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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.

Tracking Information
First Submitted Date January 8, 2022
First Posted Date January 25, 2022
Last Update Posted Date February 24, 2022
Actual Study Start Date June 11, 2021
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 21, 2022)
Composite Safety Success Rate [ Time Frame: 12 Months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 21, 2022)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Device Global Registry for the IlluminOss Bone Stabilization System
Official Title IlluminOss Device Global Registry - A Prospective, Post-Market, Multi-Center Evaluation of the Clinical Outcomes of the IlluminOss Device
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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
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.
Condition
  • Traumatic Fracture
  • Pathological Fracture
Intervention Device: IlluminOss Device
Patients may enroll in the registry if they have been implanted (retrospective) or will be implanted (prospective) with the IlluminOss device.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 21, 2022)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Lisa Holt, PhD 401-714-0008 lholt@illuminoss.com
Contact: Caitlin Smith, MPH 401-714-0008 csmith@illuminoss.com
Listed Location Countries Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05206981
Other Study ID Numbers REP-2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party IlluminOss Medical, Inc.
Original Responsible Party Same as current
Current Study Sponsor IlluminOss Medical, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Dietmar Pennig, Prof. Dr. St. Vinzenz-Hospital (Teaching Hospital, University of Cologne)
PRS Account IlluminOss Medical, Inc.
Verification Date February 2022