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NCT Number: NCT06580379

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.

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.

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Key information

Conditions

Spine Fusion Back Injuries Behavior Navigation, Spatial Spatial Behavior Spatial Navigation Spinal Injuries Spine Degeneration Spine Injury Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spine surgery

Procedure

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

Primary outcomes

  1. Number of Data Collection completed

    Time frame: 3 years (initial recording duration)

    Success in recording 25 RGB-D videos of spine surgeries along with corresponding CT scans

  2. Number of Data points collected containing a variety of exposed spine anatomy

    Time frame: 3 years (initial recording duration)

    Collected samples should contain a wide variety of exposed vertebrae, including cervical, thoracic and lumbar vertebrae

  3. Patient diversity in Ethnicity

    Time frame: 3 years (initial recording duration)

    Patients undergoing surgery should be diverse in terms of ethnicity, diversity being the % of patients who are not 'white british'

  4. Patient diversity in Age

    Time frame: 3 years (initial recording duration)

    Patients undergoing surgery should be diverse in terms of age, diversity being captured by range and standard deviation measures

Secondary outcomes

  1. Usefulness for training navigation system

    Time frame: 4 years (initial recording duration + 1)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Connor Daly, MEng

CONTACT

[email protected]

7528869070 ext. 44

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Imperial College Healthcare NHS Trust

Registry information

Acronym: SPIVOS

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 30, 2024
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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