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)

Surgify Medical Oy30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Spine Surgery

Interventions

A burr used in spine surgery

Eligibility

Sex: ALLMin age: 21 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: From enrollment to the end of the surgery until the end of the stay in the recovery room.