Five-Year Trends in Center of Rotation After Single-Level Cervical Arthroplasty with the Prestige-LP Disc

2019 ◽  
Vol 132 ◽  
pp. e941-e948 ◽  
Author(s):  
Xu Hu ◽  
Majiao Jiang ◽  
Hao Liu ◽  
Xin Rong ◽  
Ying Hong ◽  
...  
Keyword(s):  
Cervical Arthroplasty ◽  
Center Of Rotation ◽  
Single Level ◽  
The Prestige

The Effect of Deviated Center of Rotation on Flexion-Extension Range of Motion After Single-Level Cervical Arthroplasty

Spine ◽  
2014 ◽  
Vol 39 ◽  
pp. B12-B18 ◽  
Author(s):  
Xin Rong ◽  
Quan Gong ◽  
Hao Liu ◽  
Ying Hong ◽  
Jigang Lou ◽  
...  
Keyword(s):  
Range Of Motion ◽  
Cervical Arthroplasty ◽  
Center Of Rotation ◽  
Single Level ◽  
Flexion Extension

scholarly journals Cervical arthroplasty: what does the labeling say?

2017 ◽  
Vol 42 (2) ◽  
pp. E2 ◽  
Author(s):  
Mazda K. Turel ◽  
Mena G. Kerolus ◽  
Owoicho Adogwa ◽  
Vincent C. Traynelis
Keyword(s):  
Outcome Measures ◽  
Revision Surgery ◽  
Controlled Trial ◽  
Neck Disability Index ◽  
Specific Treatment ◽  
The United States ◽  
Cervical Disc ◽  
Cervical Arthroplasty ◽  
Single Level ◽  
Level Group

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.

Range of motion change after cervical arthroplasty with ProDisc-C and Prestige artificial discs compared with anterior cervical discectomy and fusion

2007 ◽  
Vol 7 (1) ◽  
pp. 40-46 ◽  
Author(s):  
Ung-Kyu Chang ◽  
Daniel H. Kim ◽  
Max C. Lee ◽  
Rafer Willenberg ◽  
Se-Hoon Kim ◽  
...  
Keyword(s):  
Range Of Motion ◽  
Axial Rotation ◽  
Anterior Cervical Discectomy ◽  
Artificial Disc ◽  
Lateral Bending ◽  
Cervical Arthroplasty ◽  
Cervical Discectomy ◽  
Motion Modes ◽  
Adjacent Segments ◽  
The Prestige

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.

Superiority of Multilevel Cervical Arthroplasty Outcomes Versus Single-Level Outcomes

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

P4. A clinical and radiographic comparison of the prestige cervical disc system to fusion for the treatment of single level degenerative disease

2003 ◽  
Vol 3 (5) ◽  
pp. 152 ◽  
Author(s):  
Thomas Zdeblick ◽  
J. Brotchi ◽  
S. Gill ◽  
R. Haid ◽  
R. Nelson ◽  
...  
Keyword(s):  
Degenerative Disease ◽  
Cervical Disc ◽  
Single Level ◽  
The Prestige

Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial

2007 ◽  
Vol 6 (3) ◽  
pp. 198-209 ◽  
Author(s):  
Praveen V. Mummaneni ◽  
J. Kenneth Burkus ◽  
Regis W. Haid ◽  
Vincent C. Traynelis ◽  
Thomas A. Zdeblick
Keyword(s):  
Anterior Cervical Discectomy ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Control Group ◽  
Adjacent Segment ◽  
Segmental Motion ◽  
Disc Arthroplasty ◽  
Cervical Discectomy ◽  
Single Level ◽  
The Prestige

Object The authors report the results of a prospective randomized multicenter study in which the results of cervical disc arthroplasty were compared with anterior cervical discectomy and fusion (ACDF) in patients treated for symptomatic single-level cervical degenerative disc disease (DDD). Methods Five hundred forty-one patients with single-level cervical DDD and radiculopathy were enrolled at 32 sites and randomly assigned to one of two treatment groups: 276 patients in the investigational group underwent anterior cervical discectomy and decompression and arthroplasty with the PRESTIGE ST Cervical Disc System (Medtronic Sofamor Danek); 265 patients in the control group underwent decompressive ACDF. Eighty percent of the arthroplasty-treated patients (223 of 276) and 75% of the control patients (198 of 265) completed clinical and radiographic follow-up examinations at routine intervals for 2 years after surgery. Analysis of all currently available postoperative 12- and 24-month data indicated a two-point greater improvement in the neck disability index score in the investigational group than the control group. The arthroplasty group also had a statistically significant higher rate of neurological success (p = 0.005) as well as a lower rate of secondary revision surgeries (p = 0.0277) and supplemental fixation (p = 0.0031). The mean improvement in the 36-Item Short Form Health Survey Physical Component Summary scores was greater in the investigational group at 12 and 24 months, as was relief of neck pain. The patients in the investigational group returned to work 16 days sooner than those in the control group, and the rate of adjacent-segment reoperation was significantly lower in the investigational group as well (p = 0.0492, log-rank test). The cervical disc implant maintained segmental sagittal angular motion averaging more than 7°. In the investigational group, there were no cases of implant failure or migration. Conclusions The PRESTIGE ST Cervical Disc System maintained physiological segmental motion at 24 months after implantation and was associated with improved neurological success, improved clinical outcomes, and a reduced rate of secondary surgeries compared with ACDF.

Differences between soft-disc herniation and spondylosis in cervical arthroplasty: CT-documented heterotopic ossification with minimum 2 years of follow-up

2012 ◽  
Vol 16 (2) ◽  
pp. 163-171 ◽  
Author(s):  
Jau-Ching Wu ◽  
Wen-Cheng Huang ◽  
Tsung-Hsi Tu ◽  
Hsiao-Wen Tsai ◽  
Chin-Chu Ko ◽  
...  
Keyword(s):  
Heterotopic Ossification ◽  
Clinical Outcomes ◽  
Disc Herniation ◽  
Cervical Disc ◽  
Artificial Disc ◽  
Cervical Arthroplasty ◽  
Single Level ◽  
Arm Pain ◽  
Estimated Blood Loss

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.

scholarly journals Multilevel cervical arthroplasty: current evidence. A systematic review

2017 ◽  
Vol 42 (2) ◽  
pp. E4 ◽  
Author(s):  
Andrei F. Joaquim ◽  
K. Daniel Riew
Keyword(s):  
Systematic Review ◽  
Clinical Studies ◽  
Case Reports ◽  
Current Evidence ◽  
Cervical Disc ◽  
Cervical Disc Arthroplasty ◽  
Cervical Arthroplasty ◽  
Study Objective ◽  
Single Level ◽  
Cervical Surgery

OBJECTIVE Cervical disc arthroplasty (CDA) has been demonstrated to be an effective treatment modality for single-level cervical radiculopathy or myelopathy. Its advantages over an anterior cervical discectomy and fusion (ACDF) include motion preservation and decreased reoperations at the index and adjacent segments up to 7 years postoperatively. Considering the fact that many patients have multilevel cervical disc degeneration (CDD), the authors performed a systematic review of the clinical studies evaluating patients who underwent multilevel CDA (2 or more levels). METHODS A systematic review in the MEDLINE database was performed. Clinical studies including patients who had multilevel CDA were selected and included. Case reports and literature reviews were excluded. Articles were then grouped according to their main study objective: 1) studies comparing multilevel CDA versus ACDF; 2) studies comparing single-level CDA versus multilevel CDA; and 3) multilevel CDA after a previous cervical spine surgery. RESULTS Fourteen articles met all inclusion criteria. The general conclusions were that multilevel CDA was at least as safe and effective as ACDF, with preservation of cervical motion when compared with ACDF and potentially with fewer reoperations expected in most of the studies. Multilevel CDAs are clinically effective as single-level surgeries, with good clinical and radiological outcomes. Some studies reported a higher incidence of heterotopic ossification in multilevel CDA when compared with single-level procedures, but without clinical relevance during the follow-up period. A CDA may be indicated even after a previous cervical surgery in selected cases. CONCLUSIONS The current literature supports the use of multilevel CDA. Caution is necessary regarding the more restrictive indications for CDA when compared with ACDF. Further prospective, controlled, multicenter, and randomized studies not sponsored by the device manufactures are desirable to prove the superiority of CDA surgery over ACDF as the treatment of choice for CDD in selected cases.

Analysis of in vivo kinematics of 3 different cervical devices: Bryan disc, ProDisc-C, and Prestige LP disc

2011 ◽  
Vol 15 (6) ◽  
pp. 630-635 ◽  
Author(s):  
Izabela Kowalczyk ◽  
Bruno C. R. Lazaro ◽  
Marie Fink ◽  
Doron Rabin ◽  
Neil Duggal
Keyword(s):  
Cervical Spine ◽  
Sagittal Balance ◽  
Adjacent Segment ◽  
Cervical Arthroplasty ◽  
Measurement Analysis ◽  
Bryan Disc ◽  
Index Level ◽  
The Impact ◽  
The Prestige

Object Cervical arthroplasty has emerged as a means of preventing adjacent segment disease by preserving motion, restoring sagittal balance, and mimicking natural spinal kinematics. The purpose of this retrospective in vivo study was to characterize the impact of arthroplasty on sagittal balance and segmental kinematics of the cervical spine. Methods Sixty patients receiving the Bryan disc, ProDisc-C, or Prestige LP disc were retrospectively analyzed. Only single-level arthroplasty cases were included in this study. Lateral dynamic radiographs of the cervical spine were evaluated using quantitative measurement analysis software to determine the kinematics at the index level both preoperatively and 1 year postoperatively. Collected parameters included range of motion (ROM), disc angles, shell angles, anterior and posterior disc heights (ADHs/PDHs), translation, and center of rotation (COR). Preoperative and postoperative data were compared using the Student t-test, with p < 0.05 indicating significance. Results The Bryan and Prestige LP discs preserved motion, whereas the ProDisc-C increased segmental ROM from extension to flexion. Following surgery, the Bryan disc exhibited significant shell angle kyphosis, while ProDisc-C and Prestige LP retained lordosis. Both ADHs and PDHs decreased following insertion of the Bryan disc. In contrast, the ProDisc-C increased the ADHs and PDHs by 80% and 52%, respectively, and the Prestige LP disc increased the ADHs and PDHs by 20%. Only the ProDisc-C demonstrated significant translation of 0.7 mm. The ProDisc-C shifted the COR x by 0.9 mm anteriorly, while the Prestige LP disc demonstrated a significant superior shift of 2.2 mm in COR y. Conclusions All discs adequately maintained ROM at the surgical level. The greatest difference among the 3 devices was in the disc height and index angle measurements.

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