An observational study in Cervical Spinal Cord Injury, sponsored by AO Foundation, AO Spine. Completed at 10 sites in 6 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by AO Foundation, AO Spine · Observational
A multicenter, international, prospective, observational case series patient cohort with incomplete cervical SCI without instability will be enrolled to obtain information and data that could inform the feasibility of administering a set of additional core and optional outcome assessments in cervical SCI patients to capture the aspects of neurologic impairment. Baseline, intraoperative, and postoperative characteristics, including demographics, injury details, treatment details, neurological assessments, gait and balance assessments and upper extremity assessments, will be recorded for adult patients.
This prospective multicenter study will enroll 50 adult patients with acute traumatic cervical SCI with ISNCSCI AIS Grade D or sensory deficits only without biomechanical instability.
Patients will be assessed at the baseline visit and subsequently be followed up at 3 and 6 months. All decisions regarding the treatment and clinical management will be left to the attending spinal surgeon and will follow the local standard of care.
The core outcome assessments include:
All core outcome assessments will be performed at the baseline, 3-, and 6-month visits except for the PROMs, SCIM v3, key pinch and tip-to-tip pinch, which will be assessed only at the 3- and 6-month visits.
The optional outcome assessment is the multiparametric quantitative spinal cord magnetic resonance imaging (MRI)/diffusion tensor imaging (DTI) which will be performed at baseline, 3-, and 6-month visits if it is done at the surgeon's discretion.
The goal of this study is to obtain information and data that could inform the feasibility of administering a set of additional core and optional outcome assessments in cervical SCI patients with incomplete tetraplegia without spinal instability to capture the aspects of neurologic impairment that may not be well represented in the ISNCSCI examination.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's enrollment of 50 is below the median of 60 across 332 observational studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →AO Foundation, AO Spine is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with traumatic incomplete cervical SCI without instability
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cervical collar, Halo ring, Halo vest, cervical braces, skeletal skull traction, MAP, steroids, observation or bedrest
Anterior discectomy and instrumented fusion (single level), Anterior discectomy and instrumented fusion (multi-level), Posterior decompression-laminectomy, Posterior decompression-laminoplasty, Posterior decompression and instrumented fusion, Combined anterior and posterior decompression and instrumented fusion
The proportion of the core outcome assessments successfully completed at each visit
For baseline and each FU visit, the completion status of each core outcome assessment
Time frame: up to 6 months
Time required to complete the individual core outcome assessments
For baseline and each FU visit, the time required for completion for each core outcome assessment will be recorded (start time, end time, and duration in mins)
Time frame: up to 6 months
Total time required to complete all core outcome assessments at each visit
The time required for completion will be measured to the nearest 0.1 second by using a digital timer, and the timing should start at the start of giving instructions to the patients or explaining the tests to the patients (start time) and end when the final score of the test is obtained (end time).
Time frame: up to 6 months
Completion rate of individual core outcome assessments (and their scorings if applicable)
Completion rate of individual core outcome assessments at each visit.
Time frame: up to 6 months
Completion rate of the multiparametric quantitative spinal cord MRI/DTI
Completion rate of the multiparametric quantitative spinal cord MRI/DTI
Time frame: up to 6 months
FU visit compliance rate and reasons for non-compliance
Completion status of FU visits, recorded at 3- and 6-month visits
Time frame: up to 6 months
Patient accrual rate
Whether the patient drops out from the study, recorded at the time of dropout
Time frame: up to 6 months
Results from the core outcome assessment ISNCSCI
Motor and sensory scores (motor score 0-100, pin prick score 0-112), AIS Grades, Clinical syndrome (Central Cord/Brown-Sequard/Anterior Cord/Conus Medullaris/Cauda Equina/No clinical syndrome/Not assessed)
Time frame: up to 6 months
Results from the core outcome assessment SF-36 v2
Eight scale scores (0-100): physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, general mental health, social functioning, energy/fatigue or vitality, and general health perceptions
Time frame: up to 6 months
Results from the core outcome assessment Neuropathic pain score
Score 0-100
Time frame: up to 6 months
Results from the core outcome assessment SCIMv3
Three subscales: Self-care (0-20), Respiration and Sphincter Management (0-40), Mobility (room and toilet, 0-40)
Time frame: up to 6 months
Results from the core outcome assessment WISCI v2
Level of walking (score 0-20)
Time frame: up to 6 months
Results from the core outcome assessment Key pinch and tip-to-tip pinch
Pinch strength in kg
Time frame: up to 6 months
Results from the core outcome assessment GRASSP v2
Eight subtest scores Strength (0-50), Palmar sensation (0-12), Prehension Ability (0-12), Prehension Performance (0-20)
Time frame: up to 6 months
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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AO Foundation, AO Spine