Spine FusionSPIVOSNCT06580379
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 of Spine Fusion and Spine Injury, run by Imperial College London.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Fusion, Spine Injury, Spine Degeneration
- What is being tested?
- Spine surgery
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult spine surgery candidates treated within the Imperial College Healthcare NHS Trust , with the capacity to consent (non-vulnerable)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Spine surgery
- Keywords
- Imaging, Depth Imaging, Spine Surgery, Intraoperative Registration
- Medical subject headings
- Spinal Injuries, Spatial Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine surgeryProcedure or surgery
Spine surgery, such as fusion requiring the need for precise intraoperative registration and navigation
| Study group | Role | What they receive |
|---|---|---|
| Spine Surgery Patients | non-vulnerable adults undergoing spine surgery, with a posterior approach Receives: Procedure: Spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Data Collection completed
Success in recording 25 RGB-D videos of spine surgeries along with corresponding CT scans
Measured: 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
Measured: 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'
Measured: 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
Measured: 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.
Measured: 4 years (initial recording duration + 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine FusionStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
- Investigators
- Salvatore Russo, MD, Principal investigator, Imperial College Healthcare Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580379
- Sponsor's protocol ID
- 168041
- Acronym
- SPIVOS
- Status last verified
- Aug 2024
- First submitted
- 28 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan as of yet to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06580379
- Acronym / sponsor ID
- SPIVOS / 168041
- Conditions
- Spine Fusion, Spine Injury, Spine Degeneration, Navigation, Spatial
- Keywords
- Imaging, Depth Imaging, Spine Surgery, Intraoperative Registration
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spine Surgery Patients | – | Procedure: Spine surgerynon-vulnerable adults undergoing spine surgery, with a posterior approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult spine surgery candidates treated within the Imperial College Healthcare NHS Trust , with the capacity to consent (non-vulnerable)
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spine surgerySpine surgery, such as fusion requiring the need for precise intraoperative registration and navigation | Procedure or surgery | Spine Surgery Patients |
Primary outcome
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
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
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'
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
1 secondary outcome
Usefulness for training navigation system
Time frame: 4 years (initial recording duration + 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Individual participant dataSharing planned: No. There is no plan as of yet to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salvatore Russo, MD principal investigator
Imperial College Healthcare Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Spine Fusion and Spine Injury, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Connor Daly, MEng (7528869070 ext. 44, cd1723@ic.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Data Collection completed (time frame: 3 years (initial recording duration)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.