Cervical Arthroplasty with Myelopathy

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.

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Differences between soft-disc herniation and spondylosis in cervical arthroplasty: CT-documented heterotopic ossification with minimum 2 years of follow-up. Wu JC, Huang WC, Tu TH, et al. J Neurosurg Spine 2012 Feb;16(2):163–71. Epub 2011 Dec 2.

The Spine Journal ◽

10.1016/j.spinee.2012.07.016 ◽

2012 ◽

Vol 12 (6) ◽

pp. 536-537

Keyword(s):

Heterotopic Ossification ◽

Disc Herniation ◽

Cervical Arthroplasty

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Adjacent-level arthroplasty following cervical fusion

Neurosurgical FOCUS ◽

10.3171/2016.11.focus16412 ◽

2017 ◽

Vol 42 (2) ◽

pp. E5 ◽

Cited By ~ 7

Author(s):

Deshpande V. Rajakumar ◽

Akshay Hari ◽

Murali Krishna ◽

Subhas Konar ◽

Ankit Sharma

Keyword(s):

Cobb Angle ◽

Anterior Cervical Discectomy ◽

Cervical Disc ◽

Cervical Fusion ◽

Adjacent Level ◽

Cervical Disc Disease ◽

Disc Disease ◽

Cervical Arthroplasty ◽

Arm Pain

OBJECTIVE Adjacent-level disc degeneration following cervical fusion has been well reported. This condition poses a major treatment dilemma when it becomes symptomatic. The potential application of cervical arthroplasty to preserve motion in the affected segment is not well documented, with few studies in the literature. The authors present their initial experience of analyzing clinical and radiological results in such patients who were treated with arthroplasty for new or persistent arm and/or neck symptoms related to neural compression due to adjacent-segment disease after anterior cervical discectomy and fusion (ACDF). METHODS During a 5-year period, 11 patients who had undergone ACDF anterior cervical discectomy and fusion (ACDF) and subsequently developed recurrent neck or arm pain related to adjacent-level cervical disc disease were treated with cervical arthroplasty at the authors' institution. A total of 15 devices were implanted (range of treated levels per patient: 1–3). Clinical evaluation was performed both before and after surgery, using a visual analog scale (VAS) for pain and the Neck Disability Index (NDI). Radiological outcomes were analyzed using pre- and postoperative flexion/extension lateral radiographs measuring Cobb angle (overall C2–7 sagittal alignment), functional spinal unit (FSU) angle, and range of motion (ROM). RESULTS There were no major perioperative complications or device-related failures. Statistically significant results, obtained in all cases, were reflected by an improvement in VAS scores for neck/arm pain and NDI scores for neck pain. Radiologically, statistically significant increases in the overall lordosis (as measured by Cobb angle) and ROM at the treated disc level were observed. Three patients were lost to follow-up within the first year after arthroplasty. In the remaining 8 cases, the duration of follow-up ranged from 1 to 3 years. None of these 8 patients required surgery for the same vertebral level during the follow-up period. CONCLUSIONS Artificial cervical disc replacement in patients who have previously undergone cervical fusion surgery appears to be safe, with encouraging early clinical results based on this small case series, but more data from larger numbers of patients with long-term follow-up are needed. Arthroplasty may provide an additional tool for the management of post-fusion adjacent-level cervical disc disease in carefully selected patients.

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

Journal of Neurosurgery Spine ◽

10.3171/spi-07/07/040 ◽

2007 ◽

Vol 7 (1) ◽

pp. 40-46 ◽

Cited By ~ 70

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.

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