Safety and Efficacy Study of Treatment of Pathological Fractures in Humerus

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a prospective, multi-center, open label study to evaluate the Photodynamic Bone Stabilization System (PBSS) when used for the treatment of painful impending and actual fractures of the humerus secondary to metastatic malignancy.

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 Fracture Metastatic Bone Disease

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 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.

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<br>Photodynamic Bone Stabilization System (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 |
| --- | --- | --- |
| Change in Pain | Change in VAS score from baseline. VAS is measured on a scale range from 0-100mm with 0 (no pain) to 100 (worst imaginable pain). | Baseline and 90 days | 
| Change in Function | Change in Revised Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS). MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation. | Baseline and 90 days | 
| Summary of Clinical Safety Success | No serious device related complications, no additional surgical interventions, and no device fracture, migrations, mal-alignment or loss of reduction or fixation | Up to Day 7-14, Up to Day 30, Up to Day 90, Up to Day 180, Up to Day 360 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at Palpation | Pain on palpation and clinical significance | 90, 180 and 360 days | 
| Duration of Index Procedure | Duration of index procedure (hours) | 1 Day | 
| Activities of Daily Living Score Through All Follow-up Intervals | Change from Baseline in Activities of Daily Living Score (EORTC QLQ BM22) for each of the four scales at follow-up visits. There are two symptom scales (painful sites and pain characteristics) and two functional scales (functional interface and psychosocial aspects). All scales will be transformed to range in score from 0 to 100. A high score for the symptom scales represented a high level of symptomatology or problems, while a high score for the functional scales represents a high level of functioning. | Baseline, 90, 180 and 360 days | 
| MSTS Upper Extremity Functional Outcome | Musculoskeletal Tumor Society Rating Scale for Upper Extremity (MSTS) Functional Outcome. MSTS score is a six-item scale. It ranges from 0 to 30. Higher score is associated with better function. Scores were divided by 30 and multiplied by 100 to facilitate interpretation. | 90, 180, 360 days | 
| Assessment of Post-Surgery Status | Number and percent of subjects who receive physical therapy, supportive orthopedic device, or analgesic medication | Surgery & Discharge, 7-14, 30, 90, 180, 360 days | 
| Summary of Procedure and Device-Related Complications Rate | Procedure and device-related complications rate presented at follow-up visits | up to day 90, up to day180 since day 90, up to 360 since day 180 | 
| Summary of Change From Baseline Range of Motion by Visit and Test | Range of motions tests (abduction, extension, flexion, lateral rotation and medial rotation) for active range of motion and passive range of motion for the affected and unaffected arm. | Baseline, 90, 180 and 360 Days | 
| Length of Hospital Stay | Length of hospital stay (from day of procedure to day of discharge) | From day of procedure until the day of hospital discharge (up to 36 days) |