A Randomized Controlled Trial of Early versus Late Surgical Decompression for Thoracic and Thoracolumbar Spinal Cord Injury in 73 Patients

Abstract

Convincing clinical evidence exists to support early surgical decompression in the setting of cervical spinal cord injury (SCI). However, clinical evidence on the effect of early surgery in patients with thoracic and thoracolumbar (from T1 to L1 [T1-L1]) SCI is lacking and a critical knowledge gap remains. This randomized controlled trial (RCT) sought to evaluate the safety and efficacy of early (<24 h) compared with late (24-72 h) decompressive surgery after T1-L1 SCI. From 2010 to 2018, patients (‡16 years of age) with acute T1-L1 SCI presenting to a single trauma center were randomized to receive either early (<24 h) or late (24-72 h) surgical decompression. The primary outcome was an ordinal change in American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade at 12-month follow-up. Secondary outcomes included complications and change in ASIA motor score (AMS) at 12 months. Outcome assessors were blinded to treatment assignment. Of 73 individuals whose treatment followed the study protocol, 37 received early surgery and 36 underwent late surgery. The mean age was 29.74-11.4 years. In the early group 45.9% of patients and in the late group 33.3% of patients had a ‡1-grade improvement in AIS (odds ratio [OR] 1.70, 95% confidence interval [CI]: 0.66-4.39, p = 0.271); significantly more patients in the early (24.3%) than late (5.6%) surgery group had a ‡2-grade improvement in AIS (OR 5.46, 95% CI: 1.09-27.38, p = 0.025). There was no statistically significant difference in the secondary outcome measures. Surgical decompression within 24 h of acute traumatic T1-L1 SCI is safe and is associated with improved neurological outcome, defined as at least a 2-grade improvement in AIS at 12 months.

Clinical Trials Targeting Secondary Damage after Traumatic Spinal Cord Injury

“…DS almost always involves a laminectomy, which is the removal of the vertebral lamina, and is often coupled with vertebral instrumentation to restore stability of the spinal column. Several clinical studies have found that performing DS within 24 h of the primary SCI is associated with shorter hospital stays and increased probability of post-operative neurological recovery, while other studies of surgeries within 72 days or later of injury did not report any benefits [ 41 , 98 , 99 , 100 , 101 , 102 , 103 , 104 , 105 , 106 ]. In general, studies have found benefits of early DS only for patients with incomplete injuries and AIS B–D, but not with more severe, complete injuries, and AIS A [ 42 , 43 , 107 ].…”

Which treatment provides the best neurological outcomes in acute spinal cord injury?

“…8 We look forward to future subgroup analyses and comparisons with the results of recent tSCI studies at the thoracolumbar spine level. 81,82…”

Surgical Considerations to Improve Recovery in Acute Spinal Cord Injury

“…85 This rationale provided the basis for a recent RCT of early surgical intervention for acute thoracic SCI. 86 Another way of thinking about this is having the control group receive the standard of care (usual care), rather than withholding a therapy with known benefit. 87 Conflict of interest can be reduced by having the patient's surgeon be a different person than the study investigator-termed parallel care.…”

“…Freedman proposed the widely accepted idea that RCTs are ethical if there is truly clinical equipoise between the 2 treatments—that is, there is no consensus between experts in the field on which treatment is superior [ 85 ]. This rationale provided the basis for a recent RCT of early surgical intervention for acute thoracic SCI [ 86 ]. Another way of thinking about this is having the control group receive the standard of care (usual care), rather than withholding a therapy with known benefit [ 87 ].…”