Dissolvable screws could spare kids a second surgery

NCT ID NCT07473947

Disease control Sponsor: Inion Oy Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 80 children and teens who receive special dissolvable screws to fix broken bones in the ankle, knee, or elbow. The screws are designed to hold the bone in place while it heals and then safely dissolve over time, avoiding the need for a second surgery to remove them. Researchers will track bone healing and any problems for up to 4 years.

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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 80 people

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

Started

May 2026

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 17 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: 1\. Informed consent signed by parents or legal guardians, and assent from the child if of appropriate age and cognitive ability \< 18 years 3. Suitable and in need for an operation indicated for subject device 4. Ability to give adequate input for the PROM questionnaires 5. Willingness and ability to comply with rehabilitation instructions. 6. Availability for follow-up visits. Exclusion Criteria: 1. Active infection 2. Patient conditions including limited blood supply (e.g. patients with severe circulatory disorder of the lower or upper limb) 3. Patient conditions including insufficient quality or quantity of bone (diagnosed osteoporosis, conditions causing secondary osteoporosis e.g. diabetes, rheumatism, eating disorder) 4. Patient conditions where patient cooperation cannot be guaranteed (alcohol use, drug abuse etc.) 5. Patients with known allergy to the implant constituents or its degradation products. 6. Spinal and craniomaxillofacial indications. 7. High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation

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Conditions

The condition(s) this trial relates to.

Ankle Fractures Elbow Fractures Knee Fractures

As listed by the trial registrant

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

Ankle fractures Elbow fractures Knee fractures

How to take part

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

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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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.

Dissolvable screws could spare kids a second surgery

What the study statuses mean