Lower incidence of dysphagia with cervical arthroplasty compared with ACDF in a prospective randomized clinical trial.
METHODS
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.


OBJECTIVE
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.


BACKGROUND
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 resolution of the dysphagia was greatly improved in the PCM group compared with the instrumented ACDF control group.
McAfee
Paul C
PC
St. Joseph Medical Center, Scoliosis and Spine Center, Baltimore, MD 21204, USA. mack8132@gmail.com
Cappuccino
Andrew
A
Cunningham
Bryan W
BW
Devine
John G
JG
Phillips
Frank M
FM
Regan
John J
JJ
Albert
Todd J
TJ
Ahrens
Jeanette E
JE
D000328:Adult; D001178:Arthroplasty / Q000009:adverse effects* / Q000706:statistics & numerical data; D002574:Cervical Vertebrae / Q000473:pathology / Q000601:surgery; D003680:Deglutition Disorders / Q000453:epidemiology*; D017586:Diskectomy / Q000009:adverse effects* / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D015994:Incidence; D016268:Internal Fixators / Q000009:adverse effects; D007403:Intervertebral Disc / Q000473:pathology / Q000601:surgery; D007405:Intervertebral Disc Displacement / Q000473:pathology / Q000503:physiopathology / Q000601:surgery; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D011183:Postoperative Complications / Q000453:epidemiology*; D011446:Prospective Studies; D011843:Radiculopathy / Q000473:pathology / Q000503:physiopathology / Q000601:surgery; D013117:Spinal Cord Compression / Q000473:pathology / Q000503:physiopathology / Q000601:surgery; D013123:Spinal Fusion / Q000009:adverse effects* / Q000706:statistics & numerical data; D055009:Spondylosis / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D016896:Treatment Outcome