This trial is active, not recruiting.

Condition humerus fracture metastatic bone disease
Treatment photodynamic bone stabilization system (pbss)
Sponsor IlluminOss Medical, Inc.
Start date March 2015
End date June 2017
Trial size 81 participants
Trial identifier NCT02338492, 14-03-PATHOLHUM-02


The purpose of this study is to collect safety and performance data of the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
The PBSS is comprised of an inflatable, thin walled polyethylene terephthalate (PET; Dacron™) balloon mounted on an insertion catheter. This balloon catheter system is designed to deliver the monomer cement to the fracture site via the medullary canal of the bone
photodynamic bone stabilization system (pbss)
Treatment of impending and actual pathological fractures of the humerus

Primary Outcomes

Pain reduction
time frame: 90 days
Functional improvement
time frame: 90 days
Clinical safety success: No Serious Device Related Complications, No additional surgical interventions
time frame: 90 days
Radiographic safety success: No device fracture, migrations, mal-alignment or loss of reduction or fixation
time frame: 90 days

Secondary Outcomes

Clinical safety success
time frame: 90, 180 and 360 days
Radiographic safety success: No device fracture, migrations, mal-alignment or loss of reduction or fixation
time frame: 90, 180 and 360 days
Duration of index procedure and length of hospital stay
time frame: 90, 180, 360 days
Activities of Daily Living score through all follow-up intervals
time frame: 90, 180, 360 days
Disability status
time frame: 90, 180, 360 days
Evaluation of duration of physical therapy prescription
time frame: 90, 180, 360 days
Assessment of prescription and over-the-counter analgesic medication use
time frame: 90, 180, 360 days
Survivability from time of index procedure to death
time frame: 90, 180, 360 days
Incidence and number of Adverse Events
time frame: 90, 180, 360 days
Incidence and number of procedure- and device-related complications
time frame: 90, 180, 360 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - General Inclusion Criteria 1. Skeletally mature adult males and females 18 years of age or older. 2. Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease. 3. Females: neither pregnant nor intending to become pregnant during the course of the study, defined as: 1. Postmenopausal for at least 1 year OR 2. Documented oophorectomy or hysterectomy 3. Surgically sterile OR 4. 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 4. Patient, or his/her legally authorized representative, is able to understand and provide informed consent. 5. Willing and able to comply with post-operative treatment protocol and follow-up visit schedule. 6. VAS Pain Score > 60mm on 100mm scale. -Impending Fracture-Specific Inclusion Criteria 7. Documented presence of at least one metastatic lesion of the humerus. 8. Mirels Criteria Score ≥ 8. (specific to the target humeral lesion and subject to minimum VAS score requirements) 9. Destruction of cortical bone at impending fracture site > 50%. -Actual Fracture-Specific Inclusion Criteria 10. Fracture is closed, Gustilo Type I or II. Exclusion Criteria: - General Exclusion Criteria 1. Primary tumor (osteogenic origin, etc.) at site. 2. 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. 3. Active or incompletely treated infections that could involve the device implant site. 4. Distant foci of infection that may spread to the implant site. 5. Allergy to implant materials or dental glue. 6. In the investigator's judgment, functional deficit in the target humerus with an etiology other than bone metastases (e.g. due to vascular insufficiency). 7. In the investigator's judgment, focal neurologic deficit as a result of metastases in the brain, spine, or other central nervous system disorders. 8. Uncooperative patients, or patients who are incapable of following directions (for example, as a consequence of a neurological or psychiatric disorder). 9. Prisoner -Impending Fracture-Specific Exclusion Criteria 10. Mirels Score < 8 (specific to target humeral lesion). 11. Destruction of cortical bone at impending fracture site < 50%. 12. Prior surgery and/or prior fracture of affected site. 13. Any articular component to impending fracture site. -Actual Fracture-Specific Exclusion Criteria 14. Open fractures with severe contamination. 15. Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable. 16. Patients whose intramedullary canal at site of fracture measures smaller than the diameter of the sheath provided.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by IlluminOss Medical, Inc..
Location data was received from the National Cancer Institute and was last updated in June 2016.