Early surgical treatment in cervical spinal cord injury (SCI) patients is associated with similar motor recovery 1 year post injury compared to delayed surgical treatment, but with faster recovery within the first 6 months, according to the JAMA Network Open published Study results.
In older adults, spinal cord injuries associated with falls are mostly incomplete, meaning they are the result of low-energy trauma. They are also associated with pre-existing canal stenosis as a result of degenerative changes or ossification of the posterior longitudinal ligament. The decision as to when surgical treatment should be performed is controversial as the evidence of early surgical decompression in incomplete cervical SCI with no bone injuries is unknown.
The aim of the current study was to investigate how effective early surgical treatment is in patients with pre-existing cervical canal stenosis with acute traumatic paraplegia.
The open, randomized, Optimal Treatment of Spinal Cord Injury Related to the Cervical Canal Stenosis (OSCIS) Study was conducted in 43 hospitals in Japan from December 1, 2011 to November 2019. Eligible participants were aged 20 to 79 years with acute trauma cervical SCI, rated Impairment Scale C by the American Spinal Injury Association (ASIA), with cervical canal stenosis due to pre-existing medical conditions and no bone injury or spinal instability that requires surgical treatment.
Patients were randomized (1: 1) to early surgical treatment within 24 hours of admission or to delayed surgical treatment after at least 2 weeks of conservative treatment. The primary endpoint was an improvement in the mean ASIA motor score, the total score of the spinal cord independence measure (SCIM), and the proportion of patients who were able to walk independently 1 year after the injury.
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 surgery group and 33 patients in the delayed surgery group. From this cohort, 56 patients (80%) had data for at least 1 primary endpoint after 1 year.
A consistent effect on the primary endpoints was found after 1 year with no significant difference between the early surgical treatment group and the delayed surgical treatment group (mean [SD] Change from baseline in ASIA motor score, 53.7 [14.7] versus 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] against 71.3 [27.3]; absolute difference 6.6; 95% CI, -7.2 to 20.4; P = .34; 21 out of 30 patients can walk independently [70%] versus 16 out of 26 patients [62%]; P = .51).
In the mixed design analysis of variance, a significant difference in mean change in ASIA motor score was observed between the early and late surgical treatment groups (F1.49 = 4.80; P = 0.03; 51 patients).
After 2 weeks, patients in the early surgical treatment group had better motor recovery compared to those in the delayed surgical treatment group (mean [SD] Score, 34.2 [18.8] against 18.9 [20.9]) and after 3 months (mean [SD] Score, 49.1 [15.1] versus 37.2 [20.9]) and after 6 months (mean [SD] Score, 51.5 [13.9] vs 41.3 [23.4], or).
Regarding adverse events, paralysis worsened in 6 patients in each group, and death occurred in 3 patients in each group.
Under several study constraints, the researchers found that their sample size was smaller than their original goal and a significant number of patients were lost to follow-up. In addition, the rehabilitation program was not standardized and detailed information on the severity or extent of the spinal cord compression was not available.
“Our results suggest that early surgical treatment leads to faster neurological recovery than delayed surgical treatment, but this finding needs further validation,” said the researchers. “These results provide critical information for clinical decision-making, the optimization of health care and a basis for future research.”
Disclosure: Some of the study authors stated links with biotech, pharmaceutical, and / or device companies. For a full list of author disclosures, see the original reference.
OSCIS investigator; 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 pre-existing cervical stenosis: a randomized clinical trial. JAMA network open. Published online November 9, 2021. doi: 10.1001 / jamanetworkopen.2021.33604