Surgify Halo™ versus Rosen burr for cutting performance and usability in spine surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label, parallel-group comparison enrolling about 30 adult patients undergoing spine surgery that requires bone removal. Participants will be randomly assigned to have bone work performed with the Surgify Halo™ device or with the conventional Rosen burr, and surgeons will record usability and performance metrics during the procedures. Key outcomes include amount of chattering during use, cutting performance, and surgeon-rated usability, with safety monitoring for device-related issues. The device is intended for shaping and removal of hard tissue and bone and will be used in a single-center surgical setting at North Shore University Hospital.

Why it matters

Who can join: the full rules

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

Where it's running

• North Shore University Hospital
  New York, New York, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.