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(prospective) with the IlluminOss device.",[14,19],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Lisa Holt, PhD","CONTACT","401-714-0008","lholt@illuminoss.com",{"name":20,"role":16,"phone":17,"phoneExt":7,"email":21},"Caitlin Smith, MPH","csmith@illuminoss.com",[23,37,55,72,91,103,114,130,140,162,178,193,213,233,243,251],{"facility":24,"status":25,"city":26,"state":27,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":7},"Gulf Orthopedics","COMPLETED","Mobile","Alabama","36604","United States","US",{"type":32,"coordinates":33},"Point",[34,35],-88.04305,30.69436,{"lat":35,"lon":34},{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":29,"countryCode":30,"cosmosGeoPoint":43,"geoPoint":47,"contacts":48},"Cedars-Sinai Medical Center","RECRUITING","Los Angeles","California","90048",{"type":32,"coordinates":44},[45,46],-118.24368,34.05223,{"lat":46,"lon":45},[49,52],{"name":50,"role":16,"phone":7,"phoneExt":7,"email":51},"Arman 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Post-Market, Multi-Center Evaluation of the Clinical Outcomes of the IlluminOss Device","Inclusion Criteria:\n\n1. Patient has been deemed a candidate for the IlluminOss device\n2. Patient is male or non-pregnant female\n3. Patient is willing and able to comply with the postoperative scheduled clinical and radiographic evaluations\n4. Patient is willing and able to give informed consent if required\n5. Traumatic patient is over the age of 50\n6. IlluminOss procedure is the initial procedure to treat the traumatic injury\n\nExclusion Criteria:\n\nUnited States (U.S.)\n\nThis product is contraindicated in U.S. patients who have:\n\n1. an active or incompletely treated infection that could involve the site where the device will be implanted;\n2. are allergic to any of the implant materials or to dental glue;\n3. have an intramedullary canal measuring smaller than the diameter of the delivery sheath provided at the site of the fracture;\n4. distant foci of infections which may spread to the implant site, have open fractures with severe contamination;\n5. or in patients for whom delivery sheath is unable to cross fracture site after proper fracture reduction and realignment.\n\nEuropean Union (EU)\n\nThis product is contraindicated in EU patients who have:\n\nFor all Bones:\n\n1. Patients who are considered skeletally immature.\n2. Presence of active or incompletely treated infections that could involve the site where the device will be implanted.\n3. Patients allergic to any of the implant materials, or to dental glue.\n4. Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.\n5. Uncooperative patient or patient with neurologic disorder, incapable of following directions.\n6. Distant foci of infections which may spread to the implant site.\n7. Vascular insufficiency.\n8. Open fractures with severe contamination.\n9. Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.\n10. Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment.\n\n    For acute Humerus fractures:\n11. Patients who are under the age of Fifty (50)\n\n    For all bones excluding pathologic Humerus:\n12. Metabolic disorders which may impair bone formation.\n13. Osteomalacia.\n14. Vascular insufficiency, muscular atrophy, or neuro-muscular disease.","ALL","50 Years",{"count":271,"type":272},300,"ESTIMATED","1 Year","OBSERVATIONAL","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.",[277,278],"Traumatic Fracture","Pathological Fracture","2026-04-14",{"date":281,"type":282},"2026-04-17","ACTUAL",{"date":284,"type":282},"2021-06-11",{"date":286,"type":272},"2026-12",{"name":5,"class":6},16]