An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)
A burr used in spine surgery: A burr used in spine surgery
Study 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.
Eligibility
Sex
ALL
Min age
21 Years
Max age
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
Primary outcome measure(s)
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)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.