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
- Conditions
- bone healingupper arm fracture1001732210005944
- Registration Number
- NL-OMON40648
- Lead Sponsor
- IlluminOss Medical In.
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method