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.

Not yet recruiting

• Conditions: Spine Fusion; Spine Injury; Spine Degeneration; Navigation, Spatial
• Interventions: Procedure: Spine surgery

• Registration Number: NCT06580379
• Lead Sponsor: Imperial College London

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-28
• Study First Submitted QC: 2024-08-28
• Last Update Submitted: 2024-08-28
• Study First Posted: 2024-08-30
• Last Update Posted: 2024-08-30
• Study Start: 2024-10
• Primary Completion: 2027-10
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Spine Surgery Patients	Spine surgery	non-vulnerable adults undergoing spine surgery, with a posterior approach

Primary Outcome Measures

Name	Time	Method
Number of Data Collection completed	3 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 anatomy	3 years (initial recording duration)	Collected samples should contain a wide variety of exposed vertebrae, including cervical, thoracic and lumbar vertebrae
Patient diversity in Ethnicity	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'
Patient diversity in Age	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 Outcome Measures

Name	Time	Method
Usefulness for training navigation system	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.