Surgify Halo for Spinal Surgery

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Surgify Medical Oy

Disqualifiers: Previous surgery, Bone abnormalities, Vulnerable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: From enrollment to the end of the surgery until the end of the stay in the recovery room

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

How does the Surgify Halo treatment differ from other treatments for spinal surgery?

The Surgify Halo treatment is unique because it provides external fixation and immobilization for the cervical spine, which is crucial for healing and stability in cases of spine fractures or dislocations. Unlike other treatments, it avoids the complications of spinal fusion by using a halo apparatus to maintain bone and ligament healing, offering a reliable alternative for achieving stability. ^{1 2 3 4 5}

What is the purpose of this trial?

The purpose of this research study is to: test the usability and performance of the medical device Surgify Halo ™ in revision 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 Criteria

This trial is for individuals undergoing revision spine surgery. Participants should be eligible for the surgical procedure and have no conditions that would exclude them from using the Surgify Halo™ or Rosen Burr devices.

Inclusion Criteria

Ability to understand the purpose and risks of the study and to give written informed consent

I am between 21 and 85 years old.

I need surgery for my spine or head that involves removing bone.

Exclusion Criteria

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

I have had surgery in the same area before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spine surgery using either the Surgify Halo or the Rosen burr device

From enrollment to the end of the surgery until the end of the stay in the recovery room

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

Treatment Details

Interventions

• Surgify HaloTM

Trial Overview The study aims to compare a new medical device, Surgify Halo™, with the standard Rosen Burr in terms of usability and performance during spine surgery. It will specifically evaluate 'chattering' and cutting effectiveness.

Participant Groups

Group I: Surgify Halo Experimental Treatment 1 Intervention

Group II: State of art Rosen burr Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Surgify Medical Oy

Lead Sponsor

Trials

2

Recruited

50+

North Shore University Hospital

Collaborator

Trials

15

Recruited

3,700+

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Halo instrumentation for the correction and immobilization of the cervical spine]. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Frontolateral pins for halo ring placement: reassessment of a common neurosurgical procedure with CT measurements of skull thickness. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Halo immobilization of cervical spine fractures. Indications and results. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

[Experiences with external fixation of the cervical spine in the halo-yoke system]. [2016]

5. China pubmed.ncbi.nlm.nih.gov

[Analysis of the clinical effects of the modified halo pelvic frame for the treatment of severe scoliosis with rigidity]. [2011]