The purpose of this research study is to:
test the usability and performance of the medical device Surgify Halo ™ in spine surgery test the level of "chattering " during the use of the device test the cutting performance of Surgify Halo™in comparison to the usual drill bit used in spine surgery ( Rosen burr).
This medical device is available for its indications for shaping and removal of hard tissue and bone in neurosurgical, spinal, ENT, and general surgical procedures.
The target is to enroll 30 participants in this study.
Disease of the spine requiring surgery with bone removal
Ability to understand the purpose and risks of the study and to give written informed consent
Age 21-85 years
Abnormalities of bone tissue
Vulnerable patients (such as prisoners, Individuals with limited or no reading skills, decisionally impaired persons, persons in nursing homes, patients in emergency), and pregnant women
Allergy or hypersensitivity to medical-grade stainless steel or any alloying components
Problems with blood clotting
Parallel
A burr used in spine surgery
DeviceA burr used in spine surgery
Usability and performance of the medical device Surgify Halo ™ in revision spine surgery
Test the level of "chattering " during the use of the device and test the cutting performance of Surgify Halo™ in comparison to the usual drill bit used in spine surgery ( Rosen burr)
Click on the lead sponsor to view all of their trials.
Surgify Medical Oy
Lead sponsor
North Shore University Hospital
Collaborator
