Cervical total disc replacement (cTDR) is still considered a developing technology, with widespread clinical use beginning in the early 2000s. Despite being relatively new to the marketplace, the literature surrounding cTDR is abundant.
Cervical total disc replacement (TDR) 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, evidence suggests that cervical TDR 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).
While anterior cervical discectomy and fusion (ACDF) has been the standard of care for 2-level disease, a randomized clinical trial (RCT) suggested similar outcomes.
There are also critical debates regarding the long-term effects of heterotopic ossification (HO) and the prevalence of adjacent-level degeneration.
Nunley et al. conducted a thorough review of literature published in the United States (US) and outside the US to report the current global state of cTDR research and clinical use. Search criteria were restricted to publications with a clinical patient population, excluding finite element analyses, biomechanical studies, cadaver studies, surgical technique-specific papers, and case studies. US publications mostly encompass the results of the highly controlled Food and Drug Administration Investigational Device Exemption trials. The predominantly level I evidence in the US literature supports the use of cTDR at 1 and 2 surgical levels when compared to anterior cervical discectomy and fusion. In general, the outside the US studies typically have smaller patient populations, are rarely controlled, and include broader surgical indications. Though these studies are of lower levels of evidence, they serve to advance patient indications in the use of cTDR. Complications such as secondary surgery, heterotopic ossification, and adjacent segment degeneration also remain a focus of studies. Other external challenges facing cTDR technology include regulatory restrictions and health economics, both of which are beginning to be addressed. Combined, the evidence for cTDR is robust supporting a variety of clinical indications 14).
Several large-scale clinical trials demonstrate the efficacy of 1- and 2-level cervical disc arthroplasty (CDA) for degenerative disc disease (DDD) in the subaxial cervical spine, while other studies reveal that during physiological neck flexion, the C4-5 and C5-6 discs account for more motion than the C3-4 level, causing more degenerative disc disease (DDD).
The results of a observational study were in accordance with those of the published randomized controlled trials (RCTs), suggesting substantial pain reduction both after anterior cervical interbody fusion (AIF) and Cervical total disc replacement, with slightly greater benefit after arthroplasty. The analysis of atypical patients suggested that, in patients outside the spectrum of clinical trials, both surgical interventions appeared to work to a similar extent to that shown for the cohort in the matched study. Also, in the longer-term perspective, both therapies resulted in similar benefits to the patients 15).
The available evidence showed that most of the pre-selected factors had no effect on outcome after CTDR, and the range of motion (ROM) success rate, incidence of heterotopic ossification (HO) and radiographic adjacent segment degeneration (r-ASD)/adjacent segment disease (ASD), and surgery rate for ASD are acceptable. There is a lack of evidence for some factors 16).
With a significant exception of a Cochrane review, the methodological quality of systematic reviews evaluating the evidence of C-ADR versus ACDF has to be improved. 17).
Cervical total disc replacement presented favorable functional outcomes, fewer adverse events, and fewer secondary surgical procedures. The efficacy and safety of cervical total disc replacement are superior to those of fusion. Longer-term, multicenter studies are required for a better evaluation of the long-term efficacy and safety of the two procedures.
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 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).
Cervical artificial disc replacement (ADR) is indicated for the treatment of severe radiculopathy permitting neural decompression and maintenance of motion.
The clinical and radiographic outcomes in cervical ADR patients using the ProDisc-C device (DePuy Synthes, West Chester, PA, USA) with a 5-9 year follow-up were collected through a prospective registry, with retrospective analysis performed on 24 consecutive patients treated with cervical ADR by a single surgeon. All patients underwent single- or two-level ADR with the ProDisc-C device. Outcome measures included neck and arm pain (visual analogue scale), disability (neck disability index [NDI]), complications and secondary surgery rates. Flexion-extension cervical radiographs were performed to assess range of motion (ROM) of the device and adjacent segment disease (ASD). Average follow-up was 7.7 years. Neck and arm pain improved 60% and 79%, respectively, and NDI had an improvement of 58%. There were no episodes of device migration or subsidence. Mean ROM of the device was 6.4°. Heterotopic ossification was present in seven patients (37%). Radiographic ASD below the device developed in four patients (21%) (one single-level and three two-level ADR). No patient required secondary surgery (repeat operations at the index level or adjacent levels). Fourteen out of 19 patients (74%) were able to return to employment, with a median return to work time of 1.3 months. The ProDisc-C device for cervical ADR is a safe option for patients providing excellent clinical outcomes, satisfactory return to work rates and maintenance of segmental motion despite radiographic evidence of heterotopic ossification and ASD on long-term follow-up 28).
Between November 2008 and July 2016, 16 patients with prior implantation underwent removal of the Galileo-type disc prosthesis (Signus, Medizintechnik, Germany) due to a call back by industry. In 10 patients C-ADR was replaced with an alternative prosthesis, 6 patients received an ACDF. Duration of surgery, time to revision, surgical procedure, complication rate, neurological status, histological findings and outcome were examined in two institutions.
The C-ADR was successfully revised in all patients. Surgery was performed through the same anterior approach as the initial access. Duration of the procedure varied between 43 and 80min. Access-related complications included irritation of the recurrent nerve in one patient and mal-positioning of the C-ADR in another patient. Follow up revealed two patients with permanent mild/moderate neurologic deficits, NDI (neck disability index) ranged between 10 and 42%.
Anterior exposure of the cervical spine for explantation and revision of C-ADR performed through the initial approach has an overall complication rate of 18.75%. Replacements of the Galileo-type disc prosthesis with an alternative prosthesis or conversion to ACDF are both suitable surgical options without significant difference in outcome 29).
As part of an FDA IDE trial, a single center collected prospective outcomes data on 47 patients randomized in a 1:1 ratio to ACDF or arthroplasty.
Success of both surgical interventions remained high at the 10-year interval. Both arthrodesis and arthroplasty demonstrated statistically significant improvements in neck disability index, visual analog scale neck and arm pain scores at all intervals including 7- and 10-year periods. Arthroplasty demonstrated an advantage in comparison to arthrodesis as measured by final 10-year NDI score (8 vs. 16, P = 0.0485). Patients requiring reoperation were higher in number in the arthrodesis cohort (32%) in comparison with arthroplasty (9%) (P = 0.055).
At 7 and 10 years, cervical arthroplasty compares favorably with ACDF as defined by standard outcomes scores in a highly selected population with radiculopathy 30).
A total of 200 subjects underwent single-level activC® (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.
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.
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 ) 31)
A total of 225 patients received the Mobi-C cervical total disc replacement device and 105 patients received ACDF. The Mobi-C and ACDF follow-up rates were 90.7% and 86.7%, respectively (p = 0.39), at 60 months. There was significant improvement in all outcome scores relative to baseline at all time points. The Mobi-C patients had significantly more improvement than ACDF patients in terms of Neck Disability Index score, SF-12 Physical Component Summary, and overall satisfaction with treatment at 60 months. The reoperation rate was significantly lower with Mobi-C (4%) versus ACDF (16%). There were no significant differences in the adverse event rate between groups.
Both cervical total disc replacement and ACDF significantly improved general and disease-specific measures compared with baseline. However, there was significantly greater improvement in general and disease-specific outcome measures and a lower rate of reoperation in the 2-level disc replacement patients versus ACDF control patients. Clinical trial registration no. NCT00389597 ( clinicaltrials.gov ) 32).
Twenty patients (12 females, 8 males; median age 45.6 ± 6.9 years) treated by ACDA (BryanDisc®, Medtronic, Minneapolis, USA) underwent plain functional radiography and kinematic MRI of the cervical spine at 3T before and 6 and 24 months after surgery.
A sagittal T2-weighted (T2w) 2D turbo spin echo (TSE) sequence and a 3D T2w dataset with secondary axial reconstruction were acquired. Signal intensity of all nonoperated discs was measured in regions of interest (ROI). Disc heights adjacent to the operated segment were measured. Range of motion (ROM) was evaluated and compared to plain functional radiographs. Clinical outcome was evaluated using the visual analog scale (VAS) for head, neck and radicular pain, and the neck disability index (NDI).
Mean ROM of the cervical spine on functional plain radiographs was 21.25 ± 8.19, 22.29 ± 4.82 and 26.0 ± 6.9 degrees preoperatively and at 6-month and 24-month follow-up, respectively. Mean ROM at MRI was 27.1 ± 6.78, 29.45 ± 9.51 and 31.95 ± 9.58 degrees, respectively. There was good correlation between both techniques. Follow-up examinations demonstrated no signs of progressive degenerative disc disease of adjacent levels. All patients had clinical improvement up to 24 months after surgery.
After ACDA, kinematic MRI allows evaluation of the ROM with excellent correlation to plain functional radiographs. Mid-term follow-up after ACDA is without evidence of progressive DDD of adjacent segments 33).
A prospective, multicenter, randomized, unblinded clinical trial. Patients with symptomatic degenerative disc disease were enrolled to receive 1- or 2-level treatment with either TDR as the investigational device or ACDF as the control treatment. There were 260 patients in the 1-level study (179 TDR and 81 ACDF patients) and 339 patients in the 2-level study (234 TDR and 105 ACDF patients). RESULTS At 5 years, the occurrence of subsequent surgical intervention was significantly higher among ACDF patients for 1-level (TDR, 4.5% [8/179]; ACDF, 17.3% [14/81]; p = 0.0012) and 2-level (TDR, 7.3% [17/234]; ACDF, 21.0% [22/105], p = 0.0007) treatment. The TDR group demonstrated significantly fewer index- and adjacent-level subsequent surgeries in both the 1- and 2-level cohorts.
Five-year results showed treatment with cervical TDR to result in a significantly lower rate of subsequent surgical intervention than treatment with ACDF for both 1 and 2 levels of treatment. Clinical trial registration no.: NCT00389597 ( clinicaltrials.gov ) 34).