Single-Level Cervical Arthroplasty with Prodisc-C Vivo Artificial Disc

Spine ◽  
2021 ◽  
Vol Publish Ahead of Print ◽  
Author(s):  
Shuo Cao ◽  
Yanbin Zhao ◽  
Yu Sun ◽  
Weishi Li ◽  
Feifei Zhou ◽  
...  
2012 ◽  
Vol 16 (2) ◽  
pp. 163-171 ◽  
Author(s):  
Jau-Ching Wu ◽  
Wen-Cheng Huang ◽  
Tsung-Hsi Tu ◽  
Hsiao-Wen Tsai ◽  
Chin-Chu Ko ◽  
...  

Object Cervical arthroplasty is a valid option for patients with single-level symptomatic cervical disc diseases causing neural tissue compression, but postoperative heterotopic ossification (HO) can limit the mobility of an artificial disc. In the present study the authors used CT scanning to assess HO formation, and they investigated differences in radiological and clinical outcomes in patients with either a soft-disc herniation or spondylosis who underwent cervical arthroplasty. Methods Medical records, radiographs, and clinical evaluations of consecutive patients who underwent single-level cervical arthroplasty were reviewed. Arthroplasty was performed using the Bryan disc. The patients were divided into a soft-disc herniation group and a spondylosis group. Clinical outcomes were measured using the visual analog scale (VAS) for neck and arm pain and the Neck Disability Index (NDI), whereas HO grading was determined by studying CT scans. Radiological and clinical outcomes were analyzed, and the minimum follow-up duration was 24 months. Results Forty-seven consecutive patients underwent a single-level cervical arthroplasty. Forty patients (85.1%) had complete radiological evaluations and clinical follow-up of more than 2 years. Patients were divided into 1 of 2 groups: soft-disc herniation (16 cases) and the spondylosis group (24 cases). Their mean age was 45.51 ± 11.12 years. Sixteen patients (40%) were female. Patients in the soft-disc herniation group were younger than those in the spondylosis group, but the difference was not statistically significant (42.88 vs 47.26, p = 0.227). The mean follow-up duration was 38.83 ± 9.74 months. Sex, estimated blood loss, implant size, and perioperative NSAID prescription were not significantly different between the groups (p = 0.792, 0.267, 0.581, and 1.000, respectively). The soft-disc herniation group had significantly less HO formation than the spondylosis group (1 HO [6.25%] vs 14 Hos [58.33%], p = 0.001). Almost all artificial discs in both groups remained mobile (100% and 95.8%, p = 0.408). The clinical outcomes were not significantly different between the groups at all postoperative time points of evaluation, and clinical improvements were also similar. Conclusions Clinical outcomes of single-level cervical arthroplasty for soft-disc herniation and spondylosis were similar 3 years after surgery. There was a significantly higher rate of HO formation in patients with spondylosis than in those with a soft-disc herniation. The mobility of the artificial disc is maintained, but the long-term effects of HO and its higher frequency in spondylotic cases warrant further investigation.


2004 ◽  
Vol 17 (6) ◽  
pp. 1-4 ◽  
Author(s):  
J. Patrick Johnson ◽  
Carl Lauryssen ◽  
Helen O. Cambron ◽  
Robert Pashman ◽  
John J. Regan ◽  
...  

Object The authors evaluated cervical spine radiographs to determine sagittal alignment in patients who underwent one- or two-level arthroplasty with the Bryan cervical artificial disc prosthesis. Methods The curvature of the surgically treated spinal segments and the overall curvature of the cervical spine were evaluated in 13 patients who underwent 16 cervical arthroplasty device placements. Preoperative and postoperative lateral radiographs were reviewed and compared using standardized techniques for measuring spinal curvature. Patients who underwent a single-level cervical arthroplasty had a 4.7° mean reduction (p < 0.05) in lordosis after cervical artificial disc replacement. The three patients who underwent two-level cervical arthroplasty had no significant changes in the sagittal alignment. Conclusions Patients who underwent arthroplasty with a Bryan cervical artificial disc had a focal loss of lordosis (that is, kyphosis) at the treated levels after single-level procedures. Nevertheless, there was no significant change in the overall sagittal curvature of the cervical spine after single-level artificial disc replacements. The patients who underwent two-level artificial disc placement had no significant changes in lordosis at the treated levels or in the overall curvature. The likely source of this outcome appears to be the endplate milling procedures that reorient the vertebral endplates.


2019 ◽  
Vol 29 (11) ◽  
pp. 2670-2674 ◽  
Author(s):  
Yanbin Zhao ◽  
Feifei Zhou ◽  
Yu Sun ◽  
Shengfa Pan

2017 ◽  
Vol 42 (2) ◽  
pp. E2 ◽  
Author(s):  
Mazda K. Turel ◽  
Mena G. Kerolus ◽  
Owoicho Adogwa ◽  
Vincent C. Traynelis

OBJECTIVE The aim of this paper was to comprehensively review each of the Food and Drug Administration (FDA)–approved labels of 7 total cervical disc replacements, assess the exact methodology in which the trial was conducted, and provide a broad comparison of these devices to allow each surgeon to determine which disc best suits his or her specific treatment goals based on the specific labels and not the studies published. METHODS The FDA-approved labels for each of the 7 artificial discs were obtained from the official FDA website. These labels were meticulously compared with regard to the statistical analysis performed, the safety and efficacy data, and the randomized controlled trial that each artificial disc was involved in to obtain the FDA approval for the product or device. Both single-level and 2-level approvals were examined, and primary and secondary end points were assessed. RESULTS In the single-level group, 4 of the 7 artificial discs—Prestige LP, Prestige ST, Bryan, and Secure-C—showed superiority in overall success. Prestige ST showed superiority in 3 of 4 outcome measures (neurological success, revision surgery, and overall success), while the other aforementioned discs showed superiority in 2 or fewer measures (Prestige LP, neurological and overall success; Bryan, Neck Disability Index [NDI] and overall success; Secure-C, revision surgery and overall success; Pro-Disc C, revision surgery). The PCM and Mobi-C discs demonstrated noninferiority across all outcome measures. In the 2-level group, Prestige LP and Mobi-C demonstrated superiority in 3 outcome measures (NDI, secondary surgery, and overall success) but not neurological success. CONCLUSIONS This paper provides a comprehensive analysis of 7 currently approved and distributed artificial discs in the United States. It compares specific outcome measures of these devices against those following the standard of care, which is anterior cervical discectomy and fusion. This information will provide surgeons the opportunity to easily answer patients' questions and remain knowledgeable when discussing devices with manufacturers.


2007 ◽  
Vol 7 (1) ◽  
pp. 40-46 ◽  
Author(s):  
Ung-Kyu Chang ◽  
Daniel H. Kim ◽  
Max C. Lee ◽  
Rafer Willenberg ◽  
Se-Hoon Kim ◽  
...  

Object Range of motion (ROM) changes were evaluated at the surgically treated and adjacent segments in cadaveric specimens treated with two different cervical artificial discs compared with those measured in intact spine and fusion models. Methods Eighteen cadaveric human cervical spines were tested in the intact state for the different modes of motion (extension, flexion, lateral bending, and axial rotation) up to 2 Nm. Three groups of specimens (fitted with either the ProDisc-C or Prestige II cervical artificial disc or submitted to anterior cervical discectomy and fusion [ACDF]) were tested after implantation at C6–7 level. The ROM values were measured at treated and adjacent segments, and these values were then compared with those measured in the intact spine. Results At the surgically treated segment, the ROM increased after arthroplasty compared with the intact spine in extension (54% in the ProDisc-C group, 47% in the Prestige group) and in flexion (27% in the ProDisc-C group, 10% in the Prestige group). In bending and rotation, the postarthroplasty ROMs were greater than those of the intact spine (10% in the ProDisc-C group and 55% in the Prestige group in bending, 17% in the ProDisc-C group and 50% in the Prestige group in rotation). At the adjacent levels the ROMs decreased in all specimens treated with either artificial disc in all modes of motion (< 10%) except for extension at the inferior the level (29% decrease for ProDisc-C implant, 12% decrease for Prestige disc). The ROM for all motion modes in the ACDF-treated spine decreased at the treated level (range 18–44%) but increased at the adjacent levels (range 3–20%). Conclusions Both ProDisc-C and Prestige artificial discs were associated with increased ROM at the surgically treated segment compared with the intact spine with or without significance for all modes of testing. In addition, adjacent-level ROM decreased in all modes of motion except extension in specimens fitted with both artificial discs.


Spine ◽  
2007 ◽  
Vol 32 (12) ◽  
pp. 1337-1344 ◽  
Author(s):  
Luiz Pimenta ◽  
Paul C. McAfee ◽  
Andy Cappuccino ◽  
Bryan W. Cunningham ◽  
Roberto Diaz ◽  
...  

2019 ◽  
Vol 184 (Supplement_1) ◽  
pp. 637-643 ◽  
Author(s):  
Hoon Choi ◽  
Jamie L Baisden ◽  
Narayan Yoganandan

Abstract Purpose The objective of this study is to directly compare different types of cervical artificial disc implants using an in vivo model capable of simulating the axial load on a neck that is similar to the human neck. Methods Cervical arthroplasty was performed at C3-4 in 14 healthy female adult Alpine goats. The goats were divided into three groups. Group A received Bryan (unconstrained one-piece design); Group B received ProDisc-C (semi-constrained two-piece design); and Group C received Mobi-C (unconstrained three-piece design) artificial discs. The goats were monitored in a veterinary unit for 6 months with radiography at regular intervals. Results Each goat tolerated cervical arthroplasty well and had satisfactory placement of their implant per intra-operative radiography. Implants monitored in Group A demonstrated no migration. One out of five implants in Group B experienced anterior migration at 3 months. In Group C, anterior migration and disintegration occurred in all four implants, with migration occurring during the first postoperative week in three implants and after 5 weeks in the fourth. Conclusions Unconstrained multi-piece artificial cervical discs may be prone to anterior migration and extrusion out of the disc space. This outcome deserves attention in individuals with a hypermobile neck and/or an occupation involving the use of a head-supported mass, such as helmets.


2019 ◽  
Vol 132 ◽  
pp. e941-e948 ◽  
Author(s):  
Xu Hu ◽  
Majiao Jiang ◽  
Hao Liu ◽  
Xin Rong ◽  
Ying Hong ◽  
...  

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