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Not yet recruitingNCT06580379SPIVOSUpdated Aug 30, 2024

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.

An observational study in Spine Fusion, Spine Injury and Spine Degeneration, sponsored by Imperial College London. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-30.

Sponsored by Imperial College London · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
25
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Spine Fusion
  • Spine Injury
  • Spine Degeneration
  • Navigation, Spatial

Keywords

  • Imaging
  • Depth Imaging
  • Spine Surgery
  • Intraoperative Registration
03

In context

Spinal Injuries

57 studies on the registry are indexed under Spinal Injuries; 15 are open to participants now.

This study's planned enrollment of 25 is below the median of 92 across 22 observational studies indexed under Spinal Injuries.

Browse Spinal Injuries studies →

Lead sponsor

Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
25 participants (estimated)
Patient registry
No

Groups and cohorts

  • Spine Surgery Patients

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

    Procedure: Spine surgery

Interventions

  • ProcedureSpine surgery

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

06

What researchers measure

Primary outcomes

  1. Number of Data Collection completed

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

    Time frame: 3 years (initial recording duration)

  2. 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

    Time frame: 3 years (initial recording duration)

  3. Patient diversity in Ethnicity

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

    Time frame: 3 years (initial recording duration)

  4. Patient diversity in Age

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

    Time frame: 3 years (initial recording duration)

Secondary outcomes

  1. 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.

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — There is no plan as of yet to share IPD

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2024; primary completion for Oct 2027, 36 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2024
First posted
Aug 30, 2024
StartEst.
Oct 2024
Primary completionEst.
Oct 2027
CompletionEst.
Oct 2027
Last update
Aug 30, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06580379
Collaborators
Imperial College Healthcare NHS Trust
Responsible party
Sponsor
First posted
Aug 30, 2024
Start date
Oct 2024 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Aug 30, 2024

Study contacts

Connor Daly, MEng
Contact
cd1723@ic.ac.uk
7528869070 ext. 44
Salvatore Russo, MD
principal investigator · Imperial College Healthcare Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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