Lower Incidence of Dysphagia With Cervical Arthroplasty Compared With ACDF in a Prospective Randomized Clinical Trial Paul C. McAfee, MD,* Andrew Cappuccino, MD,w Bryan W. Cunningham, MSc,* John G. Devine, MD,z Frank M. Phillips, MD,y John J. Regan, MD,J Todd J. Albert, MD,z and Jeanette E. Ahrens, PhD# Study Design: The current study of 251 consecutive 1-level anterior cervical reconstructions was undertaken to compare the incidence of dysphagia between cervical disk replacement and conventional anterior cervical fusion and instrumentation. Objectives: This is a report of 251 patients from 5 investigational centers in the Food and drug Administration’s prospective, randomized porous-coated motion (PCM) trial using a validated dysphagia outcomes instrument. The dysphagia data for both PCM and anterior cervical diskectomy and fusion (ACDF) patients were reviewed from 5 centers to (1) compare the severity of dysphagia, (2) compare the postoperative incidence of dysphagia, and (3) to compare the resolution of perioperative dysphagia. Summary of Background Data: Dysphagia and dysphonia after anterior surgical approaches to the cervical spine have been previously reported. The current prospective, randomized investigation quantifies clinical dysphagia based on 3 criteria- severity, incidence, and resolution—in a time-course evaluation. Methods: Patients between 18 and 65 years with 1-level symptomatic cervical radiculopathy and/or myelopathy for progressive neurologic symptoms, were randomized to undergo anterior decompression and PCM arthroplasty (N = 151) or ACDF (control) (N = 100). Patients self-reported dysphagia severity using the Bazaz scale preoperatively and at follow-up. The Bazaz scale has 4 classes of severity based upon the problems with swallowing that the patient has with both liquids and solids. Results: The Bazaz results demonstrate that although both the PCM and ACDF groups exhibited an initial postoperative problem with swallowing, the PCM group continued to improve with increasing time after implantation, whereas the ACDF only improved minimally. The PCM treatments indicated significantly lower incidence of dysphagia at 3 and 12 months postoperatively compared with ACDF controls (P <0.05). An increase in dysphagia severity at either the 6-week or 3-month follow-up visit was reported in 35 (42%) PCM and 29 (64%) ACDF subjects. Long-term resolution of these symptoms was noted in 74% (26/35) of the PCM subjects as compared with 41.4% (12/29) of the ACDF subjects (P = 0.015). Conclusions: In a prospective randomized clinical study the incidence of postoperative dysphagia and the long-term resolu- tion of the dysphagia was greatly improved in the PCM group compared with the instrumented ACDF control group. Key Words: cervical disk replacement, cervical arthroplasty, dysphagia and dysphonia, prospective randomized clinical trial, level of evidence—level 1 study (J Spinal Disord Tech 2010;23:1–8) KEY POINTS  A prospective randomized trial of 251 patients en- rolled from 5 centers in a study by Food and Drug Administration (FDA) demonstrated a lower incidence of moderate and severe dysphagia with cervical arthroplasty versus anterior cervical diskectomy and fusion (ACDF) at all follow-up intervals from 6 weeks to 2 years after similar anterior cervical approaches.  The percent improvement of the Neck Disability Index and Visual Analog Scale (VAS) clinical outcomes instruments were significantly improved for PCM prosthetic implantations and ACDF compared with baseline (P <0.05).  This prospective randomized series of 251 patients resulted in a significantly lower incidence of patients with moderate and severe dyphagia by the Bazaz criteria for cervical disk replacement compared with ACDF surgical controls.  In this clinical study the number of cases with resolu- tion of the dysphagia from 3 months postoperatively Copyright r 2010 by Lippincott Williams & Wilkins Received for publication June 28, 2008; accepted December 29, 2008. From the *St. Joseph Medical Center, Scoliosis and Spine Center, Baltimore, MD; wLockport Hospital, Buffalo, NY; zMadigan Army Base, Seattle, WA; yRush Presbyterian Hospital, Chicago, IL; JCedars Sinai Hospital, Los Angeles, CA; zRothman Institute, Chestnut Street, Philadelphia, PA; and #Pivotal Research Solutions, South Greenville Avenue, Allen, TX. Reprints: Paul C. McAfee, MD, St. Joseph Medical Center, Scoliosis and Spine Center, O’Dea Medical Building #104, 7505 Osler Drive, Towson, MD 21204 (e-mail: mack8132@gmail.com). ORIGINAL ARTICLE J Spinal Disord Tech  Volume 23, Number 1, February 2010 www.jspinaldisorders.com | 1