Introduction: The objective of this research was to assess the impact of complications on clinical and patient outcomes following surgical treatment of cervical spondylotic myelopathy (CSM).
Methods: The AOSpine North America CSM study is a recently completed prospective multicenter study of surgical treatment for CSM. Standardized forms were used for collection of adverse events, both early (within 30 days of surgery) and late (31 days–2 years after surgery). Data collection was externally monitored to help ensure integrity and completeness. Outcomes measures included: Neck Disability Index (NDI), modified Japanese Orthopaedic Assessment (mJOA), SF36v2, and Nurick. Multivariate regression based predictor selection and general linear modeling were used to calculate associations between complications and patient outcomes.
Results: 278 subjects were enrolled (mean age=56.3, SD=11.7; 59% males). Of 306 adverse events, 64 were independently adjudicated to be early complications and 14 to be late complications. 44 subjects (15.8%) had one or more early complications, and 12 (4.3%) had one or more late complications. The extent of improvement in mJOA was negatively associated with the presence of early and late complications (P=0.0422). Both subjects with early and late complications experienced poorer results than subjects with no complications. Moreover, improvement in NDI was also negatively associated with the presence of complications (P=0.0036). However, only early complications impacted NDI outcomes. Subjects without early complications experienced significant improvement in NDI (12.89, 95% CI=10.45–15.33). In contrast, subjects with early complications did not experience improvement in NDI (mean change=3.32, 95% CI=-2.50-9.14). No association between complications and improvements in SF36v2 or Nurick were identified.
Conclusions: These data suggest possible impact of complications on clinical outcomes following surgical treatment for CSM based on the NDI and mJOA, but not based on the SF36 or Nurick.
Patient Care: Better understanding of the possible impact of complications on outcome measures following surgical treatment for cervical spondylotic myelopathy may prove useful for patient counseling, surgical decision making, and for on-going efforts to improve the safety of patient care.
Learning Objectives: 1. Improved understanding of the complication rates associated with operative treatment for cervical spondylotic myelopathy.
2. Appreciation of the possible impact of complications on the degree of improvement of outcomes measures following surgical treatment for cervical spondylotic myelopathy.