IlluminOss Hand Fracture International Clinical Feasibility Study

Study Overview
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Brief Summary
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The purpose of this study is to assess the initial safety and technical feasibility of the IlluminOss System in the treatment of fractures of bones in the hand.

Official Title
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IlluminOss Medical- Photodynamic Bone Stabilization System- International Study

Conditions
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Orthopedic Fractures

Intervention / Treatment
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* Device: IlluminOss device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skeletally mature Patient or his/her legal guardian understands the nature of the procedure and is willing to comply with associated follow-up evaluations, and provides written informed consent prior to the procedure Female patients must be of non-child bearing potential, or have a negative pregnancy test within prior 48 hours Acute fracture of metacarpal or phalangeal bone(s) that requires reduction and internal fixation Fracture has occurred within past 3 weeks Fracture types: transverse, short oblique, or any fracture pattern in which the comminuted segment is equal to or less than the diameter of the bone at fracture site Exclusion Criteria: Patient is pregnant, lactating or female patients who intend to become pregnant during the course of the study Patient has experienced a crush, mangling, or burn type injury Patient has probable history of infection or confirmed infection at baseline Patient has previous diagnosis of a significant bone disorder that may impair bone healing Patient has a life expectancy of < 26 weeks Pathological fracture secondary to tumor Open fracture of Gustilo-Anderson Type II or III

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: IlluminOss device<br>IlluminOss bone-pin device | Device: IlluminOss device<br>* The IlluminOss™ Bone Stabilization System is designed to deliver the device to the fracture site via the medullary canal of the bone using percutaneous techniques. Once the device is in place and has spanned the fracture site, the device is expanded and hardened to reduce and stabilize the fracture, to aid in the support and healing of the bone fracture by primary callous formation and remodeling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location. |  | Immediately post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Fracture Union |  | 180 day | 
| Rate of Anatomic Alignment |  | 180 Day | 
| Functionality Score |  | 180 Day | 
| Grip Strength |  | 180 Day | 
| Range of Motion |  | 180 day | 
| Incidence of Reintervention of Target Fracture |  | 180 Day | 
| Bone Pin Migration |  | 180 Day | 
| Adverse Event Rate |  | 180 day |