Device Global Registry for the IlluminOss Bone Stabilization System

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.

Conditions

Traumatic Fracture, Pathological Fracture

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Study Overview

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Study Details

Study overview

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.

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

Device Global Registry for the IlluminOss Bone Stabilization System

Condition
Traumatic Fracture
Intervention / Treatment

-

Contacts and Locations

Mobile

Gulf Orthopedics, Mobile, Alabama, United States, 36604

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Denver

Presbyterian St Luke's Medical Ctr, Denver, Colorado, United States, 80218

Miami

University of Miami Hospital, Miami, Florida, United States, 33136

Weston

Weston Outpatient Surgical Center, Weston, Florida, United States, 33326

Fort Wayne

Parkview Health, Fort Wayne, Indiana, United States, 46845

Bronx

Jacobi Medical Center, Bronx, New York, United States, 10461

Asheville

Mission Hospital, Asheville, North Carolina, United States, 28801

Winston-Salem

Wake Forest Baptist Health, Winston-Salem, North Carolina, United States, 27157

Philadelphia

Temple University Hospital, Philadelphia, Pennsylvania, United States, 19140

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

IlluminOss Medical, Inc.,

Study Record Dates

2024-12