Actively Recruiting
Device Global Registry for the IlluminOss Bone Stabilization System
Led by IlluminOss Medical, Inc. · Updated on 2026-04-17
300
Participants Needed
16
Research Sites
285 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Device Global Registry for the IlluminOss Bone Stabilization System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Active or incompletely treated infection at the device implant site
- Allergy to any implant materials or dental glue
- Intramedullary canal smaller than delivery sheath diameter at fracture site
- Distant infections that may spread to implant site
- Open fractures with severe contamination
- Delivery sheath unable to cross fracture site after proper reduction and realignment
- Skeletally immature patients (EU only)
- Uncooperative or neurologically impaired patients unable to follow directions (EU only)
- Vascular insufficiency (EU only)
- Extremely comminuted fractures with probable insufficient balloon holding power (EU only)
- Patients under age 50 with acute humerus fractures (EU only)
- Metabolic disorders impairing bone formation (EU only)
- Osteomalacia (EU only)
- Muscular atrophy or neuromuscular disease (EU only)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Gulf Orthopedics
Mobile, Alabama, United States, 36604
Completed
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
3
Presbyterian St Luke's Medical Ctr
Denver, Colorado, United States, 80218
Actively Recruiting
4
University of Miami Hospital
Miami, Florida, United States, 33136
Actively Recruiting
5
Weston Outpatient Surgical Center
Weston, Florida, United States, 33326
Actively Recruiting
6
Parkview Health
Fort Wayne, Indiana, United States, 46845
Withdrawn
7
Jacobi Medical Center
The Bronx, New York, United States, 10461
Actively Recruiting
8
Mission Hospital
Asheville, North Carolina, United States, 28801
Withdrawn
9
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
10
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
11
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
12
Ortho Rhode Island
Wakefield, Rhode Island, United States, 02879
Actively Recruiting
13
Memorial Hermann Hospital
Katy, Texas, United States, 77494
Actively Recruiting
14
St Vinzenz Hospital
Cologne, Germany
Withdrawn
15
Johannes Wesling Hospital Minden
Minden, Germany
Completed
16
Petrus Hospital
Wuppertal, Germany
Completed
Research Team
L
Lisa Holt, PhD
CONTACT
C
Caitlin Smith, MPH
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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