A Safety and Efficacy Study of the Treatment of Impending and Actual Pathological Fractures in the Humerus From Metastatic Bone Disease

Study Overview
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Brief Summary
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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.

Official Title
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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
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Humerus Pathological Fracture

Intervention / Treatment
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* Device: Photodynamic Bone Stabilization System


Participation Criteria
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Eligibility Criteria
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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 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. Exclusion Criteria: -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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Photodynamic Bone Stabilization System (PBSS)<br>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. | Device: Photodynamic Bone Stabilization System<br>* Treatment of impending and actual pathological fractures of the humerus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Reduction | VAS Pain Score change of > -33% compared to baseline | 90 days | 
| Functional Improvement (Barthel Index of Activities of Daily Living (ADLs) improvement of > +10% from baseline -EORTC QLQ-C30 improvement of > +10% from baseline -EORTC QLQ-BM22 improvement of > +10% from baseline) | Barthel Index of Activities of Daily Living (ADLs) improvement of > +10% from baseline EORTC QLQ-C30 improvement of > +10% from baseline EORTC QLQ-BM22 improvement of > +10% from baseline | 90 days | 
| Clinical Safety Success (No Serious Device Related Complications -No additional surgical interventions: revisions, supplements, fixations or removals) | No Serious Device Related Complications No additional surgical interventions: revisions, supplements, fixations or removals | 90 days | 
| Radiographic Safety Success (No device fracture, migrations, mal-alignment or loss of reduction or fixation) | No device fracture, migrations, mal-alignment or loss of reduction or fixation | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Reduction (VAS Pain Score change of > -33% compared to baseline) | VAS Pain Score change of > -33% compared to baseline | 90, 180 and 360 days | 
| Functional Improvement (-Barthel Index of Activities of Daily Living (ADLs) improvement of > +10% from baseline, -EORTC QLQ-C30 improvement of > +10% from baseline -EORTC QLQ-BM22 improvement of > +10% from baseline) | Barthel Index of Activities of Daily Living (ADLs) improvement of > +10% from baseline, EORTC QLQ-C30 improvement of > +10% from baseline EORTC QLQ-BM22 improvement of > +10% from baseline | 90, 180, 360 days | 
| Clinical Safety Success (No Serious Device Related Complications -No additional surgical interventions: revisions, supplements, fixations or removals) | No Serious Device Related Complications No additional surgical interventions: revisions, supplements, fixations or removals | 90, 180, 360 days | 
| Radiographic Safety Success (No device fracture, migrations, mal-alignment or loss of reduction or fixation) | No device fracture, migrations, mal-alignment or loss of reduction or fixation | 90, 180, 360 days | 
| Duration of index procedure and length of hospital stay |  | 90, 180, 360 days | 
| Disability status | Determined per Investigator assessment | 90, 180, 360 days | 
| Evaluation of duration of physical therapy prescription |  | 90, 180, 360 days | 
| Assessment of prescription and over-the-counter analgesic medication use |  | 90, 180, 360 days | 
| Survivability from time of index procedure to death |  | 90, 180, 360 days | 
| Incidence and number of AEs |  | 90, 180, 360 days | 
| Incidence and number of procedure- and device-related complications |  | 90, 180, 360 days | 
| Activities of Daily Living score through all follow-up intervals | Barthel Index of Activities of Daily Living (ADLs), EORTC QLQ-C30 and EORTC QLQ-BM22 | 90, 180, 360 days | 
| VAS Pain score from baseline through all follow-up intervals | VAS pain scale | 90, 180, 360 days |