Incomplete Cervical SCI Without Instability
Key facts
- Where
- Baltimore, Milwaukee, and San Francisco, United StatesSee the 3 sites
Where in United States
- UMD STC Neurosurgery ClinicBaltimore, United StatesNo longer taking part
- Medical college of Winsconsine, NeurosurgeryMilwaukee, United StatesNo longer taking part
- San Francisco General HospitalSan Francisco, United StatesNo longer taking part
Trial details
- Who runs it
- AO Foundation, AO Spine
- Trial code
- NCT05653206
- Record updated
- 6 October 2026
- Original description
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.Read full original descriptionShow less
IN-TWIN: Traumatic Incomplete Tetraplegia Without Instability: a Prospective Multicenter Feasibility Study of Outcomes and Prognosis
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.
Inclusion: Age 18-80 years, inclusive; Diagnosis of acute traumatic cervical SCI with ISNCSCI AIS Grade D or sensory deficits only within 92 hours post injury; Cervical neurological level of injury (C2-C8); MRI, using any imaging protocols (conventional, multiparametric, or quantitative), taken according to standard of care; Presence of spinal cord compression on the MRI; Absence of biomechanical instability to the extent that would mandate stabilization surgery by the treating surgeon; Ability to provide informed consent according to the IRB/EC defined and approved procedures.
Exclusion: Concomitant traumatic brain injury or polytrauma that could preclude accurate or reliable assessments of the outcome assessments; Uncontrolled severe systemic diseases, preexisting neurological, musculoskeletal, or general medical conditions which could preclude accurate assessments or FUs; Nontraumatic SCI; Individuals unable to undergo MRI.