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Bone block surgery could fix severe flat feet, small study hopes

NCT ID NCT07515170

Disease control Sponsor: Istituto Ortopedico Rizzoli 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a surgery called SAMBB for people with severe, progressive flat feet (PCFD). The surgery uses a small bone graft to realign the foot. Researchers will use 3D weight-bearing CT scans to measure how well the foot alignment improves. The study plans to enroll 20 adults aged 18–80.

What this could mean

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

Active substance
Subtalar arthrodesis with mini/medial bone block (SAMBB) surgery
What this could lead to
If successful, this could confirm that SAMBB surgery effectively corrects severe flat-foot deformities, offering a reliable surgical option for patients.
What could go wrong
This is a very small, early study (20 people) with no control group, so results may not apply to everyone. Surgery carries standard risks like infection or incomplete correction.

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 20 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2029

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 80 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: * Patients of both sexes, aged between 18 and 80 years * Patients affected by grade A2 Progressive Collapsing Foot Deformity (PCFD) * Patients who have provided informed consent to participate in the study Exclusion Criteria: * Patients who have previously undergone corrective surgery on the deformity under study. * Patients with prior lower limb fractures resulting in altered biomechanics. * Patients affected by PCFD of grade A1, B2, C2, E1, or E2 according to the PCFD classification \[2\]. * Patients with active acute or chronic infections. * Patients with chronic inflammatory joint diseases. * Patients with significant lower limb trauma occurring after the surgical intervention. * Patients with pre-existing gait abnormalities (e.g., amputations, neuromuscular diseases, poliomyelitis, hip dysplasia). * Patients with cognitive deficits. * Patients with concomitant neurological disorders. * Patients affected by cancer. * Pregnant patients.

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Conditions

The condition(s) this trial relates to.

flatfoot

As listed by the trial registrant

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

Flat foot

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

  • Istituto Ortopedico Rizzoli

    Bologna, 40136, Italy

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