Multicenter, randomized, double-blind placebo-control intramedullary decompression for acute complete spinal cord contusion injury

Abstract

Introduction:Spinal cord injury is one of the main causes of severe neurological trauma and disability. Intramedullary decompression of acute spinal cord contusion in acute phase is one of the important therapeutic exploration methods. Due to the lack of multicenter, randomized, double-blind, placebo-controlled clinical studies, true effect of this treatment remains controversial.Objective of the study:This design of the study is to explore the safety and neurorestorative effects of intramedullary decompression for acute complete spinal cord contusion injury.Design of the study:We design the prospective, multicenter, randomized, double- blind placebo-controlled trial (MRDPT) for acute (less than 24 hours after injury) spinal cord contusion injury. Sixty patients with acute complete spinal cord contusion injury (20 in cervical 4 to thoracic 1, 20 in thoracic 2 to thoracic 9, and 20 in thoracic 10 to lumbar vertebra 1) are selected according to the selected conditions. All patients receive conventional treatments such as reduction and fixation of spinal fractures and/or spinal spondylolisthesis, bone external decompression relieves spinal cord compression. At the same time, group A (n = 30, 10 of each segment group) undergoes intramedullary decompression surgery and group B (n = 30) does not undergo intramedullary decompression. All relevant functional changes before, after, and during the follow-up period are recorded to ensure objective evaluation of the results of the treatment.Ethics and dissemination:The clinical study protocol and consent form were approved by China Branch of International Association of Neurorestoratology and the ethics committees of the hospitals which join this trial. Registration No. of this study is ChiCTR1800020458. Findings will be published in peer-reviewed journals.