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New implant could boost flatfoot surgery success

NCT ID NCT06211504

Disease control Sponsor: Region Skane 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a small implant in the sinus tarsi (a space in the foot) to standard flatfoot surgery helps correct the deformity better than surgery alone. 130 adults with flexible flatfoot will be randomly assigned to get the implant or not. Researchers will measure foot alignment on X-rays and patient-reported outcomes over 2 years.

What this could mean

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

Active substance
sinus tarsi implant (ProStop device)
What this could lead to
If successful, adding this small implant could improve foot alignment and reduce the chance of deformity returning after surgery.
What could go wrong
This is an early-stage randomized trial with 130 people. The implant may not provide extra benefit over standard surgery alone, and there are risks like infection or implant migration.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 130 people

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

Started

Jul 2024

Expected to finish

Dec 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

16 to 75 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 with AAFD stage II, in whom the talonavicular uncoverage is not considered by the treating surgeon to require an additional lateral column lengthening * Age 16-75 years, either sex * Failed non-surgical treatment including 3 months of physiotherapy Exclusion Criteria: * Previous ipsilateral surgery for AAFD * General hypermobility (Beighton score \> 6) * Osteoarthritis in the hindfoot joints, ankle joint or first tarsometatarsal joint * Rheumatoid arthritis * Inability to answer patient-reported outcome measures (PROMs) due to language difficulties or cognitive disorder * Current smoker * Current pregnancy * Severe medical illness * Known abuse of drugs and/or alcohol * Previous ipsilateral hindfoot fracture including Lisfranc injury

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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.

Acquired adult flatfoot deformity Flat foot Flexible flatfoot

How to take part

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

  1. The places running it

    10 sites. 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

  • Capio Ortho Center

    RECRUITING

    Malmö, Skåne County, 215 32, Sweden

  • Capio Ortho Center Göteborg

    RECRUITING

    Gothenburg, Västra Götaland County, Sweden

  • Department of Orthopedics - Eksjö Hospital

    NOT_YET_RECRUITING

    Eksjö, 575 81, Sweden

  • Department of Orthopedics - Falun Hospital

    NOT_YET_RECRUITING

    Falun, 791 82, Sweden

  • Department of Orthopedics - Hässleholm Hospital

    RECRUITING

    Hässleholm, Skåne County, 281 38, Sweden

  • Department of Orthopedics - Sahlgrenska University Hospital

    NOT_YET_RECRUITING

    Mölndal, 431 80, Sweden

  • Department of Orthopedics - Skåne University Hospital Malmö

    NOT_YET_RECRUITING

    Malmö, Skåne County, 214 28, Sweden

  • Department of Orthopedics - Uppsala University Hospital

    RECRUITING

    Uppsala, 751 85, Sweden

  • Department of Orthopedics - Växjö

    NOT_YET_RECRUITING

    Vaxjo, 352 34, Sweden

  • Department of Orthopedics - Östersund Hospital

    RECRUITING

    Östersund, 831 83, Sweden

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