Incomplete Cervical SCI Without Instability

Running, not enrolling

Conditions studied: Cervical Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT05653206

Run by

AO Foundation, AO Spine

People needed

50

Starts

2023-12-11

Expected to finish

2027-08-18

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Nontraumatic SCI
• 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
• Individuals unable to undergo MRI

Where it is running

• San Francisco General Hospital — San Francisco, California, United States
• UMD STC Neurosurgery Clinic — Baltimore, Maryland, United States
• Medical college of Winsconsine, Neurosurgery — Milwaukee, Wisconsin, United States
• Instituto de Ortopedia E Traumatologia Do Hospital Das Clinicas Da Universidade de Sao Paulo — São Paulo, Brazil
• St. Michael's Hospital — Toronto, Canada
• Toronto Western Hospital University Health Network — Toronto, Canada
• Vancouver Spine Research Program, Blusson Spinal Cord Centre — Vancouver, Canada
• BG Klinikum Murnau gGmb, BGU Murnau, Trauma Center Murnau — Murnau am Staffelsee, Germany
• Indian Spinal Injuries Centre — New Delhi, India
• Orthopaedics, Centro Hospitalar Universitário do Porto — Porto, Portugal

Full record on ClinicalTrials.gov

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