A Prospective, Multi-Center Study of the IlluminOss® Photodynamic Bone Stabilization System for the Treatment of Impending and Actual Pathological Fractures in the Humerus from Metastatic Bone Disease - PBSS - Pathological Humerus Fractures

IlluminOss Medical In.0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

Trial is onging in other countries

•General inclusion criteria:
•- Skeletally mature adult males and females 18 years of age or older
•- Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease
•- Females: neither pregnant nor intending to become pregnant during the course of the study
•- Able to understand and provide informed consent
•- Willing and able to comply with post-operative treatment protocol and follow-up visit schedule;Impending Fracture-Specific Inclusion Criteria:
•- Documented presence of solitary metastatic lesion.
•- Mirels Criteria Score >= 8.
•- Destruction of cortical bone at impending fracture site > 50%.;Actual Fracture-Specific Inclusion Criteria:
•- Radiograph-confirmed diagnosis of acute, single isolated fracture of the humerus. AO classification 11A1, 11A2 and 11B1, 11B2 and 12A1,12A2 and 12B1, 12B2 and 13A1,13A2 and 13B1, 13B2.
•- Fracture is closed, Gustilo Type I or IIA

•General Exclusion Criteria:
•- Primary tumor (osteogenic origin, etc.) at site
•- Impending fracture or actual fracture location other than humerus
•- Current concomitant traumatic fracture of any other location
•- Active or incompletely treated infections that could involve the device implant site
•- Distant foci of infection that may spread to the implant site
•- Allergy to implant materials or dental glue
•- Vascular insufficiency, muscular atrophy, or neuromuscular disease at implant site
•- Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder);Impending Fracture-Specific Exclusion Criteria:
•- Mirels Score < 8
•- Destruction of cortical bone at impending fracture site < 50%
•- Prior surgery and/or prior fracture of affected site
•- Any articular component to impending fracture site;Actual Fracture-Specific Exclusion Criteria:
•- Index treatment is greater than 28 days post fracture
•- Open fractures with severe contamination
•- Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable
•- Delivery sheath is unable to cross fracture site after proper fracture reduction and realignment
•- Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided

发起方

IlluminOss Medical In.