ProDisc-C versus fusion with Cervios chronOS prosthesis in cervical degenerative disc disease: Is there a difference at 12 months?

Abstract

Study design: Prospective cohort study.Objective: The aim of the study was to compare clinical results and to determine differences in outcomes between anterior cervical discectomy and fusion (ACDF) and disc arthroplasty in patients treated for symptomatic cervical degenerative disc disease.Methods: Forty patients with cervical degenerative disc disease were treated with ProDisc-C disc arthroplasty and 40 patients with fusion using an intervetebral spacer with integrated fixation (Cervios chronoOS) implants without additional anterior fixation. Fifty disc prostheses were placed in the first group and 52 intervertebral spacers were implanted in the second group. Clinical outcomes were assessed before and 12 months following the procedure using the neck disability index (NDI) and visual analog scale (VAS) for neck and arm pain, with 15% improvement in NDI and 20% in VAS defined as a clinically significant.Results: Eighty patients with cervical degenerative disc disease with a mean age of 49.7 years were included in the study with a minimum follow-up of 12 months. The groups were similar at baseline both clinically and statistically (P > .05) except for age and VAS for arm pain. Both groups had a statistically significant improvement in NDI and VAS for neck and arm pain (P < .05) and the arthroplasty group had a better improvement according to NDI (74.3% of patients in the arthroplasty group achieved ≥15% improvement in NDI versus 65.7% of patients in ACDF group).Conclusions: Both ProDisc C and Cervios chronoOS prostheses resulted in significant pain reduction and functional outcome for the patients with slightly better results in the group treated with disc arthroplasty 12 months after the surgery.Methods evaluation and class of evidence (CoE)Methodological principle:Study Design RCT Cohort study• Case control Case seriesMethods Concealed allocation (RCT) Intent to treat (RCT) Blinded/independent evaluation of primary outcome• Follow-up ≥85%• Adequate sample size• Control for confoundingEvidence class:IIIThe definiton of the different classes of evidence is available on page 83.

Outcomes After Cervical Disc Arthroplasty Versus Stand-Alone Anterior Cervical Discectomy and Fusion: A Meta-Analysis

“…Screening of the titles and abstracts revealed 64 articles, which were assessed for inclusion in our meta-analysis by full text screening. After applying exclusion criteria, 12 total studies were included in our study, 23 - 34 which were included in our quantitative analysis. A PRISMA flow sheet for our meta-analysis is displayed in Figure 1.…”

“…Stand-alone interbody devices used in the included studies, when specified, included the Brantigan cervical I/F (DePuy Spine, Inc, Raynham, MA), Zero-P (DePuy Synthes Spine, Raynham, MA), Cervios (DePuy Synthes Spine, Raynham, MA), Solis (Stryker Spine, Allendale, NJ), MC+ (Zimmer Biomet, Warsaw, IN), and Shell (Advantage Manufacturing Technologies Company, Nonnweiler, Germany). Only one study 27 measuring NDI scores included both single- and 2-level patients, and was included in this meta-analysis. All other studies were single-level studies.…”

“…A total of 2 studies specified upright radiographic images, 23 , 26 whereas 2 studies did not specify imaging protocol in their publications. 27 , 33 A forest plot of segmental angle results is provided in Figure 2 .…”

“…NDI scores were reported in 7 studies. 24 , 26 - 29 , 32 , 33 One study was excluded for absent standard deviation values, 33 and a total of 6 studies were included. Studies rated the NDI scores on a scale of 0 to 50.…”

“…This is especially important when reviewing rates of ASD and dysphagia, where length of follow-up influences disease prevalence. One study measuring NDI scores included multilevel treatments, 27 and this was one factor we were unable to account for.…”