Coverage Policy Manual
Policy #: 2006039
Category: Surgery
Initiated: December 2006
Last Review: June 2023
  Artificial Vertebral Disc, Cervical Spine
Description:
Cervical degenerative disc disease is a manifestation of spinal spondylosis that causes deterioration of the intervertebral discs of the cervical spine. Symptoms of cervical degenerative disc disease include arm pain, weakness, and paresthesias associated with cervical radiculopathy. Disc herniation, osteophytes, kyphosis, or instability that compress the spinal cord can result in myelopathy, which is manifested by subtle changes in gait or balance, and, in severe cases, leads to weakness in the arms or legs and numbness of the arms or hands. The prevalence of degenerative disc disease secondary to cervical spondylosis increases with age. An estimated 60% of individuals older than 40 years have radiographic evidence of cervical degenerative disc disease. By age 65, 95% of men and 70% of women have at least 1 degenerative change evident at the radiographic examination. It is estimated that approximately 5 million adults in the United States are disabled to an extent by spine-related disorders, although only a small fraction of those are clear candidates for spinal surgery.
 
Anterior cervical discectomy and fusion has historically been considered the definitive surgical treatment for symptomatic degenerative disc disease of the cervical spine. The goals of anterior cervical discectomy and fusion are to relieve pressure on the spinal nerves (decompression) and to restore spinal column alignment and stability. Resolution of pain and neurologic symptoms may be expected in 80% to 100% of anterior cervical discectomy and fusion patients. Anterior cervical discectomy and fusion involves an anterolateral surgical approach, decompression of the affected spinal level, discectomy, and placement of a PEEK (polyetheretherketone) or titanium interbody cage plus autograft or allograft bone in the prepared intervertebral space to stimulate healing and eventual fusion between the vertebral endplates. A metal anterior cervical plate is attached to the adjoining vertebral bodies to stabilize the fusion site, maintain neck lordosis, and reduce the need for prolonged postoperative brace application that is needed following anterior cervical discectomy and fusion without an anterior plate. Although there may be slight differences between autograft and allograft sources in the postoperative rate of union, clinical studies have demonstrated similar rates of postoperative fusion (90%-100%) and satisfactory outcomes using either bone source. Studies have suggested that altered adjacent-segment kinematics following fusion may lead to adjacent-level degenerative disc disease and the need for secondary surgery.
 
Cervical disc arthroplasty is proposed as an alternative to anterior cervical discectomy and fusion for patients with symptomatic cervical degenerative disc disease. In cervical disc arthroplasty, an artificial disc device is secured in the prepared intervertebral space rather than an interbody cage and/or bone. An anterior plate is not used to stabilize the adjacent vertebrae, and postsurgical external orthosis is usually not required. The cervical disc arthroplasty was designed to maintain anatomic disc space height, normal segmental lordosis, and physiological motion patterns at the index and adjacent cervical levels. The potential to reduce the risk of adjacent-level degenerative disc disease above or below a fusion site has been the major reason driving device development and use. Disc arthroplasty and anterior cervical discectomy and fusion have very similar surgical indications, primarily unremitting pain due to radiculopathy or myelopathy, weakness in the extremities, or paresthesia. However, the chief complaint in cervical disc arthroplasty candidates should be radicular or myelopathic symptoms in the absence of significant spondylosis or spondylolisthesis.
 
Regulatory Status
In 2007, the Prestige® ST Cervical Disc (Medtronic) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process as a class III device. The Prestige ST Cervical Disc is composed of stainless steel and is indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy. The device is implanted using an open anterior approach. Intractable radiculopathy and/or myelopathy should be present, with at least 1 of the following items producing symptomatic nerve root and/or spinal cord compression as documented by patient history (eg, pain [neck and/or arm pain], functional deficit, and/or neurologic deficit) and radiographic studies (eg, magnetic resonance imaging [MRI], computed tomography [CT], x-rays): herniated disc and/or osteophyte formation. FDA has required the Prestige disc manufacturer to conduct a 7-year postapproval clinical study of the safety and function of the device and a 5-year enhanced surveillance study to more fully characterize adverse events (AEs) in a broader patient population.
 
The Prestige® LP artificial cervical disc was approved by FDA in 2014. The Prestige® LP differs from the original Prestige cervical disc in terms of material and fixation. The LP implant is composed of a proprietary titanium-ceramic composite and has 2 rails that press-fit into holes created during the surgical procedure. In 2016, the Prestige® LP was approved by FDA for 2 adjacent levels.
 
Another disc arthroplasty product, the ProDisc-C® (Synthes Spine) was approved by FDA through the premarket approval process in 2007. As with the Prestige ST Cervical Disc, FDA approval of ProDisc-C is conditional on 7-year follow-up of the 209 subjects included in the noninferiority trial (discussed in Rationale section), 7-year follow-up of 99 continued access subjects, and a 5-year enhanced surveillance study to more fully characterize AEs when the device is used under general conditions of use. Post approval study reports are to be delivered to FDA annually.
 
The Bryan® Cervical Disc (Medtronic Sofamor Danek) consists of 2 titanium-alloy shells encasing a polyurethane nucleus and has been available outside of the United States since 2002. In 2009, the Bryan Cervical Disc was approved by FDA for treatment using an anterior approach of single-level cervical degenerative disc disease defined as any combination of the following: disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy resulting in impaired function and at least 1 clinical neurologic sign associated with the cervical level to be treated, and necessitating surgery as demonstrated using CT, myelography and CT, and/or MRI. Patients receiving the Bryan Cervical Disc should have failed at least 6 weeks of nonoperative treatment before implantation. As a condition for device approval, FDA has required the manufacturer to extend its followup of enrolled subjects to 10 years after surgery. The study will involve the investigational and control patients from the pivotal investigational device exemption (IDE) study arm, as well as the patients who received the device as part of the continued-access study arm. In addition, the manufacturer must perform a 5-year enhanced surveillance study of the disc to more fully characterize AEs when the device is used in a broader patient population.
 
More recently, continued FDA approval requires completion of 2 post approval studies. One study provides extended follow-up of the premarket pivotal cohort out to 7 years. The second study provides 10-year enhanced surveillance of AE data. Continued approval is contingent on submission of annual reports, which include the number of devices sold, heterotopic ossification, device malfunction, device removal, other serious device-related complications, and analysis of all explanted discs.
 
Devices in addition to those described above that have an FDA approval for use in the United States are described below. FDA Product Code: MJO
 
    • ProDisc-C® (Centinal Spine) has 2 metal (cobalt-chromium alloy) endplates and a polyethylene. It received FDA Approval P070001 in 2007
    • The PCM [porous-coated motion] Cervical Disc® (NuVasive) received FDA approval in 2012 (P100012). The PCM® is a semi-constrained device consisting of 2 metal (cobalt-chromium alloy) endplates and a polyethylene insert that fits between the endplates.
    • Secure®-C (Globus Medical) was approved in 2012 (P100003). The Secure®-C is a 3-piece semiconstrained device with 2 metal (cobalt chromium molybdenum alloy) endplates and a polyethylene insert.
    • The Mobi-C® (LDR Spine) received FDA approval in 2013. Mobi-C® is 3-piece semiconstrained device with metal (cobalt-chromium alloy) endplates and a polyethylene insert. The Mobi-C® is approved for 1- (P110002) or 2-level (P110009) disc replacement.
    • The M6®-C [Orthofix (previously Spinal Kinetics)] received FDA approval in 2019 (P170036). It is an ultra-high molecular weight polyethylene weaved fiber creating a matrix (artificial annulus) within a sheath and titanium alloy endplates.
    • Simplify® Cervical Artificial Disc[NuVasive (previously Simplify Medical)] received FDA approval (P200022) in 2020. It has PEEK endplates and a mobile ceramic core and is MRI compatible.
 
Effective 1/1/09, there are CPT category I codes for a single interspace: 22856 and 22861.  There are add-on CPT category III codes for implantation in additional interspaces: 0092T, 0095T and 0098T. Prior to 1/1/09, the following Category III codes were used: 0090T, 0093T, 0095T, 0096T and 0098T.
 
Coverage of artificial intervertebral discs for treating the lumbar spine is addressed in policy # 2004022.
Policy/
Coverage:
Effective June 2020
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage
Criteria
 
Cervical disc arthroplasty (CDA) for single level (from C3-C7) or at a second simultaneous contiguous level (from C3-C7) meets member benefit certificate primary coverage criteria and is covered when ALL of the following criteria are met:
 
1. The device is approved by FDA; AND
2. The patient is skeletally mature; AND
3. The patient has intractable cervical radicular pain or myelopathy:
        • which has failed at least 6 weeks of conservative nonoperative treatment, including active pain management program or protocol, under the direction of a physician, with pharmacotherapy that addresses neuropathic pain and other pain sources AND physical therapy; OR
        • if the patient has severe or rapidly progressive symptoms of nerve root or spinal cord compression requiring hospitalization or immediate surgical treatment; AND
4. Degeneration is documented by magnetic resonance imaging (MRI), computed tomography
(CT), or myelography; AND
5. The patient is free from contraindication to cervical disc arthroplasty.
 
Subsequent cervical disc arthroplasty at an adjacent level meets member benefit certificate primary coverage criteria when ALL of the following criteria are met:
 
1. Criteria 1 to 5 above are met; AND
2. The device is FDA-approved for 2-levels; AND
3. The planned subsequent procedure is at a different cervical level than the initial cervical disc arthroplasty; AND
4. Clinical documentation that the initial cervical disc arthroplasty is fully healed.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Cervical disc arthroplasty does not meet member benefit certificate primary coverage criteria for all other indications, including the following:
    • Disc implantation at more than 2 levels  
    • Combined use of an artificial cervical disc and fusion
    • Prior surgery at the treated level
    • Previous fusion at another cervical level
    • Multilevel disc disease
    • Translational instability
    • Anatomical deformity (eg, ankylosing spondylitis)
    • Rheumatoid arthritis or other autoimmune disease
    • Presence of facet arthritis
    • Active infection
    • Metabolic bone disease (eg, osteoporosis, osteopenia, osteomalacia)
    • Malignancy
 
For members with contracts without primary coverage criteria, cervical disc arthroplasty is considered investigational for all other indications including, but not limited to, the indications listed in this section above. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to June 2020
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage
Criteria
 
Cervical artificial intervertebral disc implantation for single level (from C3-C7) or at a second simultaneous contiguous level (from C3-C7) meets member benefit certificate primary coverage criteria and is covered when ALL of the following criteria are met:
 
1. The device is approved by FDA; AND
2. The patient is skeletally mature; AND
3. The patient has intractable cervical radicular pain or myelopathy:
        • which has failed at least 6 weeks of conservative nonoperative treatment, including active pain management program or protocol, under the direction of a physician, with pharmacotherapy that addresses neuropathic pain and other pain sources AND physical therapy; OR
        • if the patient has severe or rapidly progressive symptoms of nerve root or spinal cord compression requiring hospitalization or immediate surgical treatment; AND
4. Degeneration is documented by magnetic resonance imaging (MRI), computed tomography
(CT), or myelography; AND
5. The patient is free from contraindication to cervical artificial intervertebral disc implantation.
 
Subsequent cervical artificial intervertebral disc implantation at an adjacent level meets member benefit certificate primary coverage criteria when ALL of the following criteria are met:
 
1. Criteria 1 to 6 above are met; AND
2. The device is FDA-approved for 2-levels; AND
3. The planned subsequent procedure is at a different cervical level than the initial cervical artificial disc replacement; AND
4. Clinical documentation that the initial cervical artificial intervertebral disc implantation is fully healed.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Cervical artificial intervertebral disc implantation does not meet member benefit certificate primary coverage criteria for all other indications, including the following:
    • Disc implantation at more than 2 levels  
    • Combined use of an artificial cervical disc and fusion
    • Prior surgery at the treated level
    • Previous fusion at another cervical level
    • Multilevel disc disease
    • Translational instability
    • Anatomical deformity (eg, ankylosing spondylitis)
    • Rheumatoid arthritis or other autoimmune disease
    • Presence of facet arthritis
    • Active infection
    • Metabolic bone disease (eg, osteoporosis, osteopenia, osteomalacia)
    • Malignancy
 
For members with contracts without primary coverage criteria, cervical artificial intervertebral disc implantation is considered investigational for all other indications including, but not limited to, the indications listed in this section above. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective October 2016- November 2017
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage
Criteria
 
Cervical artificial intervertebral disc implantation meets member benefit certificate primary coverage criteria and is covered when ALL of the following criteria are met:
 
1. The device is approved by FDA; AND
2. The patient is skeletally mature; AND
3. The patient has intractable cervical radicular pain or myelopathy:
        • which has failed at least 6 weeks of conservative nonoperative treatment, including active pain management program or protocol, under the direction of a physician, with pharmacotherapy that addresses neuropathic pain and other pain sources AND physical therapy; OR
        • if the patient has severe or rapidly progressive symptoms of nerve root or spinal cord compression requiring hospitalization or immediate surgical treatment; AND
4. Degeneration is documented by magnetic resonance imaging (MRI), computed tomography
(CT), or myelography; AND
5. Cervical degenerative disc disease is limited to a single level from C3-C7; AND
6. The patient is free from contraindication to cervical artificial intervertebral disc implantation
 
Simultaneous cervical artificial intervertebral disc implantation at a second contiguous level meets member benefit certificate primary coverage criteria and is covered if the above criteria are met for each disc level, and the device is FDA-approved for 2-levels.
 
Subsequent cervical artificial intervertebral disc implantation at an adjacent level meets member benefit certificate primary coverage criteria when ALL of the following criteria are met:
 
1. Criteria 1 to 6 above are met; AND
2. The device is FDA-approved for 2-levels; AND
3. The planned subsequent procedure is at a different cervical level than the initial cervical artificial disc replacement; AND
4. Clinical documentation that the initial cervical artificial intervertebral disc implantation is fully healed.
 
 Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Cervical artificial intervertebral disc implantation does not meet member benefit certificate primary coverage criteria for all other indications, including the following:
    • Disc implantation at more than 2 levels  
    • Combined use of an artificial cervical disc and fusion
    • Prior surgery at the treated level
    • Previous fusion at another cervical level
    • Multilevel disc disease
    • Translational instability
    • Anatomical deformity (eg, ankylosing spondylitis)
    • Rheumatoid arthritis or other autoimmune disease
    • Presence of facet arthritis
    • Active infection
    • Metabolic bone disease (eg, osteoporosis, osteopenia, osteomalacia)
    • Malignancy
 
For members with contracts without primary coverage criteria, cervical artificial intervertebral disc implantation is considered investigational for all other indications including, but not limited to, the indications listed in this section above. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
EFFECTIVE PRIOR TO OCTOBER 2016
 
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
Cervical artificial intervertebral disc implantation meets member benefit certificate primary coverage criteria and is covered when ALL of the following criteria are met:
 
    1. The device is approved by FDA; AND
    2. The patient is skeletally mature; AND
    3. The patient has intractable cervical radicular pain or myelopathy:
      • which has failed at least 6 weeks of conservative nonoperative treatment, including active pain management program or protocol, under the direction of a physician, with pharmacotherapy that addresses neuropathic pain and other pain sources AND physical therapy; OR
      • if the patient has severe or rapidly progressive symptoms of nerve root or spinal cord compression requiring hospitalization or immediate surgical treatment; AND
4. Degeneration is documented by magnetic resonance imaging (MRI), computed tomography (CT), or myelography; AND
5. Cervical degenerative disc disease is limited to a single level from C3-C7; AND
6. The patient is free from contraindication to cervical artificial intervertebral disc implantation
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Cervical artificial intervertebral disc implantation does not meet member benefit certificate primary coverage criteria for all other indications, including the following:
 
    • Disc implantation at more than 1 level
    • Combined use of an artificial cervical disc and fusion
    • Prior surgery at the treated level
    • Previous fusion at another cervical level
    • Multilevel disc disease
    • Translational instability
    • Anatomical deformity (eg, ankylosing spondylitis)
    • Rheumatoid arthritis or other autoimmune disease
    • Presence of facet arthritis
    • Active infection
    • Metabolic bone disease (eg, osteoporosis, osteopenia, osteomalacia)
    • Malignancy
 
For members with contracts without primary coverage criteria, cervical artificial intervertebral disc implantation is considered investigational for all other indications including, but not limited to, the indications listed in this section above. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
EFFECTIVE PRIOR TO AUGUST 2015
The use of an artificial disc in the cervical spine is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, the use of an artificial disc in the cervical spine is considered investigational and is not covered.  Investigational services are exclusions in the member benefit contract.
Rationale:
Thus far, there is limited published information about the impact of these devices on clinical outcomes. The largest clinical reports that have been published are case series. Such reports are not sufficient evidence for evaluating this technology; studies must be done with appropriate control groups.
 
The largest published study involving a trial reports preliminary results on 33 patients who received either the Bryan cervical disc or cervical fusion at one center.  This report is preliminary and involves a small number of patients. It is difficult to draw conclusions from this paper.
 
Information on the Prestige cervical disc is available from their application to the FDA.  This information reports on a randomized study of anterior cervical fusion (with bone graft and plate stabilization) versus artificial cervical disc for patients with discogenic neck pain that did not improve with 6 weeks of conservative therapy. This study was designed as a non-inferiority trial with a non-inferiority margin of 10%. Results presented to the FDA were for 137 investigational and 148 control patients who were evaluated at 2 years post-surgery. This represented about half of the total population (276 and 265, respectively). The results showed equivalent results for the Neck Disability Index (NDI), with 81% of both groups showing at least a 15-point improvement. While these results are encouraging, several methodological and clinical issues will need to be considered in analyzing these data. The issues include the following: first, the study was not blinded (investigators and patients knew which procedure they had received); second, given the clinical situation, 2 years of follow-up may not be adequate to evaluate long-term results; third, consideration should be given to a study that also involves a non-surgical control group; and fourth, some experimental patients had increased neck (6.2% vs. 0.8% at 2 years) and arm pain (9.4% and 5.8%) after the procedure.
 
Nabhan and colleagues reported on 25 patients assigned to disc prosthesis group or discectomy and fusion using a cage with bone graft and anterior plate.  At 24 weeks postoperatively there was significant pain reduction in the neck and arm without significant difference in the groups.  Cervical spine segmental motion decreased over time in both groups of patients but the loss was significantly higher in the fusion group at 24 weeks.
 
Whethert a 24 month follow-up period is of sufficient length to permit conclusions about the long-term device performance, durability, and potential need for revision is unknown.  Some artificial lumbar disc devices degenerated after 24 months.  The FDA approval conditions for the Prestige disc required the manufacturer to continue the initial IDE study for 7 years to evaluate the safety and functions of the device and to perform a 5-year enhanced surveillance study to look at adverse events associated with the device in a broader patient population.
 
2011 Update
This policy is being updated with information with from the available scientific literature through June 2011 on the Prestige Cervical Disc, the Pro-Disc C and the Bryan Cervical Disc.
 
Single Level Arthroplasty
Prestige Cervical Disc
The Prestige disc received U.S. Food and Drug Administration (FDA) marketing approval in 2007. Information on the Prestige cervical disc is available from a published report of the pivotal trial and from Medtronic’s Premarket Approval (PMA) application to the FDA (Mummaneni, 2007) (fda.gov).  These documents report results from a randomized study of anterior cervical fusion (with allograft bone and plate stabilization) versus the artificial cervical disc for patients with non-axial pain and other symptoms secondary to radiculopathy or myelopathy that did not improve with a minimum 6 weeks of conservative therapy. The study was designed as a randomized, nonblinded noninferiority trial with a 10% margin. Results for 137 investigational and 148 control patients who were evaluated at 2 years post-surgery were presented to the FDA in the PMA application. These patients represented about half of the total population (276 and 265, respectively), while the peer-reviewed paper reported on about 75% of cases.
 
Three primary outcome variables were used in the Prestige trial: the Neck Disability Index (NDI), neurological status, and functional spinal unit (FSU) height. The NDI is a validated multidimensional instrument that measures the effects of pain and disability on a patient’s ability to manage everyday life (Vernon, 1991). It is a modification of the Oswestry Low Back Pain Index, based on the response to 10 questions that focus on neck pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. The response to each question ranges from 1 to 5, with a lower numeric score representing a better pain and disability status for that variable. A total NDI score is obtained by adding individual question scores and dividing by the maximum total of 50, if all questions are answered. Therefore, NDI scores range from 0% to 100%, with a lower percentage indicating less pain and disability. The neurological status is a composite measure of motor function, sensory function, and deep tendon reflexes. It is used to judge if patients are within normal parameters for those categories based on physiological measurement. Neurological success in the Prestige trial was based on postoperative maintenance or improvement of condition as compared to preoperative status for each component. The anterior FSU height is a radiographic measure of interdiscal space. Comparison of the immediate postoperative FSU height with the 6-week postoperative value shows whether or not the disc space has decreased, which indicates that graft or device subsidence has occurred. Secondary outcome measures include the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) mental and physical component summaries, neck and arm pain status, patient satisfaction, patient global perceived effect, gait assessment, foraminal compression test, adjacent level stability and measurements, return to work, and physician’s perception.
 
Both data sources for the Prestige disc trial showed equivalent results. Thus, 81% of both groups showed at least a 15-point improvement for the NDI, demonstrating noninferiority to fusion, but not superiority. Similarly, the FSU height measure also demonstrated evidence of noninferiority but not superiority. Neurological status showed non-inferiority and statistical superiority for the disc compared to fusion. This contributed to the overall success composite endpoint demonstrating superiority for the disc compared to fusion. While maintained or improved neurological status was more frequent following AIDA, it was unclear whether examiners were blinded. The majority of secondary outcome measures for the disc were deemed noninferior to ACDF, but none was statistically superior. Perioperative results and adverse events were similar in both groups, with very few serious complications.
 
ProDisc-C
Murrey et al. reported 2-year results from the pivotal FDA randomized noninferiority trial to determine the safety and efficacy of ProDisc-C in comparison with ACDF (Murrey, 2009). In this trial, 103 patients received the ProDisc-C implant and 106 were treated with fusion; participants were blinded to intervention until following surgery. Follow-up between 6 weeks and 2 years was reported to be 85% in the summary of safety and effectiveness data presented to the FDA (fda.gov). Reasons for the loss to follow-up were not described but appear to have included 2 patients in the ProDisc-C group who had the implant removed and 5 patients in the fusion group who had undergone additional surgical procedures to modify the original implant. Non-inferiority was achieved for the FDA-defined combined endpoint of neurologic examination, neck disability index, adverse events, and device success, with 72% of ProDisc-C and 68% of fusion patients achieving success in all 4 component endpoints. Clinical outcomes at 24 months’ follow-up were reported to be similar in the ProDisc-C and fusion groups for the following components: neurological success (91% vs. 88%, respectively), neck disability index (21.4 vs. 20.5 points), reduction in pain scores (e.g., 46 mm vs. 43 mm reduction in neck pain on a visual analogue scale), and patient satisfaction (83 mm vs. 80 mm).
 
Nabhan et al. reported 1-year clinical and radiological results of 49 patients randomized to receive a ProDisc-C artificial disc or fusion (Nabhan, 2007). Measurements taken at 3, 6, 12, 24, and 52 weeks showed a decrease in segmental motion at the index level in both groups over the first 12 weeks after surgery; at 52 weeks, segmental translation (xyz axis) was about 1 mm greater in the ProDisc-C group. Clinical results were similar in the two groups, with a 70% reduction in neck pain and 86% reduction in arm pain in the ProDisc-C group and a 68% reduction in neck pain and 83% reduction in arm pain in the ACDF group. As noted by the authors, longer follow-up is needed to determine the effect of this implant on cervical motion and stress at adjacent levels.
 
A post hoc subgroup analysis of 199 participants with myelopathy from the Prestige ST (n=111) and Bryan (n=88) trials found similar improvement in postoperative neurological status and gait at 24 months (Prestige ST: AIDA 90% [95% CI: 79% to 97%] and ACDF 81% [95% CI: 65% to 92%]; Bryan: AIDA 90% [95% CI: 76% to 97%] and ACDF 77% [95% CI: 76% to 97%]) (Riew, 2008). The authors noted that "although short-term results of cervical disc arthroplasty appear encouraging, studies with at least five to ten years of follow-up are required before cervical disc replacement can be viewed as a standard treatment for disc-based cervical myelopathy."
 
Bryan Cervical Disc
In 2009, Heller et al. reported 2-year follow-up results from the IDE trial for the Bryan disc (Heller, 2009). The trial employed inclusion/exclusion criteria and a composite outcome identical to the ProDisc-C trial. A total of 582 patients were randomized to the Bryan disc (n=290) or ACDF (n=292). Thirty-seven patients declined surgery in the AIDA group; 80 patients declined surgery in the ACDF group. Twelve patients crossed over from AIDA to ACDF, 1 crossed over from ACDF to AIDA, and 2 patients were excluded from ACDF due to protocol violations, leaving 242 patients who underwent AIDA and 223 who underwent ACDF. In the AIDA and ACDF arms, mean age (44.4 and 44.7 years), sex (45.5% and 51.1% men) and NDI scores (51.4 and 50.2) were similar. All but 1 patient who underwent AIDA and 3 patients in the ACDF arm had documented neurological abnormalities. After 2 years follow-up, data were available for 230 (95%) patients from the AIDA group and 194 (87%) who underwent ACDF. The overall success outcome was achieved more often after AIDA (82.6% vs. 72.7%), with a mean 4.1 point greater improvement in the NDI scores. As measured by the composite endpoint, AIDA was superior to ACDF. At 24 months, neck pain scores were lower following AIDA, while other secondary outcomes were similar. Adverse event rates were similar in the two arms—1.7% in AIDA and 3.2% in ACDF arms, requiring revision.
 
In 2010, 4-year follow-up was reported from 1 site (47 patients; 21 Bryan and 26 ACDF) that participated in the Bryan IDE trial described above. (12) The preoperative NDI scores were 51.1 for the Bryan and 51.5 for the ACDF groups. Follow-up in the patients who underwent arthroplasty was 100% at 2 years and 86% at 4 years. Follow-up in the ACDF group was 96% at 2 years and 77% at 4 years. At 2 years, postoperative NDI scores were 12.4 for the Bryan group and 19 for the ACDF group. At 4 years, NDI scores were 10 in the Bryan group and 15.9 in the ACDF group (reported as 16.7 in the abstract). The NDI success (> 15 points improvement) at 48 months was 93.3% for Bryan arthroplasty and 82.4% for the ACDF group. Similar results were obtained for neck pain and arm pain. SF-36 scores were not different between the groups. Six patients required reoperation from the index procedures; 6 procedures were performed in the control group (3 for adjacent level disease, 1 for remote level disease, and 2 for pseudoarthrosis) compared with 1 in the arthroplasty group (adjacent level disease).
 
Goffin et al. reported 4- and 6-year follow-up from phase I and phase II trials of the Bryan disc in 2010 (Goffin, 2010). The total potential patient population for long-term follow-up was 98 patients (89 with 1-level and 9 with 2-level); 59 of the patients were at least 6 years postoperative. Although 4 patients from the phase I study declined to participate in the extended follow-up study, their results were included in the safety data. Mean neck pain at 4 and 6 years postoperatively was 2.2 and 2.0, respectively. Mean arm pain at 4 and 6 years was 2.4 and 2.3, respectively. Six patients experienced events that were believed to be related to the device, including minor device migration, device removal, hoarseness and vocal cord paralysis, while 3 of the 6 cases involved pain or neurological symptoms. The prosthesis was removed from 1 patient at 6 years after the index surgery because of progressive spinal cord compression due to recurrent posterior osteophyte formation. About 90% of patients were classified as having excellent or good outcomes at 4 and 6 years. The success rate estimated by Kaplan-Meier analysis was 94% at 7 years following surgery.
 
Two-level Arthroplasty
Two Level Bryan Cervical Disc
In 2009, Cheng et al. reported 2-year follow-up from a randomized controlled trial of the Bryan disc versus ACDF with autograft in 65 patients with 2-level disc disease (Cheng, 2009). One patient from the arthroplasty group and 2 patients from the ACDF group were lost to follow-up. Neck pain and arm pain measured by visual analog scores (VAS) tended to be better in the Bryan group (1.8 and 1.9, respectively) than the ACDF group at 12-month follow-up (2.5 and 2.4, respectively), and continued to improve at 2-year follow-up (Bryan, 1.5 and 1.4; ACDF, 2.6 and 2.7, respectively). The NDI and the SF-36 physical component scores were also significantly better in the Bryan group at both 12- and 24-month follow-up. These results support the short-term safety of the Bryan disc in 2-level disc disease; longer-term results are needed to evaluate the safety and efficacy of this device in comparison with ACDF for 2-level disc disease.
 
Adverse Events
Progressive spinal cord compression due to osteophyte formation has been observed with cervical disc arthroplasty (Goffin, 2010). The first case of a delayed hypersensitivity reaction to metal ions after disc arthroplasty was reported in 2009 (Cavanaugh, 2009). Although no intracellular or extracellular metal alloy particles were detected in the tissue, the lymphocyte-dominated response was thought to be similar to reactions reported in patients with metal-on-metal hip prostheses. The patient had complete resolution of symptoms following implant removal and fusion.
 
Summary
At the present time, there is limited published information about the impact of cervical arthroplasty devices on clinical outcomes over the long term (5 or more years). While the early results are encouraging, given the natural history of the disease, 2-year follow-up (limited evidence on 4-year follow-up) is inadequate to evaluate long-term results, in particular any effect of the device on adjacent-level disc degeneration, device durability, adverse events, and revisability. As noted by others, “at least 5 years of follow-up will be needed to assess the long-term functionality of the prosthesis and protective influence on adjacent levels.” (Goffin, 2003) Longer term results are expected, given the FDA requirement for a 7-year post-approval clinical study of the safety and function of the device, and a 5-year enhanced surveillance study of the disc to more fully characterize adverse events in a broader patient population.
 
In summary, 2-year results from randomized controlled trials indicate that AIDA is no worse than ACDF. Evidence to date has not shown a beneficial effect of any cervical disc product on the development of adjacent level disease, whereas long-term complication rates with artificial discs remain unknown.
 
2012 Update
A search of the MEDLINE database through September 2012 did not reveal any new information that would prompt a change in the coverage statement. The following is a summary of the key literature identified.
 
In 2011, Coric et al. reported the 24-month pivotal multicenter randomized IDE trial of the metal-on-metal Kineflex C artificial disc (n=136) compared to ACDF performed with allograft and anterior plate (n=133) (Coric, 2011). There were no significant differences between the Kineflex C and ACDF groups for operative time, blood loss, length of hospital stay, or reoperation rate at the index level. The overall success rate was significantly greater in the Kineflex C group (85%) compared with the ACDF group (71%). (Overall success was defined as a composite measure of neurological evaluation, > 20% improvement in NDI, no device failure, no reoperation at the index level, and no major device-related adverse event.) There were 6 index-level reoperations (5%) in the Kineflex C group, including 1 case of metal sensitivity and 2 for device migration. There were 7 index-level surgeries (7.6%) in the ACDF group, including 3 for pseudarthrosis and 4 for instrumentation failure (removal or revision of the original anterior plate and screw construct). There was no significant difference between groups in VAS pain scores or NDI. Although fewer Kineflex C patients showed severe adjacent-level radiographic changes (9% vs. 24.8%), there was no significant difference between the groups in the adjacent-level reoperation rate (7.6% for the Kineflex C group and 6.1% for the ACDF group) at short-term follow-up.
 
The need for longer-term studies remains to assess device failure and other long-term complications. An accompanying editorial notes that while the 24-month IDE trials of artificial discs have been well done, and these new motion saving mechanical devices may potentially be better than ACDF, a number of complications can occur with arthroplasty that include dislodgement, vertical vertebral body fracture, device failure, and heterotopic ossification (Hadley, 2011). Given that no mechanical device has an infinite lifespan and we do not know the failure rate, time-frame, or consequences of failure of cervical arthroplasty devices, a longer period of scientific scrutiny was advised to determine the real efficacy of artificial cervical discs.
 
Mobi-C
Huppert et al. compared outcomes between single (n=175) and multi-level (2-4 levels, n=56) AIDA with the Mobi-C device in a prospective multi-center study from Europe (Huppert, 2011). The age of the patients was significantly higher and the time since symptom onset was significantly longer in the multi-level group. At 2 years, there was no significant difference between groups for the radicular VAS, cervical VAS, or NDI. Range of motion was similar in the 2 groups. The overall success rate was 69% for the single-level group and 69% for the multi-level groups. There was a trend for more patients in the single-level group to return to work (70% vs. 46%), and for the return to work to occur sooner (4.8 months vs. 7.5 months). A similar percentage of patients underwent adjacent-level surgery (2.3% for single-level and 3.6% for multi-level).
 
Adverse Events
 
Adjacent Segment Degeneration
Maldonado et al. evaluated adjacent-level degeneration in a prospective cohort study of 85 patients treated with AIDA and 105 treated with ACDF for single-level degenerative disc disease (Maldonado, 2011). The rationale for treatment allocation was not described. At 3 years after surgery, radiographic evidence of adjacent-segment disease was found in 10.5% of patients in the ACDF group and in 8.8% of subjects in the AIDA group (not significantly different). There was no significant difference between groups in VAS arm pain or NDI.
 
Device Failure
Reports of device failure may emerge with increased use of artificial discs and longer follow-up. One case report describes failure of a Bryan cervical disc due to a fatigue fracture of the flexible polyether urethane sheath at 8 years after implantation (Fan, 2012). Degradation of the sheath, including surface fissures and full-thickness cracks, has been observed in 27% of retrieved Bryan discs (Kurtz, 2011). Another case was reported of fragmented fracture of the ceramic-on-ceramic Discocerv® Cervidisc Evolution at 1 month after implantation (Nguyen, 2011). This artificial disc is not available in the U.S.
 
Heterotopic Ossification
A meta-analysis of heterotopic ossification (McAfee Grade 3-4) after AIDA was published by Chen et al. in 2012 (Chen, 2012). Included in the metal-analysis were 8 studies (617 patients). The pooled prevalence of any heterotopic ossification was 44.6% at 12 months after AIDA and 58.2% at 24 months after AIDA. The pooled prevalence of advanced heterotopic ossification was 11.1% after 12 months and 16.7% after 24 months. Although no publication bias was identified, there was significant heterogeneity in study results.
 
Hypersensitivity Reaction
In 2011, Guyer et al. reported 4 cases of a lymphocytic reaction to a metal-on-metal artificial disc (1 Kineflex-C cervical disc and 3 lumbar) that required revision (Guyer, 2011). The mode of failure was determined to be compression of neural tissue or other adjacent structures by a soft-tissue mass. Three patients had a good outcome after the explantation and revision surgery; 1 patient continued to have residual symptoms related to the neural compression caused by the mass. No hypersensitivity reactions have been reported from Prestige stainless steel implants to date, however, periprosthetic tissue explanted after 1 to 7 years commonly showed focal metallosis (Kurtz, 2011).
 
Conclusions
The evidence on adverse effects of cervical AIDA raises questions on the overall risk/benefit ratio for these devices. The potential to reduce adjacent-level degenerative disc disease has been the major rationale driving device development and use of AIDA. Evidence to date has not demonstrated a reduction in adjacent level disease with use of artificial cervical discs.
 
 
The rates of device failure and the need for reoperations due to device failure or malfunction are not well defined. Reports of device failure that occur at time periods longer than the average follow-up in the clinical trials highlights the need for longer term studies to further define these adverse events.
 
Heterotopic ossification could potentially have a negative impact on the goal of mobility with AIDA. Studies to date indicate a high rate of heterotopic ossification at short-term follow-up. Longer follow-up with clinical outcome measures is needed to evaluate the clinical significance of heterotopic ossification following AIDA.
 
2013 Update
A literature search was conducted using the MEDLINE database through September 2013. There was no new information identified that would prompt a change in the coverage statement.
 
In 2013, a Cochrane systematic review with a meta-analysis of 9 studies (2400 patients) with 1 to 2 years of follow-up was published (Boselie, 2013). Seven of the 9 studies were conducted in the U.S. as FDA-regulated investigational device exemption (IDE) trials. The quality of the evidence was graded as very low to moderate, due in part to the non-blinded outcome measures. Results of the AIDA group were statistically better than the anterior cervical discectomy and fusion (ACDF) group for many of the primary comparisons, but differences were small (<10% of the scale) and not considered to be clinically relevant. No significant difference between AIDA and fusion was found for adjacent level surgery.
 
Five-year results of the FDA regulated pivot trial for ProDisc-C were published in 2013 with follow-up rates of 72.7% for ProDisc-C and 63.5% for ACDF (Zigler, 2013; Delamarter, 2013). Outcomes on the NDI were found to be similar (50-60% improved), along with VAS for arm pain (18 for both groups) and scores on the SF-36. VAS for neck pain was modestly improved with ProDisc-C compared to ACDF (21 vs. 30), although the proportion of patients who achieved a clinically significant improvement in neck pain was not reported. There was a lower percentage of patients with ProDisc-C who had secondary surgery at either the index or adjacent level (2.9% vs. 14.5%).
 
Results of the 2-year FDA-regulated multicenter randomized non-inferiority trial of the PCM Cervical Disc were reported by Phillips and colleagues in 2013 (Phillips, 2013). The investigator and surgical staff were not blinded to treatment assignment, and patients were informed of the treatment assignment after surgery. Out of the 416 patients who were randomized (224 PCM, 192 ACDF), 340 (82%, 189 PCM and 151 ACDF) were per protocol for the 24-month primary endpoint of overall success. Overall success was defined as at least 20% improvement in NDI; absence of reoperation, revision, or removal; maintenance or improvement in neurological status; and absence of radiographic or major complications during the 24-month follow-up period. At 24 months, overall success was 75.1% in the PCM group and 64.9% in the ACDF group, which was statistically non-inferior and superior for AIDA. There was a trend toward a greater neurological success rate in the PCM group (94.7%) compared with ACDF (89.5%, p = 0.10). There was no significant difference between the groups for VAS pain scores, SF-36 component scores, or implant- or surgery-related adverse events (5.2% PCM vs. 5.4% ACDF). Patients with prior fusion were included in this study. Overall success for the 2 sub-groups in this analysis was similar (65.4% PCM and 64.3% ACDF).
 
At the present time, there is insufficient evidence to determine the impact of cervical arthroplasty devices on clinical outcomes over the long term. Results of trials that report 4-5 year outcomes are consistent with continued noninferiority of AIDA for all devices, but uncertainty remains as to whether the benefits of these devices outweigh the risks. Evidence to date has not shown a consistent beneficial effect of any cervical disc product on the development of adjacent level disease, whereas long-term complication rates with artificial discs remain unknown. The limited evidence on 4-5 year follow-up is inadequate to evaluate long-term results, in particular any effect of the device on adjacent-level disc degeneration, device durability, adverse events, and revisions due to device malfunction. Longer term results are expected, given the FDA requirement for 7-10 year post-approval studies of the safety and function of the devices, and a 5-year enhanced surveillance study of the disc to more fully characterize adverse events in a broader patient population. The longer follow-up is needed to better define the risk/benefit ratio of these devices. The policy statement is unchanged.
   
2014 Update
A literature search conducted through September 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A number of meta-analyses have been published, with varying results. The most comprehensive was a
2013 Cochrane systematic review with a meta-analysis of 9 studies (2400 patients) with 1 to 2 years of follow-up (Boselie, 2013). Seven of the 9 studies were conducted in the U.S. as FDA-regulated investigational device
 
Five-year results of this trial were published in 2013 with follow-up rates of 72.7% for ProDisc-C and
63.5% for ACDF (Zigler, 2013; Delamarter, 2013). Outcomes on the NDI were found to be similar (50%-60% improved), along with VAS for arm pain (18 for both groups) and scores on the SF-36. VAS for neck pain was modestly improved with ProDisc-C compared to ACDF (21 vs 30), although the proportion of patients who achieved a clinically significant improvement in neck pain was not reported. There was a lower percentage of patients with ProDisc-C who had secondary surgery at either the index or adjacent level (2.9% vs 14.5%).
 
Mobi-C
 
Mobi-C is the only artificial disc that is approved for 1- or 2-level cervical disc disease. The 1-level Mobi-C trial randomized 169 patients to receive AIDA and 87 to ACDF (FDA, 2013). Patient characteristics were generally similar to the other trials. Patient with multilevel disease or previously treated cervical disease were excluded from the trial. At 24 months, the follow-up rate was 93%. Designed as a noninferiority trial,
noninferiority criteria were met for NDI mean improvement, percent NDI success (≥15-point improvement), and overall success. The overall protocol-specified success rate was higher in the Mobi-C group than the ACDF group (73.7% vs 65.3%), which met noninferiority criteria but did not meet superiority criteria. Cumulative subsequent surgical interventions at the index level were numerically lower in the AIDA group than the ACDF group (1.2% vs 6.2%).
 
Results from the 2-level Mobi-C IDE trial were reported by Davis et al in 2013 (Davis, 2013). In this noninferiority trial, 225 patients received the Mobi-C device at 2 contiguous levels and 105 patients received 2-level ACDF. The follow-up rate was 98.2% for the AIDA group and 94.3% for the ACDF group at 24 months. Both groups showed significant improvement in NDI score, VAS neck pain, and VAS arm pain from baseline to each follow-up point, with Mobi-C meeting the noninferiority margin. Subsequent testing for superiority showed that AIDA patients had significantly greater improvement than ACDF patients in NDI at all time points and had higher NDI success rates (78.2% vs 61.8%) and overall success rates (69.7% vs 37.4%). AIDA resulted in significantly greater improvement in VAS neck pain at 3 and 6 months postoperatively but not at 12 or 24 months. Arm pain scores did not differ between the groups.
 
The Mobi-C group had a lower incidence of device-related adverse events (16.7% vs 34.3%), serious adverse events (23.9% vs 32.4%) and a lower reoperation rate (3.1% vs 11.4%). At 24 months, adjacent-level degeneration was observed in the superior segment in 13.1% of AIDA patients and 33.3% of ACDF patients. Adjacent-level degeneration was observed in the inferior segment in 2.9% of AIDA patients and 18.1% of ACDF patients.
 
Device Failure
One case of anterior migration of the Mobi-C disc was reported (Tsermoulas, 2013).
 
 
PCM Cervical Disc
 
Results of the 2-year FDA-regulated multicenter randomized noninferiority trial of the PCM Cervical Disc were reported by Phillips et al in 2013 (Phillips, 2013). The investigator and surgical staff were not blinded to treatment assignment, and patients were informed of the treatment assignment after surgery. Of the 416 patients who were randomized (224 PCM, 192 ACDF), 340 (82%, 189 PCM and 151 ACDF) were per protocol for the 24-month primary end point of overall success. Overall success was defined as at least 20% improvement in NDI; absence of reoperation, revision, or removal; maintenance or improvement in neurological status; and absence of radiographic or major complications during the 24-month follow-up period. At 24 months, overall success was 75.1% in the PCM group and 64.9% in the ACDF group, which met both the noninferiority and superiority criteria. There was a trend toward a greater neurological success rate in the PCM group (94.7%) compared with ACDF (89.5%, p=0.10). There was no significant difference between the groups for VAS pain scores, SF-36 component scores, or implant- or surgery related adverse events (5.2% PCM vs 5.4% ACDF). Patients with prior fusion were included in this study. Overall success for the 2 subgroups in this analysis was similar (65.4% PCM and 64.3% ACDF).
 
SECURE-C
 
The FDA-regulated SECURE-C trial was a multicenter un-blinded noninferiority trial with151 patients randomized to receive AIDA and 140 patients randomized to ACDF (FDA, 2012). Patients with multilevel disease or previously treated cervical disease were excluded from the trial. Overall success was defined by FDA as a 15-point or more improvement in NDI; absence of reoperation, revision, or removal; stable or improved neurologic status, and absence of radiographic or major complications during the 24-month follow-up period. At 24 months, the follow up rate was 87%. Noninferiority criteria were met for NDI mean improvement, percent NDI success (89.2% vs 84.5%), neurologic success (96.0% vs 94.9%), and overall success (83.8% vs 73.2%, AIDA vs ACDF, all respectively) using FDA-defined criteria. The overall success rate as specified in the protocol at 24 months (>25% improvement in NDI, no removals and no complications) was also higher in the SECURE-C group than the ACDF group (90.1% vs 71.1%), which met both noninferiority criteria as well as superiority criteria. Cumulative secondary surgical interventions at the treated level were lower in the AIDA group than the ACDF group (2.5% vs 9.7%).
 
A 2013 report from Coric and colleagues group reported minimum 48-month follow-up (range, 48-108) of 74 patients who had received a Bryan or Kineflex cervical disc (Coric, 2013). There were no significant differences between the groups in the mean NDI or median VAS scores. There were 3 reoperations (7.3%) at the index (n=1) or adjacent levels (n=2) in the AIDA group and 1 (3%) adjacent level reoperation in the ACDF group.
 
2015 Update
A literature search was conducted using the MEDLINE database. Post hoc analysis of data from the pivotal 1- and 2-level Mobi-C trials was reported by Bae et al in 2015 (Bae, 2015).Comparison showed no significant difference between 1- and 2-level AIDA on clinical outcomes (NDI, VAS, SF-12), major complication rates (4.3% for 1-level and 4.0% for 2-level AIDA), or subsequent surgery rates (3.0% of 1-level and 4.0% of 2-level). Clinically relevant heterotopic ossification was observed in 23.8% of 1-level patients and 25.7% of 2-level patients.
 
After 2 years of follow-up, trials of all the artificial cervical discs met noninferiority criteria as measured by the Neck Disability Index and overall success composite outcome. Mid-term outcomes have been reported on 4 of the devices (Prestige ST, ProDisc-C, Mobi-C, Bryan discs). The trial results are consistent with continued noninferiority of artificial intervertebral disc arthroplasty (AIDA) for all devices and lower cumulative reoperation rates at 4 to 5 years. Longer term results are expected, given the FDA requirement for 7- to 10-year postapproval studies of the safety and function of the devices, and 5- to 10- year enhanced surveillance study of these discs to more fully characterize adverse events in a broader patient population. Based on these results, combined with expert opinion, the coverage statement has been revised.
  
2016 Update
A literature search conducted through September 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2016, Hu and colleagues published a meta-analysis of 8 randomized controlled trials (RCTs; total N=2368 patients) reporting mid-term outcomes (at least 48 months) (Hu, 2016). All 8 studies were rated as low risk of bias, despite lack of blinding.
 
Mobi-C
Hisey and colleagues published 2-, 4- and 5-year results from the single-level Mobi-C trial, with a follow-up rate of 85.5% for the Mobi-C group and 78.9% for ACDF at 5-years (Hisey, 2015; Hisey, 2014; Hisey, 2016). The primary outcome was overall success, as defined by a modified FDA-approved measure designed for the post-approval study (PAS). The criteria for success were a minimum of a 30-point improvement in NDI score (100-point scale) compared to baseline; no device-related subsequent surgery; no device-related adverse events; no neurologic deterioration; and no intraoperative changes in treatment. Overall success in the Mobi-C group was non-inferior to ACDF but did not achieve superiority, with a success rate of 61.9% for Mobi-C and 52.2% for ACDF. Range of motion was preserved with Mobi-C through 5 years, even though grade 4 HO was observed in 8.5% of Mobi-C patients. Adjacent segment degeneration was significantly lower with Mobi-C, but radiographically determined adjacent segment degeneration remained above 30% at 5-year follow-up in this group. Throughout the 5-year follow-up, Mobi-C patients had a lower incidence of subsequent surgeries (Mobi-C, 4.9%; ACDF, 17.3%; p<0.01).
 
Similar results were reported in an independently funded multicenter RCT from Asia of single-level arthroplasty with the Mobi-C device compared to ACDF (N=111) (Zhang, 2014). Outcomes for pain and function were similar for the Mobi-C and ACDF groups at 48-month follow-up. There was significantly more radiographically determined adjacent-level degeneration and a higher incidence of secondary surgery with ACDF (1 Mobi-C vs 3 ACDF patients).
 
In 2016, Radcliff and colleagues published 5-year results from the Mobi-C 2-level IDE trial (Radcliff, 2016). Follow-up rates were 82.7% of patients for the Mobi-C group (8.9% study failures) and 68.6% for the ACDF group (21.0% study failures). Excluding patients who dropped from the study due to death or device failures, follow-up rates were 90.7% for the Mobi-C group and 86.7% for the ACDF group. Improvement in the Mobi-C group was significantly better than in the ACDF group for the NDI and SF-12 PCS scores. There were no significant differences between groups for VAS neck and arm pain scores, neurologic status, or for SF-36 MCS scores. The FDA-defined composite measure of success was significantly better for the Mobi-C group (61%) than for the ACDF group (31%; p<0.001) and there were significantly fewer secondary surgeries in the Mobi-C group (7.1%) compared with the ACDF group (21%; p<0.001). This was due to fewer index level reoperations (4.3% vs 16.2%, p<0.001) and adjacent-level reoperations (3.1% vs 11.4%) with the Mobi-C devices. Clinically relevant HO (grade III or IV) was observed in 29.7% of the Mobi-C patients, but the Mobi-C patients had significantly less adjacent-segment degeneration (50.7%) than ACDF patients (90.5%; p<0.001).
 
Spine Tango
In 2016, Staub and colleagues evaluated the clinical effectiveness of AIDA from 987 patients in the Spine Tango registry (Staub, 2016). The primary outcome measures were neck and arm pain relief and the Core Outcome Measures Index (COMI). One analysis evaluated outcomes from a matched pair of patients (190 pairs) who met the selection criteria of published RCTs. With an average follow-up of 17 months, there were small but statistically significant differences in outcomes between AIDA and ACDF. The mean group differences on a 10-point scale for both pain measures was 0.6 points in postoperative neck pain (p=0.0 4) and 0.7 points in arm pain (p=0.02); mean COMI score difference was 0.8 points (p=0.01). Change scores did not differ significantly. The probability of being a responder (2-point change) was significantly better in the AIDA group for arm pain relief (78.4% vs 67.4%, p=0.02) and COMI score (81.6% vs 67.9%, p<0.01), but not neck pain relief (62.1% vs 57.9%, p=NS).
 
For patients excluded from the RCTs, most commonly due to age greater than 60 years or spondylosis, there were no significant differences in clinical outcomes between AIDA and ACDF. A third analysis compared outcomes of AIDA and ACDF in patients who had follow-up of more than 2 years (mean, 55.0 months; range, 27.0-76.5 months). After controlling for patient age, patients treated with AIDA had significantly higher responder rates for arm pain relief (80.0%) compared with patients treated with ACDF (64.9%; p=0.05), with no significant difference in responder rates between the 2 groups for neck pain relief or COMI. The rate of adjacent-level degeneration and secondary surgeries were not assessed.
 
Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this review are listed below:
 
Ongoing:
(NCT00432159) is an industry-sponsored or cosponsored trial. A Multi-Center, Prospective, Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion for the Treatment of Cervical Degenerative Disc Disease (DISCOVER™ IDE Study); planned enrollment 500; projected completion date May 2016 (ongoing)
 
(NCT01763619) is an industry-sponsored or cosponsored trial. Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease; planned enrollment 50; projected completion date May 2016 (ongoing)
 
(NCT01609374) is an industry-sponsored or cosponsored trial. Prospective, Concurrently Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Spinal Kinetics™ M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Symptomatic Cervical  Radiculopathy; planned enrollment 243; projected completion date May 2017.
 
(NCT00637156) is an industry-sponsored or cosponsored trial. A Prospective, Randomized, Controlled, Multicenter Pivotal Clinical Trial of the Artificial Cervical Disc-LP at Two Levels for Symptomatic Cervical Disc Disease; planned enrollment 397; projected completion date March 2018.
 
(NCT02403453) is an industry-sponsored or cosponsored trial. RHINE™ Cervical Disc Clinical Study; planned enrollment 166; projected completion date June 2021.
 
Unpublished
(NCT00637312) is an industry-sponsored or cosponsored trial. Clinical Trial Comparing the Blackstone Advent™ Cervical Disc to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of One Level Degenerative Disc Disease; planned enrollment 108; terminated
 
(NCT00478088) is an industry-sponsored or cosponsored trial. A Pivotal, Multi-Center, Randomized, Controlled Trial Evaluating The Safety and Effectiveness of The NeoDisc™ Versus Instrumented Anterior Cervical Discectomy and Fusion (ACDF) in Subjects With Single-Level Cervical Disc Disease; planned enrollment 488; completed 2012.
 
North American Spine Society
The 2015 guidelines from the North American Spine Society (NASS) state that “Cervical artificial disc replacement (CADR, also known as cervical total disc replacement and cervical arthroplasty) may be indicated for the following diagnoses with qualifying criteria, when appropriate:
 
1. Radiculopathy related to nerve root compression from one or 2-level degenerative disease (either herniated disc or spondylotic osteophyte) from C3-4 to C6-7 with or without neck pain that has been refractory to medical or nonoperative management.
2.  Myelopathy or myeloradiculopathy related to central spinal stenosis from one or 2-level degenerative disc disease from C3-4 to C6-7 with or without neck pain.” (NASS, 2015)
 
2017 Update
A literature search conducted using the MEDLINE database through September 2017 did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted through November 2018.  There was no new information identified that would prompt a change in the coverage statement.  
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Hu et al published a systematic review and meta-analysis of 8 RCTs (l nN=2368) reporting mid-term outcomes (at least 48 months) comparing artificial intervertebral disc arthroplasty with anterior cervical discectomy and fusion (Hu, 2016). This meta-analysis had the highest AMSTAR rating out of 14 meta-analyses published between 2011 and 2017 (Zhai, 2020). All 8 trials included in Hu et al were rated as low risk of bias, despite lack of blinding. Only 2 trials reported on overall success, and 3 reported on Neck Disability Index success (Burkus, 2014; Sasso, 2011; Phillips, 2015). Six trials reported neurologic success data; pooled data favored the cervical disc arthroplasty group to a small degree (relative risk [RR], 1.04; 95% confidence interval (CI), 1.01 to 1.08; p=0.01). Pooled data also showed a significant benefit of cervical disc arthroplasty for secondary procedures at the index level (6 studies); r RR, 0.40; 95% CI, 0.28 to 0.58; p<0.001) and at the adjacent level (5 studies); r RR, 0.42; 95% CI, 0.26 to 0.70; p<0.002) (Burkus, 2014; Sasso, 2011; Coric, 2013; Davis, 2015; Hisey, 2015; Janssen, 2015; Zhang, 2014).
 
Similar findings were reported by Deng et al in a meta-analysis of 9 studies with 48 to 120 months of follow-up (Deng, 2020). Symptomatic adjacent-level disease requiring surgery was significantly lower following cervical disc arthroplasty compared to anterior cervical discectomy and fusion.
 
Two and 4-year results from the 2-level Mobi-C investigational device exemption trial were reported by Davis et al with 5- and 7-year results published by Radcliff et al (Davis, 2015; Davis, 2013; Radcliff, 2016; Radcliff, 2017). Clinically relevant heterotopic ossification (grade III or IV) was observed in 29.7% of the Mobi-C patients at 5 years, but the Mobi-C patients had significantly less adjacent-segment degeneration (50.7%) than anterior cervical discectomy and fusion patients (90.5%; p<0.001).
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2021, the International Society for the Advancement of Spine Surgery issued a position statement on cervical and lumbar disc replacement (Schroeder, 2021). Based on a review of the available evidence-based scientific literature, the Society "strongly supports both cervical and lumbar total disc replacements, including multi-level use as approved by the FDA, as safe and effective treatment alternatives to fusion in appropriately selected patients. FDA study guidelines and labelling regarding inclusion and exclusion criteria should be followed for use."
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
A meta-analysis by Toci et al that included 19 RCTs (N=4655) found a lower risk of adjacent segment degeneration with cervical disc arthroplasty compared to anterior cervical discectomy with fusion (14.4% vs. 19.7%; p<.001), as well as adjacent segment disease (3.8% vs. 6.1%; p<.001) and reoperation rates (3.1% vs. 6.1%; p<.001) (Toci, 2022).
 
Likewise, a meta-analysis by Peng et al that included 30 RCTs (sample size ranged from 79 to 545 participants per study) and compared cervical disc arthroplasty to anterior cervical discectomy with fusion in patients with cervical degenerative disc disease with either radiculopathy or myelopathy found improved overall success, neurological success, and Neck Disability Index success with cervical disc arthroplasty (Peng, 2022). Follow-up ranged from 1 to 10 years andmost studies included single-level cervical disc arthroplasty.
 
A multicenter non-inferiority RCT was done using the Simplify Cervical Disc (FDA, 2023). The primary outcome measure was improvement of NDI in >15 patients, maintenance or improvement in neurologic function, and no serious adverse events or supplemental surgical procedures. Participants included individuals with intractable radiculopathy (arm pain and/ora neurological deficit) with or without neck pain or myelopathy at 1 level from C3 to C7. 150 participants received the Simplify, and historical controls from a previous IDE study from 2005-2007 was looked at for 133 participants. Results in participants who received the simplify (150 participants) are as follows: Overall Success 93%, NDI Success 97.9%, Neurologic Success 99.3%, Secondary Surgeries 2.9%, Pain Medication 10.8%. The results for the other 133 participants are as follows: Overall Success 73.6%, NDI Success 88%, Neurologic Success 94.7%, Secondary Surgeries 2.9%, Pain Medication 36.8%.
 
In 2021, the Simplify Cervical Disc received FDA approval for implantation at 2 levels (previously approved for implantation at only 1 level). Overall success was achieved in 86.7% of Simplify Cervical Disc patients and 77.1% of anterior cervical discectomy and fusion controls at 24 months follow-up (Coric, 2022).
CPT/HCPCS:
22856Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection); single interspace, cervical
22858Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection); second level, cervical (List separately in addition to code for primary procedure)
22861Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical
22864Removal of total disc arthroplasty (artificial disc), anterior approach, single interspace; cervical
References: Burkus JK, Traynelis VC, Haid RW, Jr., et al.(2014) Clinical and radiographic analysis of an artificial cervical disc: 7- year follow-up from the Prestige prospective randomized controlled clinical trial: Clinical article. J Neurosurg Spine. Oct 2014;21(4):516-528. PMID 25036218

Artificial intervertebral disc arthroplasty for treatment of degenerative disc disease of the cervical spine. Blue Cross Blue Shield Association Technology Evaluation Center 2008; vol 22:no. 12.

Bae HW, Kim KD, Nunley PD, et al.(2015) Comparison of Clinical Outcomes of One and Two-level Total Disc Replacement: 4-year Results from a Prospective, Randomized, Controlled, Multicenter IDE Clinical Trial. Spine (Phila Pa 1976). Mar 17 2015. PMID 25785955

Boselie TF, Willems PC, van Mameren H et al.(2013) Arthroplasty versus fusion in single-level cervical degenerative disc disease: a cochrane review. Spine (Phila Pa 1976) 2013; 38(17):E1096-107.

Boselie TF, Willems PC, van Mameren H et al.(2013) Arthroplasty versus fusion in single-level cervical degenerative disc disease: a cochrane review. Spine (Phila Pa 1976) 2013; 38(17):E1096-107.

Burkus JK, Traynelis VC, Haid RW, et al.(2014) Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial: Clinical article. J Neurosurg Spine. Oct 2014; 21(4): 516-28. PMID 25036218

Cavanaugh DA, Nunley PD, Kerr EJ, 3rd et al.(2009) Delayed hyper-reactivity to metal ions after cervical disc arthroplasty: a case report and literature review. Spine (Phila Pa 1976) 2009; 34(7):E262-5.

Chen J, Wang X, Bai W et al.(2012) Prevalence of heterotopic ossification after cervical total disc arthroplasty: a meta-analysis. Eur Spine J 2012; 21(4):674-80.

Cheng L, Nie L, Zhang L et al.(2009) Fusion versus Bryan Cervical Disc in two-level cervical disc disease: a prospective, randomised study. Int Orthop 2009; 33(5):1347-51.

Coric D, Finger F, Boltes P.(2006) Prospective randomized controlled study of the Bryan Cervical Disc: early clinical results from a single investigational site. J Neurosurg Spine, 2006; 4:31-5.

Coric D, Guyer RD, Bae H, et al.(2022) Prospective, multicenter study of 2-level cervical arthroplasty with a PEEK-on-ceramic artificial disc. J NeurosurgSpine. Apr 01 2022: 1-11. PMID 35364570

Coric D, Kim PK, Clemente JD et al.(2013) Prospective randomized study of cervical arthroplasty and anterior cervical discectomy and fusion with long-term follow-up: results in 74 patients from a single site. J Neurosurg Spine 2013; 18(1):36-42.

Coric D, Nunley PD, Guyer RD et al.(2011) Prospective, randomized, multicenter study of cervical arthroplasty: 269 patients from the Kineflex|C artificial disc investigational device exemption study with a minimum 2-year follow-up: clinical article. J Neurosurg Spine 2011; 15(4):348-58.

Davis RJ, Kim KD, Hisey MS et al.(2013) Cervical total disc replacement with the Mobi-C cervical artificial disc compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled multicenter clinical trial. J Neurosurg Spine 2013; 19(5):532-45.

Davis RJ, Nunley PD, Kim KD, et al.(2014) Two-level total disc replacement with Mobi-C cervical artificial disc versus anterior discectomy and fusion: a prospective, randomized, controlled multicenter clinical trial with 4-year followup results. J Neurosurg Spine. Nov 7 2014:1-11. PMID 25380538

Delamarter RB, Zigler J.(2013) Five-year Reoperation Rates, Cervical Total Disc Replacement versus Fusion, Results of a Prospective Randomized Clinical Trial. . Spine (Phila Pa 1976) 2013; 38(9):711-7.

Delamarter RB, Zigler J.(2013) Five-year Reoperation Rates, Cervical Total Disc Replacement versus Fusion, Results of a Prospective Randomized Clinical Trial. Spine (Phila Pa 1976) 2013; 38(9):711-7.

Deng Y, Li G, Liu H, et al.(2020) Mid- to long-term rates of symptomatic adjacent-level disease requiring surgery after cervical total disc replacement compared with anterior cervical discectomy and fusion: a meta-analysis of prospective randomized clinical trials. J Orthop Surg Res. Oct 12 2020; 15(1): 468. PMID 33046082

Fan H, Wu S, Wu Z et al.(2012) Implant failure of Bryan cervical disc due to broken polyurethane sheath: a case report. Spine (Phila Pa 1976) 2012; 37(13):E814-6.

Garrido BJ, Taha TA, Sasso RC.(2010) Clinical outcomes of Bryan cervical disc arthroplasty. A prospective, randomized, controlled, single site trial with 48-month follow-up. J Spinal Disord Tech 2010.

Goffin J, Van Calenbergh F, van Loon J et al.(2003) Intermediate follow-up after treatment of degenerative disc disease with the Bryan Cervical Disc Prosthesis: single-level and bi-level. Spine (Phila Pa 1976) 2003; 28(24):2673-8.

Goffin J, van Loon J, Van Calenbergh F et al.(2010) A clinical analysis of 4- and 6-year follow-up results after cervical disc replacement surgery using the Bryan Cervical Disc Prosthesis. J Neurosurg Spine 2010; 12(3):261-9.

Gornet MF, Burkus JK, Shaffrey ME, et al.(2015) Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion: a prospective, multicenter investigational device exemption study. J Neurosurg Spine. Jul 31 2015:1-16. PMID 26230424

Gornet MF, Lanman T, McConnell J, et al.(2015) Two-level cervical disc arthroplasty vs. ACDF: A prospective, randomized, controlled multicenter clinical trial with 5-year results. Eur Spine J. 2015;24(6 (SUPPL. 1)):S704. PMID

Guyer RD, Shellock J, MacLennan B et al.(2011) Early failure of metal-on-metal artificial disc prostheses associated with lymphocytic reaction: diagnosis and treatment experience in four cases. Spine (Phila Pa 1976) 2011; 36(7):E492-7.

Hacker FM, Babcock RM, Hacker RJ.(2013) Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site. Spine (Phila Pa 1976). Dec 15 2013;38(26):2223- 2226. PMID 24335628

Hadley MN.(2011) The real value of cervical arthroplasty? J Neurosurg Spine 2011; 15(4):345-6; discussion 46-7.

Heller JG, Sasso RC, Papadopoulos SM et al.(2009) Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial. Spine (Phila Pa 1976) 2009; 34(2):101-7.

Hisey MS, Bae HW, Davis R, et al.(2014) Multi-center, prospective, randomized, controlled investigational device exemption clinical trial comparing Mobi-C Cervical Artificial Disc to anterior discectomy and fusion in the treatment of symptomatic degenerative disc disease in the cervical spine. Int J Spine Surg. 2014;8. PMID 25694918

Hisey MS, Bae HW, Davis RJ, et al.(2015) Prospective, randomized comparison of cervical total disk replacement versus anterior cervical fusion: results at 48 months follow-up. J Spinal Disord Tech. May 2015;28(4):E237- 243. PMID 25310394

Hisey MS, Zigler JE, Jackson R, et al.(2016) Prospective, randomized comparison of one-level Mobi-C Cervical Total Disc replacement vs. anterior cervical discectomy and fusion: results at 5-year follow-up. Int J Spine Surg. 2016;10:10. PMID 27162712

http://fda.gov/ohrms/dockets/ac/06/briefing/2006-4243b1_00_index.htm.

Hu Y, Lv G, Ren S, et al.(2016) Mid- to long-term outcomes of cervical disc arthroplasty versus anterior cervical discectomy and fusion for treatment of symptomatic cervical disc disease: a systematic review and metaanalysis of eight prospective randomized controlled trials. PLoS One. 2016;11(2):e0149312. PMID 26872258

Huppert J, Beaurain J, Steib JP et al.(2011) Comparison between single- and multi-level patients: clinical and radiological outcomes 2 years after cervical disc replacement. Eur Spine J 2011; 20(9):1417-26.

Janssen ME, Zigler JE, Spivak JM, et al.(2015) ProDisc-C Total Disc replacement versus anterior cervical discectomy and fusion for single-level symptomatic cervical disc disease: seven-year follow-up of the prospective randomized U.S. Food and Drug Administration Investigational Device Exemption Study. J Bone Joint Surg Am. Nov 4 2015;97(21):1738-1747. PMID 26537161

Kurtz SM, Toth JM, Siskey R et al.(2011) The latest lessons learned from retrieval analysis of ultra-high molecular weight polyethylene, metal-on-metal, and alternative bearing total disc replacements. Semin Spine Surg 2011; 24(1):57-70.

Maldonado CV, Paz RD, Martin CB.(2011) Adjacent-level degeneration after cervical disc arthroplasty versus fusion. Eur Spine J 2011; 20 Suppl 3:403-7.

Mummaneni PV, Burkus JK, et al.(2007) Clinical and radiographical analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine, 2007; 6:198-209.

Murrey D, Janssen M, Delamarter R et al.(2009) Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic Spine J 2009; 9(4):275-86.

Nabhan A, Ahihelm F, et al.(2007) Disc replacement using Pro-Disc C versus fusion: a prospective randomised and controlled radiographic and clinical study. Eur Spine J 2007; 16(3):423-30.

Nguyen NQ, Kafle D, Buchowski JM et al.(2011) Ceramic fracture following cervical disc arthroplasty: a case report. J Bone Joint Surg Am 2011; 93(22):e132(1-4).

North American Spine Society. NASS coverage policy recommendations: Cervical artificial disc replacement. 2014; https://www.spine.org/Documents/PolicyPractice/CoverageRecommendations/CervicalArtificialDiscReplacement. pdf. Accessed December 15, 2014.

North American Spine Society.(2015) NASS coverage policy recommendations: Cervical artificial disc replacement. 2015; https://www.spine.org/PolicyPractice/CoverageRecommendations/AboutCoverageRecommendations.aspx.

Peng Z, Hong Y, Meng Y, et al.(2022) A meta-analysis comparing the short- and mid- to long-term outcomes of artificial cervical disc replacement (ACDR)with anterior cervical discectomy and fusion (ACDF) for the treatment of cervical degenerative disc disease. Int Orthop. Jul 2022; 46(7): 1609-1625. PMID 35113188

Phillips FM, Geisler FH, Gilder KM, et al.(2015) Long-term Outcomes of the US FDA IDE Prospective, Randomized Controlled Clinical Trial Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion. Spine (Phila Pa 1976). May 15 2015; 40(10): 674-83. PMID 25955086

Phillips FM, Geisler FH, Gilder KM, et al.(2015) Long-term outcomes of the US FDA IDE prospective, randomized controlled clinical trial comparing PCM cervical disc arthroplasty with anterior cervical discectomy and fusion. Spine (Phila Pa 1976). May 15 2015;40(10):674-683. PMID 25955086

Phillips FM, Lee JY, Geisler FH et al.(2013) A Prospective, randomized, controlled clinical investigation comparing PCM Cervical disc arthroplasty with anterior cervical discectomy and fusion: 2-year results from the US FDA IDE Clinical Trial. Spine (Phila Pa 1976) 2013; 38(15):E907-18.

Phillips FM, Lee JY, Geisler FH et al.(2013) A Prospective, Randomized, Controlled Clinical Investigation Comparing PCM Cervical Disc Arthroplasty With Anterior Cervical Discectomy and Fusion: 2-Year Results From the US FDA IDE Clinical Trial. Spine (Phila Pa 1976) 2013; 38(15):E907-18.

ProDisc-C Summary of safety and effectiveness data. http://www.fda.gov/cdrh/pdf7/p070001b.pdf . Accessed March, 2009.

Radcliff K, Coric D, Albert T.(2016) Five-year clinical results of cervical total disc replacement compared with anterior discectomy and fusion for treatment of 2-level symptomatic degenerative disc disease: a prospective, randomized, controlled, multicenter investigational device exemption clinical trial. J Neurosurg Spine. Mar 25 2016:1-12. PMID 27015130

Radcliff K, Davis RJ, Hisey MS, et al.(2017) Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C(C) Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up. Int J Spine Surg. 2017; 11: 31. PMID 29372135

Riew KD, Buchowski JM, Sasso R et al.(2008) Cervical disc arthroplasty compared with arthrodesis for the treatment of myelopathy. J Bone Joint Surg Am 2008; 90(11):2354-64.

Sasso RC, Anderson PA, Riew KD, et al.(2011) Results of cervical arthroplasty compared with anterior discectomy and fusion: four-year clinical outcomes in a prospective, randomized controlled trial. J Bone Joint Surg Am. Sep 21 2011; 93(18): 1684-92. PMID 21938372

Schroeder GD, Vaccaro AR, Divi SN, et al.(2021) 2021 Position Statement From the International Society for the Advancement of Spine Surgery on Cervical and Lumbar Disc Replacement. Int J Spine Surg. Feb 2021; 15(1): 37-46. PMID 33900955

Staub LP, Ryser C, Roder C, et al.(2016) Total disc arthroplasty versus anterior cervical interbody fusion: use of the Spine Tango registry to supplement the evidence from randomized control trials. Spine J. Feb 2016;16(2):136-145. PMID 26674445

Toci GR, Canseco JA, Patel PD, et al.(2022) The Incidence of Adjacent Segment Pathology After Cervical Disc Arthroplasty Compared with Anterior Cervical Discectomy and Fusion: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. World Neurosurg. Apr 2022; 160: e537-e548. PMID 35085804

U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health.(2009) Report of United States Clinical Study Results (G010188) -- Prestige® Cervical Disc System. http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4243b1_02.pdf . Accessed March, 2009.

U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health.(2012) Summary of safety and effectiveness data: SECURE-C. 2012. Available online at: http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100003b.pdf. Last accessed November, 2013.

U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health.(2013) Summary of Safety and Effectiveness Data: Mobi-C. 2013. Available online at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110002b.pdf. Last accessed November, 2013.

U.S. Food and Drug Administration (FDA).(2023) Summary of Safety and Effectiveness: Simplify Cervical Artificial Disc. https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200022S003B.pdf. Accessed March 6, 2023.

Vaccaro A, Beutler W, Peppelman W, et al.(2013) Clinical outcomes with selectively constrained SECURE-C cervical disc arthroplasty: two-year results from a prospective, randomized, controlled, multicenter investigational device exemption study. Spine (Phila Pa 1976). Dec 15 2013;38(26):2227-2239. PMID 24335629

Vernon H, Mior S.(1991) The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther 1991; 14(7):409-15.

Zhai S, Li A, Li X, et al.(2020) Total disc replacement compared with fusion for cervical degenerative disc disease: A systematic review of overlapping meta-analyses. Medicine (Baltimore). May 2020; 99(19): e20143. PMID 32384498

Zhang HX, Shao YD, Chen Y, et al.(2014) A prospective, randomised, controlled multicentre study comparing cervical disc replacement with anterior cervical decompression and fusion. Int Orthop. Dec 2014;38(12):2533-2541. PMID 25209344

Zigler JE, Delamarter R, Murrey D et al.(2013) ProDisc-C and anterior cervical discectomy and fusion as surgical treatment for single-level cervical symptomatic degenerative disc disease: five-year results of a Food and Drug Administration study. Spine (Phila Pa 1976) 2013; 38(3):203-9.

Zigler JE, Delamarter R, Murrey D et al.(2013) ProDisc-C and anterior cervical discectomy and fusion as surgical treatment for single-level cervical symptomatic degenerative disc disease: five-year results of a Food and Drug Administration study. Spine (Phila Pa 1976) 2013; 38(3):203-9.
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