Study Design. Randomized clinical trial.
Objective. This study is evaluates whether the use of a cervical collar after single-level anterior cervical fusion with plating increases the fusion rate and improved clinical outcomes.
Summary of Background Data. Plates limit motion between the graft and the vertebra in anterior cervical fusion. Still, the use of cervical collars after instrumented anterior cervical fusion is widely practiced.
Methods. Patients enrolled in an FDA-regulated, multicenter trial in 32 centers treated with single-level decompression and arthrodesis using allograft and an anterior cervical plate were included in the analysis. Patients were divided into Braced and Nonbraced groups regardless of type of brace. SF-36, Neck Disability Index (NDI), Numerical Rating Scales (0–100) for neck and arm pain were determined before surgery, 1.5, 3, 6, 12, and 24 months after surgery. Fusion was assessed by independent radiologists at 6, 12, and 24 months after surgery using upright AP, lateral, and flexion-extension views. Fusion success was defined as the presence of bridging trabecular bone, angulation of less than or equal 4° on flexion-extension radiographs; and absence of radiolucencies.
Results. Two hundred fifty-seven patients were included in the analysis, 149 were braced and 108 were not. Demographic characteristics and baseline outcome measures of both groups were similar. There was also no statistically significant difference in any of the clinical measures at baseline except for SF-36 Physical Component Summary score. The SF-36 Physical Component Summary, NDI, neck, and arm pain scores were similar in both groups at all time intervals and showed statistically significant improvement when compared with preoperative scores. There was no difference in the proportion of patients working at any time point between the Braced and Nonbraced group. Independent radiologists reported higher rates of fusion in the Nonbraced group over all time intervals, none of which were statistically significant.
Conclusion. Our results show that the use of a cervical brace does not improve the fusion rate or the clinical outcomes of patients undergoing single-level anterior cervical fusion with plating.