classic Lapidus surgery * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, general physical problem of the participant, etc. * Inability or contraindications to undergo the investigated intervention * Pregnant women

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Conditions

The condition(s) this trial relates to.

Hallux Valgus musculoskeletal system disorder

As listed by the trial registrant

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

Hallux valgus Orthopedic disorder

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

  • EOC

    RECRUITING

    Lugano, 6900, Switzerland

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