Evaluation of Dysphagia and Dysphonia with the PCM Cervical Disc Compared to ACDF in a Prospective Randomized Clinical Trial: Two-Year Results from the US IDE Study

Evaluation of Dysphagia and Dysphonia with the PCM Cervical Disc Compared to ACDF in a... <h5>Background Context</h5> The PCM® Cervical Disc is a recently FDA-approved non-constrained cervical disc arthroplasty device with a low-profile design. The investigational device exemption (IDE) clinical trial conducted in the United States is the largest reported multicenter prospective randomized clinical trial explicitly evaluating dysphagia and dysphonia in patients treated with anterior cervical approaches.</P><h5>Purpose</h5> To compare the incidence and magnitude of dysphagia and dysphonia in patients with cervical degenerative spondylosis treated with the PCM Cervical Disc compared to anterior cervical discectomy and fusion (ACDF) with allograft plate.</P><h5>Study Design/Setting</h5> Prospective, randomized, multicenter, IRB-approved IDE clinical trial evaluating longitudinal outcomes over 2 years comparatively between arthroplasty and fusion groups.</P><h5>Patient Sample</h5> Patients 18-65 years of age with degenerative disc disease at one level between C3 and T1, with or without prior cervical fusion, with neurologic symptoms unresponsive to conservative care were included. A total of 404 patients were treated (214 PCM, 190 ACDF). The per protocol patient sample at 2 years included 211 in the PCM group and 184 in the ACDF control group.</P><h5>Outcome Measures</h5> Assessments included visual analog scale (VAS) scores for hoarseness and swallowing (both 0-100mm) and the Bazaz criteria. Additionally, all adverse events (AE) related to soft tissue retraction, dysphasia, or dysphonia were concurrently recorded.</P><h5>Methods</h5> Outcome measures were tested for significant differences between the arthroplasty and fusion group at postoperative visits, as well as change from baseline to the 2-year postoperative visit for the Bazaz criteria.</P><h5>Results</h5> In both groups, the mean swallowing VAS scores were highest 6 weeks postoperatively (PCM 24.7mm, ACDF 26.9mm) and gradually improved at each subsequent postoperative visit. At 2 years, PCM patients reported lower mean swallowing scores (8.8mm vs 12.1mm; P=0.045) and lower mean hoarseness scores (7.3mm vs 10.1mm; P=0.330). 87.7% (164/187) of PCM patients and 82.6% (123/149) of ACDF patients reported maintenance or improvement in Bazaz score from baseline (p=0.214). The incidence of AEs categorized as surgery-related dysphagia and/or dysphonia was 5.1% (11/214) in the PCM patients compared to 10.5% (20/190) in the ACDF patients (p=0.060). In both treatment groups, patients with prior anterior cervical fusion generally had higher swallowing and hoarseness VAS scores and higher Bazaz scores compared to those without a prior fusion. At 2 years, in patients with prior cervical fusion, the impact of a subsequent anterior approach was worse for patients undergoing ACDF compared to cervical arthroplasty in mean swallowing (PCM 10.4mm, ACDF 25.3mm) as well as mean hoarseness (PCM 7.7mm, ACDF 19.9mm).</P><h5>Conclusions</h5> The treatment of symptomatic single-level cervical spondylosis with PCM maintains motion and achieves clinical outcomes that are at least equivalent to ACDF. PCM patients had lower swallowing and hoarseness VAS scores and higher percentage of patients who maintained or improved in Bazaz score. The results infer reduced trauma to surrounding soft tissue following treatment with PCM. Unlike previously reported series of BMP-2 used for ACDF, no treated patient in this IDE clinical trial was readmitted for hospitalization or to the intensive care unit for acute respiratory distress in either treatment group. PCM Cervical Disc is a viable and safe reconstruction option resulting in reduced dysphagia and dysphonia, including patients with prior cervical fusion.</P><h5>FDA Device/Drug Status</h5> PCM Cervical Disc (Approved for this indication).</P> http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png The Spine Journal Elsevier

Evaluation of Dysphagia and Dysphonia with the PCM Cervical Disc Compared to ACDF in a Prospective Randomized Clinical Trial: Two-Year Results from the US IDE Study

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Publisher
Elsevier
Copyright
Copyright © 2013 Elsevier Ltd
ISSN
1529-9430
DOI
10.1016/j.spinee.2013.07.301
Publisher site
See Article on Publisher Site

Abstract

<h5>Background Context</h5> The PCM® Cervical Disc is a recently FDA-approved non-constrained cervical disc arthroplasty device with a low-profile design. The investigational device exemption (IDE) clinical trial conducted in the United States is the largest reported multicenter prospective randomized clinical trial explicitly evaluating dysphagia and dysphonia in patients treated with anterior cervical approaches.</P><h5>Purpose</h5> To compare the incidence and magnitude of dysphagia and dysphonia in patients with cervical degenerative spondylosis treated with the PCM Cervical Disc compared to anterior cervical discectomy and fusion (ACDF) with allograft plate.</P><h5>Study Design/Setting</h5> Prospective, randomized, multicenter, IRB-approved IDE clinical trial evaluating longitudinal outcomes over 2 years comparatively between arthroplasty and fusion groups.</P><h5>Patient Sample</h5> Patients 18-65 years of age with degenerative disc disease at one level between C3 and T1, with or without prior cervical fusion, with neurologic symptoms unresponsive to conservative care were included. A total of 404 patients were treated (214 PCM, 190 ACDF). The per protocol patient sample at 2 years included 211 in the PCM group and 184 in the ACDF control group.</P><h5>Outcome Measures</h5> Assessments included visual analog scale (VAS) scores for hoarseness and swallowing (both 0-100mm) and the Bazaz criteria. Additionally, all adverse events (AE) related to soft tissue retraction, dysphasia, or dysphonia were concurrently recorded.</P><h5>Methods</h5> Outcome measures were tested for significant differences between the arthroplasty and fusion group at postoperative visits, as well as change from baseline to the 2-year postoperative visit for the Bazaz criteria.</P><h5>Results</h5> In both groups, the mean swallowing VAS scores were highest 6 weeks postoperatively (PCM 24.7mm, ACDF 26.9mm) and gradually improved at each subsequent postoperative visit. At 2 years, PCM patients reported lower mean swallowing scores (8.8mm vs 12.1mm; P=0.045) and lower mean hoarseness scores (7.3mm vs 10.1mm; P=0.330). 87.7% (164/187) of PCM patients and 82.6% (123/149) of ACDF patients reported maintenance or improvement in Bazaz score from baseline (p=0.214). The incidence of AEs categorized as surgery-related dysphagia and/or dysphonia was 5.1% (11/214) in the PCM patients compared to 10.5% (20/190) in the ACDF patients (p=0.060). In both treatment groups, patients with prior anterior cervical fusion generally had higher swallowing and hoarseness VAS scores and higher Bazaz scores compared to those without a prior fusion. At 2 years, in patients with prior cervical fusion, the impact of a subsequent anterior approach was worse for patients undergoing ACDF compared to cervical arthroplasty in mean swallowing (PCM 10.4mm, ACDF 25.3mm) as well as mean hoarseness (PCM 7.7mm, ACDF 19.9mm).</P><h5>Conclusions</h5> The treatment of symptomatic single-level cervical spondylosis with PCM maintains motion and achieves clinical outcomes that are at least equivalent to ACDF. PCM patients had lower swallowing and hoarseness VAS scores and higher percentage of patients who maintained or improved in Bazaz score. The results infer reduced trauma to surrounding soft tissue following treatment with PCM. Unlike previously reported series of BMP-2 used for ACDF, no treated patient in this IDE clinical trial was readmitted for hospitalization or to the intensive care unit for acute respiratory distress in either treatment group. PCM Cervical Disc is a viable and safe reconstruction option resulting in reduced dysphagia and dysphonia, including patients with prior cervical fusion.</P><h5>FDA Device/Drug Status</h5> PCM Cervical Disc (Approved for this indication).</P>

Journal

The Spine JournalElsevier

Published: Sep 1, 2013

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