NCT05206981 · IlluminOss Medical, Inc.
Device Global Registry for the IlluminOss Bone Stabilization System
What this study is about
This is a multi-center, observational patient registry. 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.
View original scientific description
This is a multi-center, observational patient registry. 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient has been deemed a candidate for the IlluminOss device
- Patient is male or non-pregnant female
- Patient is willing and able to comply with the postoperative scheduled clinical and radiographic evaluations
- Patient is willing and able to give informed consent if required
- Traumatic patient is over the age of 50
- 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:
- an active or incompletely treated infection that could involve the site where the device will be implanted;
- are allergic to any of the implant materials or to dental glue;
- have an intramedullary canal measuring smaller than the diameter of the delivery sheath provided at the site of the fracture;
- distant foci of infections which may spread to the implant site, have open fractures with severe contamination;
- 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:
- Patients who are considered skeletally immature.
- Presence of active or incompletely treated infections that could involve the site where the device will be implanted.
- Patients allergic to any of the implant materials, or to dental glue.
- Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.
- Uncooperative patient or patient with neurologic disorder, incapable of following directions.
- Distant foci of infections which may spread to the implant site.
- Vascular insufficiency.
- Open fractures with severe contamination.
- Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
- Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment. For acute Humerus fractures:
- Patients who are under the age of Fifty (50) For all bones excluding pathologic Humerus:
- Metabolic disorders which may impair bone formation.
- Osteomalacia.
- Vascular insufficiency, muscular atrophy, or neuro-muscular disease.
Where
- Mobile, Alabama
- Los Angeles, California
- Denver, Colorado
- Miami, Florida
- Weston, Florida
- Fort Wayne, Indiana
- The Bronx, New York
- Asheville, North Carolina
- Winston-Salem, North Carolina
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Wakefield, Rhode Island
And 1 more location — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 17, 2026 · Source of record for eligibility and locations