Duraplasty for Acute Traumatic Spinal Cord Injury

Description

This is a prospective, multi-center, randomized, single-blinded controlled trial aimed at evaluating safety and effectiveness of expansile duraplasty in people hospitalized for acute traumatic spinal cord injury (SCI).

Traumatic SCI remains a challenging clinical problem for which treatment options remain limited, despite significant ongoing efforts by industry, non-profit organizations and academia to unveil the mechanisms behind it. There is currently no clearly beneficial pharmaceutical therapy for SCI, so in the absence of suitable pharmacotherapy, early surgical decompression and optimization of spinal cord perfusion have been emerged as targets for intervention. Common surgical techniques do not address intrathecal compression due to spinal cord swelling. The lack of dural decompression after SCI is in contrast to traumatic brain injury, where dural opening is a routine part of decompressive craniectomy. There remains a paucity of data on whether durotomy or expansile duraplasty may provide additional benefit in decompressing the injured spinal cord, though preclinical animal data has for decades been in favor of early decompression, and there is evidence from non-randomized human studies that suggest duraplasty may lead to improved outcomes for SCI patients. These data, along with other published SCI research, served as motivation to explore expansile duraplasty in humans.

Specific objectives of this randomized clinical trial are to evaluate (i) effectiveness of the expansile duraplasty in improving neurologic motor outcomes in patients with acute traumatic SCI; (ii) safety of expansile duraplasty in acute traumatic SCI patients; (iii) exploratory effectiveness of reducing intrathecal pressure (ITP) by expansile duraplasty in patients with acute traumatic SCI.

Eligible patients admitted at participating sites will be approached for study participation prior to their standard of care (SOC) index surgery for acute traumatic SCI. Consenting participants will be randomized into either the Experimental or Control group, and those in the Experimental group will receive expansile duraplasty during their SOC surgery. A blood sample, cerebrospinal fluid (CSF) sample, motorsensory assessment, and magnetic resonance imaging (MRI) scan will be obtained pre-operatively. Additional CSF samples, motorsensory assessments, and MRI scan will be obtained post-operatively during participants’ subsequent stay in the intensive care unit (ICU) and acute care units. During this stay, participants will receive standard of care medical treatment for SCI that is standardized across all sites (except where specified), including: close monitoring, including hemodynamic and pressure monitoring; intrathecal pressure measurement, at least once hourly for five days; maintenance of spinal cord perfusion pressure (SCPP) at 65 and above, via vasopressor administration as needed, for at least five days; post-treatment rehabilitation and occupational therapy procedures, per standard of care at the investigational site. During this time also, the participants will be monitored for Adverse Events (AEs). Questionnaires will be administered and clinical information such as injury characteristics, vitals measurements, and lab results will be collected during the participants’ hospital stay.

Study follow-up visits occur at 6 and 12 months post-injury, with the primary endpoint at the 6-month follow-up. At the follow-up visits, vitals will be measured, a motorsensory assessment completed, and questionnaires on pain and quality of life will be administered. The Investigator will assess participants at each study visit for the occurrence of AEs.