4. Single-level cervical disc replacement using a PEEK-on-ceramic implant: Results of a multicenter FDA IDE trial with 24-month follow up

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.

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Intraoperative Anterior Migration of the Prestige-LP Cervical Disc Owing to an Inappropriate Implantation Sequence During Continuous 2-Level Artificial Cervical Disc Replacement: A Case Report with 8-Year Follow-Up

World Neurosurgery ◽

10.1016/j.wneu.2018.05.093 ◽

2018 ◽

Vol 116 ◽

pp. 194-200 ◽

Cited By ~ 3

Author(s):

Yang Meng ◽

Xiaofei Wang ◽

Zhengyang Zhao ◽

Beiyu Wang ◽

Tingkui Wu ◽

...

Keyword(s):

Case Report ◽

Disc Replacement ◽

Cervical Disc ◽

Cervical Disc Replacement ◽

Anterior Migration ◽

The Prestige

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Clinical and radiological outcome at 10 years of follow-up after total cervical disc replacement

European Spine Journal ◽

10.1007/s00586-017-5204-6 ◽

2017 ◽

Vol 26 (9) ◽

pp. 2441-2449 ◽

Cited By ~ 28

Author(s):

Christoph Mehren ◽

Franziska Heider ◽

Christoph J. Siepe ◽

Bernhard Zillner ◽

Ralph Kothe ◽

...

Keyword(s):

Disc Replacement ◽

Cervical Disc ◽

Radiological Outcome ◽

Cervical Disc Replacement ◽

Clinical And Radiological Outcome

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Artificial cervical disc replacement with the Prestige-LP prosthesis for the treatment of non-contiguous 2-level cervical degenerative disc disease: A minimum 24-month follow-up

Clinical Neurology and Neurosurgery ◽

10.1016/j.clineuro.2016.11.015 ◽

2017 ◽

Vol 152 ◽

pp. 57-62 ◽

Cited By ~ 7

Author(s):

Tingkui Wu ◽

Beiyu Wang ◽

Chen Ding ◽

Yang Meng ◽

Jigang Lou ◽

...

Keyword(s):

Degenerative Disc Disease ◽

Disc Replacement ◽

Cervical Disc ◽

Disc Disease ◽

Degenerative Disc ◽

Cervical Disc Replacement ◽

Cervical Degenerative Disc Disease ◽

The Prestige

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Four-year results of a prospective single-arm study on 200 semi-constrained total cervical disc prostheses: clinical and radiographic outcome

Journal of Neurosurgery Spine ◽

10.3171/2016.3.spine15810 ◽

2016 ◽

Vol 25 (5) ◽

pp. 556-565 ◽

Cited By ~ 15

Author(s):

Hans-Jörg Meisel ◽

Lubomír Jurák ◽

Jussi Antinheimo ◽

Ricardo Arregui ◽

Bernhard Bruchmann ◽

...

Keyword(s):

Total Disc Replacement ◽

Neck Disability Index ◽

Disc Replacement ◽

Cervical Disc ◽

Adjacent Segment ◽

Radiographic Outcome ◽

Cervical Disc Replacement ◽

Arm Pain ◽

Facet Joint Degeneration

OBJECTIVE Recent studies have described encouraging outcomes after cervical total disc replacement (cTDR), but there are also critical debates regarding the long-term effects of heterotopic ossification (HO) and the prevalence of adjacent-level degeneration. The aim in this paper was to provide 4-year clinical and radiographic outcome results on the activ C disc prosthesis. METHODS A total of 200 subjects underwent single-level activ C (Aesculap AG) implantation between C-3 and C-7 for the treatment of symptomatic degenerative disc disease. Clinical and radiographic assessments were performed preoperatively, intraoperatively, at discharge, and again at 6 weeks, 6 months, 1 year, 2 years, and 4 years. Radiographic evaluations were done by an independent core laboratory using a specific software for quantitative motion analysis. RESULTS Neck Disability Index (NDI) and visual analog scale (VAS) score for neck and arm pain decreased significantly from baseline to the 4-year follow-up. The mean improvement for NDI was 20, for VAS severity and frequency of neck pain 26.4 and 28, and for VAS severity and frequency of arm pain 30.7 and 35.1, respectively. The neurological situation improved for the majority of patients (86.4%); 76.1% of cases were asymptomatic. Subsequent surgical interventions were reported in 7% of the cases, including device removals in 3%. In 2.5% a subsidence greater than 3 mm was recorded; 1 of these cases also had a migration greater than 3 mm. No device displacement, expulsion, disassembly, loose or fractured device, osteolysis, or facet joint degeneration at the index level was observed. Segmental lordotic alignment changed from −2.4° preoperatively to −6.2° at 4 years, and postoperative height was maintained during the follow-up. Advanced HO (Grade III and IV) was present in 27.1% of the cases; 82.4% showed segmental mobility. A progression of radiographic adjacent-segment degeneration occurred in 28.2%, but only 4.5% required surgical treatment. CONCLUSIONS The activ C is a safe and effective device for cervical disc replacement confirming the encouraging results after cTDR. Clinical trial registration no.: NCT02492724 (clinicaltrials.gov)

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