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.

NCT06580379 | Not Yet Recruiting

• 1 other identifier: 168041
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Spine Fusion; Spine Injury; Spine Degeneration; Navigation, Spatial

Keywords

Imaging; Depth Imaging; Spine Surgery; Intraoperative Registration

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Usefulness for training navigation system

  4 years (initial recording duration + 1)

Study Arms (1)

Spine Surgery Patients

non-vulnerable adults undergoing spine surgery, with a posterior approach

Procedure: Spine surgery

Interventions

Spine surgery PROCEDURE

Spine surgery, such as fusion requiring the need for precise intraoperative registration and navigation

Spine Surgery Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

MeSH Terms

Conditions

Spinal Injuries; Spatial Navigation

Condition Hierarchy (Ancestors)

Back Injuries; Wounds and Injuries; Spatial Behavior; Behavior

Study Officials

• Salvatore Russo, MD

  Imperial College Healthcare Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Connor Daly, MEng

CONTACT

7528869070; cd1723@ic.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share