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.
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
- Recruiting
University of Cambridge
Cambridge, County
Saniya Mediratta
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 group | Role | What they receive |
|---|---|---|
| Radiologically confirmed traumatic spine injury | Not described Receives: Other: Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Mortality
Assessment of survival
Measured: At discharge or 6 weeks post-admission, whichever comes first
Length of Stay
Hospital and ICU
Measured: At discharge or at 6 weeks post-admission (whichever comes first)
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)
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)
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.
- First posted1 Jun 2023
- Study start12 Jul 2021
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine InjuryStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- NIHR Global Health Research Group on Neurotrauma
- Responsible party
- Principal investigator, Saniya Mediratta, University of Cambridge
- Investigators
- Saniya Mediratta, Principal investigator, NIHR Global Health Research Group on NeurotraumaJibin Francis, Principal investigator, NIHR Global Health Research Group on NeurotraumaPeter Hutchinson, Principal investigator, NIHR Global Health Research Group on NeurotraumaRikin Trivedi, Principal investigator, NIHR Global Health Research Group on Neurotrauma
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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Global Neurotrauma Outcomes Study: Spine
- ClinicalTrials.gov ID
- NCT05883618
- Acronym / sponsor ID
- GNOS Spine / GNOSSpine
- Conditions
- Spine Injury, Trauma
- Keywords
- Traumatic spine injury, Global burden
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- NIHR Global Health Research Group on Neurotrauma
- Study start
- 12 Jul 2021 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 1 Jun 2023 (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.
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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiologically confirmed traumatic spine injury | – | Other: Exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with radiologically confirmed traumatic spine injury
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| ExposureHuman Development Index of Country | Other | Radiologically confirmed traumatic spine injury |
Primary outcome
Frankel Grade
Time frame: At discharge or 6 weeks post-admission, whichever comes first
A = complete motor and sensory loss (poor outcome), E = no neurological symptoms or signs (good outcome)
5 secondary outcomes
Mortality
Time frame: At discharge or 6 weeks post-admission, whichever comes first
Length of Stay
Time frame: At discharge or at 6 weeks post-admission (whichever comes first)
Peri-operative Complications
Time frame: At discharge or at 6 weeks post-admission (whichever comes first)
Independence with activities of daily living (ADLs)
Time frame: At discharge or at 6 weeks post-admission (whichever comes first)
Mobility
Time frame: At discharge or at 6 weeks post-admission (whichever comes first)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: 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.
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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. This study is not recruiting at the moment.
Saniya Mediratta principal investigator
NIHR Global Health Research Group on Neurotrauma
Jibin Francis principal investigator
NIHR Global Health Research Group on Neurotrauma
Peter Hutchinson principal investigator
NIHR Global Health Research Group on Neurotrauma
1 site in 1 country: see every site and its status.
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.