- Department of Orthopaedic Surgery, Johns Hopkins Medical Instititutions, 3333 N. Calvert St. Suite 400, Baltimore, MD 21218
- Union Memorial Department of Orthopaedic Surgery, Assistant Professor, Johns Hopkins Medical Instititutions, 3333 N. Calvert St. Suite 400, Baltimore, MD 21218
P. Justin Tortolani
Union Memorial Department of Orthopaedic Surgery, Assistant Professor, Johns Hopkins Medical Instititutions, 3333 N. Calvert St. Suite 400, Baltimore, MD 21218
DOI:10.4103/2152-7806.98582Copyright: © 2012 Moatz B. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
How to cite this article: Moatz B, Tortolani PJ. Cervical disc arthroplasty: Pros and cons. Surg Neurol Int 17-Jul-2012;3:
How to cite this URL: Moatz B, Tortolani PJ. Cervical disc arthroplasty: Pros and cons. Surg Neurol Int 17-Jul-2012;3:. Available from: http://sni.wpengine.com/surgicalint_articles/cervical-disc-arthroplasty-pros-and-cons/
Background:Cervical disc arthroplasty has emerged as a promising potential alternative to anterior cervical discectomy and fusion (ACDF) in appropriately selected patients. Despite a history of excellent outcomes after ACDF, the question as to whether a fusion leads to adjacent segment degeneration remains unanswered. Numerous US investigational device exemption trials comparing cervical arthroplasty to fusion have been conducted to answer this question.
Methods:This study reviews the current research regarding cervical athroplasty, and emphasizes both the pros and cons of arthroplasty as compared with ACDF.
Results:Early clinical outcomes show that cervical arthroplasty is as effective as the standard ACDF. However, this new technology is also associated with an expanding list of novel complications.
Conclusion:Although there is no definitive evidence that cervical disc replacement reduces the incidence of adjacent segment degeneration, it does show other advantages; for example, faster return to work, and reduced need for postoperative bracing.
Keywords: Total disc replacement, anterior cervical discectomy and fusion, complications, adjacent segment degeneration, dysphagia, return to work, bracing
Anterior cervical discectomy and fusion (ACDF) is the current gold standard for managing symptomatic anterior cervical degenerative disc disease.[
To date, three cervical total disc replacement (TDR) devices have been approved by the Food and Drug Administration (FDA) for single-level anterior cervical disc procedures. They include the Bryan Disc (Medtronic Sofamor Danek, Memphis, TN, USA), the Prestige Disc (Medtronic Sofamor Danek, Memphis, TN, USA), and the ProDisc-C (Synthes Spine West Chester, PA, USA) [
There are several purposes of this review; to critically examine where cervical TDR stands today, to summarize what we have learned thus far, and to evaluate whether a new “gold standard” alternative is on the horizon.
The incidence of cervical disc degeneration after ACDF fusion has been studied extensively. Gore and Sepic examined 50 patients after anterior cervical fusion over a followup interval of 21 years.[
Fusions, consisting of ACDF, did not seem to alter the natural history for the evolution of spondylotic changes. To assess clinically relevant adjacent segment degeneration after cervical fusion, Hilibrand et al. conducted a landmark Kaplan–Meier analysis.[
If the need for additional surgery was caused by the fusion, then one would expect that the greater the number of levels fused, the higher the risk for developing new radiculopathy or myelopathy.[
The present data raise significant doubt as to whether cervical TDR will reduce or eliminate the risk of adjacent segment disease. Unfortunately, the followup intervals utilized by the US Investigational Device Exemption (IDE) studies have not yet provided enough long-term data to address this crucial issue. Recently Nunley et al. examined the 4- to 7-year outcomes of patients enrolled in 5 different cervical TDR trials; they reported a 2.3% incidence of symptomatic adjacent segment disease.[
In addition to the paucity of data justifying cervical TDR in reducing adjacent segment disease, there remain the crucial questions as to whether cervical TDR confers improved outcomes in other domains; for example, postoperative pain and neurologic function? The FDA IDEs conducted thus far provide the highest quality data available to address these controversies.[
Some series reported better neurologic outcomes with TDR versus ACDF. Mummaneni et al. reported statistically significant neurologic improvement/success in patients undergoing Prestige ST cervical TDR versus ACDF.[
Taken together, the results of the US IDEs suggest that cervical TDR is a reasonable alternative to fusion, but with some notable caveats. First, patient selection bias was present; in each study, patients had to enter a trial to undergo TDR, but did not have to enter any trial to have an ACDF. Second, although patients were randomized and their treatment allotments were “blinded initially,” patients were “unblinded” on subsequent followup visits. These inherent biases may have negatively impacted the results of patients who were randomized to fusions. Third, there was also the potential for bias in favor of cervical TDR in the US IDEs as these were industry-sponsored trials; for example, many of the investigators disclosed financial relationships with industry sponsors, and data interpretation might have been inappropriately skewed in favor of TDR. Fourth, the noninferiority study design of these trials precluded conclusions regarding the superiority of cervical TDR over ACDF [
Although cervical TDR may represent a viable alternative to fusion, opponents of cervical TDR have also raised issues regarding the number of contraindications to its use. Contraindications described by the FDA have included: isolated axial neck pain, ankylosing spondylitis or pregnancy, rheumatoid arthritis, autoimmune disease, diffuse idiopathic skeletal hyperostosis, severe spondylosis with bridging osteophytes or ossification of the posterior longitudinal ligament, disc height loss > 50%, spinal infection, metal allergy to components of the prosthesis, severe osteoporosis/osteopenia, active malignancy, metabolic bone disease, trauma, segmental instability, 3 or more levels requiring treatment, insulin dependent diabetes mellitus, human immunodeficiency virus, hepatitis B/C, morbid obesity, absence of motion < 2 degrees, and posterior facet arthrosis [
THE BEST CANDIDATES FOR MOTION SPARING DTR ARE YOUNGER PATIENTS, BUT LONGEVITY INCREASES WEAR AND TEAR
Since cervical TDR is motion sparing, and not motion restoring, the best candidates should be the younger patients with excellent baseline segmental motion [
Flexion (a) and lateral (b) radiographs demonstrating virtually no motion at the C5–C6 level of a patient with cervical degenerative disc disease and cervical radiculopathy. Postoperative radiographs in flexion (c) and extension (d) following cervical total disc replacement show minimal motion. Cervical total disc replacement should not have been performed in this scenario
Dysphagia decreased by TDR
Dysphagia is a well-known complication following anterior cervical decompression and plating (ACDF) [
Disadvantages of TDR—dysphagia increased by TDR
In contrast to the studies presented, Anderson et al. found more rather than less frequent complaints of dysphagia in patients receiving the Bryan artificial disc (TDR) versus those undergoing ACDF.[
Advantages of minimal to no bracing for TDR
Patients who undergo anterior cervical arthroplasty (TDR) may benefit from little to no bracing, along with earlier range of motion, fewer restrictions, and earlier return to work. Two studies reported that patients undergoing TDR returned to work in fewer days (13–16 days) versus those undergoing ACDF.[
Adverse events specifically associated with cervical TDR can be categorized by type: implant failure/wear, bone-implant failures, iatrogrenic deformity, segmental kyphosis, failed kinematics, neurologic injury, and infection. Another major risk factor that is often unanticipated is the host response to the arthroplasty, resulting in heterotopic ossification (HO) and osteolysis [
One of the most studied complications of TDR is HO [
The etiology of HO associated with cervical TDR is unknown. Some speculate that repeated trauma to the longus colli musclulature is a contributing factor, while others implicate the extensive vertebral endplate preparation or milling of the bone as a causative factor. Clearly, if HO reaches the point of autofusion in a large number of patients, the theoretic benefit of motion preservation is lost. An example of this was found in Leung et al. study, wherein 62% of patients had less than 2 degrees of motion at the affected surgical levels.[
Multiple studies have reported postoperative kyphosis as an adverse outcome of cervical arthroplasty/TDR.[
Although the goal of cervical arthroplasty is to maintain the normal cervical range of motion and biomechanics, some patients develop postoperative segmental kyphosis. Troyanovich et al. argued that adjacent levels compensate for the kyphotic level, but that undue stress at these adjacent interspaces accelerates adjacent segment degeneration.[
Several authors have reported implant migration or subsidence leading to surgical failures following cervical TDR [
Other complications of cervical arthroplasty include the generation of wear debris, and the resultant immune reactions. Goffin et al. noted that with motion, the Bryan disc prosthesis generates wear debris that can incite an inflammatory reaction and a cascade of events leading to pain, osteolysis, and/or loosening [
Further studies are needed to investigate the prevalence of metal ion debris, and to evaluate its long-term clinical consequences after TDR. In Guyer et al. imaging studies after TDR revealed a mass lesion attributed to metal ion debris in all cases.[
The insertion of certain TDR devices carries the potential risk of iatrogenic vertebral body fractures. In 1 case, Datta et al. observed an intraoperative sagittal split fracture produced within the C6 vertebral body during insertion of adjacent “keeled” prostheses at contiguous C5–C6 and C6–C7 levels.[
No clear evidence of superiority of TDR versus ACDF
Over the past 10 years, cervical TDR has emerged as an alternative to ACDF for carefully selected patients. To date, definitive evidence to support a reduction in the incidence of adjacent segment disease following index-level TDR surgery is still lacking. This point is worth emphasizing given the fact that the US IDEs were powered to answer this very question.
Pros of TDR
Distinct advantages of cervical TDR seem to be a more rapid return to work, the avoidance of harvesting iliac crest bone graft (using instead) allograft bone, and the lack of necessity for postoperative bracing.
TDR: Not a new gold standard for treating cervical spondylotic radiculopathy or myelopathy
Because of the multiplicity of contraindications and the previously reported/emerging complication profiles, which may require life-long surveillance, cervical TDR does not, at this time, appear to represent a new gold standard for the treatment of cervical spondylotic radiculopathy or myelopathy. Continued followup on patients enrolled in the US IDE studies will undoubtedly shed new light on the relative merits (pros) and demerits (cons) of cervical TDR.
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