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New bone-stabilizing device under real-world watch

NCT ID NCT05206981

Disease control Sponsor: IlluminOss Medical, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 300 people who receive the IlluminOss device to treat broken bones from injury or disease. Researchers will track how well the device works, how safely it performs, and how patients recover over time. The goal is to gather real-world data on bone healing and return to daily activities.

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 300 people

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

Started

Jun 2021

Expected to finish

Dec 2026

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.

Who is studied

The primary objective of the study is to collect safety and performance data on the IlluminOss Device when used to provide stabilization and alignment for the treatment of traumatic or impending and pathologic fractures. The device will be used in a manner consistent with the treating physician's regular clinical practice.

Ages

50 years and older

Sex

Anyone

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. Patient has been deemed a candidate for the IlluminOss device 2. Patient is male or non-pregnant female 3. Patient is willing and able to comply with the postoperative scheduled clinical and radiographic evaluations 4. Patient is willing and able to give informed consent if required 5. Traumatic patient is over the age of 50 6. IlluminOss procedure is the initial procedure to treat the traumatic injury Exclusion Criteria: United States (U.S.) This product is contraindicated in U.S. patients who have: 1. an active or incompletely treated infection that could involve the site where the device will be implanted; 2. are allergic to any of the implant materials or to dental glue; 3. have an intramedullary canal measuring smaller than the diameter of the delivery sheath provided at the site of the fracture; 4. distant foci of infections which may spread to the implant site, have open fractures with severe contamination; 5. or in patients for whom delivery sheath is unable to cross fracture site after proper fracture reduction and realignment. European Union (EU) This product is contraindicated in EU patients who have: For all Bones: 1. Patients who are considered skeletally immature. 2. Presence of active or incompletely treated infections that could involve the site where the device will be implanted. 3. Patients allergic to any of the implant materials, or to dental glue. 4. Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided. 5. Uncooperative patient or patient with neurologic disorder, incapable of following directions. 6. Distant foci of infections which may spread to the implant site. 7. Vascular insufficiency. 8. Open fractures with severe contamination. 9. Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable. 10. Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment. For acute Humerus fractures: 11. Patients who are under the age of Fifty (50) For all bones excluding pathologic Humerus: 12. Metabolic disorders which may impair bone formation. 13. Osteomalacia. 14. Vascular insufficiency, muscular atrophy, or neuro-muscular disease.

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Conditions

The condition(s) this trial relates to.

bone fracture Fractures, Spontaneous

As listed by the trial registrant

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

Pathological fracture Traumatic fracture

How to take part

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

  1. The places running it

    10 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

  • Cedars-Sinai Medical Center

    RECRUITING

    Los Angeles, California, 90048, United States

  • Gulf Orthopedics

    COMPLETED

    Mobile, Alabama, 36604, United States

  • Jacobi Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • Johannes Wesling Hospital Minden

    COMPLETED

    Minden, Germany

  • Memorial Hermann Hospital

    RECRUITING

    Katy, Texas, 77494, United States

  • Mission Hospital

    WITHDRAWN

    Asheville, North Carolina, 28801, United States

  • Ortho Rhode Island

    RECRUITING

    Wakefield, Rhode Island, 02879, United States

  • Parkview Health

    WITHDRAWN

    Fort Wayne, Indiana, 46845, United States

  • Petrus Hospital

    COMPLETED

    Wuppertal, Germany

  • Presbyterian St Luke's Medical Ctr

    RECRUITING

    Denver, Colorado, 80218, United States

  • St Vinzenz Hospital

    WITHDRAWN

    Cologne, Germany

  • Temple University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • University of Miami Hospital

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Wake Forest Baptist Health

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Weston Outpatient Surgical Center

    RECRUITING

    Weston, Florida, 33326, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.