Does Intra-Operative Methylprednisolone Improve Outcomes of Surgery for Degenerative Cervical Myelopathy? - A Prospective Randomized Study.

Abstract

Randomized controlled trial. In this study, we hypothesize administering fixed-dose intravenous steroid (Methylprednisolone) intraoperatively would reduce neuroinflammation and enhance functional and radiological outcomes in decompressive surgeries for DCM. Primary objectives were to assess effect of intraoperative MP on modified Japanese Orthopedic Association (mJOA) score, Nurick grade, and MRI signal changes. This prospective triple-blinded randomized controlled trial included 65 patients allocated into MP (n = 33) and control (n = 32) groups. MP (dose-1g) was administered intraoperatively at the beginning of decompression. Clinical outcome measures included mJOA score, Nurick grading, mJOA recovery rate (mJOA RR), Nurick recovery rate (NRR), and complication rates in both groups at 1-, 3-and 24-month follow-up. Radiological outcome was assessed by analyzing regression of T2W and T1W SI changes on MRI scans as per Chen's grading at 24-months follow-up. MP group exhibited greater improvement in mJOA scores at 24-months (mean improvement: +6.69 vs +6.42; difference: +0.27, 95% CI: -0.37 to +0.91) but was statistically insignificant (P = .107). Similarly, mJOA-RR showed a moderate effect size of 0.42 (95% CI: 0.04 to 0.80) and 0.37 (95% CI: -0.01 to 0.75) at 1-and 3-months follow-up respectively. NRR improvements were observed, with effect sizes of 0.40 (95% CI: 0.02 to 0.78) and 0.49 (95% CI: 0.11 to 0.87) at 1- and 3-months respectively, but not statistically significant (P = .28). At 24-months, MP group had significantly better MRI outcome (Chen grading: mean change +1.15 vs +0.83; effect size: -0.71, 95% CI: -1.09 to -0.33; P = .038).Complication rates were comparable between both groups, emphasizing safety of MP administration. Although null hypothesis was not proven, intraoperative MP administration in DCM surgery demonstrated safety and suggested potential neuroprotective benefits to enhance clinical recovery and reduce spinal cord signal changes. However, further large-scale, multicentric studies are needed to validate these findings and optimize its dose.