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Dissolvable foot implant holds up after 5 years, new study aims to prove

NCT ID NCT06525532

Knowledge-focused 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how well a dissolvable implant placed in the foot joint of children and teens (ages 8-15) works after at least 5 years. Researchers will use MRI scans and foot function scores to see if the implant has dissolved properly and if patients are doing well. The goal is to gather long-term information, not to test a new treatment.

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.

Participants

About 35 people

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

Started

Jun 2024

Expected to finish

Dec 2026

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.

Who is studied

pediatric population with subtalar arthrorisis surgery with reabsorbable endorthesis implant in PLLA

Ages

8 to 15 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: * Age between 8 and 15 years at the time of surgery * Arthrorrhosis of the subtalar with reabsorbable endorthotic implant in PLLA * Minimum follow-up of 5 years Exclusion Criteria: * Revisions/explantation of the endorthesis device * Patients with active acute or chronic infections * Patients with chronic inflammatory joint diseases * Patients with previous significant trauma of the lower limbs following surgery * Patients with pre-existing anomalies of ambulatory kinematics (amputations, neuro-muscular diseases, poliomyelitis, hip dysplasias) * Patients with cognitive deficits * \- Patients with concomitant neurological pathologies * Patients suffering from tumor pathology * Patients with cardiac pacemakers or other prostheses equipped with electronic circuits * Patients with intracranial metal implants, metal heart valves, vascular clips, ferromagnetic endovascular filters/stents/coils, Swan-Ganz catheters or in any case positioned close to vital anatomical structures * Patients with orthopedic metal prostheses * Patients with cochlear implants or fixed hearing aids, lens prostheses with ferromagnetic intra-ocular points, IUD (coil) or splinters made of ferromagnetic material * Pregnant patients * Patients with insulin pumps and non-removable contact lenses

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As listed by the trial registrant

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

Lower limb deformity

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

    RECRUITING

    Bologna, 40136, Italy