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.
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
Enrollment
300
Patients may enroll in the registry if they have been implanted (retrospective) or will be implanted (prospective) with the IlluminOss device.
Gulf Orthopedics
Mobile, Alabama, United States
COMPLETEDCedars-Sinai Medical Center
Los Angeles, California, United States
Composite Safety Success Rate
Time frame: 12 Months
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Presbyterian St Luke's Medical Ctr
Denver, Colorado, United States
RECRUITINGUniversity of Miami Hospital
Miami, Florida, United States
RECRUITINGWeston Outpatient Surgical Center
Weston, Florida, United States
RECRUITINGParkview Health
Fort Wayne, Indiana, United States
WITHDRAWNJacobi Medical Center
The Bronx, New York, United States
RECRUITINGMission Hospital
Asheville, North Carolina, United States
WITHDRAWNWake Forest Baptist Health
Winston-Salem, North Carolina, United States
RECRUITINGTemple University Hospital
Philadelphia, Pennsylvania, United States
RECRUITING...and 6 more locations