Device Global Registry for the IlluminOss Bone Stabilization System

Launched by ILLUMINOSS MEDICAL, INC. · Jan 21, 2022

Keywords

ClinConnect Summary

The Device Global Registry for the IlluminOss Bone Stabilization System is a clinical trial aimed at gathering information about the safety and effectiveness of a new device used to help stabilize broken bones. This study is designed for patients who have experienced traumatic fractures or have fractures due to other medical conditions. The trial is currently recruiting participants, specifically men and non-pregnant women over the age of 50 who are suitable candidates for the IlluminOss device and are willing to attend follow-up appointments for check-ups and imaging tests.

To be eligible for this trial, patients must not have any active infections at the fracture site, allergies to the materials used in the device, or certain other health issues that could complicate the treatment. Participants can expect to receive the IlluminOss procedure as their first treatment for a fracture and will be monitored closely to see how well the device works in helping their bones heal. It's important for potential participants to understand that this registry will help improve future treatments for fractures, contributing to better care for patients like them.

Gender

ALL

Eligibility criteria

• 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.