An observational study in Spine Injury and Trauma, sponsored by University of Cambridge. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by University of Cambridge · Observational
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.
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.
57 studies on the registry are indexed under Spinal Injuries; 15 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 92 across 22 observational studies indexed under Spinal Injuries.
Browse Spinal Injuries studies →University of Cambridge is the lead sponsor of 116 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All adult patients with radiologically confirmed traumatic spine injury
Centre inclusion Criteria
Patient inclusion and exclusion criteria Inclusion Criteria
Exclusion Criteria
Other: Exposure
Human Development Index of Country
Frankel Grade
A = complete motor and sensory loss (poor outcome), E = no neurological symptoms or signs (good outcome)
Time frame: At discharge or 6 weeks post-admission, whichever comes first
Mortality
Assessment of survival
Time frame: At discharge or 6 weeks post-admission, whichever comes first
Length of Stay
Hospital and ICU
Time frame: 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)
Time frame: 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
Time frame: 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.)
Time frame: At discharge or at 6 weeks post-admission (whichever comes first)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Following publication of the main results
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