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Open access

Fred H. Geisler, Ali Moghaddamjou, Jamie R. F. Wilson, and Michael G. Fehlings

OBJECTIVE

Methylprednisolone (MP) to treat acute traumatic spinal cord injury (ATSCI) remains controversial since the release of the second National Acute Spinal Cord Injury Study (NASCIS2) in 1990. As two historical studies, NASCIS2 and Sygen in ATSCI, used identical MP dosages, it was possible to construct a new case-level pooled ATSCI data set satisfying contemporary criteria and able to clarify the effect of MP.

METHODS

The new pooled data set was first modernized by excluding patients with injury levels caudal to T10, lower-extremity American Spinal Injury Association (ASIA) motor scores (LEMSs) ≥ 46, Glasgow Coma Scale scores ≤ 11, and age < 15 or > 75 years, and then standardized to the ASIA grading and scoring format. A new updated NASCIS2 data set from this pooled data set contained 31.6% fewer patients than the 1990 NASCIS2 data set.

RESULTS

In the new pooled data set, recovery of LEMSs from baseline to 26 weeks, the primary outcome variable, was separated statistically into five different injury severity cohorts (p < 0.0001). The severity cohorts contained groups with severe floor (62.9%) and ceiling (10.7%) effects, which do not contribute to drug effects. The new NASCIS2 data set duplicated the p value for MP versus placebo in the sub-subgroup analysis of MP initiated ≤ 8 hours (the subgroup) and recovery of motor function on only the right side of the body (a further subgroup within the ≤ 8-hour subgroup), presented as the positive MP effect in the original NASCIS2 reporting. However, current statistical interpretation considers results seen only in post hoc sub-subgroups, without multi-test corrections, to be random effects without clinical significance. The combined case-level pooled data set from the NASCIS2 and Sygen studies increased the MP group from 106 to 431 patients, creating a new MP combined group. This new data set served as a surrogate for a contemporary MP study and found that administration of MP did not enhance ASIA motor score improvement in the lower extremities at 26 weeks. Secondary analysis of descending ASIA motor and sensory cervical neurological levels in cervical ATSCI patients at 26 weeks also found no MP drug effect.

CONCLUSIONS

Analysis of both the new updated NASCIS2 data set and the new case-matched pooled data set from two historical ATSCI studies revealed that administration of MP after spinal cord injury did not demonstrate any enhancement in neurological recovery at 26 weeks. The results of this analysis warrant review by clinical guideline groups.

Free access

Jetan H. Badhiwala, Sean N. Leung, Yosef Ellenbogen, Muhammad A. Akbar, Allan R. Martin, Fan Jiang, Jamie R. F. Wilson, Farshad Nassiri, Christopher D. Witiw, Jefferson R. Wilson, and Michael G. Fehlings

OBJECTIVE

Degenerative cervical myelopathy (DCM) is the most common cause of spinal cord dysfunction in adults. Multilevel ventral compressive pathology is routinely managed through anterior decompression and reconstruction, but there remains uncertainty regarding the relative safety and efficacy of multiple discectomies, multiple corpectomies, or hybrid corpectomy-discectomy. To that end, using a large national administrative healthcare data set, the authors sought to compare the perioperative outcomes of anterior cervical discectomy and fusion (ACDF), anterior cervical corpectomy and fusion (ACCF), and hybrid corpectomy-discectomy for multilevel DCM.

METHODS

Patients with a primary diagnosis of DCM who underwent an elective anterior cervical decompression and reconstruction operation over 3 cervical spinal segments were identified from the 2012–2017 National Surgical Quality Improvement Program database. Patients were separated into those undergoing 3-level discectomy, 2-level corpectomy, or a hybrid procedure (single-level corpectomy plus additional single-level discectomy). Outcomes included 30-day mortality, major complication, reoperation, and readmission, as well as operative duration, length of stay (LOS), and routine discharge home. Outcomes were compared between treatment groups by multivariable regression, adjusting for age and comorbidities (modified Frailty Index). Effect sizes were reported by adjusted odds ratio (aOR) or mean difference (aMD) and associated 95% confidence interval.

RESULTS

The study cohort consisted of 1298 patients; of these, 713 underwent 3-level ACDF, 314 2-level ACCF, and 271 hybrid corpectomy-discectomy. There was no difference in 30-day mortality, reoperation, or readmission among the 3 procedures. However, on both univariate and adjusted analyses, compared to 3-level ACDF, 2-level ACCF was associated with significantly greater risk of major complication (aOR 2.82, p = 0.005), longer hospital LOS (aMD 0.8 days, p = 0.002), and less frequent discharge home (aOR 0.59, p = 0.046). In contrast, hybrid corpectomy-discectomy had comparable outcomes to 3-level ACDF but was associated with significantly shorter operative duration (aMD −16.9 minutes, p = 0.002).

CONCLUSIONS

The authors found multiple discectomies and hybrid corpectomy-discectomy to have a comparable safety profile in treating multilevel DCM. In contrast, multiple corpectomies were associated with a higher complication rate, longer hospital LOS, and lower likelihood of being discharged directly home from the hospital, and may therefore be a higher-risk operation.