Device Global Registry for the IlluminOss Bone Stabilization System
Start Date
6/11/2021
Completion Date
12/1/2026
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.
Eligibility Criteria
Age Range: 50 years to No maximum
Interventions
IlluminOss Device
Conditions
Locations
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
The 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
St Vinzenz Hospital
Cologne,
Germany
Johannes Wesling Hospital Minden
Minden,
Germany
Petrus Hospital
Wuppertal,
Germany