Long-Term Clinical Results of Cervical Total Disc Replacement with a Self-Adjusting Mobile Core Prosthesis after 10-Year Follow-Up

Current cervical total disc replacement (TDR) designs incorporate a variety of different biomaterials including polyethylene, stainless steel, titanium (Ti), and cobalt-chrome (CoCr). These materials are most important in their utilization as bearing surfaces which allow for articular motion at the disc space. Long-term biological effects of implanted materials include wear debris, host inflammatory immune reactions, and osteolysis resulting in implant failure. We review here the most common materials used in cervical TDR prosthetic devices, examine their bearing surfaces, describe the construction of the seven current cervical TDR devices that are approved for use in the United States, and discuss known adverse biological effects associated with long-term implantation of these materials. It is important to appreciate and understand the variety of biomaterials available in the design and construction of these prosthetics and the considerations which guide their implementation.

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Early development and progression of heterotopic ossification in cervical total disc replacement

Journal of Neurosurgery Spine ◽

10.3171/2011.8.spine11303 ◽

2012 ◽

Vol 16 (1) ◽

pp. 31-36 ◽

Cited By ~ 38

Author(s):

Soo Eon Lee ◽

Chun Kee Chung ◽

Tae Ahn Jahng

Keyword(s):

Clinical Outcome ◽

Heterotopic Ossification ◽

Total Disc Replacement ◽

Disc Replacement ◽

Adjacent Segment ◽

Segmental Motion ◽

Cervical Total Disc Replacement ◽

The Mean ◽

Grade Iii

Object The purpose of cervical total disc replacement (TDR) is to decrease the incidence of adjacent segment disease through motion preservation. Heterotopic ossification (HO) is a well-known complication after hip and knee arthroplasties. There are few reports regarding HO in patients undergoing cervical TDR, however; and the occurrence of HO and its effects on cervical motion have rarely been reported. Moreover, temporal progression of HO has not been fully addressed. One goal of this study involved determining the incidence of HO following cervical TDR, as identified from plain radiographs, and demonstrating the progression of HO during the follow-up period. A second goal consisted of determining whether segmental motion could be preserved and identifying the relationship between HO and clinical outcomes. Methods The authors conducted a retrospective clinical and radiological study of 28 consecutive patients who underwent cervical TDR with Mobi-C prostheses (LDR Medical) between September 2006 and October 2008. Radiological outcomes were evaluated using lateral dynamic radiographs obtained preoperatively and at 1, 3, 6, 12, and 24 months postoperatively. The occurrence of HO was interpreted on lateral radiographs using the McAfee classification. Cervical range of motion (ROM) was also measured. The visual analog scale (VAS) and Neck Disability Index (NDI) were used to evaluate clinical outcome. Results The mean follow-up period was 21.6 ± 7.0 months, and the mean occurrence of HO was at 8.0 ± 6.6 months postoperatively. At the last follow-up, 18 (64.3%) of 28 patients had HO: Grade I, 6 patients; Grade II, 8 patients; Grade III, 3 patients; and Grade IV, 1 patient. Heterotopic ossification progression was proportional to the duration of follow-up; HO was present in 3 (10.7%) of 28 patients at 1 month; 7 (25.0%) of 28 patients at 3 months; 11 (42.3%) of 26 patients at 6 months; 15 (62.5%) of 24 patients at 12 months; and 17 (77.3%) of 22 patients at 24 months. Cervical ROM was preserved in Grades I and II HO but was restricted in Grades III and IV HO. Clinical improvement according to the VAS and NDI was not significantly correlated with the occurrence of HO. Conclusions The overall incidence of HO after cervical TDR was relatively high. Moreover, HO began unexpectedly to appear early after surgery. Heterotopic ossification progression was proportional to the time that had elapsed postoperatively. Grade III or IV HO can restrict the cervical ROM and may lead to spontaneous fusion; however, the occurrence of HO did not affect clinical outcome. The results of this study indicate that a high incidence of HO with the possibility of spontaneous fusion is to be expected during long-term follow-up and should be considered before performing cervical TDR.

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Vertebral body split fracture after a single-level cervical total disc replacement

Journal of Neurosurgery Spine ◽

10.3171/2011.11.spine11210 ◽

2012 ◽

Vol 16 (3) ◽

pp. 231-235 ◽

Cited By ~ 11

Author(s):

Tsung-Hsi Tu ◽

Jau-Ching Wu ◽

Li-Yu Fay ◽

Chin-Chu Ko ◽

Wen-Cheng Huang ◽

...

Keyword(s):

Surgical Treatment ◽

Total Disc Replacement ◽

Radicular Pain ◽

Disc Replacement ◽

Viable Option ◽

Disc Disease ◽

Cervical Total Disc Replacement ◽

Single Level ◽

Linear Fracture

Cervical total disc replacement (TDR) is a viable option for the surgical treatment of degenerative disc disease. This 67-year-old nonsmoking male patient underwent single-level ProDisc-C cervical TDR at C5–6 without any intraoperative problem. His radicular pain improved and he had no neck pain immediately after the operation. However, on postoperative Day 3, a radiograph demonstrated a vertical split fracture of the C-5 vertebra. This fracture was managed conservatively, and 2 years postoperatively a follow-up CT scan demonstrated stable device position and fusion of the fracture. Although the linear fracture caused no neurological symptoms or device migration, the authors advocate prudence in selection and installation of keel-design prostheses, even in a single-level cervical TDR scenario.

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Long-term clinical results following Charite III lumbar total disc replacement

The Spine Journal ◽

10.1016/j.spinee.2017.08.252 ◽

2018 ◽

Vol 18 (6) ◽

pp. 917-925 ◽

Cited By ~ 3

Author(s):

Shibao Lu ◽

Siyuan Sun ◽

Chao Kong ◽

Wenzhi Sun ◽

Hailiang Hu ◽

...

Keyword(s):

Total Disc Replacement ◽

Clinical Results ◽

Disc Replacement ◽

Lumbar Total Disc Replacement

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Heterotopic ossification after cervical total disc replacement: determination by CT and effects on clinical outcomes

Journal of Neurosurgery Spine ◽

10.3171/2010.11.spine10444 ◽

2011 ◽

Vol 14 (4) ◽

pp. 457-465 ◽

Cited By ~ 61

Author(s):

Tsung-Hsi Tu ◽

Jau-Ching Wu ◽

Wen-Cheng Huang ◽

Wan-Yuo Guo ◽

Ching-Lan Wu ◽

...

Keyword(s):

Ct Scan ◽

Heterotopic Ossification ◽

Total Disc Replacement ◽

Disc Replacement ◽

Segmental Motion ◽

Cervical Total Disc Replacement ◽

Plain Radiographs ◽

Bryan Disc ◽

The Mean

Object Heterotopic ossification (HO) after cervical total disc replacement (TDR) has been reported to impede artificial disc motion. In all previously reported cases of HO, assessment was based on plain radiographs. The authors hypothesized that CT scan is a more sensitive and accurate detector. The aims of this study were to assess the actual incidence of HO and its effect on outcome in a cohort of patients undergoing cervical TDR with the Bryan disc and to compare HO detection by means of plain radiographs and CT. Methods The authors retrospectively assessed data from medical records, radiological studies, and clinical evaluations of patients who underwent 1- or 2-level cervical TDR with the Bryan disc and were followed up for more than 12 months. The presence and grading of HO according to the McAfee classification were assessed by CT scan, and these findings were compared with findings on plain radiographs. Thirty-six patients (mean age 46.61 ± 7.24 years; range 29–60 years; 21 men and 15 women) who underwent Bryan TDR at 52 levels were included in the study. The mean duration of CT follow-up was 19.03 ± 4.64 months; the mean duration of clinical follow-up was 26.78 ± 7.20 months. Results On the basis of CT, HO was identified in 18 (50%) of 36 patients and 25 (48.1%) of 52 levels treated. Grade 1 HO was present in 9 of the levels treated (17.3%), Grade 2 in 13 levels (25.0%), Grade 3 in 2 levels (3.8%), and Grade 4 in 1 level (1.9%). Nineteen (76%) of the 25 affected levels were in patients who had undergone 2-level TDR. There was no significant association with patient sex or disc pathology. There was a tendency for HO development among older patients, but this finding was not statistically significant (mean age 48.8 ± 6.8 in patients with HO vs 44.4 ± 7.2 in those without HO, p = 0.065). Although HO was found in 25 levels, 96.2% of the treated levels (50 of 52) had segmental range of motion on dynamic (flexion and extension) radiographs. The concordance between HO grading by CT and radiography was high, with an intraclass correlation coefficient of 0.822 (lower limit of 95% CI: 0.710, p < 0.001). Patients who had HO had the same clinical success rate as those who did not (94.4% vs 94.4%, p = 1.00). The visual analog scale scores for neck and arm pain were significantly improved in both the HO and the non-HO group. Conclusions The rate of HO detected by CT scan in this cohort of patients undergoing cervical TDR with a Bryan disc was 48.1% per level treated and 50% per patient with minimal limitation of segmental motion (96.2% of levels remained mobile), but plain radiograph is an acceptable detection tool. Two-level surgery has a higher risk of HO, although development of HO does not affect clinical outcome.

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Seven-Year Clinical Results of Cervical Total Disc Replacement Compared with Anterior Discectomy and Fusion for Treatment of Two-Level Symptomatic Degenerative Disc Disease: A Prospective, Randomized, Controlled, Multicenter FDA Clinical Trial

The Spine Journal ◽

10.1016/j.spinee.2016.07.113 ◽

2016 ◽

Vol 16 (10) ◽

pp. S204

Author(s):

Kris E. Radcliff ◽

Reginald J. Davis ◽

Gregory A. Hoffman ◽

Hyun W. Bae ◽

Michael S. Hisey ◽

...

Keyword(s):

Clinical Trial ◽

Degenerative Disc Disease ◽

Total Disc Replacement ◽

Clinical Results ◽

Disc Replacement ◽

Disc Disease ◽

Cervical Total Disc Replacement ◽

Degenerative Disc ◽

Randomized Controlled ◽

Anterior Discectomy And Fusion

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Mid- to long-term rates of symptomatic adjacent-level disease requiring surgery after cervical total disc replacement compared with anterior cervical discectomy and fusion: a meta-analysis of prospective randomized clinical trials

Journal of Orthopaedic Surgery and Research ◽

10.1186/s13018-020-01957-3 ◽

2020 ◽

Vol 15 (1) ◽

Author(s):

Yifei Deng ◽

Guangzhou Li ◽

Hao Liu ◽

Ying Hong ◽

Yang Meng

Keyword(s):

Anterior Cervical Fusion ◽

Anterior Cervical Discectomy ◽

Disc Replacement ◽

Cervical Disc ◽

Cervical Fusion ◽

Adjacent Level ◽

Cervical Total Disc Replacement ◽

Cervical Disc Replacement

Abstract Background Thus far, no meta-analysis focusing on the mid- to long-term incidence of adjacent segment disease requiring surgery after cervical total disc replacement and anterior cervical discectomy and fusion has been published yet. This study aimed to compare mid- to long-term rates of symptomatic adjacent-level disease requiring surgery after cervical disc replacement and anterior cervical fusion. Methods A meta-analysis was performed, and only randomized controlled trials with a follow-up period of more than 48 months reporting rates of symptomatic adjacent-level disease requiring surgery after cervical total disc replacement and anterior cervical discectomy and fusion were included. Results The analysis revealed that the overall rate of symptomatic adjacent-level disease requiring surgery in the cervical disc replacement group was significantly lower than that of the anterior cervical fusion group at 48–120 months’ follow-up. The subgroup analysis of different follow-up periods also yielded the same results. The rate of symptomatic adjacent-level disease requiring surgery in the cervical disc replacement group using unrestricted prosthesis was significantly lower than that of the anterior cervical fusion group (p < 0.001); however, the cervical disc replacement group using semi-restricted prosthesis showed no statistical difference compared with the fusion group. Conclusions Our review suggests that cervical disc replacement is preferable to anterior cervical fusion in reducing the incidence of symptomatic adjacent-level disease requiring surgery at mid- to long-term follow-up. A review of the literature also demonstrated that randomized controlled trials investigating the rate of symptomatic adjacent-level disease requiring surgery were insufficient; therefore, studies focusing on this subject with longer-term follow-up are warranted.

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