Longitudinal assessment of segmental motion of the cervical spine following total disc arthroplasty: a comparative analysis of devices

J Neurosurg Spine 37:556–562, 2022

Total disc arthroplasty (TDA) has been shown to be an effective and safe treatment for cervical degenerative disc disease at short- and midterm follow-up. However, there remains a paucity of literature reporting the differences between individual prosthesis designs with regard to device performance. In this study, the authors evaluated the longterm maintenance of segmental range of motion (ROM) at the operative cervical level across a diverse range of TDA devices.

METHODS In this study, the authors retrospectively evaluated all consecutive patients who underwent 1- or 2-level cervical TDA between 2005 and 2020 at a single institution. Patients with a minimum of 6 months of follow-up and lateral flexion/extension radiographs preoperatively, 2 months postoperatively, and at final follow-up were included. Radiographic measurements included static segmental lordosis, segmental range of motion (ROM) on flexion/extension, global cervical (C2–7) ROM on flexion/extension, and disc space height. The paired t-test was used to evaluate improvement in radiographic parameters. Subanalysis between devices was performed using one-way ANCOVA. Significance was determined at p < 0.05.

RESULTS A total of 85 patients (100 discs) were included, with a mean patient age of 46.01 ± 8.82 years and followup of 43.56 ± 39.36 months. Implantations included 22 (22.00%) M6-C, 51 (51.00%) Mobi-C, 14 (14.00%) PCM, and 13 (13.00%) ProDisc-C devices. There were no differences in baseline radiographic parameters between groups. At 2 months postoperatively, PCM provided significantly less segmental lordosis (p = 0.037) and segmental ROM (p = 0.039). At final follow-up, segmental ROM with both the PCM and ProDisc-C devices was significantly less than that with the M6-C and Mobi-C devices (p = 0.015). From preoperatively to 2 months postoperatively, PCM implantation led to a significant loss of lordosis (p < 0.001) and segmental ROM (p = 0.005) relative to the other devices. Moreover, a significantly greater decline in segmental ROM from 2 months postoperatively to final follow-up was seen with ProDiscC, while segmental ROM increased significantly over time with Mobi-C (p = 0.049).

CONCLUSIONS Analysis by TDA device brand demonstrated that motion preservation differs depending on disc design. Certain devices, including M6-C and Mobi-C, improve ROM on flexion/extension from preoperatively to postoperatively and continue to increase slightly at final follow-up. On the other hand, devices such as PCM and ProDisc-C contributed to greater segmental stiffness, with a gradual decline in ROM seen with ProDisc-C. Further studies are needed to understand how much segmental ROM is ideal after TDA for preservation of physiological cervical kinematics.

 

Failure in cervical total disc arthroplasty

The Spine Journal 22 (2022) 353−369

Cervical total disc arthroplasty (TDA) is an alternative procedure to anterior cervical discectomy and fusion that facilitates neural decompression while both preserving motion of the spinal unit and decreasing the risk for degenerative changes at adjacent segments. However, due to its more recent introduction in clinical practice and low complication rates, the modes by which TDA may fail remain to be described.

PURPOSE: This study sought to identify the modes and frequencies of cervical TDA failure in order to propose a novel classification system.

STUDY DESIGN: Retrospective cohort and systematic review.

PATIENT SAMPLE: Patients who underwent single or two-level TDA for cervical radiculopathy or myelopathy at a single institution and in the literature of medium and large prospective studies. OUTCOME MEASURES: Cervical TDA failure, defined as subsequent surgical intervention at the index segment.

METHODS: This study retrospectively reviewed patients who underwent single or two-level TDA for cervical radiculopathy or myelopathy at a single institution to identify the potential implant failure modes. A systematic review and meta-analysis of prospective data in the literature was then performed to further supplement failure mode identification and to describe the rates at which the various failure types occurred. Statistical analysis included betweengroup comparisons of Non-Failed and Failed patients and frequencies of each failure type among Failed patients.

RESULTS: A retrospective review at our institution of 169 patients (201 levels) identified eight failures, for a failure rate of 4.7%. Additionally, seven patients were revised who had the primary surgery at an outside institution. The systematic review of 3976 patients (4525 levels) identified 165 (4.1%) additional failures. Using this data, six primary failure types were classified, with several subtypes. These include recurrent or persistent index-level stenosis (Type I); migration (Type II) presenting as gross extrusion (A) or endplate failure with subsidence/acute fracture (B); instability (Type III) due to mechanical loosening (A), septic loosening (B), or device fracture (C); device motion loss (Type IV) such as “locking” of the device in kyphosis; implantation error (Type V) due to malposition (A) or improper sizing (B); and wear (Type VI) either without osteolysis (A) or with wear-particle-induced osteolysis (B). Stenosis (Type I) was the most common mode of failure found both through retrospective review and in the literature.

CONCLUSIONS: Cervical TDA fails through six primary mechanisms. While rates of certain failures requiring subsequent surgical intervention are low, it is possible that these complications may become more prevalent upon further longitudinal observation. Thus, future application and validation of this classification system is warranted to evaluate how failure frequencies change over time and with larger patient samples. © 2021 Elsevier Inc. All rights reserved.

Comparison of Multilevel Cervical Disc Replacement and Multilevel Anterior Discectomy and Fusion: A Systematic Review of Biomechanical and Clinical Evidence

World Neurosurg. (2018) 116:94-104

OBJECTIVE: The aim of this study was to comprehensively compare the clinical and biomechanical efficiency of anterior cervical discectomy and fusion (ACDF) with anterior cervical disc replacement (ACDR) for treatment of multilevel cervical disc disease using a meta-analysis and systematical review.

METHODS: A literature search was performed using PubMed, MEDLINE, EMBASE, and the Cochrane Library for articles published between January 1960 and December 2017. Both clinical and biomechanical parameters were analyzed. Statistical tests were conducted by Revman 5.3. Nineteen studies including 10 clinical studies and 9 biomechanical studies were filtered out.

RESULTS: The pooled results for clinical efficiency showed that no significant difference was observed in blood loss (P [ 0.09; mean difference [MD], 7.38; confidence interval [CI], e1.16 to 15.91), hospital stay (P[ 0.33; MD, L0.25; CI, L0.76 to 0.26), Japanese Orthopaedic Association scores (P [ 0.63; MD, L0.11; CI, L0.57 to 0.34), visual analog scale (P [ 0.08; MD, L0.50; CI, L1.06 to 0.05), and Neck Disability Index (P [ 0.33; MD, L0.55; CI, L1.65 to 0.56) between the 2 groups. Compared with ACDF, ACDR did show increased surgical time (P [ 0.03; MD, 31.42; CI, 2.71e60.14). On the other hand, ACDR showed increased index range of motion (ROM) (P < 0.00001; MD, 13.83; CI, 9.28e 18.39), lower rates of adjacent segment disease (ASD) (P [ 0.001; odds ratio [OR], 0.27; CI, 0.13e0.59), complications (P [ 0.006; OR, 0.62; CI, 0.45e0.87), and rate of subsequent surgery (P < 0.00001; OR, 0.25; CI, 0.14e0.44). As for biomechanical performance, ACDR maintained index ROM and avoided compensation in adjacent ROM and tissue pressure.

CONCLUSIONS: Multilevel ACDR may be an effective and safe alternative to ACDF in terms of clinical and biomechanical performance. However, further multicenter and prospective studies should be conducted to obtain a stronger and more reliable conclusion.

Cost-effectiveness analysis: comparing single-level cervical disc replacement and single-level anterior cervical discectomy and fusion

CDR

J Neurosurg Spine 19:546–554, 2013

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 costeffectiveness 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.