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.
We 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.
Study Design. Prospective, multicenter, randomized clinical trial.
Objective. To evaluate the long-term safety and effectiveness of the PCM Cervical Disc compared with anterior cervical discectomy and fusion (ACDF) in treatment of patients with symptomatic single- level degenerative spondylosis between C3–C4 and C7–T1 with or without prior cervical fusion.
Summary of Background Data. The 2-year results of the PCM Cervical Disc trial have been reported previously. The current study reports the long-term results of the same trial.
Methods. Patients with single-level cervical spondylosis and radiculopathy with or without myelopathy unresponsive to nonoperative treatment were enrolled. The per protocol patient sample at 5 years included 293 patients (163 PCM, 130 ACDF). Adverse events and secondary surgical procedures are reported on the cohorts through current follow-up, which include 110 patients (68 PCM, 42 ACDF) at 7 years.
Results. At 5 years postoperative, all patient-reported outcomes— neck and arm pain visual analogue scale score, neck disability index, and general health (36-Item Short Form Health Survey physical and mental component scores: physical component summary, mental component summary)—were significantly improved from baselines in both groups, and mean scores were significantly better in the PCM group for neck disability index (P = 0.001), neck pain (P = 0.002), general health (Pphysical component summary= 0.014; P mental component summary= 0.004), and patient satisfaction (P = 0.005).
PCM patients trended toward fewer 2- to 7-year device-related
serious adverse events (1/214, 0.5% PCM; 2/190, 1.1% ACDF) and secondary surgical procedures (7/211, 3.3% PCM; 14/290, 7.6% ACDF). Adjacent-level degeneration was radiographically more frequent after ACDF (33.1% PCM, 50.9% ACDF; P = 0.006) and was the primary indication for the increase in late-term secondary surgical procedures after ACDF.
Conclusion. The long-term results show good clinical outcomes after ACDF and PCM arthroplasty. PCM patients showed greater improvement in neck disability index and neck pain scores with a lower rate of radiographical adjacent-level degeneration and a trend toward fewer secondary surgical procedures. These data support PCM arthroplasty to be a viable and sustainable alternative to ACDF.
Level of Evidence: 1
The purpose of cervical total disc replacement (TDR) is to decrease the incidence of adjacent segment disease through motion preservation. Heterotopic ossification (HO) is a well-known complication after hip and knee arthroplasties. There are few reports regarding HO in patients undergoing cervical TDR, however; and the occurrence of HO and its effects on cervical motion have rarely been reported. Moreover, temporal progression of HO has not been fully addressed. One goal of this study involved determining the incidence of HO following cervical TDR, as identified from plain radiographs, and demonstrating the progression of HO during the follow-up period. A second goal consisted of determining whether segmental motion could be preserved and identifying the relationship between HO and clinical outcomes.
Methods. The authors conducted a retrospective clinical and radiological study of 28 consecutive patients who underwent cervical TDR with Mobi-C prostheses (LDR Medical) between September 2006 and October 2008. Radiological outcomes were evaluated using lateral dynamic radiographs obtained preoperatively and at 1, 3, 6, 12, and 24 months postoperatively. The occurrence of HO was interpreted on lateral radiographs using the McAfee classification. Cervical range of motion (ROM) was also measured. The visual analog scale (VAS) and Neck Disability Index (NDI) were used to evaluate clinical outcome.
Results. The mean follow-up period was 21.6 ± 7.0 months, and the mean occurrence of HO was at 8.0 ± 6.6 months postoperatively. At the last follow-up, 18 (64.3%) of 28 patients had HO: Grade I, 6 patients; Grade II, 8 patients; Grade III, 3 patients; and Grade IV, 1 patient. Heterotopic ossification progression was proportional to the duration of follow-up; HO was present in 3 (10.7%) of 28 patients at 1 month; 7 (25.0%) of 28 patients at 3 months; 11 (42.3%) of 26 patients at 6 months; 15 (62.5%) of 24 patients at 12 months; and 17 (77.3%) of 22 patients at 24 months. Cervical ROM was preserved in Grades I and II HO but was restricted in Grades III and IV HO. Clinical improvement according to the VAS and NDI was not significantly correlated with the occurrence of HO.
Conclusions. The overall incidence of HO after cervical TDR was relatively high. Moreover, HO began unexpectedly to appear early after surgery. Heterotopic ossification progression was proportional to the time that had elapsed postoperatively. Grade III or IV HO can restrict the cervical ROM and may lead to spontaneous fusion; however, the occurrence of HO did not affect clinical outcome. The results of this study indicate that a high incidence of HO with the possibility of spontaneous fusion is to be expected during long-term follow-up and should be considered before performing cervical TDR.
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