Safety and Efficacy Study of the Treatment of Humerus Fractures

Study Overview
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Brief Summary
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The purpose of this study is to collect safety and performance data on the use of the Photodynamic Bone Stabilization System (PBSS) when used to provide stabilization and alignment for the treatment of acute humerus fractures.

Official Title
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CE Marking Study of the IlluminOss Photodynamic Bone Stabilization System for the Treatment of Humerus Fractures

Conditions
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Acute Humerus Fractures

Intervention / Treatment
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* Device: Photodynamic Bone Stabilization System


Participation Criteria
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Eligibility Criteria
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Fracture-Specific Inclusion Criteria Radiograph-confirmed diagnosis of acute, single isolated fracture of the humerus. AO classification 11A2, 11A3 and 11B1, 11B2 and 12A1, 12A2, 12A3 and 12B1, 12B2. Fracture is closed, Gustilo Type I or II. General Inclusion Criteria Skeletally mature men and women, 50 years of age or older at time of index injury. a) Female patients of child bearing potential agree to use double barrier method of contraception b) Female patients of non-child bearing potential must meet one of the following criteria: Postmenopausal for at least 1 year, or Documented oophorectomy or hysterectomy, or Surgically sterile Willing and able to understand and sign the informed consent. 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. Marked bone loss or bone resorption patients, who due to a prior delayed union or non-union of the bones or other illnesses, may not be able to have their fracture adequately reduced prior to placement of the IlluminOss-device. This could leave bone void spaces that would preclude the device from maintaining alignment of the fractured bone. Previous fracture of affected limb. General Exclusion Criteria Pregnant or lactating. Active or incompletely treated infections that could involve the site where the device will be implanted. Distant foci of infections that may spread to the implant site Uncooperative patients or patients, who are incapable of following directions (for example as a consequence of a neurological or psychiatric disorder). Concomitant metabolic disorders that may impair bone formation. Osteomalacia. Allergic to implant materials or dental glue. Vascular insufficiency, muscular atrophy, or neuro-muscular disease. Polytrauma patients (multiple injuries resulting from a high-impact event, eg- a motor vehicle accident). Life expectancy less than one year due to concurrent illness.

Ages Eligible for Study
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Minimum Age: 50 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 acute humerus fractures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal radiographic fracture healing | Two of four cortices or two of four views demonstrating bridging on standard radiographs | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the incidence of adverse events |  | 180 and 360 days | 
| Assessment of the procedure- and device-related complication rate |  | 180 and 360 days | 
| Evaluation of complete radiographic healing | Three of four cortices or three of four views demonstrating bridging, with dissolution of the majority (greater than or equal to 75% on orthogonal views) of fracture lines | 180 and 360 days | 
| Evaluation of normal radiographic healing | Two of four cortices or two of four views demonstrating bridging on standard radiographs | 360 days | 
| Assessment of no pain at palpation status | Clinical assessment | 180 and 360 days | 
| Assessment of return to pre-fracture mobility status | Clinical assessment | 180 and 360 days | 
| Comparison of pain visual analog score (VAS) from baseline to all follow up intervals |  | 180 and 360 days | 
| Comparison of Disability of the Arm, Shoulder and Hand score from baseline to all follow up intervals |  | 180 and 360 days | 
| Comparison of Constant shoulder score from baseline to all follow up intervals |  | 180 and 360 days | 
| Assessment of range of motion | Clinical assessment | 180 and 360 days | 
| Assessment of disability status | Per Investigator assessment | 180 and 360 days | 
| Assessment of return to work status |  | 180 and 360 days |