Traumatic FractureNCT05206981
Device Global Registry for the IlluminOss Bone Stabilization System
An observational study of Traumatic Fracture and Pathological Fracture, run by IlluminOss Medical, Inc. at 16 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Traumatic Fracture, Pathological Fracture
- What is being tested?
- IlluminOss Device
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 11 Jun 2021to Dec 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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;
Show all 26Show fewer
- 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.
- Distant foci of infections which may spread to the implant site.
- Vascular insufficiency.
- Open fractures with severe contamination.
- Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
- Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment.
- For acute Humerus fractures:
- Patients who are under the age of Fifty (50)
- For all bones excluding pathologic Humerus:
- Metabolic disorders which may impair bone formation.
- Osteomalacia.
- Vascular insufficiency, muscular atrophy, or neuro-muscular disease.
Trial locations and contacts
16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 2 countries
United States13 sites, 10 recruiting
- Withdrawn
Mission Hospital
Asheville, North Carolina, 28801
- Recruiting
Presbyterian St Luke's Medical Ctr
Denver, Colorado, 80218
Melinda Washman, 303.839.7789, melinda.washam@healthonecares.com
Daniel Lerman, MD
- Withdrawn
Parkview Health
Fort Wayne, Indiana, 46845
- Recruiting
Memorial Hermann Hospital
Katy, Texas, 77494
Sterling Boutte, Sterling.Boutte@uth.tmc.edu
Layla Haidar, 713-486-5529, layla.haidar@uth.tmc.edu
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Arman Jordan, Arman.Jordan@cshs.org
Charles Moon, MD
- Recruiting
University of Miami Hospital
Miami, Florida, 33136
Anastasiya Drandarov, axd1361@med.miami.edu
Brooke Crawford, MD
- Completed
Gulf Orthopedics
Mobile, Alabama, 36604
- Recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Kriti Rawat, kriti.rawat@temple.edu
Theresa Pazionis
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Beata Krawczyk, krawbx@UPMC.EDU
Richard McGough, MD
- Recruiting
Jacobi Medical Center
The Bronx, New York, 10461
Francisco Reinoso, francisco.reinoso@nychhc.org
Milan Sen, MD
- Recruiting
Ortho Rhode Island
Wakefield, Rhode Island, 02879
Jennifer Stedman, jstedman@orthopedicsri.com
Michael Bradley, MD
- Recruiting
Weston Outpatient Surgical Center
Weston, Florida, 33326
David Shenassa, MD
- Recruiting
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Ariel Brotherton, abrother@wakehealth.edu
Martha Holden, mholden@wakehealth.edu
Germany3 sites
- Withdrawn
St Vinzenz Hospital
Cologne
- Completed
Johannes Wesling Hospital Minden
Minden
- Completed
Petrus Hospital
Wuppertal
About this study
Official title: IlluminOss Device Global Registry - A Prospective, Post-Market, Multi-Center Evaluation of the Clinical Outcomes of the IlluminOss Device
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.
Read the detailed description
This is a registry database which will collect patient data as part of a physician's standard of care. Medical data will be collected on patients via questionnaires in either web based or paper forms. Both prospective and retrospective data will be entered into the database. Data collection will begin during the initial visit to the clinic. Demographic, surgical, hospital discharge, and adverse event data will be collected as well as patient reported outcomes including the PROMIS physical function, Visual Analog Pain Score (VAS), and Veterans Rand 12 (VR 12) surveys. Patients will be asked to complete these surveys at the pre-operative and post operative visits at 75 days, 6 months, and 12 months.
- Conditions
- Traumatic Fracture, Pathological Fracture
- Being tested
- IlluminOss Device
- Medical subject headings
- Fractures, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IlluminOss DeviceDevice
Patients may enroll in the registry if they have been implanted (retrospective) or will be implanted (prospective) with the IlluminOss device.
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Safety Success Rate
Measured: 12 Months
Secondary outcomes (8)
Complications/Adverse Events
Measured: 12 Months
Successful Device Implantation
Measured: 12 Months
Fracture Healing
Measured: 12 Months
Disability & Return to Work Status
Measured: 12 Months
Discharge Status
Measured: 12 Months
Visual Analog Pain Score
Measured: 12 Months
Veterans Rand 12 Item Health Survey
Measured: 12 Months
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start11 Jun 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- IlluminOss Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206981
- Sponsor's protocol ID
- REP-2012
- Status last verified
- Apr 2026
- First submitted
- 8 Jan 2022
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IlluminOss Device Global Registry - A Prospective, Post-Market, Multi-Center Evaluation of the Clinical Outcomes of the IlluminOss Device
- ClinicalTrials.gov ID
- NCT05206981
- Acronym / sponsor ID
- REP-2012
- Conditions
- Traumatic Fracture, Pathological Fracture
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IlluminOss Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a registry database which will collect patient data as part of a physician's standard of care. Medical data will be collected on patients via questionnaires in either web based or paper forms. Both prospective and retrospective data will be entered into the database. Data collection will begin during the initial visit to the clinic. Demographic, surgical, hospital discharge, and adverse event data will be collected as well as patient reported outcomes including the PROMIS physical function, Visual Analog Pain Score (VAS), and Veterans Rand 12 (VR 12) surveys. Patients will be asked to complete these surveys at the pre-operative and post operative visits at 75 days, 6 months, and 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (26 listed)
- United States (U.S.)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IlluminOss DevicePatients may enroll in the registry if they have been implanted (retrospective) or will be implanted (prospective) with the IlluminOss device. | Device | – |
Primary outcome
Composite Safety Success Rate
Time frame: 12 Months
8 secondary outcomes
Complications/Adverse Events
Time frame: 12 Months
Successful Device Implantation
Time frame: 12 Months
Fracture Healing
Time frame: 12 Months
Disability & Return to Work Status
Time frame: 12 Months
Discharge Status
Time frame: 12 Months
Visual Analog Pain Score
Time frame: 12 Months
Veterans Rand 12 Item Health Survey
Time frame: 12 Months
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Fracture and Pathological Fracture, run by IlluminOss Medical, Inc. at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Holt, PhD (401-714-0008, lholt@illuminoss.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Safety Success Rate (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.