Abstract
BACKGROUND: Cervical traumatic spinal cord injuries (TSCIs) are the most prevalent type of traumatic spinal cord injury, marked by high disability rates, considerable medical expenses, and a poor prognosis for functional recovery. The clinical effectiveness of bony decompression in improving functional outcomes following TSCI remains limited, even when performed ultra-early (within 12 or 8 h), emphasizing the uncertainty and insufficient understanding of the extent of adequate decompression. The ISCUD trial aims (1) to evaluate the benefits and risks of combining expansive duroplasty with standard treatment compared to standard treatment alone; (2) to investigate whether spinal cord perfusion status, assessed by indocyanine green, is related to the development of spinal cord swelling as measured by intramedullary lesion length; and (3) to determine the necessity for additional expansive duroplasty based on these assessments. METHODS: This is a prospective, phase III, single-center, randomized controlled superiority trial. We aim to recruit 104 adults with acute, severe, traumatic cervical spinal cord injury with an American Spinal Injury Association Impairment Scale grade A, B, or C who will be randomized 1:1 to undergo bony decompression alone or bony decompression with duroplasty. Patients and outcome assessors are blinded to study arm. The primary outcome is the change in motor score at 6 months compared to admission; while the secondary outcome assess the sensory score, the neurological outcome, the assessments of function (grasp, walking, urinary and anal sphincter control), quality of life at 6 months, the safety of duroplasty, the impact of mechanistic study on the patient's recovery. The ISCUD trial aims to establish qualitative and quantitative selection criteria for cervical TSCIs patients who may experience additional benefits from receiving expansive duroplasty. Estimated study duration is 24 months (1 month set-up, 12 months recruitment, 12 months to complete follow-up, 2 months data analysis and reporting results). DISCUSSION: The current clinical management guidelines for spinal cord injury are fundamentally informed by principles derived from the management of traumatic brain injury. The ISCUD trial not only tests the hypothesis that additional duroplasty is beneficial to patients with cervical TSCIs but also incorporates mechanistic study results with clinical outcomes to provide qualitative and quantitative criteria for neurosurgeons to determine whether additional duroplasty should be performed. TRIAL REGISTRATION: Clinicaltrials.gov NCT06552507. Registered on 2024/08/14.