RECRUITING

Device Global Registry for the IlluminOss Bone Stabilization System

Conditions

Traumatic Fracture Pathological Fracture

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

IlluminOss Device Global Registry - A Prospective, Post-Market, Multi-Center Evaluation of the Clinical Outcomes of the IlluminOss Device

Quick Facts

Study Start:2021-06-11

Study Completion:2024-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05206981

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.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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. 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. 11. Patients who are under the age of Fifty (50) 12. Metabolic disorders which may impair bone formation. 13. Osteomalacia. 14. Vascular insufficiency, muscular atrophy, or neuro-muscular disease.

Inclusion Criteria

Exclusion 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

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.
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.
11. Patients who are under the age of Fifty (50)
12. Metabolic disorders which may impair bone formation.
13. Osteomalacia.
14. Vascular insufficiency, muscular atrophy, or neuro-muscular disease.

Contacts and Locations

Study Contact

Lisa Holt, PhD

CONTACT

401-714-0008

lholt@illuminoss.com

Caitlin Smith, MPH

CONTACT

401-714-0008

csmith@illuminoss.com

Study Locations (Sites)

Gulf Orthopedics

Mobile, Alabama, 36604

United States

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

Presbyterian St Luke's Medical Ctr

Denver, Colorado, 80218

United States

University of Miami Hospital

Miami, Florida, 33136

United States

Weston Outpatient Surgical Center

Weston, Florida, 33326

United States

Parkview Health

Fort Wayne, Indiana, 46845

United States

Jacobi Medical Center

Bronx, New York, 10461

United States

Mission Hospital

Asheville, North Carolina, 28801

United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157

United States

Temple University Hospital

Philadelphia, Pennsylvania, 19140

United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232

United States

Ortho Rhode Island

Wakefield, Rhode Island, 02879

United States

Memorial Hermann Hospital

Katy, Texas, 77494

United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2021-06-11

Study Completion Date2024-12

Study Record Updates

Study Start Date2021-06-11

Study Completion Date2024-12

Terms related to this study

Additional Relevant MeSH Terms

Traumatic Fracture
Pathological Fracture