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

Paul C. McAfee, Andrew Cappuccino, Bryan W. Cunningham, John Glenden DeVine, Frank M. Phillips, John J. Regan, Todd J. Albert, Jeanette E. Ahrens

Research output: Contribution to journalArticle

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Abstract

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 resolution of the dysphagia was greatly improved in the PCM group compared with the instrumented ACDF control group.

Original languageEnglish (US)
Pages (from-to)1-8
Number of pages8
JournalJournal of Spinal Disorders and Techniques
Volume23
Issue number1
DOIs
StatePublished - Feb 1 2010

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Diskectomy
Deglutition Disorders
Arthroplasty
Randomized Controlled Trials
Incidence
Deglutition
Dysphonia
Radiculopathy
Spinal Cord Diseases
United States Food and Drug Administration
Neurologic Manifestations
Decompression

Keywords

  • Cervical arthroplasty
  • Cervical disk replacement
  • Dysphagia and dysphonia
  • Level of evidence-level 1 study
  • Prospective randomized clinical trial

ASJC Scopus subject areas

  • Surgery
  • Orthopedics and Sports Medicine
  • Clinical Neurology

Cite this

Lower incidence of dysphagia with cervical arthroplasty compared with ACDF in a prospective randomized clinical trial. / McAfee, Paul C.; Cappuccino, Andrew; Cunningham, Bryan W.; DeVine, John Glenden; Phillips, Frank M.; Regan, John J.; Albert, Todd J.; Ahrens, Jeanette E.

In: Journal of Spinal Disorders and Techniques, Vol. 23, No. 1, 01.02.2010, p. 1-8.

Research output: Contribution to journalArticle

McAfee, Paul C. ; Cappuccino, Andrew ; Cunningham, Bryan W. ; DeVine, John Glenden ; Phillips, Frank M. ; Regan, John J. ; Albert, Todd J. ; Ahrens, Jeanette E. / Lower incidence of dysphagia with cervical arthroplasty compared with ACDF in a prospective randomized clinical trial. In: Journal of Spinal Disorders and Techniques. 2010 ; Vol. 23, No. 1. pp. 1-8.
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AU - McAfee, Paul C.

AU - Cappuccino, Andrew

AU - Cunningham, Bryan W.

AU - DeVine, John Glenden

AU - Phillips, Frank M.

AU - Regan, John J.

AU - Albert, Todd J.

AU - Ahrens, Jeanette E.

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N2 - 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 resolution of the dysphagia was greatly improved in the PCM group compared with the instrumented ACDF control group.

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KW - Cervical arthroplasty

KW - Cervical disk replacement

KW - Dysphagia and dysphonia

KW - Level of evidence-level 1 study

KW - Prospective randomized clinical trial

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