Dural sac decompression and spinal cord untethering for treating obsolete spinal cord injury: protocol for a prospective, multicenter cohort study

Abstract

Background and objectives: Spinal cord injury is an irreversible pathological process. Clinical findings in recent years have demonstrated that dural sac decompression can scavenge subdural hematoma and necrotic tissue, alleviate compression of the injured spinal cord, create a favorable microenvironment for regeneration of nerve repair, and promote recovery of neurological function. Therefore, this trial aims to examine the effect of dural sac decompression and spinal cord untethering for treating obsolete spinal cord injury. Design: This is a prospective, multicenter cohort study. Methods: Seventy-two patients with obsolete spinal cord injury from four clinical sites in China will be assigned to the trial group (n = 36) or control group (n = 36) according to therapeutic methods. Patients in the trial group will receive dural sac decompression and spinal cord untethering. Patients in the control group will undergo conservative treatment. All patients were followed up for 24 months. Outcome measures: The difference in American Spinal Injury Association scores between 3 months after treatment and before treatment is the primary outcome measure. For secondary outcome measures, the autonomic nervous scoring scale, the Visual Analog Scale, an electromyogram below the injured plane, somatosensory evoked potential, motor evoked potential, functional independent measure, the ID pain self-rating scale, the modified Ashworth Scale for grading spasticity, and the Penn Spasm Frequency Scale will be applied 3 months before treatment, and 1, 3, 6, 9, 12, 18, and 24 months after treatment. Urodynamic testing will be performed. Discussion: This trial is expected to provide an experimental basis for dural sac decompression and spinal cord untethering in patients with obsolete spinal cord injury. Ethics and dissemination: The protocols were approved by the Ethics Committee of Chinese PLA General Hospital on May 11th, 2016 (approval No. S2016-024-01). The study design was finished in April 2016. Recruitment of patients began in April 2017. Follow-up will be completed in December 2018. Data analysis will be completed in December 2019. The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Trial registration: This trial has been registered in the Chinese Clinical Trial Registry (registration No. ChiCTR-ONC-17010479) on January 19th, 2017. Recruitment of patients is ongoing.