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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
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.
Hospital del Trabajador
Santiago, Chile
Technical Success: Successful implantation of an IlluminOss bone-pin via percutaneous techniques at the target fracture location.
Time frame: Immediately post-surgery
Rate of Fracture Union
Time frame: 180 day
Rate of Anatomic Alignment
Time frame: 180 Day
Functionality Score
Time frame: 180 Day
Grip Strength
Time frame: 180 Day
Range of Motion
Time frame: 180 day
Incidence of Reintervention of Target Fracture
Time frame: 180 Day
Bone Pin Migration
Time frame: 180 Day
Adverse Event Rate
Time frame: 180 day
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