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NCT05653206
Incomplete Cervical SCI Without Instability
Conditions: Cervical Spinal Cord Injury
Sex: All
Ages: 18 Years – 80 Years
Enrollment: 50
Sponsor: AO Foundation, AO Spine
Location: United States
Summary
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.
Eligibility Criteria
Inclusion Criteria:Age 18-80 years, inclusiveDiagnosis of acute traumatic cervical SCI with ISNCSCI AIS Grade D or sensory deficits only within 48 hours post injuryCervical neurological level of injury (C2-C8)MRI, using any imaging protocols (conventional, multiparametric, or quantitative), taken according to standard of carePresence of spinal cord compression on the MRIAbsence of biomechanical instability to the extent that would mandate stabilization surgery by the treating surgeonAbility to provide informed consent according to the IRB/EC defined and approved proceduresExclusion Criteria:Nontraumatic SCIConcomitant traumatic brain injury or polytrauma that could preclude accurate or reliable assessments of the outcome assessmentsUncontrolled severe systemic diseases, preexisting neurological, musculoskeletal, or general medical conditions which could preclude accurate assessments or FUsIndividuals unable to undergo MRI
Source: ClinicalTrials.gov (NCT05653206). StuddyBuddy aggregates publicly available trial information.