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.
Clinical outcomes, fusion rates, and return to work rates between patients who were braced and those who were not were similar after single-level anterior cervical fusion with plating. The use of a cervical brace does not improve the clinical outcomes, the fusion rate, or return-to-work rates of patients undergoing single-level anterior cervical fusion with plating.
From the *Leatherman Spine Center, Louisville, KY; †Department of Neurosurgery, The University of Iowa Hospitals and Clinics, Iowa City, IA; and ‡Department of Orthopaedic Surgery and Rehabilitation, University of Wisconsin, Madison, WI.
Acknowledgment date: May 5,2008. Revision date: June 9, 2008. Acceptance date: June 11, 2008.
The device(s)/drug(s) is/are FDA-approved or approved by corresponding national agency for this indication.
Institutional funds were received in support of this work. Although one or more of the author(s) has/have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this manuscript, benefits will be directed solely to a research fund, foundation, educational institution, or other nonprofit organization which the author(s) has/have been associated.
Address correspondence and reprint requests to Leah Y. Carreon MD, MSc, Leatherman Spine Center, 210 East Gray Street, Suite 900, Louisville, KY 40202; E-mail: email@example.com