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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.

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.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06580379
Acronym
SPIVOS
Enrollment
25
Registered
2024-08-30
Start date
2024-10-31
Completion date
2027-10-31
Last updated
2024-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Imaging, Depth Imaging, Spine Surgery, Intraoperative Registration

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.

Interventions

PROCEDURESpine surgery

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

Sponsors

Imperial College Healthcare NHS Trust
CollaboratorOTHER
Imperial College London
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Data Collection completed3 years (initial recording duration)Success in recording 25 RGB-D videos of spine surgeries along with corresponding CT scans
Number of Data points collected containing a variety of exposed spine anatomy3 years (initial recording duration)Collected samples should contain a wide variety of exposed vertebrae, including cervical, thoracic and lumbar vertebrae
Patient diversity in Ethnicity3 years (initial recording duration)Patients undergoing surgery should be diverse in terms of ethnicity, diversity being the % of patients who are not 'white british'
Patient diversity in Age3 years (initial recording duration)Patients undergoing surgery should be diverse in terms of age, diversity being captured by range and standard deviation measures

Secondary

MeasureTime frameDescription
Usefulness for training navigation system4 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.

Contacts

Primary ContactConnor Daly, MEng
cd1723@ic.ac.uk7528869070

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026