Efficacy Of Cervical Disc Arthroplasty Research Articles

The Role of Cervical Disc Arthroplasty in Elite Athletes.

Cervical disc arthroplasty (CDA) for the treatment of symptomatic cervical disc herniations (CDH) is a promising treatment for professional athletes. In recent years, a number of high-profile athletes have returned to professional play within three months after CDA, raising important questions about the potential of this procedure within this patient group. We provide the first comprehensive review of available literature for the safety and efficacy of CDA in professional contact sport athletes. CDA provides theoretical biomechanical advantages over anterior cervical discectomy and fusion (ACDF) and posterior foraminotomy (PF), as CDA is the only operation for treatment of CDH that provides neural decompression, stability and height restoration, with preserved range of motion. While the comparative long-term results from each procedure are unknown, CDA has provided encouraging promise in its use in professional contact athletes. We aim to aid ongoing discussions regarding the controversies in spine surgery for professional athletes by providing a scientific review of the available evidence-based literature involving cervical disc arthroplasty in this population. In general, we believe that CDA is a viable alternative to ACDF and PF for the contact professional athlete who requires full neck range of motion and desires an expedited return to play. For collision athletes, the short- and long-term safety and efficacy profile of this procedure is promising but still unclear.

Safety and efficacy of cervical disc arthroplasty in preventing the adjacent segment disease: a meta-analysis of mid- to long-term outcomes in prospective, randomized, controlled multicenter studies.

ObjectivesCervical disc arthroplasty (CDA) has become an alternative treatment for cervical radiculopathy and myelopathy. This technique preserves appropriate motion at both the index and adjacent disc levels and consequently may prevent adjacent segment degeneration (ASD). The authors performed a meta-analysis to compare the safety and efficacy of CDA to those of the gold standard, anterior cervical discectomy and fusion (ACDF). Both surgical and clinical parameters were employed to verify the hypothesis that CDA can reduce the risk of ASD.MethodsThe meta-analysis comprised high-quality randomized controlled trials that compared CDA and ACDF treatments of cervical degenerative disc disease. Included papers reported data for at least one of the following outcomes: 1) surgical parameters, 2) questionnaire clinical indices (pre- and postoperative values), and 3) complication rates at 24 months; in addition, for ASD we analyzed 60 month or longer follow-ups. We used mean differences (MDs) or ORs to compare treatment effects between CDA and ACDF.ResultsTwenty studies with 3,656 patients (2,140 with CDA and 1,516 with ACDF) met the inclusion criteria. CDA surgery, with mean duration longer than that of ACDF, was associated with higher blood loss. Visual analog scale neck pain score was significantly smaller for CDA (mean difference =−2.30, 95% CI [−3.72; −0.87], P=0.002). The frequency of dysphagia/dysphonia (OR =0.69, 95% CI [0.49; 0.98], P=0.04) as well as the long-term ASD rate for CDA was significantly smaller (OR =0.33, 95% CI [0.21; 0.50], P<0.0001).ConclusionA significantly lower probability of ASD reoperations in the CDA cohort after a 60-month or longer follow-up was the most important finding of this study. Despite the moderate quality of this evidence, the pooled data corroborated for the very first time that CDA was efficacious in preventing ASD.

Evidence-based use of arthroplasty in cervical degenerative disc disease.

Cervical disc arthroplasty (CDA) was developed to decrease the rate of symptomatic adjacent-level disease while preserving motion in the cervical spine. The objectives of this paper are to provide criteria for proper patient selection as well as to present a comprehensive literature review of the current evidence for CDA, including randomized studies, the most recent meta-analysis findings, and long-term follow-up clinical trials as well. Currently, there are several prospective randomized controlled studies of level I of evidence attesting to the safety and efficacy of CDA in the management of cervical spondylotic disease (CSD) for one- or two-level degenerative diseases. These as well as recent meta-analyses suggest that CDA is potentially similar or even superior to anterior cervical discectomy and fusion (ACDF) when considering several outcomes, including dysphagia and re-operation rate over medium-term follow-up. Less robust studies have also reported satisfactory clinical and radiological outcomes of CDA for hybrid procedures (ACDF combined with CDA), non-contiguous disease, and even for multilevel disease (more than 2 levels). Based on this evidence we conclude that CDA is a safe and effective alternative to ACDF in properly selected patients for one- or two-level diseases. Defining superiority of specific implants and detailing optimal surgical indications will require further well-designed long-term studies.

Outcomes of single-level cervical disc arthroplasty versus anterior cervical discectomy and fusion

Several studies have established the short-term safety and efficacy of cervical disc arthroplasty (CDA) as compared to anterior cervical discectomy and fusion (ACDF). However, few single-center comparative trials have been performed, and current studies do not contain large numbers of patients. We retrospectively reviewed all patients from a single military tertiary medical center between August 2008 to August 2012 who underwent single-level CDA or single-level ACDF and compared their clinical outcomes and complications. A total of 259 consecutive patients were included in the study, 171 patients in the CDA group with an average follow-up of 9.8 (±9.9)months and 88 patients in the ACDF group with an average follow-up of 11.8 (±9.6)months. Relief of pre-operative symptoms was 90.1% in the CDA group and 86.4% in the ACDF group with rates of return to full pre-operative activity of 93.0% and 88.6%, respectively. Patients who underwent CDA had a higher rate of persistent posterior neck pain (15.8% versus 12.5%), and patients who underwent ACDF were at risk for symptomatic pseudarthrosis at a rate of 3.4%. Reoperation rates were higher in the ACDF group (5.7% versus 3.5%). To our knowledge, this review is the largest, non-funded, comparison study between single-level CDA and single-level ACDF. This study demonstrates that CDA is a safe and reliable alternative to ACDF in the treatment of cervical radiculopathy and myelopathy resulting from spondylosis and acute disc herniation.

Cervical Disc Arthroplasty Compared with Arthrodesis for the Treatment of Myelopathy

Although there have been case reports describing the use of cervical disc arthroplasty for the treatment of myelopathy, there is a concern that motion preservation may maintain microtrauma to the spinal cord, negatively affecting the clinical results. As we are not aware of any studies on the use of arthroplasty in this scenario, we performed a cross-sectional analysis of two large, prospective, randomized multicenter trials to evaluate the efficacy of cervical disc arthroplasty for the treatment of myelopathy. The patients in the current study were a cohort of patients who were enrolled in the United States Food and Drug Administration Investigational Device Exemption studies of the Prestige ST and Bryan disc replacements (Medtronic, Memphis, Tennessee). The inclusion criteria were myelopathy and spondylosis or disc herniation at a single level from C3 to C7. Clinical outcome measures were collected preoperatively and at six weeks, three months, six months, twelve months, and twenty-four months postoperatively. A total of 199 patients were included in the present study; 106 patients (53%) underwent arthroplasty, whereas ninety-three (47%) underwent arthrodesis. The Neck Disability Index, Short Form-36 scores, and specific arm and neck pain scores improved significantly from baseline at all time points. Patients in all four groups had improvement in the postoperative neurological status and gait function; at twenty-four months after surgery, 90% (95% confidence interval, 77.8% to 96.6%) of the patients in the arthroplasty group and 81% (95% confidence interval, 64.9% to 92.0%) of those in the arthrodesis group had improvement in or maintenance of the neurological status in the Prestige ST trial and 90% (95% confidence interval, 75.8% to 97.1%) of the patients in the arthroplasty group and 77% (95% confidence interval, 57.7% to 90.1%) of those in the arthrodesis group had improvement in or maintenance of the neurological status in the Bryan trial. We found that patients in both the arthroplasty and arthrodesis groups had improvement following surgery; furthermore, improvement was similar between the groups, with no worsening of myelopathy in the arthroplasty group. While the findings at two years postoperatively suggest that arthroplasty is equivalent to arthrodesis for the treatment of cervical myelopathy for a single-level abnormality localized to the disc space, the present study did not evaluate the treatment of retrovertebral compression as occurs in association with ossification of the posterior longitudinal ligament, and we cannot comment on the treatment of this condition.

Comparison of BRYAN Cervical Disc Arthroplasty With Anterior Cervical Decompression and Fusion

A prospective, randomized, multicenter study of surgical treatment of cervical disc disease. To assess the safety and efficacy of cervical disc arthroplasty using a new arthroplasty device at 24-months follow-up. Cervical disc arthroplasty preserves motion in the cervical spine. It is an alternative to fusion after neurologic decompression, whereas anterior decompression and fusion provides a rigorous comparative benchmark of success. We conducted a randomized controlled multicenter clinical trial enrolling patients with cervical disc disease. Ultimately 242 received the investigational device (Bryan Cervical Disc), and 221 patients underwent a single-level anterior cervical discectomy and decompression and fusion as a control group. Patients completed clinical and radiographic follow-up examinations at regular intervals for 2 years after surgery. Analysis of 12- and 24-month postoperative data showed improvement in all clinical outcome measures for both groups; however, 24 months after surgery, the investigational group patients treated with the artificial disc had a statistically greater improvement in the primary outcome variables: Neck disability index score (P = 0.025) and overall success (P = 0.010). With regard to implant- or implant/surgical-procedure-associated serious adverse events, the investigational group had a rate of 1.7% and the control group, 3.2%. There was no statistical difference between the 2 groups with regard to the rate of secondary surgical procedures performed subsequent to the index procedure. Patients who received the artificial cervical disc returned to work nearly 2 weeks earlier than the fusion patients (P = 0.015). Two-year follow-up results indicate that cervical disc arthroplasty is a viable alternative to anterior cervical discectomy and fusion in patients with persistently symptomatic, single-level cervical disc disease.

Cervical Disc Arthroplasty Compared with Arthrodesis for the Treatment of Myelopathy

Although there have been case reports describing the use of cervical disc arthroplasty for the treatment of myelopathy, there is a concern that motion preservation may maintain microtrauma to the spinal cord, negatively affecting the clinical results. As we are not aware of any studies on the use of arthroplasty in this scenario, we performed a cross-sectional analysis of two large, prospective, randomized multicenter trials to evaluate the efficacy of cervical disc arthroplasty for the treatment of myelopathy. The patients in the current study were a cohort of patients who were enrolled in the United States Food and Drug Administration Investigational Device Exemption studies of the Prestige ST and Bryan disc replacements (Medtronic, Memphis, Tennessee). The inclusion criteria were myelopathy and spondylosis or disc herniation at a single level from C3 to C7. Clinical outcome measures were collected preoperatively and at six weeks, three months, six months, twelve months, and twenty-four months postoperatively. A total of 199 patients were included in the present study; 106 patients (53%) underwent arthroplasty, whereas ninety-three (47%) underwent arthrodesis. The Neck Disability Index, Short Form-36 scores, and specific arm and neck pain scores improved significantly from baseline at all time points. Patients in all four groups had improvement in the postoperative neurological status and gait function; at twenty-four months after surgery, 90% (95% confidence interval, 77.8% to 96.6%) of the patients in the arthroplasty group and 81% (95% confidence interval, 64.9% to 92.0%) of those in the arthrodesis group had improvement in or maintenance of the neurological status in the Prestige ST trial and 90% (95% confidence interval, 75.8% to 97.1%) of the patients in the arthroplasty group and 77% (95% confidence interval, 57.7% to 90.1%) of those in the arthrodesis group had improvement in or maintenance of the neurological status in the Bryan trial. We found that patients in both the arthroplasty and arthrodesis groups had improvement following surgery; furthermore, improvement was similar between the groups, with no worsening of myelopathy in the arthroplasty group. While the findings at two years postoperatively suggest that arthroplasty is equivalent to arthrodesis for the treatment of cervical myelopathy for a single-level abnormality localized to the disc space, the present study did not evaluate the treatment of retrovertebral compression as occurs in association with ossification of the posterior longitudinal ligament, and we cannot comment upon the treatment of this condition.