IlluminOss Device Global Registry - A Prospective, Post-Market, Multi-Center Evaluation of the Clinical Outcomes of the IlluminOss Device
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Traumatic Fracture
- Sponsor
- IlluminOss Medical, Inc.
- Enrollment
- 300
- Locations
- 27
- Primary Endpoint
- Composite Safety Success Rate
- Status
- Recruiting
- Last Updated
- 15 days ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient has been deemed a candidate for the IlluminOss device
- •Patient is male or non-pregnant female
- •Patient is willing and able to comply with the postoperative scheduled clinical and radiographic evaluations
- •Patient is willing and able to give informed consent if required
- •Traumatic patient is over the age of 50
- •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:
- •an active or incompletely treated infection that could involve the site where the device will be implanted;
- •are allergic to any of the implant materials or to dental glue;
- •have an intramedullary canal measuring smaller than the diameter of the delivery sheath provided at the site of the fracture;
- •distant foci of infections which may spread to the implant site, have open fractures with severe contamination;
- •or in patients for whom delivery sheath is unable to cross fracture site after proper fracture reduction and realignment.
- •European Union (EU)
- •This product is contraindicated in EU patients who have:
- •For all Bones:
Outcomes
Primary Outcomes
Composite Safety Success Rate
Time Frame: 12 Months
Secondary Outcomes
- Discharge Status(12 Months)
- Visual Analog Pain Score(12 Months)
- Fracture Healing(12 Months)
- Complications/Adverse Events(12 Months)
- Successful Device Implantation(12 Months)
- Disability & Return to Work Status(12 Months)
- Veterans Rand 12 Item Health Survey(12 Months)
- Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function(12 Months)