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Spine InjuryGNOS SpineNCT05883618

Global Neurotrauma Outcomes Study: Spine

An observational study of Spine Injury and Trauma, run by University of Cambridge at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Primary aim: Characterise case-mix, processes of care and variations in nonoperative and operative management strategies, including emergency, ward, surgical and ICU care, in patients presenting with traumatic spinal injury (TSI) between centres across low and high Human Development Index (HDI) countries. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spine Injury, Trauma
What is being tested?
Exposure
How many people
1,000 participants
Where
1 siteUnited Kingdom
Study dates
12 Jul 2021to 30 May 2023
Phase
Observational
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult, Older adult

Study population: All adult patients with radiologically confirmed traumatic spine injury

Who may be able to join

None listed.

Who cannot join

  • Elective (planned) or semi-elective (patient initially discharged after emergency with planned
  • intervention at a future date) admissions
  • Patients who have previously had an admission for TSI rendering them eligible for inclusion in this study (regardless of whether they were included on the previous admission or not)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site, 1 recruiting
  • University of Cambridge

    Cambridge, County

    Saniya Mediratta

    Recruiting

Other trials in United Kingdom

About this study

Primary aim:

Characterise case-mix, processes of care and variations in nonoperative and operative management strategies, including emergency, ward, surgical and ICU care, in patients presenting with traumatic spinal injury (TSI) between centres across low and high Human Development Index (HDI) countries.

Read more

Primary outcome measure:

The primary outcome measure will be Frankel Grade at 6 weeks post-admission (or discharge, whichever comes first).

Primary comparison:

Between country groups defined by human development index

Centre eligibility:

Any unit assessing patients with TSI worldwide will be eligible to participate

Patient eligibility:

All adult patients presenting with radiologically confirmed traumatic spinal injury.

Team:

Each participating unit will form a study team of up to four investigators including a study lead, local investigator 1/2 and an independent data validator.

Time period:

Local study teams may select any 30-day period from July 12th 2021 to start their study. Patients who meet the inclusion criteria between 00:01 on day 0 and 23:59 on day 30 of the selected study period will be included.

Validation:

There will be a two-phase data validation process. Phase 1 will be prospective, validating case ascertainment, and phase 2 will be retrospective, validating operative data.

Read the detailed description

Background Traumatic spinal injury (TSI) accounts for a significant proportion of disability and death worldwide, with the majority of this burden affecting individuals in low- to middle- income countries. Crucially, to date, the current disease profile of TSI has not been characterised globally. In addition, the global approach to the care of patients following TSI is inconsistent with considerable geographical differences in process of care reported, and limited data available on the impact of these variations on outcomes following TSI. A better understanding of case-mix and processes of care is urgently needed to underpin efforts to identify ways of improving outcome relevant to different socioeconomic settings globally.

Objectives The primary objective of this study is to characterise the case-mix, processes of care and variations in nonoperative and operative management strategies, including emergency, ward, ICU care, in patients presenting with traumatic spinal injury (TSI) between centres across low and high Human Development Index (HDI) countries. The secondary aims are to summarise current local resources and management pathways for TSI through validation of provider profiling data, describe differences in indications for nonoperative and operative management, and short-term outcomes following TSI. This study aims to identify gaps in processes of care to identify targets for future interventions to improve TSI care across high and low-resource settings.

Methods A multi-centre, international, prospective, observational study. Any unit assessing patients with TSI worldwide will be eligible to participate. Each participating unit will form a study team responsible for gaining local approval, identifying patients for inclusion and conducting data collection. Data will be collected via a secure online platform in an anonymised form. Processes of care will be characterised by a detailed provider profiling exercise. A registry describing the case-mix and care of all adults presenting with radiologically confirmed TSI will be collected, in a given consecutive 30-day period during the study period starting in 2021.

Results The dataset, developed through an iterative feedback process involving clinicians from low and high Human Development Index (HDI) countries, includes patient demographics, details of injury mechanism, local injury management and, if applicable, timing and nature of surgery, post-operative care and immediate postoperative complications. Outcome measures include Frankel grade at 6 weeks post-admission (or at discharge or death, whichever event occurs first), early mortality, peri-operative complications, adverse events of special interest, functional status and mobility. Descriptive analyses of case-mix and the variations in processes of care will be conducted. Available resources, use of guidelines and variations in processes of care will be characterised using both provider profiling responses and patient-level data collected. Areas where known best practice is deficient or unavailable will be identified as potential targets for future implementation studies.

Conclusions GNOS Spine aims to provide a global snapshot of the case-mix, management, processes of care and short-term outcomes of patients presenting with TSI. In addition, the study aims to identify areas for further study, and establish a platform and clinical network to facilitate this future research in global neurotrauma and spinal surgery.

Conditions
Spine Injury, Trauma
Being tested
Exposure
Keywords
Traumatic spine injury, Global burden
Medical subject headings
Spinal Injuries, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExposureOther

    Human Development Index of Country

Study groups in NCT05883618
Study groupRoleWhat they receive
Radiologically confirmed traumatic spine injuryNot described
Receives: Other: Exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frankel Grade

    A = complete motor and sensory loss (poor outcome), E = no neurological symptoms or signs (good outcome)

    Measured: At discharge or 6 weeks post-admission, whichever comes first

Secondary outcomes (5)
  1. Mortality

    Assessment of survival

    Measured: At discharge or 6 weeks post-admission, whichever comes first

  2. Length of Stay

    Hospital and ICU

    Measured: At discharge or at 6 weeks post-admission (whichever comes first)

  3. Peri-operative Complications

    Return to operating theatre, surgical site infections, adverse events of special interest (pressure ulcer, pneumonia, DVT)

    Measured: At discharge or at 6 weeks post-admission (whichever comes first)

  4. Independence with activities of daily living (ADLs)

    Rating of specific ADLs as unaided, with aid or completely dependent

    Measured: At discharge or at 6 weeks post-admission (whichever comes first)

  5. Mobility

    Mechanism of mobility e.g. mobilising independently, mobilising with a frame, wheelchair, bed bound etc.)

    Measured: At discharge or at 6 weeks post-admission (whichever comes first)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2023
  2. Study start12 Jul 2021
  3. Primary completion30 May 2023 (estimated)
  4. Study completion30 May 2023 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05883618
Sponsor's protocol ID
GNOSSpine
Acronym
GNOS Spine
Status last verified
May 2023
First submitted
5 Mar 2023
Last updated
1 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: After publication of the main results, the pooled dataset will be available to all members of the GNOS Spine collaboration for secondary analysis, after judgement and approval of each proposed analysis by the central study team.

Questions about this trial

What is this clinical trial studying?

An observational study of Spine Injury and Trauma, run by University of Cambridge at 1 site in United Kingdom.

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 0 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Saniya Mediratta (+441223336946, info@globalspinetrauma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frankel Grade (time frame: At discharge or 6 weeks post-admission, whichever comes first). 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 1 Jun 2023; AzTrials last refreshed its copy on 30 Oct 2026.

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