Mechanical failure of the Mobi-C implant for artificial cervical disc replacement: report of 4 cases

2020 ◽  
Vol 33 (6) ◽  
pp. 727-733
Author(s):  
Jasmine A. T. DiCesare ◽  
Alexander M. Tucker ◽  
Irene Say ◽  
Kunal Patel ◽  
Todd H. Lanman ◽  
...  

Cervical spondylosis is one of the most commonly treated conditions in neurosurgery. Increasingly, cervical disc replacement (CDR) has become an alternative to traditional arthrodesis, particularly when treating younger patients. Thus, surgeons continue to gain a greater understanding of short- and long-term complications of arthroplasty. Here, the authors present a series of 4 patients initially treated with Mobi-C artificial disc implants who developed postoperative neck pain. Dynamic imaging revealed segmental kyphosis at the level of the implant. All implants were locked in the flexion position, and all patients required reoperation. This is the first reported case series of symptomatic segmental kyphosis after CDR.

2013 ◽  
Vol 19 (5) ◽  
pp. 546-554 ◽  
Author(s):  
Sheeraz A. Qureshi ◽  
Steven McAnany ◽  
Vadim Goz ◽  
Steven M. Koehler ◽  
Andrew C. Hecht

Object In recent years, there has been increased interest in the use of cervical disc replacement (CDR) as an alternative to anterior cervical discectomy and fusion (ACDF). While ACDF is a proven intervention for patients with myelopathy or radiculopathy, it does have inherent limitations. Cervical disc replacement was designed to preserve motion, avoid the limitations of fusion, and theoretically allow for a quicker return to activity. A number of recently published systematic reviews and randomized controlled trials have demonstrated positive clinical results for CDR, but no studies have revealed which of the 2 treatment strategies is more cost-effective. The purpose of this study was to evaluate the cost-effectiveness of CDR and ACDF by using the power of decision analysis. Additionally, the authors aimed to identify the most critical factors affecting procedural cost and effectiveness and to define thresholds for durability and function to focus and guide future research. Methods The authors created a surgical decision model for the treatment of single-level cervical disc disease with associated radiculopathy. The literature was reviewed to identify possible outcomes and their likelihood following CDR and ACDF. Health state utility factors were determined from the literature and assigned to each possible outcome, and procedural effectiveness was expressed in units of quality-adjusted life years (QALYs). Using ICD-9 procedure codes and data from the Nationwide Inpatient Sample, the authors calculated the median cost of hospitalization by multiplying hospital charges by the hospital-specific cost-to-charge ratio. Gross physician costs were determined from the mean Medicare reimbursement for each current procedural terminology (CPT) code. Uncertainty as regards both cost and effectiveness numbers was assessed using sensitivity analysis. Results In the reference case, the model assumed a 20-year duration for the CDR prosthesis. Cervical disc replacement led to higher average QALYs gained at a lower cost to society if both strategies survived for 20 years ($3042/QALY for CDR vs $8760/QALY for ACDF). Sensitivity analysis revealed that CDR needed to survive at least 9.75 years to be considered a more cost-effective strategy than ACDF. Cervical disc replacement becomes an acceptable societal strategy as the prosthesis survival time approaches 11 years and the $50,000/QALY gained willingness-to-pay threshold is crossed. Sensitivity analysis also indicated that CDR must provide a utility state of at least 0.796 to be cost-effective. Conclusions Both CDR and ACDF were shown to be cost-effective procedures in the reference case. Results of the sensitivity analysis indicated that CDR must remain functional for at least 14 years to establish greater cost-effectiveness than ACDF. Since the current literature has yet to demonstrate with certainty the actual durability and long-term functionality of CDR, future long-term studies are required to validate the present analysis.


2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Yifei Deng ◽  
Guangzhou Li ◽  
Hao Liu ◽  
Ying Hong ◽  
Yang Meng

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.


2005 ◽  
Vol 2 (4) ◽  
pp. 403-410 ◽  
Author(s):  
Rudolf Bertagnoli ◽  
James J. Yue ◽  
Frank Pfeiffer ◽  
Andrea Fenk-Mayer ◽  
James P. Lawrence ◽  
...  

Object. Cervical anterior decompression and total-disc replacement is currently being investigated as an alternative treatment in patients with symptomatic intervertebral cervical spondylosis with and without radiculopathy. The authors prospectively investigated the safety and efficacy of using the ProDisc-C disc for cervical arthroplasty in the treatment of symptomatic cervical spondylosis. Methods. Sixteen patients in whom a diagnosis of symptomatic cervical spondylosis had been established were prospectively treated with complete anterior cervical discectomy and ProDisc-C cervical disc arthroplasty. Overall 12 single- and four two-level procedures were performed (20 prostheses). Patients underwent pre- and multiple postoperative assessments (3 and 6 weeks and 3, 6, and 12 months). The median age of all patients was 50 years (range 32–60 years). Levels of surgery included seven C5–6, six C6–7, and three C4–5. Neck and arm pain as well as disability scores were significantly improved by 3 months and remained significantly improved at 1 year. No additional fusion surgeries were necessary at the affected or unaffected levels. Radiography revealed an affected disc motion from 4 to 12°. No surgery- or device-related complications were documented. Conclusions. Analysis of preliminary results involving ProDisc-C arthroplasty indicates significant improvement in pain and functional outcome scores. No spontaneous fusions at the level of surgery or at adjacent levels were noted. Long-term follow-up studies will be necessary before more definitive treatment recommendations can be formulated.


2015 ◽  
Vol 5 (1_suppl) ◽  
pp. s-0035-1554291-s-0035-1554291
Author(s):  
Nahed Amro ◽  
Andreas Badke ◽  
Dina Jarrar ◽  
Christoph Schätz

2020 ◽  
Vol 32 (4) ◽  
pp. 584-591
Author(s):  
Lauren Harris ◽  
Edward Dyson ◽  
Matthew Elliot ◽  
David Peterson ◽  
Christian Ulbricht ◽  
...  

Cervical disc arthroplasty is a treatment option for symptomatic cervical disc disease. There is a paucity of literature on long-term safety outcomes, durability, and device-related failure rates. The M6-C artificial cervical disc is a device with titanium alloy endplates and a complex polymeric centerpiece. To date, trials have exhibited acceptable safety profiles.This case series describes the presentation, management, and pathological findings of a delayed prevertebral periprosthetic mass anterior to the M6-C disc. Four patients at 3 different institutions underwent cervical disc replacement with the M6-C disc. Two to seven years postoperatively, they presented with dysphagia secondary to a compressive mass anterior to the disc. Case notes were reviewed to collect data on symptoms, management, and outcomes. The patients were systemically well and presented with progressive dysphagia. They had imaging findings of a mass anterior to the disc. They underwent a decompressive procedure, with 2 patients undergoing device removal and fusion. In 2 cases, a soft-tissue mass was seen intraoperatively, with frank pus. In 3 cases, Propionibacterium acnes was identified and antibiotic treatment given. Histopathology demonstrated mixed inflammatory infiltrates with foreign body–type granulomas. Postoperatively, the dysphagia resolved.The development of delayed dysphagia in a patient with an M6-C disc should prompt investigation to identify a mass lesion. To the authors’ knowledge, this is the first report of delayed infection, or suspected delayed-type hypersensitivity reaction, following M6-C disc implantation. It is important for this to be added to the device safety concerns. Further prospective studies are needed to establish the incidence and the long-term safety and failure rates of the M6-C disc.


2015 ◽  
Vol 5 (1_suppl) ◽  
pp. s-0035-1554288-s-0035-1554288
Author(s):  
Marjan Rozankovic ◽  
Sergej Marasanov ◽  
Velimir Lupret ◽  
Miroslav Vukic

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