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History of Changes for Study: NCT05206981
Device Global Registry for the IlluminOss Bone Stabilization System
Latest version (submitted February 22, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 21, 2022 None (earliest Version on record)
2 February 22, 2022 Contacts/Locations and Study Status
Comparison Format:

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Study NCT05206981
Submitted Date:  January 21, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: REP-2012
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
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2022
Overall Status: Recruiting
Study Start: June 11, 2021
Primary Completion: December 2024 [Anticipated]
Study Completion: December 2024 [Anticipated]
First Submitted: January 8, 2022
First Submitted that
Met QC Criteria:
January 21, 2022
First Posted: January 25, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
January 21, 2022
Last Update Posted: January 25, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: IlluminOss Medical, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Traumatic Fracture
Pathological Fracture
Keywords:
Open or close this module Study Design
Study Type: Observational [Patient Registry]
Observational Study Model: Cohort
Time Perspective: Other
Biospecimen Retention:
Biospecimen Description:
Enrollment: 300 [Anticipated]
Number of Groups/Cohorts 0
Target Follow-Up Duration: 1 Year
Open or close this module Groups and Interventions
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.
Open or close this module Outcome Measures
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 ]

Open or close this module Eligibility
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.
Sampling Method: Non-Probability Sample
Minimum Age: 50 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers:
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.
Open or close this module Contacts/Locations
Central Contact Person: Lisa Holt, PhD
Telephone: 401-714-0008
Email: lholt@illuminoss.com
Central Contact Backup: Caitlin Smith, MPH
Telephone: 401-714-0008
Email: csmith@illuminoss.com
Study Officials: Dietmar Pennig, Prof. Dr.
Principal Investigator
St. Vinzenz-Hospital (Teaching Hospital, University of Cologne)
Locations: United States, Rhode Island
Ortho Rhode Island
[Recruiting]
Wakefield, Rhode Island, United States, 02879
Contact:Contact: Jennifer Stedman jstedman@orthopedicsri.com
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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