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New biocomposite aims to mend broken bones better than standard care

NCT ID NCT07209033

Disease control Sponsor: Medical Inventi S.A. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 compares a new bone-regeneration material called FlexiOss® to the usual treatment for people with broken bones from accidents. About 80 adults aged 18-75 with fresh bone defects in the leg or foot will receive either FlexiOss® or standard care. Researchers will check bone healing, safety, and quality of life over 2 years.

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 80 people

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

Started

May 2025

Expected to finish

Jun 2028

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 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: 1. Age between 18 and 75 years. 2. Subject signed informed consent form and is willing to participate in the follow-up visits. 3. Subject with an existing acute primary bone defect in one of the following groups: 1. Long bones of the lower extremity (including articular tibia plateau acute fracture). 2. Bones of the foot (including articular calcaneus acute fracture). 4. Subject scheduled for orthopedic procedure with bone substitute material. Exclusion Criteria: 1. Subject with alcohol dependence syndrome or any history of substance abuse within the past year. 2. Pregnancy or breastfeeding. 3. Subject participates in another clinical trial. 4. Unstable mental condition or psychiatric concomitant disease. 5. Diagnosed severe degenerative, metabolic bone disease or any condition that in opinion of the Investigator could adversely affect bone healing and regeneration. 6. Subject with known allergies or hypersensitivity to any components of the FlexiOss® biocomposite material 7. Subject with active cancer disease and/or during related oncological treatment. 8. Contraindications for computed tomography angiography according to the site Standard of Care include, but are not limited to, allergic reactions to contrast agents and impaired renal function. 9. Subject with severe comorbidities that could interfere with the study outcomes or pose a risk during surgery and rehabilitation. 10. Any other condition precluding implantation of FlexiOss®.

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Conditions

The condition(s) this trial relates to.

disease of bone structure

As listed by the trial registrant

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

Bone defect

How to take part

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

  1. The places running it

    2 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

  • Klinika Chirurgii Urazowej Narządu Ruchu i Ortopedii CMKP Samodzielny Publiczny Szpital Kliniczny im. prof. Adama Grucy Centrum Medycznego Kształcenia Podyplomowego

    RECRUITING

    Otwock, 05-400, Poland

  • Klinika Chirurgii Urazowej i Ortopedii 5 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ

    RECRUITING

    Krakow, 30-901, Poland

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