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Bunion surgery showdown: metal vs. human bone screws

NCT ID NCT06262204

Disease control Sponsor: Orthopedic Hospital Vienna Speising 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether a screw made from donated human bone works as well as a standard metal screw for fixing bunions (hallux valgus). Forty adults will be randomly assigned to receive either the metal or the bone screw during surgery. Researchers will track pain, appearance, and bone healing over two years to see if the natural screw is a safe and effective alternative.

What this could mean

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

Active substance
human allogeneic cortical bone screw (Shark Screw®)
What this could lead to
If the bone screw works as well as metal, it could offer a natural alternative that may reduce the need for hardware removal surgery.
What could go wrong
This is a small, early-stage study with only 40 participants. The bone screw might not heal as reliably as metal, and there could be unknown risks with the allograft material.

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 40 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 85 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: * between 18 and 85 * confirmed Hallux Valgus Exclusion Criteria: * \<18 years and \>85 years * Known underlying oncological disease * Pregnant women or breastfeeding mothers * Alcohol and drug abuse * Foreseeable compliance problems * Foreseeable loss of responsibility as a study doctor * Neoplastic diseases * Active osteomyelitis * Ulcerations in the area of the skin of the surgical site * Immunosuppressive medication that cannot be discontinued

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Conditions

The condition(s) this trial relates to.

Hallux Valgus

As listed by the trial registrant

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

Hallux valgus

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

  • Abteilung für Kinderorthopädie und Fußchirurgie Orthopädisches Spital Speising

    Vienna, 1130, Austria

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