Device Global Registry for the IlluminOss Bone Stabilization System
IlluminOss Device Global Registry - A Prospective, Post-Market, Multi-Center Evaluation of the Clinical Outcomes of the IlluminOss Device
1 other identifier
observational
300
2 countries
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 11, 2021
CompletedFirst Submitted
Initial submission to the registry
January 8, 2022
CompletedFirst Posted
Study publicly available on registry
January 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 17, 2026
April 1, 2026
5.5 years
January 8, 2022
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Composite Safety Success Rate
12 Months
Secondary Outcomes (8)
Complications/Adverse Events
12 Months
Successful Device Implantation
12 Months
Fracture Healing
12 Months
Disability & Return to Work Status
12 Months
Discharge Status
12 Months
- +3 more secondary outcomes
Interventions
Patients may enroll in the registry if they have been implanted (retrospective) or will be implanted (prospective) with the IlluminOss device.
Eligibility Criteria
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. The device will be used in a manner consistent with the treating physician's regular clinical practice.
You may qualify if:
- 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 may not qualify if:
- United States (U.S.)
- This product is contraindicated in U.S. patients who have:
- an active or incompletely treated infection that could involve the site where the device will be implanted;
- are allergic to any of the implant materials or to dental glue;
- have an intramedullary canal measuring smaller than the diameter of the delivery sheath provided at the site of the fracture;
- distant foci of infections which may spread to the implant site, have open fractures with severe contamination;
- 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:
- Patients who are considered skeletally immature.
- Presence of active or incompletely treated infections that could involve the site where the device will be implanted.
- Patients allergic to any of the implant materials, or to dental glue.
- Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.
- Uncooperative patient or patient with neurologic disorder, incapable of following directions.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Gulf Orthopedics
Mobile, Alabama, 36604, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Presbyterian St Luke's Medical Ctr
Denver, Colorado, 80218, United States
University of Miami Hospital
Miami, Florida, 33136, United States
Weston Outpatient Surgical Center
Weston, Florida, 33326, United States
Parkview Health
Fort Wayne, Indiana, 46845, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
Ortho Rhode Island
Wakefield, Rhode Island, 02879, United States
Memorial Hermann Hospital
Katy, Texas, 77494, United States
St Vinzenz Hospital
Cologne, Germany
Johannes Wesling Hospital Minden
Minden, Germany
Petrus Hospital
Wuppertal, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2022
First Posted
January 25, 2022
Study Start
June 11, 2021
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share