Device Global Registry for the IlluminOss Bone Stabilization System

April 14, 2026 updated by: IlluminOss Medical, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Cologne, Germany
        • Withdrawn
        • St Vinzenz Hospital
      • Minden, Germany
        • Completed
        • Johannes Wesling Hospital Minden
      • Wuppertal, Germany
        • Completed
        • Petrus Hospital
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Completed
        • Gulf Orthopedics
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Charles Moon, MD
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Presbyterian St Luke's Medical Ctr
        • Principal Investigator:
          • Daniel Lerman, MD
        • Contact:
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital
        • Contact:
        • Principal Investigator:
          • Brooke Crawford, MD
        • Sub-Investigator:
          • Marilyn Heng, MD
      • Weston, Florida, United States, 33326
        • Recruiting
        • Weston Outpatient Surgical Center
        • Principal Investigator:
          • David Shenassa, MD
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Withdrawn
        • Parkview Health
    • New York
      • The Bronx, New York, United States, 10461
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Withdrawn
        • Mission Hospital
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Health
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cynthia Emory, MD
        • Sub-Investigator:
          • Jason Halvorson, MD
        • Sub-Investigator:
          • Holly Pilson, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Hospital
        • Contact:
        • Principal Investigator:
          • Theresa Pazionis
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
        • Principal Investigator:
          • Richard McGough, MD
    • Rhode Island
      • Wakefield, Rhode Island, United States, 02879
        • Recruiting
        • Ortho Rhode Island
        • Contact:
        • Principal Investigator:
          • Michael Bradley, MD
        • Sub-Investigator:
          • Anthony DeLuise, MD
        • Sub-Investigator:
          • Keith Monchik, MD
    • Texas
      • Katy, Texas, United States, 77494

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Composite Safety Success Rate
Time Frame: 12 Months
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Complications/Adverse Events
Time Frame: 12 Months
12 Months
Successful Device Implantation
Time Frame: 12 Months
12 Months
Fracture Healing
Time Frame: 12 Months
12 Months
Disability & Return to Work Status
Time Frame: 12 Months
12 Months
Discharge Status
Time Frame: 12 Months
12 Months
Visual Analog Pain Score
Time Frame: 12 Months
12 Months
Veterans Rand 12 Item Health Survey
Time Frame: 12 Months
12 Months
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IlluminOss Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REP-2012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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