TY - JOUR
T1 - Neurological recovery after early versus delayed surgical decompression for acute traumatic spinal cord injury
AU - Hosman, Allard J.F.
AU - Barbagallo, G.
AU - van Middendorp, Joost J.
AU - Popescu, Eugen Cezar
AU - van de Meent, Henk
AU - Öner, F. Cumhur
AU - De Iure, Federico
AU - Bonavita, Jacopo
AU - Kreinest, Michael
AU - Lindtner, Richard A.
AU - Quraishi, Nasir A.
AU - Thumbikat, Pradeep
AU - Bilić, Vide
AU - Reynolds, Jeremy J.
AU - Belci, Maurizio
AU - Börcek, Alp Özgün
AU - Morris, Seamus
AU - Hoffmann, Christoph
AU - Signorelli, Francesco
AU - Uzunov, Konstantin
N1 - Publisher Copyright:
© 2023 Author(s) et al.
PY - 2023/4
Y1 - 2023/4
N2 - Methods Patients with tSCI requiring surgical spinal decompression presenting to 17 centres in Europe were recruited. Depending on the timing of decompression, patients were divided into early (≤ 12 hours after injury) and late (> 12 hours and < 14 days after injury) groups. The American Spinal Injury Association neurological (ASIA) examination was performed at baseline (after injury but before decompression) and at 12 months. The primary endpoint was the change in Lower Extremity Motor Score (LEMS) from baseline to 12 months. Results The final analyses comprised 159 patients in the early and 135 in the late group. Patients in the early group had significantly more severe neurological impairment before surgical treatment. For unadjusted complete-case analysis, mean change in LEMS was 15.6 (95% confidence interval (CI) 12.1 to 19.0) in the early and 11.3 (95% CI 8.3 to 14.3) in the late group, with a mean between-group difference of 4.3 (95% CI -0.3 to 8.8). Using multiply imputed data adjusting for baseline LEMS, baseline ASIA Impairment Scale (AIS), and propensity score, the mean between-group difference in the change in LEMS decreased to 2.2 (95% CI -1.5 to 5.9). Conclusion Compared to late surgical decompression, early surgical decompression following acute tSCI did not result in statistically significant or clinically meaningful neurological improvements 12 months after injury. These results, however, do not impact the well-established need for acute, non-surgical tSCI management. This is the first study to highlight that a combination of baseline imbalances, ceiling effects, and loss to follow-up rates may yield an overestimate of the effect of early surgical decompression in unadjusted analyses, which underpins the importance of adjusted statistical analyses in acute tSCI research.
AB - Methods Patients with tSCI requiring surgical spinal decompression presenting to 17 centres in Europe were recruited. Depending on the timing of decompression, patients were divided into early (≤ 12 hours after injury) and late (> 12 hours and < 14 days after injury) groups. The American Spinal Injury Association neurological (ASIA) examination was performed at baseline (after injury but before decompression) and at 12 months. The primary endpoint was the change in Lower Extremity Motor Score (LEMS) from baseline to 12 months. Results The final analyses comprised 159 patients in the early and 135 in the late group. Patients in the early group had significantly more severe neurological impairment before surgical treatment. For unadjusted complete-case analysis, mean change in LEMS was 15.6 (95% confidence interval (CI) 12.1 to 19.0) in the early and 11.3 (95% CI 8.3 to 14.3) in the late group, with a mean between-group difference of 4.3 (95% CI -0.3 to 8.8). Using multiply imputed data adjusting for baseline LEMS, baseline ASIA Impairment Scale (AIS), and propensity score, the mean between-group difference in the change in LEMS decreased to 2.2 (95% CI -1.5 to 5.9). Conclusion Compared to late surgical decompression, early surgical decompression following acute tSCI did not result in statistically significant or clinically meaningful neurological improvements 12 months after injury. These results, however, do not impact the well-established need for acute, non-surgical tSCI management. This is the first study to highlight that a combination of baseline imbalances, ceiling effects, and loss to follow-up rates may yield an overestimate of the effect of early surgical decompression in unadjusted analyses, which underpins the importance of adjusted statistical analyses in acute tSCI research.
UR - http://www.scopus.com/inward/record.url?scp=85150313625&partnerID=8YFLogxK
U2 - 10.1302/0301-620X.105B4.BJJ-2022-0947.R2
DO - 10.1302/0301-620X.105B4.BJJ-2022-0947.R2
M3 - Article
C2 - 36924174
AN - SCOPUS:85150313625
SN - 2049-4394
VL - 105 B
SP - 400
EP - 411
JO - Bone and Joint Journal
JF - Bone and Joint Journal
IS - 4
ER -