Clinical trial NCT04914585: Automatic Optical Identification of the Spine Vertebrate Using Three-dimensional Optical Detection Based on a CT Test
Official title: Automatic Optical Identification of the Spine Vertebrate Using Three-dimensional Optical Detection Based on a CT Test
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Surgery of Vertebrae, Intervertebral Discs and the Spinal Cord
CT Scans
Keywords: spinal surgery
CT scans
surgical navigation
optical tracking
Lead sponsor: Deep Health Ltd.
Sponsor class: INDUSTRY
First posted: 2021-06-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Candidates for spinal surgery in the Orthopedics department at Hadassah medical center who have a previous CT scan of the spine. The participant will receive an explanation and will undergo a process of informed consent.

Brief summary: CT scans of the spine include vertebrae, intervertebral discs and the spinal cord. These tests are performed in an orderly protocol and allow for three-dimensional reconstruction of the vertebra in sagittal and coronal guides.

Detailed description: In spinal surgery, there are a number of navigation technologies based on CT scans performed before surgery (or during surgery) and identify the vertebrae (using special photographs or markers on the spine), such as Mazor with the Renaissance Robotic Surgical System used in hospitals, or BrianLab Which uses non-robotic navigation and is based on a marker located on the patient's back. These technologies are not optimal, and have a number of significant drawbacks: Because during spinal surgery, there is a displacement, the level of accuracy decreases as the surgery progresses. In addition, there is extensive use of radiation in these means since in many cases CT is performed before and during surgery.

Today, in the age of optical detection, it is possible to detect three-dimensional structures in photography and allow high levels of accuracy (less than 0.5 mm). Optical scanning does not include radiation and lasts the entire length of the operation. Of the patient and of the treating staff.

Eligibility criteria: Inclusion Criteria:

* men and women
* 18 and above years old
* Patients who have available spinal CT tests will be included in the study
* Patients who are about to undergo spinal surgery

Exclusion Criteria:

* NA

Primary outcomes:
measure: DEEP HEALTH's detection algorithm for optical detection of vertebrae in the spine in patients undergoing spinal surgery.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Advisor
name: Josh Schroeder, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farah K, Coudert P, Graillon T, Blondel B, Dufour H, Gille O, Fuentes S. Prospective Comparative Study in Spine Surgery Between O-Arm and Airo Systems: Efficacy and Radiation Exposure. World Neurosurg. 2018 Oct;118:e175-e184. doi: 10.1016/j.wneu.2018.06.148. Epub 2018 Jul 3.
citation: Gebhard F, Weidner A, Liener UC, Stockle U, Arand M. Navigation at the spine. Injury. 2004 Jun;35 Suppl 1:S-A35-45. doi: 10.1016/j.injury.2004.05.009.
citation: Mendelsohn D, Strelzow J, Dea N, Ford NL, Batke J, Pennington A, Yang K, Ailon T, Boyd M, Dvorak M, Kwon B, Paquette S, Fisher C, Street J. Patient and surgeon radiation exposure during spinal instrumentation using intraoperative computed tomography-based navigation. Spine J. 2016 Mar;16(3):343-54. doi: 10.1016/j.spinee.2015.11.020. Epub 2015 Dec 10.