A prospective, randomized, controlled clinical investigation comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion

2-year results from the US FDA IDE clinical trial

Frank M. Phillips, Joe Y B Lee, Fred H. Geisler, Andrew Cappuccino, Christopher D. Chaput, John Glenden DeVine, Christopher Reah, Kye M. Gilder, Kelli M. Howell, Paul C. McAfee

Research output: Contribution to journalArticle

100 Citations (Scopus)

Abstract

Study Design.: Prospective, multicenter, randomized Food and Drug Administration approved investigational device exemption clinical trial. Objective.: To evaluate the safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in the treatment of patients with degenerative spondylosis and neurological symptoms at 1 level between C3-C4 and C7-T1. Summary of Background Data.: Cervical disc arthroplasty in the treatment of symptomatic cervical spondylosis has been studied in other series. The PCM Cervical Disc is a nonconstrained motion-sparing alternative to ACDF. Methods.: Patients 18 to 65 years of age with single-level symptomatic cervical spondylosis with radiculopathy and/or myelopathy unresponsive to nonoperative treatment were enrolled, including patients with prior nonadjacent or adjacent single-level fusions. The per-protocol patient sample at 2 years included 342 patients (189 PCM, 153 ACDF). Longitudinal outcomes were comparatively evaluated. Results.: At 2 years postoperatively, clinical measures-neck and arm pain visual analogue scale, Neck Disability Index (NDI), SF-36, and neurological status-were significantly improved from preoperative baselines in both groups. Mean NDI score at 2 years was significantly lower in PCM group (P = 0.029). There were no statistical differences between groups in rates of surgery-related serious adverse events (5.6% PCM, 7.4% ACDF) or secondary surgical procedures (5.2% PCM, 5.4% ACDF). Patients with PCM reported lower dysphagia scores (8.8/100 vs. 12.1/100; P = 0.045) and higher patient satisfaction (82.8/100 vs. 81.4/100). Overall success, a composite endpoint including minimum 20% NDI improvement, no major complications, no neurological worsening, no secondary surgical procedures, and meeting radiographical criteria of motion for PCM and fusion for ACDF, was significantly greater in the PCM group (75.1% vs. 64.9%; P = 0.020). Conclusion.: The treatment of symptomatic single-level cervical spondylosis with PCM achieves clinical outcomes that are at least equivalent to ACDF while maintaining motion. At 2 years, patients with PCM had lower NDI scores, statistically lower rate of prolonged dysphagia, greater patient satisfaction, and superior overall success.

Original languageEnglish (US)
JournalSpine
Volume38
Issue number15
DOIs
StatePublished - Jul 1 2013
Externally publishedYes

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Diskectomy
Arthroplasty
Spondylosis
Clinical Trials
Neck
Deglutition Disorders
Patient Satisfaction
Radiculopathy
Neck Pain
Spinal Cord Diseases
United States Food and Drug Administration
Therapeutics
Visual Analog Scale
Arm
Safety
Equipment and Supplies

Keywords

  • ACDF
  • Cervical total disc replacement
  • PCM
  • Porous Coated Motion
  • arthroplasty
  • randomized clinical trial

ASJC Scopus subject areas

  • Clinical Neurology
  • Orthopedics and Sports Medicine

Cite this

A prospective, randomized, controlled clinical investigation comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion : 2-year results from the US FDA IDE clinical trial. / Phillips, Frank M.; Lee, Joe Y B; Geisler, Fred H.; Cappuccino, Andrew; Chaput, Christopher D.; DeVine, John Glenden; Reah, Christopher; Gilder, Kye M.; Howell, Kelli M.; McAfee, Paul C.

In: Spine, Vol. 38, No. 15, 01.07.2013.

Research output: Contribution to journalArticle

Phillips, Frank M. ; Lee, Joe Y B ; Geisler, Fred H. ; Cappuccino, Andrew ; Chaput, Christopher D. ; DeVine, John Glenden ; Reah, Christopher ; Gilder, Kye M. ; Howell, Kelli M. ; McAfee, Paul C. / A prospective, randomized, controlled clinical investigation comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion : 2-year results from the US FDA IDE clinical trial. In: Spine. 2013 ; Vol. 38, No. 15.
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title = "A prospective, randomized, controlled clinical investigation comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion: 2-year results from the US FDA IDE clinical trial",
abstract = "Study Design.: Prospective, multicenter, randomized Food and Drug Administration approved investigational device exemption clinical trial. Objective.: To evaluate the safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in the treatment of patients with degenerative spondylosis and neurological symptoms at 1 level between C3-C4 and C7-T1. Summary of Background Data.: Cervical disc arthroplasty in the treatment of symptomatic cervical spondylosis has been studied in other series. The PCM Cervical Disc is a nonconstrained motion-sparing alternative to ACDF. Methods.: Patients 18 to 65 years of age with single-level symptomatic cervical spondylosis with radiculopathy and/or myelopathy unresponsive to nonoperative treatment were enrolled, including patients with prior nonadjacent or adjacent single-level fusions. The per-protocol patient sample at 2 years included 342 patients (189 PCM, 153 ACDF). Longitudinal outcomes were comparatively evaluated. Results.: At 2 years postoperatively, clinical measures-neck and arm pain visual analogue scale, Neck Disability Index (NDI), SF-36, and neurological status-were significantly improved from preoperative baselines in both groups. Mean NDI score at 2 years was significantly lower in PCM group (P = 0.029). There were no statistical differences between groups in rates of surgery-related serious adverse events (5.6{\%} PCM, 7.4{\%} ACDF) or secondary surgical procedures (5.2{\%} PCM, 5.4{\%} ACDF). Patients with PCM reported lower dysphagia scores (8.8/100 vs. 12.1/100; P = 0.045) and higher patient satisfaction (82.8/100 vs. 81.4/100). Overall success, a composite endpoint including minimum 20{\%} NDI improvement, no major complications, no neurological worsening, no secondary surgical procedures, and meeting radiographical criteria of motion for PCM and fusion for ACDF, was significantly greater in the PCM group (75.1{\%} vs. 64.9{\%}; P = 0.020). Conclusion.: The treatment of symptomatic single-level cervical spondylosis with PCM achieves clinical outcomes that are at least equivalent to ACDF while maintaining motion. At 2 years, patients with PCM had lower NDI scores, statistically lower rate of prolonged dysphagia, greater patient satisfaction, and superior overall success.",
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T1 - A prospective, randomized, controlled clinical investigation comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion

T2 - 2-year results from the US FDA IDE clinical trial

AU - Phillips, Frank M.

AU - Lee, Joe Y B

AU - Geisler, Fred H.

AU - Cappuccino, Andrew

AU - Chaput, Christopher D.

AU - DeVine, John Glenden

AU - Reah, Christopher

AU - Gilder, Kye M.

AU - Howell, Kelli M.

AU - McAfee, Paul C.

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N2 - Study Design.: Prospective, multicenter, randomized Food and Drug Administration approved investigational device exemption clinical trial. Objective.: To evaluate the safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in the treatment of patients with degenerative spondylosis and neurological symptoms at 1 level between C3-C4 and C7-T1. Summary of Background Data.: Cervical disc arthroplasty in the treatment of symptomatic cervical spondylosis has been studied in other series. The PCM Cervical Disc is a nonconstrained motion-sparing alternative to ACDF. Methods.: Patients 18 to 65 years of age with single-level symptomatic cervical spondylosis with radiculopathy and/or myelopathy unresponsive to nonoperative treatment were enrolled, including patients with prior nonadjacent or adjacent single-level fusions. The per-protocol patient sample at 2 years included 342 patients (189 PCM, 153 ACDF). Longitudinal outcomes were comparatively evaluated. Results.: At 2 years postoperatively, clinical measures-neck and arm pain visual analogue scale, Neck Disability Index (NDI), SF-36, and neurological status-were significantly improved from preoperative baselines in both groups. Mean NDI score at 2 years was significantly lower in PCM group (P = 0.029). There were no statistical differences between groups in rates of surgery-related serious adverse events (5.6% PCM, 7.4% ACDF) or secondary surgical procedures (5.2% PCM, 5.4% ACDF). Patients with PCM reported lower dysphagia scores (8.8/100 vs. 12.1/100; P = 0.045) and higher patient satisfaction (82.8/100 vs. 81.4/100). Overall success, a composite endpoint including minimum 20% NDI improvement, no major complications, no neurological worsening, no secondary surgical procedures, and meeting radiographical criteria of motion for PCM and fusion for ACDF, was significantly greater in the PCM group (75.1% vs. 64.9%; P = 0.020). Conclusion.: The treatment of symptomatic single-level cervical spondylosis with PCM achieves clinical outcomes that are at least equivalent to ACDF while maintaining motion. At 2 years, patients with PCM had lower NDI scores, statistically lower rate of prolonged dysphagia, greater patient satisfaction, and superior overall success.

AB - Study Design.: Prospective, multicenter, randomized Food and Drug Administration approved investigational device exemption clinical trial. Objective.: To evaluate the safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in the treatment of patients with degenerative spondylosis and neurological symptoms at 1 level between C3-C4 and C7-T1. Summary of Background Data.: Cervical disc arthroplasty in the treatment of symptomatic cervical spondylosis has been studied in other series. The PCM Cervical Disc is a nonconstrained motion-sparing alternative to ACDF. Methods.: Patients 18 to 65 years of age with single-level symptomatic cervical spondylosis with radiculopathy and/or myelopathy unresponsive to nonoperative treatment were enrolled, including patients with prior nonadjacent or adjacent single-level fusions. The per-protocol patient sample at 2 years included 342 patients (189 PCM, 153 ACDF). Longitudinal outcomes were comparatively evaluated. Results.: At 2 years postoperatively, clinical measures-neck and arm pain visual analogue scale, Neck Disability Index (NDI), SF-36, and neurological status-were significantly improved from preoperative baselines in both groups. Mean NDI score at 2 years was significantly lower in PCM group (P = 0.029). There were no statistical differences between groups in rates of surgery-related serious adverse events (5.6% PCM, 7.4% ACDF) or secondary surgical procedures (5.2% PCM, 5.4% ACDF). Patients with PCM reported lower dysphagia scores (8.8/100 vs. 12.1/100; P = 0.045) and higher patient satisfaction (82.8/100 vs. 81.4/100). Overall success, a composite endpoint including minimum 20% NDI improvement, no major complications, no neurological worsening, no secondary surgical procedures, and meeting radiographical criteria of motion for PCM and fusion for ACDF, was significantly greater in the PCM group (75.1% vs. 64.9%; P = 0.020). Conclusion.: The treatment of symptomatic single-level cervical spondylosis with PCM achieves clinical outcomes that are at least equivalent to ACDF while maintaining motion. At 2 years, patients with PCM had lower NDI scores, statistically lower rate of prolonged dysphagia, greater patient satisfaction, and superior overall success.

KW - ACDF

KW - Cervical total disc replacement

KW - PCM

KW - Porous Coated Motion

KW - arthroplasty

KW - randomized clinical trial

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