Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus

Inclusion Criteria

• 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, defined as:
• Postmenopausal for at least 1 year OR
• Documented oophorectomy or hysterectomy
• Surgically sterile OR
• If of childbearing potential, must be practicing double-barrier method of birth control, be willing to avoid pregnancy for the period of study participation and have a negative pregnancy test at screening
• Patient, or his/her legally authorized representative, is able to understand and provide informed consent.
• Willing and able to comply with post-operative treatment protocol and follow-up visit schedule.
• VAS Pain Score > 60mm on 100mm scale.

-Impending Fracture-Specific Inclusion Criteria

• Documented presence of at least one metastatic lesion of the humerus.
• Mirels Criteria Score ≥ 8. (specific to the target humeral lesion and subject to minimum VAS score requirements)
• Destruction of cortical bone at impending fracture site > 50%.

-Actual Fracture-Specific Inclusion Criteria

• Fracture is closed, Gustilo Type I or II.

Exclusion Criteria

• General Exclusion Criteria
• Primary tumor (osteogenic origin, etc.) at site.
• Impending or actual fracture at any other location that, in the Investigator's opinion, would preclude ability to assess pain and/or function in the target humerus.
• 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.
• In the investigator's judgment, functional deficit in the target humerus with an etiology other than bone metastases (e.g. due to vascular insufficiency).
• In the investigator's judgment, focal neurologic deficit as a result of metastases in the brain, spine, or other central nervous system disorders.
• Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder).
• Prisoner

-Impending Fracture-Specific Exclusion Criteria

• Mirels Score < 8 (specific to target humeral lesion).
• 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

• Open fractures with severe contamination.
• Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
• Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.