We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 6 for:    illuminoss

Device Global Registry for the IlluminOss Bone Stabilization System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05206981
Recruitment Status : Recruiting
First Posted : January 25, 2022
Last Update Posted : February 24, 2022
Sponsor:
Information provided by (Responsible Party):
IlluminOss Medical, Inc.

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.

Condition or disease Intervention/treatment
Traumatic Fracture Pathological Fracture Device: IlluminOss Device

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: IlluminOss Device Global Registry - A Prospective, Post-Market, Multi-Center Evaluation of the Clinical Outcomes of the IlluminOss Device
Actual Study Start Date : June 11, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Intervention Details:
  • Device: IlluminOss Device
    Patients may enroll in the registry if they have been implanted (retrospective) or will be implanted (prospective) with the IlluminOss device.


Primary Outcome Measures :
  1. Composite Safety Success Rate [ Time Frame: 12 Months ]

Secondary Outcome Measures :
  1. Complications/Adverse Events [ Time Frame: 12 Months ]
  2. Successful Device Implantation [ Time Frame: 12 Months ]
  3. Fracture Healing [ Time Frame: 12 Months ]
  4. Disability & Return to Work Status [ Time Frame: 12 Months ]
  5. Discharge Status [ Time Frame: 12 Months ]
  6. Visual Analog Pain Score [ Time Frame: 12 Months ]
  7. Veterans Rand 12 Item Health Survey [ Time Frame: 12 Months ]
  8. Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function [ Time Frame: 12 Months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05206981


Contacts
Layout table for location contacts
Contact: Lisa Holt, PhD 401-714-0008 lholt@illuminoss.com
Contact: Caitlin Smith, MPH 401-714-0008 csmith@illuminoss.com

Locations
Layout table for location information
United States, Alabama
Gulf Orthopedics Recruiting
Mobile, Alabama, United States, 36604
Contact: Cathy Blache, DNP, RN,CCRC    251-459-4877    cblache@precisionclinicalresearch.com   
Principal Investigator: Russell Goode, MD         
United States, Florida
Weston Outpatient Surgical Center Not yet recruiting
Weston, Florida, United States, 33326
Principal Investigator: David Shenassa, MD         
United States, Rhode Island
Ortho Rhode Island Recruiting
Wakefield, Rhode Island, United States, 02879
Contact: Jennifer Stedman       jstedman@orthopedicsri.com   
Principal Investigator: Michael Bradley, MD         
Germany
St Vinzenz Hospital Recruiting
Cologne, Germany
Contact: Viviane Hamza, PA    49-221-7712-4114    viviane.hamza@cellitinnen.de   
Principal Investigator: Dietmar Pennig         
Sponsors and Collaborators
IlluminOss Medical, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Dietmar Pennig, Prof. Dr. St. Vinzenz-Hospital (Teaching Hospital, University of Cologne)
Layout table for additonal information
Responsible Party: IlluminOss Medical, Inc.
ClinicalTrials.gov Identifier: NCT05206981    
Other Study ID Numbers: REP-2012
First Posted: January 25, 2022    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Fractures, Spontaneous
Wounds and Injuries