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New dissolvable screws could spare patients a second surgery

NCT ID NCT05555459

Disease control Sponsor: Inion Oy 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing special screws that dissolve over time, used in foot and ankle surgeries for fractures, realignments, or joint fusions. The screws are meant to hold bones together while they heal, then safely absorb into the body. Researchers will follow 125 adults for 4 years to check if the bones heal properly and to watch for any problems like infection or the screw breaking.

What this could mean

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

Active substance
bioabsorbable headless compression screw
What this could lead to
If successful, these dissolvable screws could eliminate the need for a second surgery to remove metal hardware, simplifying recovery.
What could go wrong
This is a single-center, non-randomized study with no control group, so results may not apply broadly. Risks include non-union, screw breakage, or tissue reactions as the screw dissolves.

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 125 people

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

Started

Mar 2023

Expected to finish

Apr 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

18 years and older

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. Read the patient information bulletin on the study and signed the patient consent form 2. Adult patient (over 18-year-old) 3. Suitable and in need for surgical lower limb operation listed in the indications of this study that requires fastening of bone structures with screws (or an alternative attachment method) in the ankle or foot area, according to a statement of the investigator surgeon 4. Ability to fill in questionnaires. 5. Willingness 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 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. High-load bearing indications (e.g., diaphyseal fractures of long bones) unless used in conjunction with traditional rigid fixation 6. Patients with significant neuropathy 7. Pregnancy 8. Patients who refuse to participate 9. Lower limb tumor or metastasis 10. Complex Regional Pain Syndrome (CRPS) in operated foot

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Conditions

The condition(s) this trial relates to.

Ankle Fractures ankle injury ankylosis bone fracture Foot Deformities Foot Injuries Hallux Rigidus Hallux Valgus Metatarsalgia Morton neuroma osteoarthritis, toe tibia fracture

As listed by the trial registrant

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

Ankle fractures Calcaneus fracture Deformity of foot Deformity of toe Deformity, foot Feet deformity tarsus Foot deformities Foot fracture Foot injury Fracture of foot Fractures, bone Hallux rigidus Hallux valgus Lisfranc fracture Lisfranc injury Medial malleolus fracture Metatarsalgia Navicular fracture Talus fracture

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

  • Tampere University Hospital

    RECRUITING

    Tampere, 33520, Finland

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