Actively Recruiting
IlluminOss Device Global Registry A Prospective, Post-Market, Multi-Center Evaluation of Clinical Outcomes
Led by IlluminOss Medical, Inc. · Updated on 2026-04-17
300
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are gathering information on the IlluminOss Device, which is used to stabilize and align bones in patients with traumatic or pathological fractures. This multi-center, observational patient registry aims to collect safety and performance data on this device as part of standard medical care. The study includes patients aged 50 and older who are candidates for the device. Patients who have received or will receive the IlluminOss Device are included in the registry. Data collection starts at the initial clinic visit and includes both prospective and retrospective entries. Medical details, surgical information, hospital discharge data, and any adverse events are recorded. Participants will complete patient-reported surveys such as PROMIS physical function, Visual Analog Pain Score (VAS), and Veterans Rand 12 (VR 12) before surgery and at 75 days, 6 months, and 12 months after the procedure. Throughout the study, patients will undergo scheduled clinical and radiographic evaluations to monitor outcomes. Researchers will track safety success rates, complications, device implantation success, fracture healing, disability, return to work status, discharge status, and patient-reported outcomes over 12 months. The study is designed to observe real-world use of the device and its effects on patient recovery and function over time.
CONDITIONS
Brief 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 implant site (U.S. and EU)
- Allergy to implant materials or dental glue (U.S. and EU)
- Intramedullary canal smaller than delivery sheath diameter at fracture site (U.S. and EU)
- Distant infections that may spread to implant site (U.S. and EU)
- Open fractures with severe contamination (U.S. and EU)
- Delivery sheath unable to cross fracture site after proper reduction and realignment (U.S. and EU)
- Skeletally immature patients (EU)
- Uncooperative or neurologically impaired patients unable to follow directions (EU)
- Vascular insufficiency (EU)
- Extremely comminuted fractures with insufficient balloon holding power (EU)
- Patients under 50 years old for acute humerus fractures (EU)
- Metabolic disorders impairing bone formation excluding pathologic humerus (EU)
- Osteomalacia excluding pathologic humerus (EU)
- Muscular atrophy or neuromuscular disease excluding pathologic humerus (EU)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure
Participants undergo implantation of the IlluminOss bone stabilization device as part of their routine clinical care.
1 visit (in-person)
Duration - 12 months
Participants complete questionnaires and clinical assessments to monitor recovery and outcomes after device implantation.
Visits at approximately 75 days, 6 months, and 12 months post-operative
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
C
Caitlin Smith, MPH
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here