Anterior cervical disc arthroplasty has been shown in a number of prospective clinical studies to be a viable treatment alternative to anterior cervical discectomy and fusion (ACDF) for symptomatic cervical degenerative disc disease. In addition to preserving motion, some evidence suggests that this technique may result in a lower incidence of subsequent surgical intervention than treatment with fusion.
Furthermore, in biomechanical investigations, most authors have reported an increase in the segmental range of motion (ROM) and the intradiscal pressure (IDP) in the levels proximal and distal to a simulated mono- or bisegmental arthrodesis 4) 5) 6) 7) 8) 9) 10) 11) 12) 13).
MacDowall et al., from Sweden performed a randomized controlled trial with 153 patients (mean age 47 years) undergoing surgery for cervical radiculopathy. Eighty-three patients received an Artificial disc replacement (ADR) and 70 patients underwent fusion surgery. Outcomes after 5 years were assessed using patient-reported outcome measures using the Neck Disability Index (NDI) score as the primary outcome; motion preservation and heterotopic ossification by radiography; adjacent segment pathology (ASP) by MRI; and secondary surgical procedures.
Scores on the NDI were approximately halved in both groups: the mean score after 5 years was 36 (95% confidence interval [CI] 31-41) in the ADR group and 32 (95% CI 27-38) in the fusion group (p = 0.48). There were no other significant differences between the groups in six other patient-related outcome measures. Fifty-four percent of the patients in the ADR group preserved motion at the operated cervical level and 25% of the ADRs were spontaneously fused. Seventeen ADR patients (21%) and 7 fusion patients (10%) underwent secondary surgery (p = 0.11), with 5 patients in each group due to clinical ASP.
In patients with cervical degenerative disc disease and radiculopathy decompression as well as Artificial disc replacement, surgery did not result in better clinical or radiological outcomes after 5 years compared with anterior cervical discectomy and fusion. Clinical trial registration no.: 44347115 (ISRCTN) 14).
One hundred-nine patients with one level cervical disc herniation, were randomized to one of the following treatments: Anterior cervical disc arthroplasty (ACDA), Anterior cervical discectomy and fusion (ACDF) with intervertebral cage, Anterior cervical discectomy (ACD) without fusion. Clinical and radiological outcome was measured by NDI, Visual Analogue Scale (VAS) neck pain, VAS arm pain, SF-36, EQ-5D, patients' self-reported perceived recovery, radiographic cervical curvature, and adjacent segment degeneration (ASD) parameters at baseline and until two years after surgery. BBraun Medical paid €298.837 to cover the costs for research nurses.
The NDI declined from 41 to 47 points at baseline to 19±15 in the ACD group, 19± 18 in the ACDF group, and 20±22 in the ACDA group after surgery (p=0.929). VAS arm and neck pain declined to half its baseline value and decreased below the critical value of 40 mm. Quality of life, measured by the EQ-5D, increased in all three groups. ASD parameters were comparable in all three groups as well. No statistical differences were demonstrated between the treatment groups.
The hypothesis that ACDA would lead to superior clinical outcome in comparison to ACDF or ACD could not be confirmed during a two-year follow-up time period. Single level ACD without implanting an intervertebral device may be a reasonable alternative to ACDF or ACDA 15).
Databases including Medline, Embase, and Scopus were searched. Inclusion criteria involved prospective randomized control trials (RCTs) reporting the surgical treatment of patients with symptomatic degenerative cervical disc disease. Two independent investigators extracted the data. The strength of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) criteria. The primary outcome measures were overall and neurological success, and these were included in the meta-analysis. Standardized patient-reported outcomes, including the incidence of further surgery and adjacent segment disease, were summarized and discussed.
A total of 22 papers published from 14 randomized control trials (RCTs) were included, representing 3160 patients with follow-up of up to ten years. Meta-analysis indicated that TDR is superior to ACDF at two years and between four and seven years. In the short-term, patients who underwent TDR had better patient-reported outcomes than those who underwent ACDF, but at two years this was typically not significant. Results between four and seven years showed significant differences in Neck Disability Index (NDI), 36-Item Short-Form Health Survey (SF-36) physical component scores, dysphagia, and satisfaction, all favouring TDR. Most trials found significantly less adjacent segment disease after TDR at both two years (short-term) and between four and seven years (medium- to long-term).
TDR is as effective as ACDF and superior for some outcomes. Disc replacement reduces the risk of adjacent segment disease. Continued uncertainty remains about degeneration of the prosthesis. Long-term surveillance of patients who undergo TDR may allow its routine use 16).
Although cervical disc arthroplasty (CDA) at C3-4 was infrequent, the improved clinical outcomes of CDA were similar at C3-4 to that in the other subaxial levels of the cervical spine at the approximately 5-year follow-ups. In this Asian population, who had a propensity to have ossification of the posterior longitudinal ligament, there was more heterotopic ossification (HO) formation in patients who received CDA at the C3-4 level than in other subaxial levels of the cervical spine. While the type of artificial discs could have confounded the issue, future studies with more patients are required to corroborate the phenomenon 17).
The hypothesis that ACDA would lead to superior clinical outcome in comparison to ACDF or anterior cervical discectomy (ACD) could not be confirmed during a two-year follow-up time period. Single level ACD without implanting an intervertebral device may be a reasonable alternative to ACDF or ACDA 18).
A study is the first to report the comparative cost-effectiveness of cervical total disc replacement (cTDR) vs anterior cervical discectomy and fusion (ACDF) for 2-level degenerative disc disease at 5 years. Ament et al conclude that, because of the negative incremental cost-effective ratio (ICER), cTDR is the dominant modality 19)
Patients who underwent CTDR for single-level degenerative disease had lower readmission rates, lower reoperation rates, and reduced index and total costs than those treated with ACDF. Cervical disc arthroplasty (CDA) was effective in reducing the monthly cost of care compared with ACDF 20).
Based on a modeling evaluation, CTDR was found to be more effective and less costly over a 7-year time horizon for patients with single-level symptomatic degenerative disc disease. These results are robust across a range of scenarios and perspectives and are intended to support value-based decision making 21).
The incremental cost-effectiveness ratio of CTDR compared with traditional ACDF is lower than the commonly accepted threshold of $50,000 per QALY. This remains true with varying input parameters in a robust sensitivity analysis, reaffirming the stability of the model and the sustainability of this intervention 22).
At the same time, while generating clinical results comparable to spinal fusion, TDR incurred significantly lower costs. Therefore, both from the medical and from the financial point of view, TDR is a viable choice in the treatment of DDP 23).
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 24).
Although cervical total disc replacement (TDR) has shown equivalence or superiority to anterior cervical discectomy and fusion (ACDF), potential problems include nonphysiological motion (hypermobility), accelerated degeneration of the facet joints, particulate wear, and compromise of the mechanical integrity of the endplate during device fixation.
There is no definitive evidence that TDR has better intermediate-term results than anterior cervical discectomy and fusion (ACDF) 25).
3D motion analysis data comparing patients after ACDF and AD replacement in ten patients who underwent C5-6 ACDF and 7 who underwent C5-6 AD replacement were enrolled. Using biplanar fluoroscopy and a model-based track technique (accurate up to 0.6 mm and 0.6°), motion analysis of axial rotation and flexion-extension of the neck was performed. Three nonoperative segments (C3-4, C4-5, and C6-7) were assessed for both intervertebral rotation (coronal, sagittal, and axial planes) and facet shear (anteroposterior and mediolateral). Results There was no difference in total neck motion comparing ACDF and AD replacement for neck extension (43.3° ± 10.2° vs 44.3° ± 12.6°, p = 0.866) and rotation (36.0° ± 6.5° vs 38.2° ± 9.3°, p = 0.576). For extension, when measured as a percentage of total neck motion, there was a greater amount of rotation at the nonoperated segments in the ACDF group than in the AD group (p = 0.003). When comparing specific motion segments, greater normalized rotation was seen in the ACDF group at C3-4 (33.2% ± 4.9% vs 26.8% ± 6.6%, p = 0.036) and C6-7 (28.5% ± 6.7% vs 20.5% ± 5.5%, p = 0.009) but not at C4-5 (33.5% ± 6.4% vs 31.8% ± 4.0%, p = 0.562). For neck rotation, greater rotation was observed at the nonoperative segments in the ACDF group than in the AD group (p = 0.024), but the differences between individual segments did not reach significance (p ≥ 0.146). Increased mediolateral facet shear was seen on neck extension with ACDF versus AD replacement (p = 0.008). Comparing each segment, C3-4 (0.9 ± 0.5 mm vs 0.4 ± 0.1 mm, p = 0.039) and C4-5 (1.0 ± 0.4 mm vs 0.5 ± 0.2 mm, p = 0.022) showed increased shear while C6-7 (1.0 ± 0.4 mm vs 1.0 ± 0.5 mm, p = 0.767) did not.
This study illustrates increased motion at nonoperative segments in patients who have undergone ACDF compared with those who have undergone AD replacement. Further studies will be required to examine whether these changes contribute to adjacent-segment disease 26).
The data from a investigational device exemption (IDE) study through 48 months signify a number of clinically relevant benefits for total disc replacement (TDR) over anterior cervical discectomy and fusion (ACDF). Patients experienced improved clinical outcomes with TDR—including improvement in pain and function outcomes and superiority in overall primary endpoint success. Additionally, incidences of adjacent segment degeneration and subsequent surgeries were reduced with TDR. Perhaps future studies and also longer-term followup of this patient cohort may continue to establish 2-level cervical TDR as a superior surgical option for symptomatic degenerative disc disease 27).