Clinical UM Guideline

 

Subject: Cervical Total Disc Arthroplasty
Guideline #:  CG-SURG-60 Publish Date:    08/29/2018
Status: Reviewed Last Review Date:    07/26/2018

Description

This document addresses the use of United States (U.S.) Food & Drug Administration (FDA) approved (Pre-Market Approval [PMA]) cervical artificial intervertebral discs in cervical total disc arthroplasty to treat symptomatic cervical disc disease (SCDD) when conservative treatment options have been unsuccessful.  Cervical total disc arthroplasty, cervical total disc replacement (TDR) or cervical artificial disc replacement (CADR) refers to the surgical removal of a degenerative cervical disc (total discectomy) and replacement with an artificial cervical disc device, which is implanted to maintain the capability of motion and structural integrity of the intervertebral space.

Cervical artificial intervertebral discs addressed in this document include:

Note: For information regarding related topics, please see the following:

Clinical Indications

Medically Necessary:

Implantation of a Bryan Cervical Disc, Mobi-C Cervical Disc Prosthesis, PCM Cervical Disc System, Prestige Cervical Disc System, ProDisc-C Total Disc Replacement, or Prestige LP cervical artificial intervertebral disc at a single level is considered medically necessary when all of the individual selection criteria are met.

Implantation of a Mobi-C or Prestige LP Cervical Disc Prosthesis at two contiguous levels is considered medically necessary when all of the individual selection criteria are met.

 

Individual Selection Criteria

For all devices listed above, the individual must meet the following criteria:

  1. The individual is skeletally mature; and
  2. Replacement of a degenerated cervical disc is limited to levels between and including C3-C4 to C6-C7; and
  3. The individual does not have a previously implanted cervical artificial intervertebral disc device at another cervical level; and
  4. The individual has one or more of the following:
    1. A cervical radicular neurologic deficit; or
    2. Myelopathy due to a single-level abnormality localized to the disc space; or
    3. Intractable cervical radicular pain which has failed at least 6 weeks of conservative, non-operative treatment; and 
  5. An FDA-approved cervical artificial intervertebral device is used in accordance with FDA labeling and will be implanted using an anterior approach; and
  6. Imaging studies (for example, computed tomography [CT], magnetic resonance imaging [MRI], myelography and CT, x-rays, etc.) confirm one or more of the following at the disc space identified on neurological exam:
    1. Herniated nucleus pulposus; or
    2. Osteophyte formation; or
    3. Visible loss of disc height compared to adjacent levels; and
  7. The individual is free from contraindications to cervical total disc arthroplasty including, but not limited to those on the FDA label and all of the following:
    1. Active systemic infection or infection localized to the site of implantation; and
    2. Bone density which does not meet the minimum level specified for the implanted device*; and
    3. Marked cervical instability on neutral resting lateral or flexion/extension radiographs; with greater than 3 mm translation or greater than 11 degrees of angular difference to either adjacent level; and
    4. Clinically compromised vertebral bodies at the affected level due to:
      1. Current or past trauma (for example, radiographically confirmed fracture callous, malunion or nonunion); or
      2. Anatomical deformity (for example rheumatoid arthritis, ankylosing spondylitis); or
      3. Cervical spine malignancy; and
    5. Moderate or severe spondylosis at the level to be treated, characterized by any of the following:
      1. Bridging osteophytes; or
      2. Loss of greater than 50% normal disc height; or
      3. Two degrees or less motion, as measured on lateral flexion-extension plain radiographs; and
    6. Symptoms of cervical degenerative disc disease which are not localized to the disc space(s) to be treated.

* A dual energy X-Ray absorptiometry (DEXA) scan is not required for all individuals, but is indicated for individuals with an increased risk of osteoporosis; see CG-MED-39 Central (Hip or Spine) Bone Density Measurement and Screening for Vertebral Fractures Using Dual Energy X-Ray Absorptiometry.  See Appendix A FDA Device Specific definitions of inadequate bone density as defined by DEXA T-score for minimum bone density specifications (T-score) for each cervical artificial intervertebral disc device.

Not Medically Necessary:

Cervical total disc arthroplasty at a single level is considered not medically necessary for all other devices including, but not limited to Secure-C Cervical Artificial Disc.

Cervical total disc arthroplasty at two contiguous levels is considered not medically necessary for all other devices.

Cervical total disc arthroplasty at more than two levels or at two non-contiguous levels is considered not medically necessary for all indications.

Cervical total disc arthroplasty is considered not medically necessary when the criteria above are not met.

Hybrid constructs in a single procedure, involving cervical fusion with cervical total disc arthroplasty is considered not medically necessary for all indications.

Cervical total disc arthroplasty in an individual with a previous fusion at another cervical level is considered not medically necessary for all indications.

Coding

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

CPT

 

22856

Total 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 [Note: when billed as part of a hybrid procedure disc arthroplasty is considered not medically necessary]

22858

Total 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 [when specified as Mobi-C or Prestige LP device]

0095T

Removal of total disc arthroplasty, (artificial disc), anterior approach, each additional interspace, cervical [when specified as Mobi-C or Prestige LP device]

0098T

Revision including replacement of total disc arthroplasty (artificial disc), anterior approach, each additional interspace, cervical [when specified as Mobi-C or Prestige LP device]

 

Note: the following procedure (0375T) is considered always not medically necessary

0375T

Total disc arthroplasty (artificial disc), anterior approach, including discectomy with end plate preparation (includes osteophytectomy for nerve root or spinal cord decompression and microdissection), cervical, three or more levels

 

 

ICD-10 Procedure

 

0RR30JZ

Replacement of cervical vertebral disc with synthetic substitute, open approach

 

 

ICD-10 Diagnosis

 

 

All diagnoses

   
Discussion/General Information

Degenerative disc disease (DDD) affects 40-50% of people over the age of 40 and becomes increasingly common with advancing age.  Although it can occur at any spinal level, including the cervical spine (neck) it is most common in the lumbar spine (low back).  Disc degeneration is a complex biochemical process that occurs with the loss of normal water content within the disc resulting in the deterioration of the mechanical shock absorbing properties of the disc over time.  This will lead to bulging and decreased disc height.  The most frequent cause attributed to DDD is the natural aging process, although various associated factors may accelerate the process.  Not all individuals with disc degeneration are symptomatic with pain.

The most commonly used decompressive procedure for the cervical spine is anterior cervical discectomy and fusion (ACDF).  The procedure removes the damaged areas of the disc and fuses the remaining vertebral segment, eliminating the motion between adjacent vertebral segments, and thus reducing the pain.  The loss of mobility at the treatment segment fusion alters the biomechanics of the back, increasing the stress on adjacent segments, potentially leading to premature disc degeneration and adjacent segment disease (ASD) (Zhang, 2016).  Artificial discs have been developed as an alternative to cervical fusion.  This approach is intended to maintain motion and the normal biomechanics of the adjacent vertebrae.  A common complication of disc replacement is heterotopic ossification (HO), with incidence of HO ranging from 7.3% to 69.2%.  HO can lead to intervertebral fusion and reduced range of motion, depending upon the grade or severity of involvement (Zhou, 2015).

Bryan Cervical Disc System

The Bryan Cervical Disc System received FDA PMA on May 12, 2009.  The FDA labeling states that this device is indicated in skeletally mature individuals for reconstruction of the discs from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy that is refractory to 6 weeks of conservative therapy.  The PMA is contingent upon a 10 year (120 months) post-approval study (PAS) to evaluate long-term safety and effectiveness.  The Bryan Cervical Disc is a composite-type artificial disc designed with a low friction, wear resistant, elastic nucleus with two anatomically shaped metal plates.  A flexible membrane forms a sealed space and contains a lubricant to reduce friction, wear and tear.

Sasso and colleagues (2007b) conducted a prospective, randomized study comparing the functional outcome of single level cervical disc replacement with the Bryan Cervical Disc System to an anterior cervical fusion.  A total of 110 participants were enrolled and results of 99 participants were reported at 24 months.  Clinical outcomes for neck and arm pain were measured using Neck Disability Index (NDI), Visual Analog Scale (VAS) and Short Form-36 (SF-36).  At the 24-month follow-up, NDI for the Bryan group was 11 and the control group was 20 (p=0.005).  The mean arm pain VAS before surgery was 70 (Bryan) and 71 (control), and at the 24-month follow-up, the average arm pain VAS for the Bryan group was 14 and control 28 (p=0.014).  The mean neck pain VAS before surgery was 72 (Bryan) and 73 (control); 24-month follow-up: 16 (Bryan) and 32 (control) (p=0.005).  SF-36 scores: Physical component before surgery Bryan 34 and control 32; at 24 months: Bryan 51 and control 46 (p=0.009).  More motion was retained after surgery in the disc replacement group than the plated group at the treated level.  The disc replacement group retained an average of 7.9 degrees of flexion-extension.  In contrast, the average range of motion (ROM) in the fusion group was 0.6 degrees.  Overall, the Bryan device maintained ROM without degradation over 24 months.

Heller and colleagues (2009) in a prospective, randomized, controlled multicenter (30 sites) trial studied 242 participants who received the Bryan cervical disc and 221 participants who received ACDF.  At 24 months, 230 in the Bryan group and 194 in the ACDF group were available for evaluation.  Both groups had statistically significant reductions in the NDI at 24 months, however, the Bryan  group had a higher proportion of a greater than 15 point reduction in NDI than the ACDF group.  Both groups had reductions in neck and arm pain at each follow-up interval over 24 months; however, the Bryan group improvement was greater in all postoperative intervals.  SF-36 and neurologic success results were similar for both groups and not statistically significant.  Overall success was 82.6% in the Bryan group and 72.7% in the ACDF group.  The difference of 9.9% was statistically significant.  ROM increased only slightly in the Bryan group.  The authors stated that ROM values measured radiographically can be influenced by anatomy, technique, interpretation, or the individual’s motivation and may not indicate mechanical failure of the device.  In total, 117 individuals declined participation after randomization.  One reason for withdrawal was dissatisfaction with the assigned group.  Another limitation of the study, similar to Sasso and colleagues’ (2007b), is the short follow-up period.

Garrido and colleagues (2010) reported a 48-month, single site, follow-up from a randomized study of 47 participants as part of a multicenter study of the Bryan cervical disc.  A total of 38 participants were available at 48 months.  The Bryan cervical disc (n=18) group was compared to those having ACDF (n=20).  The Bryan disc compared favorably with ACDF for functional data analysis.  Reoperation for adjacent disc disease was necessary for 1 person in the Bryan group and 3 in the ACDF group.  The authors noted that although the outcomes supported the Bryan disc, a limitation of this study was the low number of participants precluding their ability to detect a statistical difference.

Sasso and colleagues (2011) reported 48-month follow-up data from the FDA investigational device exemption (IDE) prospective, randomized trial of the Bryan disc arthroplasty compared to ACDF.  A total of 242 participants were randomized to the arthroplasty group with the Bryan disc device and 221 participants were randomized to the ACDF group.  This is an ongoing PAS required by the FDA as part of the PMA.  A total of 181 of 242 participants who had arthroplasty, and 138 of 221 who had fusion, were available for evaluation at 48 months.  The primary endpoint of this ongoing study is a composite measure termed ‘overall success’ consisting of the primary effectiveness and safety measures.  To achieve overall success, participants had to meet all of the following: NDI improvement of ≥ 15 points, neurological improvement, no serious adverse events related to implant or procedure and no subsequent intervention classified as a treatment failure.  The NDI and SF-36 were used for assessment of pain and function.  Standardized neurological examinations were performed by the investigator or nursing staff where success was defined as maintenance or improvement of all three neurological parameters (i.e. motor and sensory function and reflexes).  All imaging was read by independent radiologists.  Cervical flexion and extension motion was assessed by cervical dynamic lateral radiographs using the Cobb measurement technique.  At the 48-month postoperative mark, overall success was achieved in 85.1% of the arthroplasty group and 75.5% in the fusion group.  No deterioration over time occurred in either group.  The authors acknowledged that subjects lost to follow-up at 48 months was a limitation of this study and may lead to attrition bias affecting the study validity.  Another limitation, not acknowledged by the authors, was that the study randomization was not blinded to the participants, which could have also introduced bias.  The authors also noted that there was no deterioration of implants at 48 months and longer follow-up is necessary to assess potential problems related to implant surface wear.

Quan (2011) reported 96-month (8-year) follow-up data from a prospective study of 30 consecutive individuals who had been treated with the Bryan cervical disc at a single institution.  Data on 9 individuals was incomplete.  Of the 21 individuals with available data, 15 participants had a single-level disc procedure and 6 participants had a two-level disc replacement procedure.  At 96 months, there was a higher rate of HO (66.7%) in multilevel operated segments compared to single-level operated segments (33.3%).  There were no additional surgeries required at the arthroplasty or adjacent levels for any of the participants at follow-up.  Eighteen of 21 participants had complete relief of preoperative symptoms and were able to carry out daily occupations without impairment.  Ten participants (47.6%) reported no neck pain and the average VAS for neck pain was 1.7 (range=0-8) for all participants.  The authors noted although the incidence of HO restricting movement appeared to increase with time, the physiological range of movement at the index site was maintained 78% of the time.  There were no serious complications or cases of prosthetic wear or failure reported.  The authors concluded, “More long-term outcomes are needed to verify the promising clinical results of cervical arthroplasty.”

A prospective study of 20 consecutive individuals who received the Bryan cervical disc and had 60-month (5-year) clinical follow-up data was reported by Ryu (2013).  The purpose of the study was to describe the long-term kinematic behavior of the Bryan cervical disc based on ROM, functional spinal unit (FSU) angle, anterior disc height (ADH), posterior disc height (PDH), sagittal translation, and center of rotation (COR).  All subjects had immediate relief of radiculopathy and/or myelopathy with no operative or device-related complications.  There was no significant change in the mean ROM from the preoperative value compared to the postoperative value (9.4 ± 5.0°).  Preoperative ROM, sagittal translation and COR were maintained up to 60 months after surgery.  There was no significant loss of disc height or kyphotic changes observed in the adjacent levels.  The long-term observations support the Bryan cervical disc prosthesis allowed functional spinal motion and maintained pre-operative kinematics of the cervical spine at the index level.  The authors noted limitations of this study included the small size and suboptimal quality of images. 

In 2013, Hacker and colleagues reported on the results of an earlier clinical trial in which participants were randomized to receive ACDF or the Bryan cervical disc (n=28).  A total of 4 of the 28 participants with artificial discs returned with pain and complications thought to be associated with their device; 2 at 4 years post-operation and 2 at 5 years post-operation.  Two of the participants ultimately had the device removed with subsequent ACDF.  The remaining 2 participants’ imaging revealed bone loss; 1 resolved after 1 year and the other was lost to follow-up.  Authors conclude that potential recipients of cervical arthroplasty require longer follow-up time frames than that of ACDF due to the potential for ‘very late’ development of device-related complications which are largely unknown with ACDF.  These complications include device malfunction, infection, failure of fusion or osteointegration of the device into adjacent vertebral bodies.

Mobi-C Cervical Disc

In 2016, Hisey and colleagues published 60-month follow-up results of a prospective, RCT comparing cervical TDR using the Mobi-C device (n=164) with ACDF (n=81) at a single level.  The follow-up rate was 85.5% in the Mobi-C group and 78.9% in the ACDF group.  A successful outcome was defined as meeting all of the following criteria: a minimum 30/100 point improvement in NDI scores compared to baseline (68.1% in the TDR group versus 62.1% in the ACDF group), no device-related subsequent surgery (3.0% in the TDR group versus 11.1% in the ACDF group) or adverse events (5.5% in the TDR group versus 3.7% in the ACDF group), no neurologic deterioration (4.3% in the TDR group versus 6.2,% in the ACDF group) and no intraoperative changes in treatment if randomized to the Mobi-C group (none reported).  At 60 months follow-up, 61.9% of individuals in the Mobi-C group and 52.2% of ACDF individuals were classified as having achieved overall success.  Grade 4 HO severe enough to measurably limit motion was reported in 8.5% of individuals in the Mobi-C group.  The authors note that Mobi-C produced results non-inferior to ACDF.

Radcliff and associates conducted a prospective, multicenter, randomized, controlled IDE trial to compare the outcomes of two-level contiguous cervical total disc replacement (TDR) using Mobi-C (n=225) versus ACDF (n=105) and report on the 5-year post-operative results (2016).  At 5 years, the follow-up rates for TDR and ACDF were 90.7% and 86.7% respectively.  Both groups reported significant improvements in NDI and VAS arm and neck pain from baseline at all points with greater improvements in the TDR group.  The TDR group underwent fewer secondary surgeries than in the ACDF group (TDR 7.1% [16/225] versus ACDF 21.0% [22/105]) (p=0.0006).  Device removal was the most common reason for a subsequent surgery in the TDR group, with the authors surmising that the device was removed to correct adjacent-level pathology rather than revise the index level.  There were no significant differences in the adverse event rate between the ACDF and TDR group.

Jackson and colleagues published the 5-year results of a prospective, multicenter, unblinded randomized clinical trial comparing the subsequent surgery rates of individuals who received either TDR with the Mobi-C device or ACDF at one or two contiguous levels (2016).  The subsequent surgery rate was defined as “any operation that occurred at the initial treatment level or at adjacent levels after the primary operation.”  A total of 260 individuals were included in the single-level study, 179 underwent TDR and 81 underwent ACDF surgery.  At 5 years, the occurrence of subsequent surgical intervention for one-level surgeries was significantly higher in the ACDF group (TDR 4.5% [8/179] versus ACDF 17.3% [14/81]; p=0.0012).  Subsequent surgeries involving the index level were 3.4% (6/179) in the TDR group and 12.3% (10/81) in the ACDF group.  Subsequent surgeries involving an adjacent level were 2.2% (4/179) in the TDR group and 11.1% (9/81) in the ACDF group.  A total of 339 individuals were included in the two-level arm of the study, 234 underwent TDR and 105 individuals underwent ACDF surgery.  At 5 years, the occurrence of subsequent surgical intervention for two-level surgeries was significantly higher in the ACDF group (TDR 7.3% [17/234] versus 21% [22/105]; p=0.0007).  Subsequent surgeries involving an index level were 4.7% (11/234) for TDR and 18.1% (19/105) for ACDF.  Subsequent surgeries involving an adjacent level were 3.4% (8/234) for the TDR group and 11.4% (12/105) for the ACDF group.  The study suggests that TDR with the Mobi-C device results in lower rates of adjacent-level disease than ACDF.

PCM Cervical Disc System

The PCM Cervical Disc received FDA PMA on October 26, 2012.  The device consists of a plastic spacer between an upper and a lower metal plate.  This allows for the preservation of disc height and flexion.  It is indicated in skeletally mature individuals for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy with or without neck pain and/or myelopathy.  The individual should have failed at least 6 weeks of conservative treatment.  The PMA is contingent upon a 7-year post-approval study (PAS) to evaluate long-term safety and effectiveness.

Phillips and colleagues (2015) reported on the long-term data from a multicenter randomized controlled trial.  The reported results include 5 year effectiveness and 7 year safety of the PCM cervical disc as compared to ACDF as treatment of symptomatic single-level degenerative spondylosis in individuals with or without prior cervical fusion.  Approximately 13% (29/218) of the individuals who underwent surgical treatment with the PCM cervical disc had a prior adjacent or non-adjacent single level fusion.  Results for this small group of individuals were not reported separately.  Follow-up rates at 60 months were reported as 74.8% (163/218) for PCM and 70.3% (130/185) for ACDF, which is comparable with other long-term cervical arthroplasty studies.  In addition, adverse events and secondary surgical procedure rates were available on 31.2% (68/218) PCM and 22.7% (42/185) ACDF individuals at 7 years postoperatively.  At 5 years, the PCM group reported mean better scores over ACDF in NDI score (20.4 versus 28.5, p=0.001) and neck pain VAS (p=0.002).  In the SF-36 survey, scores for both treatment groups were significantly improved over preoperative scores (p<0.001).  At 5 years, a clinically significant improvement of 15% or more was reported in both the physical component (PCM 73.7%, ACDF 56.7%; p=0.004) and mental component (PCM 46.2%, ACDF, 54.3%; p=0.189).  The neurological success rate was reported as 92.4% in the PCM group as compared to 87.5% in the ACDF group (p=0.229).  At 5 years, the mean flexion/extension ROM was 5.2 degrees (SD: 3.8 degrees, range: 0 degrees to 16.1 degrees) in the PCM groups as compared to 0.5 degrees (SD: 0.5 degrees, range 0 degrees to 4.1 degrees) in the ACDF group.  There were no statistically significant differences in the incidence of serious adverse events between the two groups during the first 2 years of follow-up.  Between 2 and 7 years, new serious adverse events occurred in 21.0% (45/214) of the PCM group versus 17.4% (33/190) of the ACDF group.  While the majority of the events were systemic or medical, 1 PCM case (0.5%) and 2 ACDF cases (1.1%) were device related.  The incidence of heterotopic ossification for the PCM group was reported at 6.7% (10/149) for Grade III and 6.0% (9/149) for Grade IV.

Prestige Cervical Disc System

The Prestige Cervical Disc System received FDA PMA on July 16, 2007.  This device consists of two main metal pieces, superior (upper) and inferior (lower) parts that move with respect to one another by a ball and trough mechanism.  It is indicated in skeletally mature individuals for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy.  Clinical trial outcomes have been published on this device with short-term follow-up data and inconclusive results of safety and efficacy.  Some of the short-comings of these studies, aside from lack of long-term follow-up, include non-blinded randomization and high rates of loss to follow-up (Burkus, 2010; Mummaneni, 2007).  More recently, results of the 7-year (84-month) PAS evaluating the long-term safety and effectiveness of the Prestige Cervical Disc have been published.

In 2014, Burkus and colleagues published the results of an FDA IDE, non-blinded, RCT which included 541 individuals with single-level cervical DDD and radiculopathy.  Participants at 32 medical sites were randomly assigned to one of two treatment groups: 276 in the investigational group and 265 in the control group.  The investigational group underwent anterior cervical discectomy and decompression and artificial intervertebral disc arthroplasty (AIDA) with the Prestige Cervical Disc.  The control group underwent an allograft ACDF.  The study groups were well matched demographically and appropriate for surgical fusion.  Primary outcomes of interest included NDI, SF-36, and neck and arm pain scores.  Radiographic images were also used to determine angle of motion and fusion.  Follow-up occurred at 8 time points up to 84 months (7 years).  Of the 541 participants enrolled, 73% were evaluable at 84-month follow-up (212 disc replacements and 183 fusions).  Study investigators found that the investigational arm of the study had statistically and clinically significant improvements from baseline, and compared to the control group, in NDI (p=0.002), SF-36 (p=0.017) and neck pain scores (p=0.004), in addition to neuralgic symptoms (p=0.011).  The investigational group maintained or increased angular motion at the site of disc replacement when compared to first follow-up of 1.5 months.  In the investigational group, 1 participant showed disc migration and 5 had broken or fractured Prestige screws, compared to the control group that had no occurrences of graft migration or screw fracturing.  Over 95% of participants in both groups reported at least one adverse event (not statistically different).  The investigational group was less likely to report spinal events (p<0.001) and the control group less likely to report urogenital events (p=0.024).  No difference was found in the incidence of dysphagia or dysphonia; common complications following anterior cervical spine procedures.  The rates of HO reported in this trial present the lowest rates reported of RCTs evaluating similar devices.  Results of this large, randomized clinical trial demonstrate the safety and long-term effectiveness of Prestige Cervical Disc as equitable or better than standard of care, ACDF, in the treatment of cervical-DDD at the single-level.

Prestige LP Cervical Disc System

The Prestige LP Cervical Disc is a newer system, FDA approved in 2014, which differs from the original Prestige Cervical Disc. The Prestige LP disc is implanted with two rails that are positioned off the midline spine instead of utilizing bone screws.  In addition, the older Prestige Cervical disc is composed of steel, and the Prestige LP disc is made of a titanium-ceramic composite.

In 2015, Gornet and associates reported on the results of a prospective, multicenter IDE study for Prestige LP which compared the safety and efficacy of the Prestige LP cervical disc device to a historical control group of individuals who had received ACDF.  A total of 280 individuals with single-level cervical disc disease received an implant at a single level between C-3 to C-7.  The outcomes at 24 months in this treatment group were compared to the outcomes of an ACDF historical control group (n=265) in which the same surgical approach was used.  The primary clinical endpoint, overall success, was determined using the following components: at least a 15 point improvement in NDI, maintain or improve neurological status, no more than a 2 mm decline in disc height, no serious implant or implant/surgical procedure-related AE and no secondary surgical procedure classified as a “failure”.  At 24 months, results were available for 97.1% of the investigational group and 84.0% of the historical control group.  Compared with the control group, the investigational group had numerically higher rates of NDI and neurological status success, while the control group had numerically higher success rates in disc height maintenance.  The investigational group reported a higher success rate in arm pain while the control group reported a higher success rate in neck pain.  Serious, device/procedure-related AEs were similar in the investigational (5.0%) and the control (4.9%) groups.  In the investigational group 9.6% (31 AEs in 27 individuals) versus 5.7% (21 AEs in 15 individuals) reported incidents of HO, although no formal grading was done.  At 24 months, both groups reported a similar percentage of participants undergoing secondary surgeries at an adjacent level (2.5% in the investigational group and 4.2% in the control group).  The authors concluded that both groups reported significantly improved clinical outcomes when compared to baseline, with the investigational group being statistically non-inferior to the historical control group at 24 months.

In 2016, Gornet and colleagues reported on the 84-month follow-up results of the Prestige LP IDE trial. The follow-up rate was 75.9% in the Prestige LP investigational group and 70.0% in the historical control ACDF group.  Both groups showed significant improvements in pain and disability scores at 84 months when compared to preoperative assessments.  The results at 84 months were similar to the 24-month results.  The investigational group achieved higher numerical rates of NDI success, neurological status success, as well as greater arm pain reduction.  The control group achieved higher numerical success in disc height and neck pain reduction.  Device/procedure-related AEs in the investigational group were reported as 17.5% compared to 16.6% of the control group.  Serious device/procedure-related AEs were similar across both groups: 6.1% in the investigational group compared to 5.6% in the control group.  While the study used a historical control group rather than a randomized group, the long-term results are compelling enough to support the non-inferiority of implantation of the Prestige LP device at one level.

Gornet and associates conducted a prospective, multicenter RCT which compared the Prestige LP at two adjacent levels to ACDF, in order to demonstrate non-inferiority of the Prestige LP device (2017).  Individuals with a diagnosis of degenerative disc disease (DDD) were randomized to receive Prestige LP (n=209) or ACDF (n=188) and were followed up to 24 months.  The primary endpoint, overall success, was a composite of both safety and efficacy endpoints, including an improvement of at least 15 points on the NDI scale, maintaining or improving neurological status, no serious device or procedure related AEs and no additional revision surgery.  The overall success rate was 81.4% in the Prestige LP group and 69.4% in the ACDF group.  There was no statistical difference between the groups in terms of AEs [Prestige LP; 93.3% (195/209) versus ACDF; 92.0% (173/188)], but the ACDF group had a higher rate of Grade 3 or 4 AEs [Prestige LP; 34.4% (72/209) versus ACDF; 47.9% (90/188)].  HO was reported at 27.8% (55/198) in the superior level and at 36.4% (72/198) at 24 months.  The authors noted that success rates were similar for individuals with and without severe HO.

In 2017, Lanman and colleagues reported on the 84-month follow-up results of the Prestige LP two adjacent level trial.  The follow-up rate was 76.2% in the Prestige LP group and 74.1% in the ACDF.  The overall success rates were as follows:

Follow-up (months)

Prestige LP

ACDF

36

81.6%

70.5%

60

79.6%

65.9%

84

78.6%

75.6%

At 84 months, the reported rate of serious implant or implant/surgical related AEs (Grade 3 or 4) was 3.2% in the Prestige LP group and 7.2% in the ACDF group.  The occurrence rate for second surgeries was lower in the Prestige LP group (4.2%) versus the ACDF group (14.7%).  Grade IV HO rates at either the superior or inferior level at 60 and 84 months were 11.5% and 11.9% respectively.  The authors noted that the Prestige LP was statistically superior to ACDF in the overall success rate and statistically non-inferior to ACDF in every outcome measure at 60 and 84 months.

ProDisc-C Total Disc Replacement

The ProDisc-C Total Disc Replacement device is used for disc replacement in the cervical spine and received FDA PMA in December 2007.  The FDA labeled indications for ProDisc-C Total Disc Replacement use includes those who:

The PMA is contingent upon a 7-year (84-month) PAS to evaluate long-term safety and effectiveness of the ProDisc-C Total Disc Replacement.

Nabhan (2007) studied ACDF compared to ProDisc-C prosthesis.  A total of 33 participants with refractory symptomatic cervical soft disc herniation were randomized into two treatment groups; one group was treated with ACDF and the other group was treated with cervical disc prosthesis.  Radiostereometric analysis (RSA) was used to quantify intervertebral motion immediately as well as at 3, 6, 12 and 24 weeks postoperatively.  Of the 33 participants, 8 were excluded during first RSA measurement due to some markers being obscured.  Additional clinical results were evaluated using the VAS and neurological examination.  The study results found that cervical spine segmental motion decreased over time in the presence of disc prosthesis or ACDF.  However, the loss of segmental motion was significantly higher in the ACDF group, when looked at 3, 6, 12 and 24 weeks after surgery.  Significant pain reduction was observed in the neck and arm postoperatively, without significant difference between both groups (p≥0.05).  The authors acknowledged that the study was small, thus larger studies with longer follow-up are warranted. 

Murrey (2009) reported a 24-month follow-up to determine the safety and efficacy of ProDisc-C in comparison with ACDF.  A total of 209 individuals with SCDD were included and received either the ProDisc-C or ACDF.  Of those participants included, 103 received the PRODISC-C implant and 106 were treated with fusion; participants were blinded to intervention until surgery was completed.  Follow-up between 6 weeks and 24 months was reported to be 85% (178 participants) in the summary of safety and effectiveness data.  Reasons for the loss to follow-up were not described.  Non-inferiority was achieved for the FDA-defined combined endpoint of neurologic examination, NDI, adverse events, and device success, with 72% of ProDisc-C and 68% of fusion individuals achieving success in all four component endpoints.  Clinical outcomes at 24 month follow-up were reported to be similar in the ProDisc-C and fusion groups for the following components: neurological success (91% vs. 88%, respectively), NDI (21.4 vs. 20.5 points), reduction in VAS pain scores (e.g., 46 mm vs. 43 mm), and participant satisfaction (83 mm vs. 80 mm).  Limitations of this study are the 24-month follow-up, precluding conclusions about long-term device performance, adjacent disc degradation and the possibility of revision surgery.

Delamarter and colleagues (2010) reported the results from the 24-month prospective, randomized, multicenter IDE trial of the ProDisc-C versus ACDF with 36-month follow-up, including continued access (CA) individuals.  A total of 209 individuals (n=103 ProDisc-C; n=106 ACDF), an additional 136 CA individuals, were treated at 13 sites.  From August 2003 to October 2004, 209 randomized individuals continued follow-up for 84 months.  After closure of randomized enrollment in 2004, an additional series of 136 CA participants had ProDisc-C disc replacement surgery from March 2005 to January 2008.  Evaluations included NDI, VAS for pain/satisfaction, radiographic and physical/neurologic examinations.  VAS pain and NDI score improvements from baseline were significant for all participants (p≤0.0001) but did not differ among groups.  VAS neck and arm pain intensity assessments indicated statistically significant improvement from preoperative scores regardless of treatment (p≤0.0001).  However, the scores varied during the interval evaluations.  Likewise, in the SF-36, regardless of treatment or time points, there was a statistically significant improvement in SF-36 scores from baseline (p≤0.0016).  Radiography and secondary surgeries were reported, showing that the ProDisc-C and CA groups had better outcomes.  A limitation to this study is participant accountability.  No information regarding those lost to follow-up was given.  The authors concluded that both TDR and ACDF are viable surgical options for individuals with SCDD and that both groups continue to show good clinical results at longer-term follow-up.

Zigler and colleagues (2013) published 60-month results from the ProDisc-C FDA study.  The rates of follow-up at 60 months were 72.7% (72/99 participants) for ProDisc-C and 63.5% (61/96 participants) for ACDF.  The authors utilized a sensitivity analysis using the LOCF method.  The interim data at 60 months were published, as the participants continue to be followed out to 84 months.  There was a statistically and clinically significant improvement maintained at 60 months, compared to baseline measurements.  The NDI scores had improved for both ProDisc-C and ACDF groups approximately 50% to 60% change from baseline (p<0.0001).  At 24 or 60 months, there were no significant differences between groups for the percentage changes.  Both groups had a high level of satisfaction as evidenced by the VAS scale at 60-months (86.56 for ProDisc-C and 82.74 for ACDF).  Mean flexion-extension ROM was maintained at 24 and 60 months compared to preoperative measurement for individuals treated with ProDisc-C.  However, for the ACDF participants, ROM at the index level was significantly reduced at 60 months (1.02 degrees) compared to preoperative value (7.88 degrees).  There were no device migrations of greater than 3 mm detected in either group at 60 months.  One individual with the ProDisc-C device had device subsidence and disc height decrease of greater than 3 mm.  The overall incidence of adverse events in the ProDisc-C group was 11.7% and 20.8% for the ACDF group.  The ProDisc-C cohort had a significantly different secondary surgery rate of 2.9% compared to 11.3% for the ACDF group (p=0.0292). 

In a companion study, Delamarter (2013) provided an interim report of the secondary surgical procedures performed up to 60 months from the ProDisc-C FDA IDE trial.  Excluded from the analysis were death not related to the study treatment (n=2, ProDisc-C; n=3, ACDF) and withdrawal from long-term follow-up (n=2 ProDisc-C; n=7 ACDF).  There was a statistically significant higher probability of no secondary surgery to the index and adjacent levels for individuals treated with ProDisc-C (97.1%) compared to ACDF (85.5%) (p=0.0079).  There were no ProDisc-C implant breakages or failures at 60 months.  Three ProDisc-C treated individuals had reoperations to address persistent pain and/or adjacent-level degeneration.  The device was removed in 2 participants and converted to anterior fusions.  The third ProDisc-C device was left intact with a posterior foraminotomy and fusion with stabilization.  Twelve ACDF individuals had reoperations, with 3 having more than one procedure.  There were a total of 16 reoperations, 8 at the index level and 8 for adjacent level degenerative disease.  The authors concluded based on the 60-month interim data, TDR with ProDisc-C demonstrated a significant sparing effect on the adjacent levels. 

Other devices

In 2012, the Secure-C Cervical Artificial Disc received FDA PMA which allows the manufacturer to commercially deliver the device.  Although data from studies with short-term follow-up are emerging, newer devices do not have long-term published data to support their safety and efficacy at this time (Alvin, 2014).  The FDA has required each device to complete a 7-year PAS to evaluate the long-term safety and effectiveness. 

Some contraindications from the FDA labels for the artificial intervertebral cervical disc devices include the following:

The International Society for the Advancement of Spine Surgery (ISASS) Policy Statement-Cervical Artificial Disc (Coric, 2014) notes cervical arthroplasty is indicated when individuals meet the following criteria:

Both the North American Spine Society’s (NASS) Coverage Policy Recommendation (Baisden, 2015) and the ISASS policy statement on Cervical Artificial Disc (2014) include recommendations for CADR at one and two levels. These recommendations were based on studies with several limitations, including limited 2-year follow-up, use of a device which is only FDA approved for use at a single level and a study comparing single- and two-level CADR; with no comparison to the current gold standard fusion. 

A meta-analysis by Zhao and colleagues (2015) compared the outcomes of multi-level and single-level cervical disc arthroplasty (CDA) for the treatment of cervical spondylosis and disc diseases. The studies included four prospective and four retrospective studies; a total of 506 individuals in the single-level group and 240 individuals in the multi-level group.  At 24 months post-operative, there was no significant difference between the groups in NDI, radicular VAS, and cervical VAS. The success rate, which includes both functional improvement and absence of revision surgery, was 69 and 66% in the single- and the multi-level groups, respectively (p=0.727). In addition, there was no significant difference in the incidence of reoperation or in the incidence of HO between the studies. While seven of the eight studies were reported as relatively high-quality, there were no RCTs included in the meta-analysis.  Clinical heterogeneity is high due to multiple variations including different indications for surgery, different prosthesis and different surgical techniques. The authors noted that while the results suggested that multi-level CDA is as effective as single-level CDA.

Hybrid constructs
Hybrid constructs or hybrid surgery (HS) combine fusion with CADR in a single procedure.  The intent of the hybrid construct is to avoid multi-level fusion and maintain cervical motion when the individual has more than one level of SCDD. 

Several studies have compared HS with standard surgical procedures such as ACDF, anterior cervical corpectomy and fusion (ACCF), or ADR in individuals with multilevel disc disease.  While the majority of the studies focused on two-level surgery, three and four levels were also included.  Artificial discs utilized in the studies included Bryan, Prodisc-C, and Prestige.  Studies were small (n=21-42) and with short-term follow-up (12-40 months).  Postoperative results, such as NDI, VAS, and ROM were comparable between the groups, and in some cases, statistically improved in the HS groups.  While the hybrid construct appears to be promising and a valid option in the treatment of symptomatic multilevel cervical DDD, the current studies do not support long term safety and efficacy of hybrid procedures (Barbagallo, 2009; Ding, 2014; Hey, 2012; Mao, 2015; Shin, 2009).

Jia and colleagues (2014) conducted the first systematic review of hybrid approaches to treatment of multilevel cervical DDD.  Fifteen studies, including eight biomechanical studies and seven clinical studies, were chosen for inclusion.  Although authors found that the current body of literature demonstrates improvement in validated functional scores after HS and comparable or favorable complications rates, “…the overall quality of evidence for HS was low to very low.”

Recent meta-analysis of HS and ACDF has reported comparable outcomes in pain relief between the two procedures, and superior outcomes in preservation of cervical ROM. However, the meta-analysis included primarily small prospective and retrospective studies. Studies involving different indications for surgery, implants and surgical techniques result in high clinical heterogeneity. The authors have noted that more well-designed large studies with long-term follow-up are needed to evaluate benefit and reliability of HS (Zang, 2015; Zhang, 2016).
The use of cervical artificial intervertebral discs in hybrid constructs and at multiple consecutive levels continues to be evaluated.  However, at this time, the available data from small samples published in the peer-reviewed medical literature do not permit conclusions regarding the long-term net health outcomes, safety and efficacy of hybrid constructs as a treatment for DDD affecting multiple levels and the effects on adjacent cervical levels.  The 2015 NASS Coverage Policy Recommendation notes that “strong evidence based recommendations for CADR adjacent to a previous fusion cannot be made at this time”.  

Cervical total disc arthroplasty after a prior fusion
Phillips and colleagues (2009) reported data from the prospective IDE trial of PCM artificial discs.  Between 2005 and 2007, 126 individuals received TDR with the PCM cervical artificial disc as the primary procedure.  A total of 26 individuals, previously treated with a cervical fusion, received the PCM device at an adjacent level.  After surgery, both groups had significant improvements in the NDI and VAS neck and arm pain scores compared to baseline (p=0.001).  Surgical revisions were required by 2 participants in each group, with a rate of 1.6% in the primary procedure group and 7.7% in the adjacent-to-fusion group.  The authors reported, “The data suggests TDR adjacent to a prior fusion is a viable treatment option.”  However, limitations of this study include the small number of participants in the adjacent to fusion group and the short follow-up of 24 months. 

The Phillips and colleagues (2015) study evaluating the long term results of PCM device implantation compared to ACDF included individuals with and without previous fusion.  However, clinical outcomes for those with a history of previous fusion could not be evaluated as results were not reported separately for these two study populations.

Definitions

Arthroplasty: A surgical procedure in which an artificial joint replaces a damaged joint.

Contiguous disc levels: Disc levels located adjacent (next) to each other.

Degenerative disc disease (DDD): Discogenic back pain (that is, emanating from the vertebral disc) associated with degenerative arthritic changes in the disc, which can be visualized by imaging technology (e.g., x-ray, MRI).

Herniated nucleus pulposus: A condition in which part, or all, of the soft, gelatinous central portion of an intervertebral disk is forced through a weakened part of the disk, resulting in back pain and nerve root irritation.

Heterotopic ossification (HO): Any abnormal bone formation within extraskeletal tissues.

Intervertebral discs: Soft tissues that sit between each vertebra; these discs act as cushions between the vertebrae.

Laminectomy: A surgical procedure for treating spinal stenosis by relieving pressure on the spinal cord; the lamina of the vertebra is removed or trimmed to widen the spinal canal and create more space for the spinal nerves.

Myelopathy: Functional and/or pathologic change in the spinal cord.

Neurogenic: Originating in the nervous system.

Osteoporosis: A condition in which there is reduced bone strength (bone mass and bone quality) resulting in a higher risk of fractures.

Radiculopathy: The irritation of a nerve root at any level of the spine which can be caused by protrusion of a disc.

Vertebrae: Bones that make up the spinal column, which surround and protect the spinal cord.

References

Peer Reviewed Publications:

  1. Alvin MD, Mroz TE. The Mobi-C cervical disc for one-level and two-level cervical disc replacement: a review of the literature. Med Devices (Auckl). 2014; 7:397-403.
  2. Anderson PA, Hashimoto R. Total disc replacement in the cervical spine: a systematic review evaluating long-term safety. Evid Based Spine Care J. 2012; 3(S1):9-18.
  3. Barbagallo GM, Assietti R, Corbino L, et al. Early results and review of the literature of a novel hybrid surgical technique combining cervical arthrodesis and disc arthroplasty for treating multilevel degenerative disc disease: opposite or complementary techniques? Eur Spine J. 2009; 18 Suppl 1:29-39.
  4. Bartels RH, Donk R, Verbeek AL. No justification for cervical disk prostheses in clinical practice: a meta-analysis of randomized controlled trials. Neurosurgery. 2010; 66(6):1153-1160.
  5. Beaurain J, Bernard P, Dufour T, et al. Intermediate clinical and radiological results of cervical TDR (Mobi-C) with up to 2 years of follow-up. Eur Spine J. 2009; 18(6):841-850.
  6. Blumenthal SL, Ohnmeiss DD, Guyer RD, Zigler JE. Re-operations in cervical total disc replacement compared with anterior cervical fusion: results compiled from multiple prospective FDA IDE trials conducted at a single site. Spine (Phila Pa 1976). 2013; 38(14):1177-1182.
  7. Burkus JK, Haid RW, Traynelis VC, Mummaneni PV. 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. 2010; 13(3):308-318.
  8. Burkus JK, Traynelis VC, Haid RW Jr, Mummaneni PV. Clinical and radiographic analysis of an artificial cervical disc: 7-year follow-up from the Prestige prospective randomized controlled clinical trial. J Neurosurg Spine. 2014; 21(4):516-528.
  9. Coric D, Finger F, Boltes P. Prospective randomized controlled study of the Bryan Cervical Disc: early clinical results from a single investigational site. J Neurosurg Spine. 2006; 4(1):31-35.
  10. 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. J Neurosurg Spine. 2013; 19(5):532-545.
  11. 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. 2015; 22(1):15-25.
  12. Delamarter R, Murrey D, Janssen M, 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 Journal. 2010; 4(4):122-128.
  13. Garrido BJ, Taha TA, Sasso RC. Clinical outcomes of Bryan cervical disc arthroplasty: a prospective, randomized, controlled, single site trial with 48-month follow-up. J Spinal Disord Tech. 2010; 23(6):367-371.
  14. 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. 2015; 23(5):558-573.
  15. Gornet MF, Burkus JK, Shaffrey ME, et al. Cervical disc arthroplasty with Prestige LP Disc versus anterior cervical discectomy and fusion: seven-year outcomes. Int J Spine Surg. 2016; 10:24.
  16. Gornet MF, Lanman TH, Burkus JK, et al. Cervical disc arthroplasty with the Prestige LP disc versus anterior cervical discectomy and fusion, at 2 levels: results of a prospective, multicenter randomized controlled clinical trial at 24 months. J Neurosurg Spine. 2017; 26(6):653-667.
  17. Hacker FM, Babcock RM, Hacker RJ. Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site. Spine (Phila Pa 1976). 2013; 38(26):2223-2226.
  18. Harrod CC, Hilibrand AS, Fischer DJ, Skelly AC. Adjacent segment pathology following cervical motion-sparing procedures or devices compared with fusion surgery: a systematic review. Spine (Phila Pa 1976). 2012; 37(22 Suppl):S96-S112.
  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. 2009; 34(2):101-107.
  20. Hey HW, Hong CC, Long AS, Hee HT. Is hybrid surgery of the cervical spine a good balance between fusion and arthroplasty? Pilot results from a single surgeon series. Eur Spine J. 2013; 22(1):16-22.
  21. 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. 2015; 28(4):E237-243.
  22. 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.
  23. Hu Y, Lv G, Ren S, Johansen D. 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.
  24. Jackson RJ, Davis RJ, Hoffman GA, et al. Subsequent surgery rates after cervical total disc replacement using a Mobi-C Cervical Disc Prosthesis versus anterior cervical discectomy and fusion: a prospective randomized clinical trial with 5-year follow-up. J Neurosurg Spine. 2016; 24(5):734-745.
  25. Jaramillo-de la Torre JJ, Grauer JN, Yue JJ. Update on cervical disc arthroplasty: where are we and where are we going? Curr Rev Musculoskelet Med. 2008; 1(2):124-130.
  26. Jaumard NV, Bauman JA, Guarino BB, et al. ProDisc cervical arthroplasty does not alter facet joint contact pressure during lateral bending or axial torsion. Spine (Phila Pa 1976). 2013; 38(2):E84-E93.
  27. Jia Z, Mo Z, Ding F, et al. Hybrid surgery for multilevel cervical degenerative disc diseases: a systematic review of biomechanical and clinical evidence. Eur Spine J. 2014; 23(8):1619-1632.
  28. Kan L, Kang J, Gao R, et al. Clinical and radiological results of two hybrid reconstructive techniques in noncontiguous 3-level cervical spondylosis. J Neurosurg Spine. 2014; 21(6):944-950.
  29. Kang L, Lin D, Ding Z, et al. Artificial disk replacement combined with midlevel ACDF versus multilevel fusion for cervical disk disease involving 3 levels. Orthopedics. 2013; 36(1):e88-e94.
  30. Kim SH, Chung YS, Ropper AE, et al. Bone loss of the superior adjacent vertebral body immediately posterior to the anterior flange of Bryan cervical disc. Eur Spine J. 2015 Dec; 24(12):2872-2879.
  31. Lanman TH, Burkus JK, Dryer RG, et al. Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial. J Neurosurg Spine. 2017; 27(1):7-19.
  32. Mao N, Wu J, Zhang Y, et al. A comparison of anterior cervical corpectomy and fusion combined with artificial disc replacement and cage fusion in patients with multilevel cervical spondylotic myelopathy. Spine (Phila Pa 1976). 2015; 40(16):1277-1283.
  33. Mummaneni PV, Amin BY, Wu JC, et al. Cervical artificial disc replacement versus fusion in the cervical spine: a systematic review comparing long-term follow-up results from two FDA trials. Evid Based Spine Care J. 2012; 3(S1):59-66.
  34. 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. 2007; 6(3):198-209.
  35. 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. 2009; 9(4):275-286.
  36. Nabhan A, Ahlhelm F, Pitzen T, et al. Disc replacement using PRODISC-C® versus fusion: a prospective randomized and controlled radiographic and clinical study. Eur Spine J. 2007; 16(3):423-430.
  37. Park SB, Kim KJ, Jin YJ, et al. X-ray based kinematic analysis of cervical spine according to prosthesis designs: analysis of the Mobi C, Bryan, PCM, and Prestige LP. J Spinal Disord Tech. 2015; 28(5):E291-E297.
  38. Phillips FM, Allen TR, Regan JJ, et al. Cervical disc replacement in patients with and without previous adjacent level fusion surgery: a prospective study. Spine (Phila Pa 1976). 2009; 34(6):556-565.
  39. 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). 2015; 40(10):674-683.
  40. Phillips FM, Lee JY, Geisler FH, et al. A prospective, randomized, controlled clinical investigation comparing PCM® cervical disc arthroplasty to anterior cervical discectomy and fusion: 2 year results from the US FDA IDE clinical trial. Spine (Phila Pa 1976). 2013; 38(15):E907-E918.
  41. Pocock SJ. The pros and cons of noninferiority trials. Fundamental Clin Pharmacol. 2002; (17):483-490.
  42. Porchet F, Metcalf NH. Clinical outcomes with the Prestige II cervical disc: preliminary results from a prospective randomized clinical trial. Neurosurg Focus. 2004; 1517(3):E6.
  43. Quan GM, Vital JM, Hansen S, Pointillart V. Eight-year clinical and radiological follow-up of the Bryan cervical disc arthroplasty. Spine (Phila Pa 1976). 2011; 36(8):639-646.
  44. 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. 2016; 25(2):213-224.
  45. Riew KD, Schenk-Kisser JM, Skelly AC. Adjacent segment disease and C-ADR: promises fulfilled? Evid Based Spine Care J. 2012; 3(S1):39-46.
  46. Robertson JT, Metcalf NH. Long-term outcome after implantation of the Prestige I disc in an end-stage indication: 4-year results from a pilot study. Neurosurg Focus. 2004; 1517(3):E10.
  47. Ryu WH, Kowalczyk I, Duggal N. Long-term kinematic analysis of cervical spine after single-level implantation of Bryan cervical disc prosthesis. Spine J. 2013; 13(6):628-634.
  48. Sasso RC, Anderson PA, Riew KD, Heller JG. 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. 2011; 93(18):1684-1692.
  49. Sasso RC, Best NM, Metccalf NH, Anderson PA. Motion analysis of Bryan cervical disc arthroplasty versus anterior discectomy and fusion: results from a prospective, randomized, multicenter, clinical trial. J Spinal Disord Tech. 2008; 21:393-399.
  50. Sasso RC, Smucker JD, Hacker RJ, Heller JG. Artificial disc versus fusion: a prospective, randomized study with 2-year follow-up on 99 patients. Spine. 2007a; 32(26):2933-2940.
  51. Sasso RC, Smucker JD, Hacker RJ, Heller JG. Clinical outcomes of BRYAN® cervical disc arthroplasty: a prospective, randomized, controlled, multicenter trial with 24-month follow-up. J Spinal Disord Tech. 2007b; 20(7):481-491.
  52. Shin DA, Yi S, Yoon D, et al. Artificial disc replacement combined with fusion versus two-level fusion in cervical two-level disc disease. Spine (Phila Pa 1976). 2009; 34(11):1153-1159.
  53. Singh K, Phillips FM, Park DK, et al. Factors affecting reoperations after anterior cervical discectomy and fusion within and outside of a Federal Drug Administration investigational device exemption cervical disc replacement trial. Spine J. 2012; 12(5):372-378.
  54. Upadhyaya CD, Wu JC, Trost G, et al. Analysis of the three United States Food and Drug Administration investigational device exemption cervical arthroplasty trials. J Neurosurg Spine. 2012; 16(3):216-228.
  55. Yi S, Oh J, Choi G, et al. The fate of heterotopic ossification associated with cervical artificial disc replacement. Spine (Phila Pa 1976). 2014; 39(25):2078-2083.
  56. Yin S, Yu X, Zhou S, et al. Is cervical disc arthroplasty superior to fusion for treatment of symptomatic cervical disc disease? A meta-analysis. Clin Orthop Relat Res. 2013; 471(6):1904-1919.
  57. Zang L, Ma M, Hu J, et al. Comparison of hybrid surgery incorporating anterior cervical discectomy and fusion and artificial arthroplasty versus multilevel fusion for multilevel cervical spondylosis: a meta-analysis. Med Sci Monit. 2015; 21:4057-4067.
  58. Zhang J, Meng F, Ding Y, et al. Hybrid surgery versus anterior cervical discectomy and fusion in multilevel cervical disc diseases: a meta-analysis. Medicine (Baltimore). 2016; 95(21):e3621.
  59. 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. 2014; 38(12):2533-2541.
  60. Zhang Z, Zhu W, Zhu L, Du Y. Midterm outcomes of total cervical total disc replacement with Bryan prosthesis. Eur J Orthop Surg Traumatol. 2014; 24 Suppl 1:S275-281.
  61. Zhao H, Cheng L, Hou Y, et al. Multi-level cervical disc arthroplasty (CDA) versus single-level CDA for the treatment of cervical disc diseases: a meta-analysis. Eur Spine J. 2015; 24(1):101-112.
  62. Zhou HH, Qu Y, Dong RP, et al. Does heterotopic ossification affect the outcomes of cervical total disc replacement? A meta-analysis. Spine (Phila Pa 1976). 2015; 40(6):E332-E340.
  63. 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). 2013; 38(3):203-209.
  64. Zou S, Gao J, Xu B, et al. Anterior cervical discectomy and fusion (ACDF) versus cervical disc arthroplasty (CDA) for two contiguous levels cervical disc degenerative disease: a meta-analysis of randomized controlled trials. Eur Spine J. 2017; 26(4):985-997.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. North American Spine Society (NASS). Cervical artificial disc replacement: defining appropriate coverage positions. Revised 2015.
  2. Blue Cross Blue Shield Association. Artificial intervertebral disc arthroplasty for treatment of degenerative disc disease of the cervical spine. TEC Assessment, 2008; 22(12).
  3. Blue Cross Blue Shield Association. Artificial intervertebral disc arthroplasty for treatment of degenerative disc disease of the cervical spine. TEC Assessment, 2011; 26(5).
  4. Blue Cross Blue Shield Association. Artificial intervertebral disc arthroplasty for treatment of degenerative disc disease of the cervical spine. TEC Assessment, 2014; 28(13).
  5. Boselie TF, Willems PC, van Mameren H, et al. Arthroplasty versus fusion in single-level cervical degenerative disc disease. Cochrane Database Syst Rev. 2012;(9):CD009173.
  6. Coric D. ISASS Policy Statement - Cervical Artificial Disc. Int J Spine Surg. 2014; 8. Available at: http://www.isass.org/public_policy/2014-04-23-isass-policy-statement-cervical-artificial-disc.html. Accessed on June 21, 2018.
  7. North American Spine Society (NASS). Diagnosis and Treatment of Cervical Radiculopathy from Degenerative Disorders. 2010. Available at: https://www.spine.org/Portals/0/Documents/ResearchClinicalCare/Guidelines/CervicalRadiculopathy.pdf. Accessed on June 21, 2018.
  8. U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) Database. BRYAN® Cervical Disc. P060023. Rockville, MD: FDA. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P060023. Accessed on June 21, 2018.
  9. U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) Database. Mobi-C® Cervical Disc Prosthesis. P110002, P110009. Rockville, MD: FDA. August 7, 2013; August 23, 2013. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P110002S019; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P110009. Accessed on June 21, 2018.
  10. U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) Database. PCM® Cervical Disc System. P060018. Rockville, MD: FDA. October 26, 2012. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P100012. Accessed on June 21, 2018.
  11. U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) Database. PRESTIGE® Cervical Disc System. P060018. Rockville, MD: FDA. July 16, 2007. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P060018. Accessed on June 21, 2018.
  12. U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) Database. PRESTIGE® LP Cervical Disc. P090029. Rockville, MD: FDA. July 24, 2014. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P090029. Accessed on June 21, 2018.
  13. U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) Database. PRODISC®-C Total Disc Replacement. P070001. Rockville, MD: FDA. December 17, 2007. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P070001. Accessed on June 21, 2018.
  14. U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) Database. SECURE®-C Total Disc Replacement. P100003. Rockville, MD: FDA. September 28, 2012. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100003b.pdf. Accessed on June 21, 2018.
  15. United States Preventive Services Task Force (USPSTF). Draft Recommendation Statement Osteoporosis to Prevent Fractures: Screening. Available at: https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/osteoporosis-screening#table-1-osteoporosis-screening-recommendations-of-other-organizations. Accessed on June 21, 2018.
Websites for Additional Information
  1. American Academy of Orthopedic Surgeons (AAOS). Herniated Disk. Last reviewed November 2012. Available at: http://orthoinfo.aaos.org/topic.cfm?topic=A00334. Accessed on June 21, 2018.
  2. International Society for the Advancement of Spine Surgery (ISASS). Artificial Disc Replacement. Available at: http://www.isass.org/for-patients/surgical-spine-treatments/artificial-disc-replacement/. Accessed on June 21, 2018.
  3. National Institute of Health (NIH). Osteoporosis. Available at: https://www.niams.nih.gov/Health_Info/Bone/Osteoporosis/osteoporosis_ff.asp.  Accessed on June 21, 2018.
  4. National Osteoporosis Foundations (NOF). Bone Density Exam/Testing. Available at: https://www.nof.org/patients/diagnosis-information/bone-density-examtesting/. Accessed on June 21, 2018.
  5. North American Spine Society (NASS). KnowYourBack.org. Cervical Stenosis, Myelopathy and Radiculopathy. May 19, 2009. Available at: https://www.spine.org/KnowYourBack/Conditions/DegenerativeConditions/CervicalStenosis,MyelopathyandRadiculopathy.aspx. Accessed on June 21, 2018.
Index

Artificial Discs
BRYAN
Interspinous Implant
Intervertebral Discs
Mobi-C Cervical Disc Prosthesis
PCM Cervical disc
PRESTIGE
PRESTIGE LP
PRODISC-C
SECURE

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

History

Status

Date

Action

Reviewed

07/26/2018

Medical Policy & Technology Assessment Committee (MPTAC) review. Updated References and Websites.

New

08/03/2017

MPTAC review. Initial document development. Transferred content from SURG.00055 Cervical Total Disc Arthroplasty.