IlluminOss Medical, Inc.
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…
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…
Patients may enroll in the registry if they have been implanted (retrospective) or will be implanted (prospective) with the IlluminOss device.