Spine Surgery Video Observation Study. The Creation of a Benchmark Video (RGB-Depth) Dataset to Investigate the Feasibility of Developing a Markerless Tracking System for Spine Surgery. (SPIVOS)

The primary study objective is to build a video dataset, consisting of both colour and depth information, of spine surgery that includes both 'open' and 'minimally invasive' (MIS) surgeries. Using accompanying preoperative CT scans of the patient's spine, we aim to develop a markerless tracking system for spine surgery, which the collected dataset will be used to both train, and then benchmark against.

Study Overview

• Status: Not yet recruiting
• Conditions: Spine Injury; Spine Degeneration; Spine Fusion; Navigation, Spatial
• Intervention / Treatment: Procedure: Spine surgery

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Connor Daly, MEng; Phone Number: 44 7528869070; Email: cd1723@ic.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Adult spine surgery candidates treated within the Imperial College Healthcare NHS Trust , with the capacity to consent (non-vulnerable)

Description

Inclusion Criteria:

• Candidate surgeries include all spine surgeries taking a posterior approach. This includes both 'open' and 'minimally invasive' surgeries, provided some portion of vertebrae bone is exposed.

Exclusion Criteria:

• Candidate surgeries will be excluded if the patient is under the age of 18 or the clinical lead feels the patient lacks capacity to consent.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spine Surgery Patients; non-vulnerable adults undergoing spine surgery, with a posterior approach	Procedure: Spine surgery; Spine surgery, such as fusion requiring the need for precise intraoperative registration and navigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Data Collection completed	Success in recording 25 RGB-D videos of spine surgeries along with corresponding CT scans	3 years (initial recording duration)
Number of Data points collected containing a variety of exposed spine anatomy	Collected samples should contain a wide variety of exposed vertebrae, including cervical, thoracic and lumbar vertebrae	3 years (initial recording duration)
Patient diversity in Ethnicity	Patients undergoing surgery should be diverse in terms of ethnicity, diversity being the % of patients who are not 'white british'	3 years (initial recording duration)
Patient diversity in Age	Patients undergoing surgery should be diverse in terms of age, diversity being captured by range and standard deviation measures	3 years (initial recording duration)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usefulness for training navigation system	Outcome is to leverage the recordings to train a markerless tracking system that will intraoperatively track the pose and location of the spine within the surgical site. The trained system will be benchmarked against a test subset of the collected videos. The success of the trained system will be determined by its accuracy in automatically tracking the pose of vertebrae features within the test subset videos, against the labelled pose indicated in the video by the operating surgeon.	4 years (initial recording duration + 1)

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Imperial College Healthcare NHS Trust
• Investigators: Principal Investigator: Salvatore Russo, MD, Imperial College Healthcare Trust

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: August 28, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): August 30, 2024
• Last Update Submitted That Met QC Criteria: August 28, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Imaging; Spine Surgery; Depth Imaging; Intraoperative Registration
• Additional Relevant MeSH Terms: Wounds and Injuries; Back Injuries; Spinal Injuries
• Other Study ID Numbers: 168041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan as of yet to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No