Medical Policy

Policy Num:      07.001.058
Policy Name:    Artificial Intervertebral Disc: Cervical Spine
Policy ID:          [07.001.058]  [Ac / B / M+ / P+]  [7.01.108]

Last Review:       May 17, 2024
Next Review:      May 20, 2025
 

Related Policies:

07.001.065- Artificial Intervertebral Disc: Lumbar Spine

Artificial Intervertebral Disc: Cervical Spine

Summary

Description

Several prosthetic devices are currently available for cervical disc arthroplasty. Cervical disc arthroplasty is proposed as an alternative to anterior cervical discectomy and fusion for patients with symptomatic cervical degenerative disc disease.

Summary of Evidence

For individuals who have cervical radicular pain or myelopathy who receive single-level cervical disc arthroplasty, the evidence includes randomized controlled trials (RCTs) and meta-analyses of RCTs. Relevant outcomes are symptoms, morbid events, functional outcomes, quality of life, and treatment-related morbidity. At 2 year follow-up, trials of all artificial cervical discs met non-inferiority criteria compared to anterior cervical discectomy and fusion. Mid-term outcomes have been reported on 5 devices (Prestige ST, ProDisc-C, Bryan, Mobi-C, PCM [Porous Coated Motion]). At 4 to 5 years, the trial results have been consistent with the continued non-inferiority of cervical disc arthroplasty for clinical outcomes and lower cumulative reoperation rates. Seven-year follow-up of the Prestige, ProDisc-C, and Mobi-C pivotal trials continue to show lower secondary surgery rates, although this is not a consistent finding in other reports. Serious adverse events appear to be uncommon. Heterotopic ossification can occur in a substantial proportion of spinal segments with artificial intervertebral discs but does not appear to lead to a decline in clinical outcomes. The evidence to date shows outcomes that are at least as good as the standard treatment of anterior cervical discectomy and fusion. There have been no safety signals with discs approved by the U.S. Food and Drug Administration (FDA) for single-level cervical disc arthroplasty. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have cervical radicular pain or myelopathy who receive 2-level cervical disc arthroplasty of the cervical spine, the evidence includes RCTs. Relevant outcomes are symptoms, morbid events, functional outcomes, quality of life, and treatment-related morbidity. FDA approval for the Prestige LP was based on superiority to 2-level anterior cervical discectomy and fusion in overall success at 2 years. The increase in overall success rates at 2 years has been maintained for those patients who have reached the 10-year follow-up. At 2 and 4-year follow-ups, the first artificial cervical disc approved for 2 levels (Mobi-C) was found to be superior to anterior cervical discectomy and fusion for Neck Disability Index scores, Neck Disability Index success rates, reoperation rates, and the overall success composite outcome. At 5 years, trial results were consistent with the continued superiority of 2-level cervical disc arthroplasty for clinical outcomes and lower cumulative reoperation rates. Adjacent-segment degeneration with Mobi-C was found in a significantly lower percentage of patients compared with 2-level anterior cervical discectomy and fusion patients. Based on this evidence, it can be concluded that 2-level cervical disc arthroplasty with either of these FDA-approved discs is at least as beneficial as the established alternative. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Additional Information

Not applicable.

Objective

The objective of this evidence review is to determine whether cervical disc arthroplasty improves the net health outcome compared with anterior cervical discectomy and fusion in patients who have degenerative disc disease.

Policy Statements

Cervical disc arthroplasty may be considered medically necessary when ALL of the following criteria are met:

1. The device is approved by the U.S. Food and Drug Administration (FDA);

2. The individual is skeletally mature;

3. The individual has intractable cervical radicular pain or myelopathy

   1. which has failed at least 6 weeks of conservative nonoperative treatment, including an 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

   2. if the individual has severe or rapidly progressive symptoms of nerve root or spinal cord compression requiring hospitalization or immediate surgical treatment;

4. Degeneration is documented by magnetic resonance imaging, computed tomography, or myelography;

5. Cervical degenerative disc disease is from C3 through C7; and

6. The individual is free from contraindications to cervical disc arthroplasty.

Simultaneous cervical disc arthroplasty at a second contiguous level may be considered medically necessary if the above criteria are met for each disc level, and the device is FDA-approved for 2 levels (eg, Mobi-C®, Prestige LP™).

Subsequent cervical disc arthroplasty at an adjacent level may be considered medically necessary when all of the following 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.

Cervical disc arthroplasty is considered investigational 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

• Translational instability

• Anatomic deformity (eg, ankylosing spondylitis)

• Rheumatoid arthritis or other autoimmune disease

• Presence of facet arthritis

• Active infection

• Metabolic bone disease (eg, osteoporosis, osteopenia, osteomalacia)

• Malignancy.

Policy Guidelines

Investigational uses for cervical disc arthroplasty are derived from pivotal trials' eligibility criteria. Notably, individuals with prior surgery at the treated level were generally excluded from pivotal trials of cervical disc prostheses approved for use in the United States.(Mummaneni et al, 2007; PMID 17355018)(Gornet et al, 2015; PMID 26230424)(Murrey et al, 2009; PMID 18774751)(Heller et al, 2009; PMID 19112337)(Hisey et al, 2015; PMID 25310394)(U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110002b.pdf; Accessed February 27, 2024.)(Vaccaro et al, 2013; PMID 24335629)(U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100003b.pdf; Accessed February 26, 2024.)(Phillips et al, 2021; PMID 33096243)(U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170036, Accessed February 25, 2024 )(U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200022S003B.pdf, Accessed February 24, 2024.)(Coric et al, 2022; PMID 35364570)(U.S. Food and Drug Administration (FDA), https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P090029; Accessed February 23, 2024.)(Davis et al, 2015; PMID 25380538)

Uniquely, a pivotal trial with PCM (porous-coated motion) Cervical Disc® included approximately 12% of individuals with prior adjacent or non-adjacent single-level fusions.(Phillips et al, 2013; PMID 23591659)

Coding

See the Codes table for details.

Benefit Application

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

Background

Cervical Degenerative Disc Disease

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 years, 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.

Treatment

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% to 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 through 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, computed tomography, x-rays): herniated disc and/or osteophyte formation.The FDA required Medtronic (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 in a broader patient population.

Another disc arthroplasty product, the ProDisc-C® (Synthes Spine), was approved by the FDA through the premarket approval process in 2007. As with the Prestige ST Cervical Disc, the FDA approval of ProDisc-C was made conditional on the 7 year follow-up of the 209 subjects included in the non-inferiority trial (discussed in the Rationale section), 7 year follow-up of 99 continued-access subjects, and a 5 year enhanced surveillance study to characterize more fully adverse events when the device is used under general conditions of use. The ProDisc-C Vivo is currently marketed by Centinal Spine.

More recently, continued FDA approval requires the completion of 2 postapproval 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 adverse event data. Continued approval is contingent on the 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 with FDA approval for use in the United States are described in Table 1. These devices are for 1 site or 2 contiguous sites, there are no devices approved for non-contiguous sites. FDA Product Code: MJO

Table 1. Cervical Disc Prostheses Approved for use in the United States

FDA: U.S. Food and Drug Administration; MRI: magnetic resonance imaging; PEEK: polyetheretherketone.  

Rationale

This evidence review was created in October 2006 with searches of the PubMed database. The most recent literature update was performed through February 27, 2024.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Clinical Context and Therapy Purpose

The purpose of artificial intervertebral disc arthroplasty of the cervical spine in patients who have cervical radicular pain or myelopathy is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with symptomatic cervical degenerative disc disease.

Interventions

The therapy being considered is artificial intervertebral disc arthroplasty of the cervical spine.

Comparators

Comparators of interest include anterior cervical discectomy and fusion. Cervical degenerative disc disease is initially treated conservatively using noninvasive measures (eg, rest, heat, ice, analgesics, anti-inflammatory agents, exercise). If symptoms do not improve or resolve within 6 weeks, or if symptoms progress, surgical intervention may be indicated. Candidates for surgical intervention have chronic pain or neurologic symptoms secondary to cervical degenerative disc disease and no contraindications for the procedure.

Outcomes

The general outcomes of interest are symptoms, morbid events, functional outcomes, quality of life, and treatment-related morbidity.

The Neck Disability Index is a validated multidimensional instrument that measures the effects of pain and disability on a patient's ability to manage everyday life.^1, It is a modification of the Oswestry Disability Index, based on responses to 10 questions that focus on neck pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Response options to each question range from 1 to 5, with a lower numeric score representing a better pain and disability status for that variable. A total Neck Disability Index score is obtained by adding individual question scores and dividing by the maximum total of 50 if all questions are answered. Therefore, Neck Disability Index scores range from 0% to 100%, with a lower percentage indicating less pain and disability. Neurologic status is a composite measure of motor function, sensory function, and deep tendon reflexes. It is used to judge whether patients are within normative parameters for those categories based on physiologic measurement. The anterior functional spinal unit height is a radiographic measure of interdiscal space. Comparison of the immediate postoperative functional spinal unit height with the 6-week postoperative value shows whether the disc space has decreased, which indicates that graft or device subsidence has occurred. Other outcome measures may include the 36-Item Short-Form Health Survey Mental and Physical Component Summary scores, 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.

Review of Evidence

Systematic Reviews

Hu et al (2016) published a systematic review and meta-analysis of 8 RCTs (N=2368) reporting mid-term outcomes (at least 48 months) comparing artificial intervertebral disc arthroplasty with anterior cervical discectomy and fusion.^2, This meta-analysis had the highest AMSTAR rating out of 14 meta-analyses published between 2011 and 2017.^3, 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,^4,5, and 3 reported on Neck Disability Index success.^4,5,6, 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=.01). Pooled data also showed a significant benefit of cervical disc arthroplasty for secondary procedures at the index level (6 studies) ^{4,5,7,8,9,10,}; (RR, 0.40; 95% CI, 0.28 to 0.58; p<.001) and at the adjacent level (5 studies) ^4,7,9,10,11,; (RR, 0.42; 95% CI, 0.26 to 0.70; p<.002). These trials and outcome measures are detailed below.

Latka et al (2019) conducted a meta-analysis of RCTs on cervical disc arthroplasty to evaluate safety and long-term efficacy for reducing adjacent segment degeneration.^12, The authors included 20 publications from 13 RCTs (N=3,656) that reported 24 to 60-month results of 1 or 2-level cervical disc arthroplasty versus anterior cervical discectomy and fusion. Visual analog scale for neck pain was lower in patients who had cervical disc arthroplasty (mean difference, -2.30; 95% CI,- 3.72 to -0.87, p=.002) along with the frequency of dysphagia/dysphonia (odds ratio [OR], 0.69; 95% CI, 0.49 to 0.98; p=.04). Adjacent segment degeneration was lower with cervical disc arthroplasty compared to anterior cervical discectomy and fusion (OR, 0.33; 95% CI, 0.21 to 0.50; p=.0001)

Similar findings were reported by Deng et al (2020) in a meta-analysis of 9 studies with 48 to 120 months of follow-up.^13, Symptomatic adjacent-level disease requiring surgery was significantly lower following cervical disc arthroplasty compared to anterior cervical discectomy and fusion.

Population Reference No. 1 

Single-Level Cervical Disc Arthroplasty

The pivotal trials of 9 artificial cervical discs are described in Table 2 (Kineflex is no longer marketed). All of the trials utilized a non-inferiority design that compared cervical disc arthroplasty to the standard of anterior cervical discectomy and fusion with a Food and Drug Administration (FDA)-mandated composite clinical outcome. The studied populations included patients with cervical radiculopathy or myelopathy, and the composite outcome included improvements in disability and neurologic symptoms with an absence of serious adverse events or secondary surgery at the index level. At the 24 month follow-up, all of the trials met non-inferiority and 4 of the 8 trials achieved superiority compared to anterior cervical discectomy and fusion (Table 3). Five of the trials (Prestige ST, ProDisc-C, Bryan, Mobi-C, PCM) have reported follow-up at 3 to 10 years. At 3 to 7 years, trial results are consistent with the continued non-inferiority of cervical disc arthroplasty for clinical outcomes and/or lower cumulative reoperation rates. The pivotal study of the Bryan cervical disc has the longest follow-up at 10 years, with 100 patients per group planned for the post-approval study. Overall success was 81.3% for cervical disc arthroplasty compared to 66.3% for anterior cervical discectomy and fusion (p=.005) There was a statistically significant difference in the improvement of the neck disability index between the groups (cervical disc arthroplasty: -38.3, anterior cervical discectomy and fusion: -31.1, p=.01), but there was no significant difference in arm pain or neurologic success between the cervical disc arthroplasty and anterior cervical discectomy and fusion groups. There was not a statistical difference in secondary surgeries, with 9.7% of cervical disc arthroplasty patients and 15.8% of anterior cervical discectomy and fusion patients requiring secondary surgery at either the index or adjacent level (p=.146).

Table 2. Summary of Pivotal Study Characteristics of Cervical Artificial Intervertebral Discs

ACDF: anterior cervical discectomy and fusion; CDA: cervical disc arthroplasty; FDA SSED: U.S. Food and Drug Administration Summary of Safety and Effectiveness; IDE: investigational device exemption; NDI: neck disability index; RCT: randomized controlled trial. 

Table 3. Summary of Pivotal RCT Results

ACDF: anterior cervical discectomy and fusion; CDA: cervical disc arthroplasty; NDI; neck disability index; RCT: randomized controlled trial. 

Section Summary: Single-Level Cervical Disc Arthroplasty

At 2 year follow-up, the pivotal trials of 9 artificial cervical discs met non-inferiority criteria, with 5 achieving statistical superiority compared to anterior cervical discectomy and fusion. Mid-term outcomes have been reported on 5 devices. At 3 to 7 years, trial results have been consistent with the continued non-inferiority of cervical disc arthroplasty for clinical outcomes and/or lower cumulative reoperation rates. Ten-year follow-up for the Bryan Cervical Disc continues to support the safety and efficacy of cervical disc arthroplasty. Longer-term results for other discs are expected, given the FDA requirement for 7 year postapproval studies of the safety and function of the devices, and 5 to 10 year enhanced surveillance to characterize more fully adverse events in a broader patient population. Serious adverse events appear to be uncommon. Heterotopic ossification can occur in a substantial proportion of spinal segments with artificial intervertebral discs but does not appear to lead to a decline in clinical outcomes.

Summary of Evidence

For individuals who have cervical radicular pain or myelopathy who receive single-level cervical disc arthroplasty, the evidence includes RCTs and meta-analyses of RCTs. Relevant outcomes are symptoms, morbid events, functional outcomes, quality of life, and treatment-related morbidity. At 2-year follow-up, trials of all artificial cervical discs met non-inferiority criteria compared to anterior cervical discectomy and fusion. Mid-term outcomes have been reported on 5 devices (Prestige ST, ProDisc-C, Bryan, Mobi-C, PCM [Porous Coated Motion]). At 4 to 5 years, the trial results have been consistent with the continued non-inferiority of cervical disc arthroplasty for clinical outcomes and lower cumulative reoperation rates. Seven-year follow-up of the Prestige, ProDisc-C, and Mobi-C pivotal trials continue to show lower secondary surgery rates, although this is not a consistent finding in other reports. Serious adverse events appear to be uncommon. Heterotopic ossification can occur in a substantial proportion of spinal segments with artificial intervertebral discs but does not appear to lead to a decline in clinical outcomes. The evidence to date shows outcomes that are at least as good as the standard treatment of anterior cervical discectomy and fusion. There have been no safety signals with discs approved by the FDA for single-level cervical disc arthroplasty. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 2 

Two-Level Cervical Disc Arthroplasty

In 2016, the Prestige LP received FDA approval for implantation at 2 levels.^33, Overall success was achieved in 81.4% of Prestige LP patients and 69.4% of anterior cervical discectomy and fusion controls, meeting both non-inferiority and superiority margin, with a posterior probability of near 100% and 99.3%, respectively (Table 5). Table 5 provides data on patients who reached follow-ups at intervals up to 120 months. The difference in success rates between the Prestige LP and anterior cervical discectomy and fusion patients achieved at 24 months was maintained through 10 years.

Two and 4-year results from the 2-level Mobi-C investigational device exemption trial were reported by Davis et al (2013, 2015) with 5- and 7-year results published by Radcliff et al (2016, 2017).^8,34,35,32,. 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<.001).

Table 4. Summary of Pivotal RCT Characteristics of Cervical Disc Arthroplasty at 2 Continuous Levels

ACDF: anterior cervical discectomy and fusion; CDA: cervical disc arthroplastty; FDA SSED: U.S. Food and Drug Administration Summary of Safety and Effectiveness; NDI: neck disability index; RCT: randomized controlled trial.aOverall success was achieved if the postoperative score improvement in the NDI was ≥15 points, neurological status did not worsen, and no serious implant/surgical procedure–associated adverse event, or second surgery, which was deemed “failure”, occurred.

Table 5. Follow-Up and Success Rates for 2-Level Cervical Discs Compared With 2-Level Anterior Cervical Discectomy and Fusion

ACDF: anterior cervical discectomy and fusion; CDA: cervical disc arthroplasty; FDA: SSED: US Food and Drug Administration Summary of Safety and Effectiveness; NS: not significantly different. a Not all sites were involved in the 10 yr follow-up. Patients who died (n=5) or had withdrawn from the study (n=25) were also excluded from the analysis.

Post hoc analysis of data from the pivotal 1- and 2-level Mobi-C trials was reported by Bae et al (2015).^38, The comparison showed no significant differences between 1- and 2-level cervical disc arthroplasty on clinical outcomes (Neck Disability Index, Visual Analog Scale and 12-Item Short-Form Health Survey scores), major complication rates (4.3% for 1-level cervical disc arthroplasty vs 4.0% for 2-level cervical disc arthroplasty), or subsequent surgery rates (3.0% of 1-level vs 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. Huppert et al (2011) compared outcomes between single-level (n=175) and multilevel (2 to 4 levels, n=56) cervical disc arthroplasty with the Mobi-C device in a prospective multicenter study from Europe.^39, At 2 years, there were no significant differences between groups for overall success, radicular and cervical visual analog scale scores, Neck Disability Index scores, and range of motion There was a trend for more patients in the single-level group than in the 2-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), respectively.

Section Summary: Two-Level Cervical Disc Arthroplasty

The FDA approval for the Prestige LP disc at 2 levels was based on superiority to 2-level anterior cervical discectomy and fusion at 2-year follow-up. At present, over 80% of patients have reached 3-year follow-up, and 85% of expected patients have reached 10-year follow-up. The difference in overall success rates at 2 years has been maintained at 10 years. Secondary outcome measures showed the superiority of cervical disc arthroplasty over anterior cervical discectomy and fusion.

The first artificial cervical disc approved for 2 levels (Mobi-C) was found to be noninferior to anterior cervical discectomy and fusion in the investigational device exemption trial. Superiority to anterior cervical discectomy and fusion was achieved for Neck Disability Index scores, Neck Disability Index success rates, and the overall success composite outcome. Reoperation rates were significantly lower in the Mobi-C group. At 5, and 7 years, trial results were consistent with the continued superiority of 2-level cervical disc arthroplasty for clinical outcomes and lower cumulative reoperation rates. Although a third of patients who received the Mobi-C had clinically significant heterotopic ossification, adjacent-segment degeneration with Mobi-C was found in a lower percentage of patients than in anterior cervical discectomy and fusion patients.

Summary of Evidence

For individuals who have cervical radicular pain or myelopathy who receive 2-level cervical disc arthroplasty of the cervical spine, the evidence includes RCTs. Relevant outcomes are symptoms, morbid events, functional outcomes, quality of life, and treatment-related morbidity. FDA approval for the Prestige LP™ was based on superiority to 2-level anterior cervical discectomy and fusion in overall success at 2 years. The increase in overall success rates at 2 years has been maintained for those patients who have reached the 10-year follow-up. At 2- and 4-year follow-ups, the first artificial cervical disc approved for 2 levels (Mobi-C) was found to be superior to anterior cervical discectomy and fusion for Neck Disability Index scores, Neck Disability Index success rates, reoperation rates, and the overall success composite outcome. At 5 years, trial results were consistent with the continued superiority of 2-level cervical disc arthroplasty for clinical outcomes and lower cumulative reoperation rates. Adjacent-segment degeneration with Mobi-C was found in a significantly lower percentage of patients compared with 2-level anterior cervical discectomy and fusion patients. Based on this evidence, it can be concluded that 2-level cervical disc arthroplasty with either of these FDA-approved discs is at least as beneficial as the established alternative. The evidence is sufficient to determine that the technology results in an improvement in the net health outcome.

Registry Data

Staub et al (2016) evaluated the clinical effectiveness of cervical disc arthroplasty for 987 patients in the Spine Tango registry.^43, The primary outcome measures were neck and arm pain relief and the Core Outcome Measures Index. 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 cervical disc arthroplasty and anterior cervical discectomy and fusion. The mean group differences on a 10 point scale for both pain measures were 0.6 points in postoperative neck pain (p=.04) and 0.7 points in arm pain (p=.02); the mean Core Outcome Measures Index score difference was 0.8 points (p=.01). Change scores did not differ significantly. The probability of being a responder (2-point change) was significantly better in the cervical disc arthroplasty group than in the anterior cervical discectomy and fusion group for arm pain relief (78.4% vs. 67.4% ; p=.02) and Core Outcome Measures Index score (81.6% vs. 67.9% ; p<.01) but not neck pain relief (62.1% vs. 57.9% ; p-value not significant), respectively.

For patients who would have been excluded from the RCTs, most commonly due to an age greater than 60 years or spondylosis, there were no significant differences in clinical outcomes between cervical disc arthroplasty and anterior cervical discectomy and fusion. A third analysis compared outcomes of cervical disc arthroplasty with anterior cervical discectomy and fusion in patients who had a follow-up of more than 2 years (mean, 55.0 months; range, 27.0 to 76.5 months). After controlling for patient age, patients treated with cervical disc arthroplasty had significantly higher responder rates for arm pain relief (80.0%) compared with patients treated with anterior cervical discectomy and fusion (64.9%; p=.05), with no significant difference in responder rates between groups for neck pain relief or Core Outcome Measures Index. Rates of adjacent-level degeneration and secondary surgeries were not assessed.

MacDowall et al compared 5-year outcomes of cervical disc arthroplasty and anterior cervical discectomy and fusion from the Swedish Spine Registry.^44, Using propensity matching, the investigators identified 185 patients in each group who had cervical degenerative disc disease and radiculopathy. The primary outcome was the Neck Disability Index, with a minimum clinically important difference of >15%. Scores on the Neck Disability Index were halved in both groups, but there was no significant difference (3.0%; 95% CI, -8.4 to 2.4; p=.28) between the groups. There were also no differences between the groups in EuroQol-5 Dimensions or in pain scores for the neck and arm.

Limitations of registry studies include the possibility of selection bias, which can be reduced by propensity matching.

Adverse Events

Heterotopic ossification appears to be common with cervical disc arthroplasty but there is no evidence of a large impact on clinical outcomes. A meta-analysis by Chen et al (2012) evaluating rates of heterotopic ossification (McAfee grade 3-4) after cervical disc arthroplasty included 8 studies (N=617 patients).^45, The pooled prevalence of any heterotopic ossification was 58.2% at 24 months after cervical disc arthroplasty and the pooled prevalence of advanced heterotopic ossification was 16.7% after 24 months.

Nunley et al (2018) evaluated the effect of heterotopic ossification on clinical outcomes.^46, Heterotopic ossification was radiographically graded for 164 1-level and 225 2-level cervical disc arthroplasty patients from the Mobi-C pivotal trials and correlated with clinical outcomes. At 7 years, clinically relevant (grade 3 or 4) heterotopic ossification that affects range of motion was present in 28.7% of 1-level patients and 37.4% of 2-level patients. Patients were divided into non-clinically relevant heterotopic ossification and clinically relevant (motion restricting) heterotopic ossification. Arm pain and 12-Item Short Form Health Survey scores were not significantly different between the groups. There was an interaction between heterotopic ossification and time for the Neck Disability Index (p=.04), with a statistically significant difference between groups of 4.0 beginning at 48 months. There was also a statistical interaction between heterotopic ossification and visual analog scale neck pain, with a difference of 5 to 8 mm out of 100. The clinical significance of these differences is uncertain.

Supplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Clinical Input From Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2015 Input

In response to requests, input was received from 3 physician specialty societies and 2 academic medical centers while this policy was under review in 2015. There was agreement that cervical disc replacement may be medically necessary under specified conditions. Likewise, there was agreement that combined use of an artificial disc and fusion over 2 levels was investigational. Input was mixed on the medical necessity of 2-level artificial intervertebral disc arthroplasty.

2009 Input

In response to requests, input was received from 2 physician specialty societies and 2 academic medical centers while this policy was under review in 2009. Input did not support the conclusion that artificial intervertebral disc arthroplasty is investigational.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

International Society for the Advancement of Spine Surgery

In 2021, the International Society for the Advancement of Spine Surgery issued a position statement on cervical and lumbar disc replacement.^49, 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 [Food and Drug Administration], 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."

National Institute for Health and Care Excellence

In 2010, NICE issued guidance on the artificial cervical disc, concluding that:^50,

"Current evidence on the efficacy of prosthetic intervertebral disc replacement in the cervical spine shows that this procedure is as least as efficacious as fusion in the short term and may result in a reduced need for revision surgery in the long term. The evidence raises no particular safety issues that are not already known in relation to fusion procedures….

This procedure should only be carried out in specialist units where surgery of the cervical spine is undertaken regularly.

NICE encourages further research into prosthetic intervertebral disc replacement in the cervical spine. Research outcomes should include long-term data on the preservation of mobility, occurrence of adjacent segment disease, and avoidance of revision surgery."

U.S. Preventive Services Task Force Recommendations

Not applicable.

Medicare National Coverage

A search of the Medicare National Database identified a national coverage determination on artificial intervertebral discs for the lumbar spine but not for the cervical spine.^51,

Ongoing and Unpublished Clinical Trials

Some currently ongoing and unpublished trials that might influence this review are listed in Table 6.

Table 6. Summary of Key Trials

NCT: national clinical trial.a Denotes industry-sponsored or cosponsored trial.

References

1. Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther. Sep 1991; 14(7): 409-15. PMID 1834753
2. Hu Y, Lv G, Ren S, et al. 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 Meta-Analysis of Eight Prospective Randomized Controlled Trials. PLoS One. 2016; 11(2): e0149312. PMID 26872258
3. Zhai S, Li A, Li X, et al. 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
4. Burkus JK, Traynelis VC, Haid RW, et al. 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
5. Sasso RC, Anderson PA, Riew KD, et al. 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
6. Phillips FM, Geisler FH, Gilder KM, et al. 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
7. Coric D, Kim PK, Clemente JD, et al. 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. Jan 2013; 18(1): 36-42. PMID 23140129
8. Davis RJ, Nunley PD, Kim KD, et al. 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 follow-up results. J Neurosurg Spine. Jan 2015; 22(1): 15-25. PMID 25380538
9. Hisey MS, Bae HW, Davis RJ, et al. 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): E237-43. PMID 25310394
10. Janssen ME, Zigler JE, Spivak JM, et al. 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 04 2015; 97(21): 1738-47. PMID 26537161
11. Zhang HX, Shao YD, Chen Y, et al. A prospective, randomised, controlled multicentre study comparing cervical disc replacement with anterior cervical decompression and fusion. Int Orthop. Dec 2014; 38(12): 2533-41. PMID 25209344
12. Latka D, Kozlowska K, Miekisiak G, et al. 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. Ther Clin Risk Manag. 2019; 15: 531-539. PMID 30992666
13. Toci GR, Canseco JA, Patel PD, et al. 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
14. Deng Y, Li G, Liu H, et al. 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
15. Peng Z, Hong Y, Meng Y, et al. 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
16. Mummaneni PV, Burkus JK, Haid RW, et al. Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. J Neurosurg Spine. Mar 2007; 6(3): 198-209. PMID 17355018
17. Gornet MF, Burkus JK, Shaffrey ME, et al. Cervical disc arthroplasty with PRESTIGE LP disc versus anterior cervical discectomy and fusion: a prospective, multicenter investigational device exemption study. J Neurosurg Spine. Nov 2015; 23(5): 558-573. PMID 26230424
18. Murrey D, Janssen M, Delamarter R, et al. 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 cervical disc disease. Spine J. Apr 2009; 9(4): 275-86. PMID 18774751
19. Heller JG, Sasso RC, Papadopoulos SM, et al. 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). Jan 15 2009; 34(2): 101-7. PMID 19112337
20. Hisey MS, Bae HW, Davis R, et al. 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
21. U.S. Food and Drug Administration (FDA). Summary of Safety and Effectiveness Data (SSED): Mobi-C. 2013; https://www.accessdata.fda.gov/cdrh_docs/pdf11/P110002b.pdf. Accessed February 25, 2024.
22. Phillips FM, Lee JY, Geisler FH, et al. 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). Jul 01 2013; 38(15): E907-18. PMID 23591659
23. Vaccaro A, Beutler W, Peppelman W, et al. 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): 2227-39. PMID 24335629
24. U.S. Food and Drug Administration (FDA). Summary of Safety and Effectiveness Data (SSED): SECURE-C. 2012; https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100003b.pdf. Accessed February 24, 2024.
25. U.S. Food and Drug Administration (FDA). Summary of Safety and Effectiveness: M6-C Artificial Cervical Disc. 2019. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170036. Accessed February 23, 2024.
26. Phillips FM, Coric D, Sasso R, et al. Prospective, multicenter clinical trial comparing M6-C compressible six degrees of freedom cervical disc with anterior cervical discectomy and fusion for the treatment of single-level degenerative cervical radiculopathy: 2-year results of an FDA investigational device exemption study. Spine J. Feb 2021; 21(2): 239-252. PMID 33096243
27. U.S. Food and Drug Administration (FDA) Summary of Safety and Effectiveness: Simplify Cervical Artificial Disc. https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200022S003B.pdf. Accessed February 27, 2024.
28. Burkus JK, Haid RW, Traynelis VC, et al. Long-term clinical and radiographic outcomes of cervical disc replacement with the Prestige disc: results from a prospective randomized controlled clinical trial. J Neurosurg Spine. Sep 2010; 13(3): 308-18. PMID 20809722
29. Delamarter RB, Murrey D, Janssen ME, et al. Results at 24 months from the prospective, randomized, multicenter Investigational Device Exemption trial of ProDisc-C versus anterior cervical discectomy and fusion with 4-year follow-up and continued access patients. SAS J. 2010; 4(4): 122-8. PMID 25802660
30. Zigler JE, Delamarter R, Murrey D, et al. 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). Feb 01 2013; 38(3): 203-9. PMID 23080427
31. Delamarter RB, Zigler J. Five-year reoperation rates, cervical total disc replacement versus fusion, results of a prospective randomized clinical trial. Spine (Phila Pa 1976). Apr 20 2013; 38(9): 711-7. PMID 23124255
32. Lavelle WF, Riew KD, Levi AD, et al. Ten-year Outcomes of Cervical Disc Replacement With the BRYAN Cervical Disc: Results From a Prospective, Randomized, Controlled Clinical Trial. Spine (Phila Pa 1976). May 01 2019; 44(9): 601-608. PMID 30325888
33. Hisey MS, Zigler JE, Jackson R, et al. 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
34. Radcliff K, Davis RJ, Hisey MS, et al. Long-term Evaluation of Cervical Disc Arthroplasty with the Mobi-C© Cervical Disc: A Randomized, Prospective, Multicenter Clinical Trial with Seven-Year Follow-up. Int J Spine Surg. 2017; 11(4): 31. PMID 29372135
35. Sasso WR, Ye J, Foley DP, et al. 20-year Clinical Outcomes of Cervical Disk Arthroplasty: A Prospective, Randomized, Controlled Trial. Spine (Phila Pa 1976). Jan 01 2024; 49(1): 1-6. PMID 37644726
36. Foley DP, Sasso WR, Ye JY, et al. Twenty-Year Radiographic Outcomes Following Single-Level Cervical Disc Arthroplasty: Results From a Prospective Randomized Controlled Trial. Spine (Phila Pa 1976). Mar 01 2024; 49(5): 295-303. PMID 38018773
37. Coric D, Guyer RD, Bae H, et al. Prospective, multicenter study of 2-level cervical arthroplasty with a PEEK-on-ceramic artificial disc. J Neurosurg Spine. Apr 01 2022: 1-11. PMID 35364570
38. U.S. Food and Drug Administration. Summary of Safety and Effectiveness: Prestige LP Cervical Disc. PMA Number P090029/S003. 2016; https://www.accessdata.fda.gov/cdrh_docs/pdf9/p090029s003b.pdf. Accessed February 22, 2024.
39. Davis RJ, Kim KD, Hisey MS, et al. 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: clinical article. J Neurosurg Spine. Nov 2013; 19(5): 532-45. PMID 24010901
40. Radcliff K, Coric D, Albert T. 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. Aug 2016; 25(2): 213-24. PMID 27015130
41. U.S. Food and Drug Administration (FDA). Report of United States Clinical Study Results (G010188) -- Prestige LP Cervical Disc System. 2014; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P090029 Accessed February 26, 2024.
42. Gornet MF, Lanman TH, Burkus JK, et al. Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial. J Neurosurg Spine. Jun 21 2019: 1-11. PMID 31226684
43. Bae HW, Kim KD, Nunley PD, et al. Comparison of Clinical Outcomes of 1- and 2-Level Total Disc Replacement: Four-Year Results From a Prospective, Randomized, Controlled, Multicenter IDE Clinical Trial. Spine (Phila Pa 1976). Jun 01 2015; 40(11): 759-66. PMID 25785955
44. Huppert J, Beaurain J, Steib JP, et al. Comparison between single- and multi-level patients: clinical and radiological outcomes 2 years after cervical disc replacement. Eur Spine J. Sep 2011; 20(9): 1417-26. PMID 21336970
45. Staub LP, Ryser C, Röder C, et al. 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): 136-45. PMID 26674445
46. MacDowall A, Skeppholm M, Lindhagen L, et al. Artificial disc replacement versus fusion in patients with cervical degenerative disc disease with radiculopathy: 5-year outcomes from the National Swedish Spine Register. J Neurosurg Spine. Nov 02 2018; 30(2): 159-167. PMID 30485205
47. Chen J, Wang X, Bai W, et al. Prevalence of heterotopic ossification after cervical total disc arthroplasty: a meta-analysis. Eur Spine J. Apr 2012; 21(4): 674-80. PMID 22134486
48. Nunley PD, Cavanaugh DA, Kerr EJ, et al. Heterotopic Ossification After Cervical Total Disc Replacement at 7 Years-Prevalence, Progression, Clinical Implications, and Risk Factors. Int J Spine Surg. Jun 2018; 12(3): 352-361. PMID 30276092
49. Schroeder GD, Vaccaro AR, Divi SN, et al. 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
50. National Institute for Health and Care Excellence (NICE). Prosthetic intervertebral disc replacement in the cervical spine [IPG341]. 2010; https://www.nice.org.uk/guidance/ipg341. Accessed February 27, 2024.
51. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Lumbar Artificial DISC Replacement (LADR) (150.10). 2007; https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?NCDId=313&ncdver=2&CoverageSelection=National&KeyWord=disc&KeyWordLookUp=Title&Key WordSearchType=And&from2=search.asp&bc=gAAAACAAAAAAAA%3d%3d&. Accessed February 27, 2024.

Codes

Policy History