Spine Surgery
Conditions
Brief summary
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.
Interventions
DEVICEA burr used in spine surgery
A burr used in spine surgery
Sponsors
Surgify Medical Oy
North Shore University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability and performance of the medical device Surgify Halo ™ in revision spine surgery | From enrollment to the end of the surgery until the end of the stay in the recovery room. | 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) |
Countries
United States
Outcome results
None listed