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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 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        • Withdrawn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

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

Outcome Measure
Time Frame
Composite Safety Success Rate
Time Frame: 12 Months
12 Months

Secondary Outcome Measures

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

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)

June 11, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 8, 2022

First Submitted That Met QC Criteria

January 21, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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