IlluminOss Device: Patients may enroll in the registry if they have been implanted (retrospective) or will be implanted (prospective) with the IlluminOss device.
Study summary
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.
Eligibility
Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Composite Safety Success Rate — 12 Months
Trial sites (16)
Facility
City
Region
Status
Gulf Orthopedics
Mobile
Alabama
Completed
Cedars-Sinai Medical Center
Los Angeles
California
Recruiting
Presbyterian St Luke's Medical Ctr
Denver
Colorado
Recruiting
University of Miami Hospital
Miami
Florida
Recruiting
Weston Outpatient Surgical Center
Weston
Florida
Recruiting
Parkview Health
Fort Wayne
Indiana
Withdrawn
Jacobi Medical Center
The Bronx
New York
Recruiting
Mission Hospital
Asheville
North Carolina
Withdrawn
Wake Forest Baptist Health
Winston-Salem
North Carolina
Recruiting
Temple University Hospital
Philadelphia
Pennsylvania
Recruiting
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
Recruiting
Ortho Rhode Island
Wakefield
Rhode Island
Recruiting
Memorial Hermann Hospital
Katy
Texas
Recruiting
St Vinzenz Hospital
Cologne
Germany
Withdrawn
Johannes Wesling Hospital Minden
Minden
Germany
Completed
Petrus Hospital
Wuppertal
Germany
Completed
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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