Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus

Completed · Not applicable

Conditions studied: Humerus Fracture Metastatic Bone Disease

In brief

This study will collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of fractures of the humerus secondary to metastatic cancer.

Key facts

Study ID

NCT02338492

Run by

IlluminOss Medical, Inc.

People needed

81

Starts

2015-03-01

Expected to finish

2017-07-01

Last updated by the study team

2018-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford School of Medicine — Redwood City, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Midwest Orthopaedics at Rush — Chicago, Illinois, United States
• MedStar Franklin Square Medical Center — Baltimore, Maryland, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Duke University School of Medicine — Durham, North Carolina, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• University of Pittsburgh Physicians — Pittsburgh, Pennsylvania, United States
• University Orthopedics Inc. — Providence, Rhode Island, United States
• Marshall University — Huntington, West Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.