Early surgical treatment in patients with cervical spinal cord injury (SCI) is associated with similar motor regain 1 year after injury compared with delayed surgical treatment but with faster recovery within the first 6 months, according to study results published in JAMA Network Open.
Among older adults, cervical SCIs associated with falls are mostly incomplete, meaning they’re the result of low-energy trauma. They’re also associated with preexisting canal stenosis as a result of either degenerative changes or the ossification of the posterior longitudinal ligament. The decision of when to perform surgical treatment is an area of contention as the evidence for early surgical decompression for incomplete cervical SCI without bone injuries is not known.
The objective of the current study was to examine how effective early surgical treatment is in patients with preexisting cervical canal stenosis with acute traumatic SCI.
The open-label, randomized Optimal Treatment for Spinal Cord Injury associated with the Cervical Canal Stenosis (OSCIS) trial was conducted at 43 hospitals in Japan from December 1, 2011, to November 2019. Eligible participants were aged 20 to 79 years with acute traumatic cervical SCI graded as American Spinal Injury Association (ASIA) Impairment Scale C, with cervical canal stenosis owing to pre-existing conditions, and without bone injury or spinal instability requiring surgical treatment.
The patients were randomly assigned (1:1) to receive early surgical treatment within 24 hours after admission or delayed surgical treatment after at least 2 weeks of conservative treatment. The primary outcome was improvement in mean ASIA motor score, total score of the spinal cord independence measure (SCIM), and the proportion of patients able to walk independently 1 year postinjury.
A total of 70 patients (mean [SD] age, 65.1 [9.4] years; 93% men) were included in the full analysis – 37 in the early surgical treatment group and 33 patients in the delayed surgical treatment group. From this cohort, 56 patients (80%) had data available for at least 1 primary outcome at 1 year.
A consistent effect in primary end points was found at 1 year with no significant difference between the early surgical treatment group and the delayed surgical treatment group (mean [SD] change in ASIA motor score from baseline, 53.7 [14.7] vs 48.5 [19.1]; absolute difference, 5.2; 95% CI, −4.2 to 14.5; P =.27; mean [SD] SCIM total score, 77.9 [22.7] vs 71.3 [27.3]; absolute difference, 6.6; 95% CI, −7.2 to 20.4; P =.34; able to walk independently, 21 of 30 patients [70%] vs 16 of 26 patients [62%]; P =.51).
A significant difference in mean change in ASIA motor score was observed between the early and delayed surgical treatment groups (F1,49 = 4.80; P =.03; 51 patients) in the mixed-design analysis of variance.
At 2 weeks, patients in the early surgical treatment group had better motor recovery vs those in the delayed surgical treatment group (mean [SD] score, 34.2 [18.8] vs 18.9 [20.9], respectively), as well as at 3 months (mean [SD] score, 49.1 [15.1] vs 37.2 [20.9], respectively), and at 6 months (mean [SD] score, 51.5 [13.9] vs 41.3 [23.4], respectively).
Regarding adverse events, worsening of paralysis occurred in 6 patients in each group, and death occurred in 3 patients in each group.
Among several study limitations, the researchers noted that their sample size was less than their initial target and a substantial number of patients were lost to follow-up. In addition, the rehabilitation program was not standardized and detailed information regarding severity or levels of cord compression was not available.
“Our results suggest that early surgical treatment leads to faster neurological recovery than delayed surgical treatment, but this finding requires further validation,” stated the researchers. “These findings provide crucial information for clinical decision-making, optimization of health care services, and a basis for future research.”
Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
OSCIS investigators; Chikuda H, Koyama Y, Matsubayashi Y, et al. Effect of early vs delayed surgical treatment on motor recovery in incomplete cervical spinal cord injury with preexisting cervical stenosis: a randomized clinical trial. JAMA Netw Open. Published online November 9, 2021. doi: 10.1001/jamanetworkopen.2021.33604