Registry for the IlluminOss Bone Stabilization Device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry collects safety and performance data on the IlluminOss Device used for stabilizing and aligning traumatic and pathological fractures. Patient data will be gathered through questionnaires during standard care visits, including both prospective and retrospective data. Information collected will encompass demographics, surgical details, hospital discharge, adverse events, and patient-reported outcomes at various intervals post-operation. The aim is to evaluate the effectiveness and safety of the device in real-world clinical settings.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Presbyterian St Luke's Medical Ctr
  Denver, Colorado, United States Recruiting
• University of Miami Hospital
  Miami, Florida, United States Recruiting
• Weston Outpatient Surgical Center
  Weston, Florida, United States Recruiting
• Jacobi Medical Center
  The Bronx, New York, United States Recruiting
• Wake Forest Baptist Health
  Winston-Salem, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Lisa Holt, PhD
• Email: lholt@illuminoss.com
• Phone: 401-714-0008

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.