The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 95, Issue 3

Current Concepts Review | February 06, 2013

Cervical Intervertebral Disc Replacement

Garrick W. Cason, MD¹; Harry N. Herkowitz, MD²

¹ University of Tennessee College of Medicine, Chattanooga, 7892 Giorgio Circle, Ooltewah, TN 37363. E-mail address: gwcason@gmail.com
² Department of Orthopaedic Surgery, William Beaumont Hospital, Medical Office Building 3535, West Thirteen Mile Road, Suite 744, Royal Oak, MI 48073. E-mail address: HHerkowitz@beaumont.edu

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Investigation performed at the Department of Orthopaedic Surgery, William Beaumont Hospital, Royal Oak, Michigan

J Bone Joint Surg Am, 2013 Feb 06;95(3):279-285. doi: 10.2106/JBJS.J.01042

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Abstract

Symptomatic adjacent-level disease after cervical fusion has led to the development and testing of several disc-replacement prostheses.

Randomized controlled trials of cervical disc replacement (CDR) compared with anterior cervical discectomy and fusion (ACDF) have demonstrated at least equivalent clinical results for CDR with similar or lower complication rates.

Biomechanical, kinematic, and radiographic studies of CDR reveal that the surgical level and adjacent vertebral level motion and center of rotation more closely mimic the native state.

Lower intradiscal pressures adjacent to CDR may help decrease the incidence of adjacent spinal-level disease, but long-term follow-up is necessary to evaluate this theory.

Figures in this Article

Introduction

Cervical intervertebral disc replacement is a reconstructive operative procedure performed after spinal decompression to treat radiculopathy and myelopathy. Anticipated benefits of motion-sparing devices include maintaining alignment and motion, decreasing stress on the adjacent-level disc, and potentially decreasing symptomatic adjacent spinal-level disc degeneration. Anterior cervical discectomy and fusion (ACDF) is an established procedure for the treatment of cervical radiculopathy and myelopathy resulting from spondylosis and acute soft-disc herniation. The use of anterior plates has improved one-level and two-level fusion rates and outcomes without the need for autograft^1-3. Plate and interbody autograft and/or allograft constructs also demonstrate maintenance of segmental lordosis and disc height with less interbody graft complications, such as subsidence and graft extrusion^4,5.

Concerns over symptomatic adjacent-segment disc degeneration⁶ and cadaver studies that have demonstrated increased motion and intradiscal pressures adjacent to fusion levels^7,8 have led to the development and testing of several cervical disc replacement (CDR) implants. Before CDRs are implemented routinely, they must prove to be at least as effective in relieving symptoms as ACDF, with similar or better complication profiles and reduction of the incidence of symptomatic adjacent-level degeneration. This article will review the progress that has been made in the development, application, and outcomes of CDR. Comparisons will be made with ACDF, which is the current standard treatment for these conditions.

Indications

General indications for CDR include reconstruction after neural decompression of disc herniations or foraminal osteophytes that cause radiculopathy or myelopathy between C3 and T1. Contraindications include deformity, isolated neck pain, immobile segments, instability, facet joint degeneration, and infection. Relative contraindications include rheumatoid arthritis, renal failure, osteoporosis, cancer, and preoperative corticosteroids⁹. Auerbach et al. retrospectively reviewed 167 consecutive patients who underwent elective cervical spine surgery to determine if they met selection criteria. They found that 43% of patients would be candidates for CDR and that this amount increased to 47% if treatment of adjacent-level degeneration was included¹⁰.

Brief History of CDR

Great advances have been made in the design and implantation of cervical disc prostheses. An early model, composed of a two-piece metal-on-metal ball-and-socket design with screws anchoring into the vertebral body, was plagued by persistent dysphagia and screw complications¹¹. Several redesigns and renames have led to the fifth-generation model (Prestige LP; Medtronic, Memphis, Tennessee) (Fig. 1), an unconstrained ball-and-socket device made of titanium-ceramic composite with a porous titanium plasma spray coating to facilitate bone ingrowth, that is currently in a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial¹².

Fig. 1

Fig. 1 The Prestige LP (Medtronic) is an unconstrained ball-and-socket titanium-ceramic composite prosthesis. Reproduced with permission and copyright © of the British Editorial Society of Bone and Joint Surgery, from: Denaro V, Papalia R, Denaro L, Di Martino A, Maffulli N. Cervical spinal disc replacement. J Bone Joint Surg Br. 2009 Jun; 91(6): 713-9.

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Each device has its own specific design and biomechanical and/or kinematic properties that may influence the decision to implant one particular device rather than another. These devices have been extensively studied, but they are usually compared with an ACDF model.

The Bryan CDR implant (Medtronic) (Fig. 2) is an unconstrained device with two titanium-alloy shells articulating with a polyurethane core. It is milled to a tight fit and allows for bone ingrowth from the vertebral end plates. It has been studied extensively in Europe and has twenty-four and forty-eight-month follow-up data from U.S. trials¹².

Fig. 2

Fig. 2 The Bryan cervical disc replacement (Medtronic) is an unconstrained titanium-alloy prosthesis with a polyurethane core between two articulating shells. Reproduced with permission and copyright © of the British Editorial Society of Bone and Joint Surgery, from: Denaro V, Papalia R, Denaro L, Di Martino A, Maffulli N. Cervical spinal disc replacement. J Bone Joint Surg Br. 2009 Jun; 91(6): 713-9.

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The ProDisc-C device (Synthes Spine, West Chester, Pennsylvania) (Fig. 3) is a semiconstrained metal on ultra-high molecular-weight polyethylene (UHMWPE) articulation. Keels on the surface anchor it into the vertebral end plates¹².

Fig. 3

The ProDisc-C (Synthes Spine) is a semiconstrained device with a metal-on-UHMWPE articulation and keels to anchor into the end plates.

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The PCM device (NuVasive, San Diego, California) (Fig. 4) is a two-piece metal device with a UHMWPE inner core that also has a broad radius of curvature for more vertebral end-plate support. A calcium phosphate coating helps anchor it to the end plate¹².

Fig. 4

The PCM (NuVasive) is a two-piece prosthesis with a broad radius of curvature and a polyethylene core. Reproduced, with permission, from: Cunningham BW, Hu N, Zorn CM, McAfee PC. Comparative fixation methods of cervical disc arthroplasty versus conventional methods of anterior cervical arthrodesis: serration, teeth, keels, or screws? Laboratory investigation. J Neurosurg Spine. 2010 Feb;12(2):214-20. Courtesy of Bryan W. Cunningham, MSc, and Paul C. McAfee, MD, Orthopaedic Spinal Research Laboratory, St. Joseph Medical Center, Baltimore, Maryland.

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The CerviCore device (Stryker, Allendale, New Jersey) (Fig. 5) is a semiconstrained, saddle-shaped metal-on-metal device with keels that anchor into the vertebral end plates. This type of articulation is meant to provide different kinematics during lateral bending than during flexion and extension, as is seen naturally¹². An FDA IDE trial using this device is currently in progress.

Fig. 5

The CerviCore (Stryker) is a semiconstrained, saddle-shaped device that has a metal-on-metal articulation and keels to anchor into vertebral end plates. Photograph courtesy of Jeffery S. Fishgrund, MD, Southfield, Michigan.

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The ideal CDR implant should maintain segmental motion, disc height, and lordosis while providing shock absorption. It should have long-term durability, should produce minimal debris that incites an inflammatory reaction or osteolysis, and should not alter adjacent spinal level kinematics. It should also have efficacy and complication profiles equal to or better than ACDF with an acceptable cost profile.

Biomechanics and Kinematics of CDR

One of the greatest motivators for the design and implementation of CDR is the theory that altered kinematics adjacent to cervical fusion leads to accelerated symptomatic disc degeneration and the need for additional surgical intervention. Daffner et al. used kinetic upright magnetic resonance imaging data to demonstrate that symptomatic cervical disc herniation alone does not alter adjacent level translational or angular motion regardless of the degree of spondylosis¹³. DiAngelo et al. demonstrated compensatory increased motion adjacent to cervical fusion, but not with CDR¹⁴. Elsawaf et al. followed twenty consecutive patients who underwent ACDF and, at a follow-up period of twenty-eight months, noted that five of six patients who had higher than normal adjacent-level motion developed symptomatic adjacent-level degeneration with one of the five requiring surgery within the twenty-eight month period¹⁵.

Several studies have demonstrated increased intradiscal pressures adjacent to simulated fusions and pressures similar to intact specimens adjacent to CDRs^7,16,17. Additionally, Chang et al. demonstrated increased facet forces in extension at the index level for CDR implants¹⁸. In vivo and in vitro studies have demonstrated that CDRs maintain index-level sagittal motion, translation, coupled motion in lateral bending with rotation, disc-space height, and center of rotation, as compared with preoperative or intact states^19,20. The motion at the surgical level after CDR has been maintained for twenty-four months with decreases in adjacent level motion, while levels adjacent to ACDF demonstrated increased translation at six months but not at twelve months^21,22. Comparisons of CDR to ACDF revealed a decrease in all modes of motion adjacent to the CDRs, but an increase in motion adjacent to ACDF²³. Range of motion at levels adjacent to a CDR is less at one month and at three months, but it returns to preoperative values by two years. At two years, patients with CDR demonstrated more cervical lordosis than did patients with ACDF. Although levels with less than 4 mm or 3° of motion gained more motion with CDR, this did not affect clinical outcome^24,25. Powell et al. demonstrated that the center of rotation for CDR was more posterior and cephalad as compared with preoperative values, but this shift was not significant. However, the center of rotation of levels supradjacent to fusions was located more anteriorly²⁶.

Clinical and Radiographic Results

Recent reports on ACDF with autograft (or allograft) and plating demonstrate improved fusion rates with good-to-excellent clinical results even in smokers^1-3,27-30. Fusion rates declined for two-level and three-level ACDF and plating, with fewer graft-related complications after plating^3,28-30. In randomized controlled trials, clinical improvements for ACDF and CDR were better when compared with the preoperative state. Several of these studies showed that CDR was associated with better overall success, better neurologic success, and fewer revision operations^31-35.

In a study with an average follow-up of nineteen months, Kim et al. followed fifty-one patients who had one-level or two-level disc prostheses and fifty-four patients who had one-level or two-level ACDF. Patients who underwent ACDF were 3.5 times more likely to have radiographic changes at the adjacent disc level, as evidenced by new anterior or enlarging osteophytes, increased or new narrowing of the disc space, or calcification of the anterior longitudinal ligament. Patients with two-level ACDF had more vertebral motion cephalad to and caudal to the surgical levels as compared with that in patients with CDR³⁶. At two years of follow-up, there was no difference with respect to resolution of arm and neck pain between a group of 223 patients who had undergone CDR and a group of 198 patients who had undergone ACDF, although both groups had improvement from the preoperative status. Overall patient success (postoperative score on the neck disability index >15 points higher than the preoperative score, maintenance or improvement in neurologic status, and no implant failure) and overall neurologic success (maintenance or improvement of motor and/or sensory function and deep tendon reflexes) were both higher for CDR. The CDR group also returned to work faster than the ACDF group did³¹. The results from a two-year follow-up of a randomized, controlled, clinical trial that compared CDR with ACDF demonstrated improvement for both groups in all clinical parameters as compared with the preoperative status. The CDR group had a greater improvement in the neck disability index score and a greater improvement in neck pain at all follow-up intervals. Short-Form 36 (SF-36) scores were better for CDR at 1.5 and twelve months, but not at two years, and patients in the CDR group returned to work faster than those in the ACDF group did. The overall success of the CDR group was higher than that of the ACDF group at one and two years³². A forty-eight-month follow-up of a single institution’s cohort of forty-seven patients from an ACDF versus CDR trial demonstrated maintenance of improvement in neck disability index and visual analog scale (VAS) scores with regard to neck and arm pain, with fewer secondary operations in the CDR group³³.

In an FDA IDE randomized controlled trial of 103 CDR versus 106 ACDF operations with a two-year follow-up, CDR was shown to have better neurologic success at six months but not at two years. The neck disability index score was better for the CDR group at three months but not at two years. The VAS pain scores, return-to-work status, and patient satisfaction scores were similar between the two groups at two years. Device success (defined as no revision, removal, or reoperation of the implant or supplemental fixation) was better for the CDR group (98.1% of patients) than it was for the fusion group (91.5% of patients). A post hoc analysis of minimum clinically important difference in health-related quality-of-life measures (neck disability index success, patient satisfaction, absence of pseudarthrosis in the fusion group and absence of fusion in the CDR group, improvement in VAS scores for neck or arm pain, and absence of strong narcotic and/or muscle relaxant use) revealed better results for the CDR group. Although both groups had similar clinical outcome measures at two years, the patients treated with CDR recovered from their disability and obtained neurologic success more quickly than those treated with ACDF³⁴.

Multilevel disease can be treated with CDR at multiple levels. Goffin et al. reported the four-year and six-year clinical results of CDR for eighty-nine patients with one-level and nine patients with two-level disc replacements. They demonstrated maintenance of improvement with regard to SF-36 and neck disability index parameters and reduction of neck pain and arm pain at four and six years. They reported a 6.1% index-level reoperation rate and 4.1% adjacent-level surgery rate³⁵. Pimenta et al. reported on seventy-one single-level and sixty-nine multilevel prostheses and found a higher improvement with regard to neck disability index in patients who had multilevel procedures. They reported a 94.5% survivorship at three years³⁷. Implant failure (requiring reoperation) for single and multilevel ACDF is 0.1%^1,3,38.

CDR After Previous Surgery and After Placement of Hybrid Constructs

Patients with symptomatic adjacent-level disease after previous cervical fusion or in whom posterior decompression has failed to relieve symptoms may benefit from CDR. Sekhon et al. reported the two-year follow-up results of CDR treatment in nine patients whose symptoms were attributable to degeneration adjacent to a fusion and in six patients in whom a posterior foraminotomy failed to relieve symptoms. They reported an improvement in VAS scores for arm and/or neck pain and maintenance of Oswestry Disability Index (ODI) scores for neck pain. There was a tendency for the prosthesis to fall into kyphosis postoperatively, and device subluxation in one patient in whom instability was demonstrated on the preoperative radiographs³⁹. Phillips et al. reported on the two-year follow-up results of twenty-five patients in whom a CDR was implanted after symptomatic degeneration adjacent to previous fusion and one patient who underwent CDR after previous laminectomy and foraminotomy (i.e., the previous fusion group) as compared with 126 patients in whom the CDR was the primary implant (i.e., the primary group). Both groups had postoperative improvement with regard to the neck disability index score and the VAS score for neck and arm pain. Adverse events and reoperations were 1.6% for the previous fusion group and 7.7% for the primary group. Motion at levels adjacent to fusion, particularly translation, was increased after surgery⁴⁰.

Patients with symptomatic multilevel cervical spine disease may not be candidates for CDR at every level of the cervical spine, but it may be possible to avoid long fusion constructs by combining ACDF and CDR at selected levels. Barbagallo et al. followed twenty-four patients for twenty-three months after the treatment of symptomatic multilevel cervical disease with hybrid combinations of ACDF and CDR. They noted improvement in SF-36 and neck disability index values and improvement in all but three myelopathic patients. There were no implant complications, and the prevalence of asymptomatic heterotopic ossification was 8.3%. They published selection criteria for CDR versus ACDF for each level (see Appendix)⁴¹.

Shin et al. reported on the two-year follow-up results of two cohorts of patients (a total of forty patients), with two consecutive levels of degenerative disc disease between C3 and C7, treated either with two-level ACDF (twenty patients) or a hybrid combination of CDR and ACDF (twenty patients). The hybrid group demonstrated better recovery according to neck disability index scores than did the two-level ACDF group at one and two years after surgery. The VAS neck pain was better in the hybrid group at one and twelve months, and arm pain improved equally between groups. C2 through C7 range of motion recovered more rapidly in the hybrid group, and there was more motion at the inferior adjacent level in the two-level ACDF group. There was no device-related complication or heterotopic ossification⁴².

Complications

Fountas et al. retrospectively reviewed 1015 patients who underwent primary one, two, and three-level ACDF and plating. They reported 0.1% mortality due to an esophageal perforation; 9.5% of the study patients had dysphagia, 3.1% had recurrent laryngeal nerve palsies (confirmed by laryngoscopy), 2.4% required evacuation of a hematoma, 0.5% had dural penetration, 0.3% had esophageal perforation, 0.1% had hardware failure, 0.1% had Horner’s syndrome, and 0.1% experienced a wound infection⁴³.

Analysis of complications from an FDA IDE prospective, randomized controlled trial for CDR demonstrated more general medical complications unrelated to the device for the CDR group, most of which were gastrointestinal and genitourinary events. There were more adverse events related to the operation in the CDR group (10% had dysphagia and/or dysphonia, and 2.8% had a wound infection). Perioperative neurologic events were few and the rate was similar between groups, but the CDR group had fewer reoperations than the ACDF group did⁴³. In contradistinction, Riley et al. reported a 28% incidence of dysphagia at three months after ACDF and a 21% incidence at two years⁴⁴, whereas McAfee et al. demonstrated a lower incidence of moderate and severe dysphagia (according to the Bazaz criteria) for patients who had CDR as compared with patients who had ACDF⁴⁵. Tortolani et al. measured esophageal pressures in cadavers during ACDF and plating and compared them with those measured during CDR. They found higher esophageal pressures during a C5-C6 ACDF as compared with a C3-C4 ACDF and a C5-C6 CDR. The authors suggested that the additional esophageal retraction that was necessary to drill and tap the contralateral screws in a convergent manner through the plate was a cause of the problem⁴⁶.

The report of Goffin et al. included 102 patients with CDR for evaluation of complications (four patients from phase I did not continue to phase II). Complications included one device migration due to improper milling, one evacuation of a prevertebral hematoma, ten neurologic injuries, one vocal-cord paralysis, and one device removal at six years due to a recurrent osteophyte and spinal-cord compression. Four patients had surgery for persistent or recurrent symptoms at the original surgical level and four for symptoms at other cervical levels³⁵. The placement of 229 consecutive prostheses resulted in four dural tears and five reoperations, four of which included revision to modular or more constrained CDR devices³⁷. Sagittal splits in the vertebral bodies have been reported with the use of keeled prostheses. If the device maintains functional position and no instability exists, it can be retained without affecting outcome⁴⁷.

In a study of fifty-four patients (sixty-five prostheses) who underwent CDR and had not received prophylactic nonsteroidal anti-inflammatory medication, Suchomel et al. reported that asymptomatic grade-III or grade-IV heterotopic ossification was present adjacent to 63% of the implants at four years after surgery. This did not affect clinical success, as 92% of patients said that they would have the same surgery again⁴⁸. In a two-year follow-up of seventy-two prostheses in another study, the heterotopic ossification rate was 9.4% and the rate of new radiographic adjacent segment degeneration was 12.5%. Heterotopic ossification leading to decreased motion at the index level has occurred in 11% to 44% of those with CDR and concomitant adjacent-segment degeneration. The authors suggested heterotopic ossification as the main pathophysiologic mechanism for the adjacent-segment degeneration^48,49, and it had no affect on clinical outcome.

Sekhon et al. reported that CDR in fifteen patients (twenty-four CDRs) who had previously undergone cervical spine surgery was associated with a 6.7% rate of persistent dysphagia, subluxation, and reoperation without any intraoperative complications or new neurologic deficits³⁹. The frequency of adverse events after application of 126 primary devices was equal to that of twenty-seven devices placed after previous surgery, but the revision rate was 7.7% for CDR adjacent to fusions versus 1.6% for primary application at one year⁴⁰. Complications from hybrid constructs have a lower incidence of asymptomatic heterotopic ossification without any neurologic or device-related complications^48-50.

Concerns are warranted over the exposure of the spinal column and neural elements to the particulate wear debris of the CDR components. Exposure of rabbit dura to chromium cobalt and titanium particles resulted in granular amorphous debris with activated macrophages in the cerebrospinal fluid. Epidural fibrosis, inflammatory changes, and phagocytized particles were noted on histologic examination. Local exposure to stainless steel, titanium, and UHMWPE resulted in upregulation of interleukin-6 (IL-6) in the spinal cord and epidural tissue⁵¹. Delayed metal hypersensitivity has been reported after implantation of a metal-on-metal keel-based CDR. Histopathology revealed abnormal fibrohyaline cartilage and chronic inflammation, with lymphocytes and vascular proliferation similar to what might be found adjacent to a metal-on-metal hip prosthesis⁵². These results lead to concerns that current clinical studies are not of adequate duration to demonstrate long-term safety with regard to wear-debris exposure.

Cost Analysis

Concerns regarding the cost of CDR versus that of ACDF and the financial impact on the limited health-care dollar have led to some insurance providers not covering CDR. Spinal arthroplasty was estimated to assume 47.9% of the fusion market by 2010 with a projected revenue of $2.18 billion dollars, exerting a profound economic impact on spinal surgery in the U.S.⁵³. Cost estimates for prostheses are about $4000, while the costs for an interbody device and a plate for ACDF are about $2500⁵³. It may be that the cost benefit of fewer operations for adjacent-segment degeneration will offset any increased cost for the prosthesis and that earlier return to work will increase productivity and decrease lost wages.

Summary

CDR provides predictable and reproducible relief of symptoms, preservation of index-level cervical spine motion, a decrease in adjacent-level stress, and maintenance of device survivorship at two to four years after the operation. Used alone or in combination with ACDF, CDR can yield good results in treating multilevel disease. Complications related to the device are few and are comparable with those related to ACDF. The cost of CDR implants is higher than that of interbody device and plate constructs, but the proposed benefit may be in the preservation of adjacent levels and the prevention of additional surgery. Long-term follow-up studies are necessary to determine the possible benefit of adjacent-level preservation with CDR in comparison to the benefits of fusion in the treatment of cervical radiculopathy and myelopathy.

Appendix

A table showing the factors to consider when choosing ACDF or CDR is available with the online version of this article as a data supplement at jbjs.org.

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Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

Topics

intervertebral disc of cervical vertebra ; prostheses

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Garrick W. Cason, Harry N. Herkowitz; Cervical Intervertebral Disc Replacement. The Journal of Bone & Joint Surgery. 2013 Feb;95(3):279-285.

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