Disc Arthroplasty




(1)
Department of Orthopaedic Surgery, MedStar Georgetown Univeristy Hospital, Washington, DC, USA

(2)
School of Medicine, Georgetown University, Washington, DC, USA

 



Keywords

Cervical disc arthroplasty (CDA)Total disc arthroplasty (TDA)Cervical disc replacement (CDR)Anterior cervical discectomy and fusion (ACDF)LaminoplastyMotion preservation


Introduction


The seven cervical vertebrae are separated by intervertebral discs that have dual purpose in both load bearing and motion transfer. Disc degeneration, facet arthropathy, ligamentum flavum hypertrophy, and foraminal narrowing is the natural progression from degenerative disc disease to cervical spondylosis. Anterior cervical discectomy and fusion (ACDF) is a proven modality of treatment for patients with cervical radiculopathy and myelopathy. Neurological dysfunction is consistently improved, which makes ACDF a standard against which many spine surgeries are compared. Plating has eliminated the need for postoperative immobilization [1]. Because of concern for kinematic and biomechanical issues inherent to fusion of the cervical motion segment, investigators have developed surgical alternatives.


The foremost concern with ACDF is adjacent segment degeneration, which is degeneration of a level adjacent to a fused level. With long-term follow-up of 5–10 years, adjacent segment degeneration has been found radiographically in 81.3–92.1% of patients [24]. The cause of adjacent segment degeneration is debated, with the frontrunners being related to postsurgical biomechanics and aging. However, adjacent segment degeneration and adjacent segment disease should be contrasted, with the latter having both evidence of radiographic degeneration and clinical symptoms, such as pain or neurological dysfunction [5]. Adjacent segment disease has been reported to occur at a rate of 2.9% per year and in 25.6% of patients within 10 years of ACDF [5]. Biomechanical studies have demonstrated segments adjacent to fusion constructs have increased range of motion and intradiscal pressures as compared to the native state [6, 7]. These changes are likely related to compensation of loss of motion in the fused segments.


Currently, ACDF is performed with various grafts, including allograft and iliac crest autograft. Complications such as meralgia paresthetica, fracture, chronic pain, and infection have been reported altogether at an incidence as high as 25% [810]. Pseudoarthrosis is another concern with ACDF, which becomes more prevalent as the number of segments fused increases. There has been a reported 97% fusion rate with single-level fusion, but this decreases to 83% with three-level fusions [11]. Pseudoarthrosis has been reported in 11% with single-level fusions and in 27% with multilevel fusions [12].


Because of these concerns as well as the desire to preserve motion and return patients to routine activities, cervical disc arthroplasty was developed. Following discectomy, restoration of disc height and segmental motion should allow for preservation of normal motion at adjacent levels. With cervical disc arthroplasty, autograft is unnecessary and its potential complications are avoided. Additionally, pseudoarthrosis is avoided, as well as other problems inherent to anterior cervical plating and immobilization. However, patients must have pathology primarily limited to the cervical disc, with relative sparing of the facet joints.


History


The first artificial cervical disc replacement, the Bristol/Cummins device [13], was developed and tested through the late 1980s to early 1990s. This original ball and socket design was composed of 316 L stainless steel. Technological advancements and design innovations led to the development of the currently FDA-approved devices, listed Table 3.1.


Table 3.1

Currently FDA-approved devices





















































































 

Manufacturer


Materials


Design


Articulating Method


Primary Fixation


Secondary Fixation


Modular


Bryan cervical disc


Medtronic Sofamor Danek USA Inc.


Titanium, polymer


Constrained bearing


Bi-


Milled vertebral endplates


Endplate on-growth


No


Mobi-C cervical disc


Zimmer Biomet Inc.


CoCrMo, UHMWPE


Superior endplate with ball and socket motion, inferior endplate with sliding constraint


Bi-


Lateral self-retaining teeth


Endplate on-growth


Yes


PCM


NuVasive Inc.


CoCrMo, UHMWPE


Upper endplate translation on fixed UHMWPE


Uni-


Ridged metallic endplates


Endplate on-growth


No


Prestige ST


Medtronic Sofamor Danek USA Inc.


316 L stainless steel


Ball and trough


Uni-


Vertebral body screws



No


Prestige LP


Medtronic Sofamor Danek USA Inc.


Titanium ceramic composite


Ball and trough


Uni-


Dual rails


Endplate on-growth


No


ProDisc-C


Synthes Spine


CoCrMo, UHMWPE


Ball and socket


Uni-


Central keel


Endplate on-growth


No


Secure-C


Globus Medical Inc.


CoCrMo, UHMWPE


Metal on polyethylene


Bi-


Ridged central keel


Endplate on-growth


Yes


Materials, Biomechanics, and Wear


The main metal alloys used in devices are titanium, cobalt chromium, and stainless steel [14]. There are also a number of bearing interfaces: metal-on-metal, metal-on-polymer (polyurethane), ceramic-on-ceramic and ceramic-on-polymer. The material selection and device design should be optimized so as to preserve motion, reduce friction, and improve durability. Maintenance of the normal kinematics of the spine is one of the primary goals in disc arthroplasty. The cervical spine is inherently dynamic, with flexion, extension, and lateral bending in addition to anterior and posterior translation. One example of how cervical disc arthroplasty attempts to mirror the natural motion of the cervical spine is demonstrated in Fig. 3.1. Rousseau et al. [15] examined the intervertebral kinematics after use of a ball and socket device (either the Prestige LP or Prodisc-C) and concluded this design did not fully preserve natural range of motion or center of motion between flexion and extension. This may be attributed to the absence of translation when using a constrained prosthesis [16]. Additionally, a comparison of constrained devices featuring a fixed core (Prodisc-C) and mobile core (Mobi-C) evaluated stress on the polyethylene core, pressure on the facet joint, and biomechanical impact; the fixed core device exhibited less pressure on the facet joint, more pressure on the core, and a more severe biomechanical impact if the device is not centered, while the opposite was seen in devices with a mobile core [17]. A major cause of failure of cervical disc replacement is wear debris, which can trigger an inflammatory reaction leading to osteomyelitis, pain, and loosening of the device [18]. Veruva et al. [19] conducted a systematic review to determine any adverse effects from the materials used in the different devices. It was reported that metal-on-polymer replacements could lead to polymer wear debris, thus stimulating an innate response. Metal-on-metal devices could generate metallic wear debris causing activation of the adaptive immune system and subsequent tissue reactions.

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Fig. 3.1

A-1D demonstrate the Mobi-C (Zimmer Biomet, Warsaw, IN) cervical disc replacement. The Mobi-C incorporates superior and inferior cobalt chromium molybdenum alloy endplates coated with a plasma sprayed titanium and hydroxyapatite coating and a polyethylene mobile bearing insert. The mobile bearing translates up to 1 mm on the inferior endplate, allowing flexion (a), extension (b), and lateral bending (c and d)


Indications and Contraindications


According to FDA guidelines, cervical disc arthroplasty is indicated following discectomy for intractable symptomatic cervical disc disease, and intractable radiculopathy and/or myelopathy. Contraindications vary between devices and include infection, osteoporosis, allergy to materials, severe spondylosis, compromised vertebral bodies attributed to disease or trauma, severe facet joint degeneration, cervical instability observed on imaging, and axial neck pain. Some authors have recommended a disc height of >3 mm for adequate disc space access and removal [20]. Placing an oversized implant into a collapsed disc space can potentially place excessive forces through the facet joints and lead to worsening of axial neck pain. While there are no strict criteria for degree of facet degeneration in patients being indicated for cervical disc arthroplasty, proposed criteria include developed arthritis of the zygapophyseal articular facets of the level to be operated and marked asymmetry of the articular facets, or a history of laminarthrectomy [21]. Computed tomography (CT) and magnetic resonance imaging (MRI) scans are useful to assess for the presence and degree of facet arthropathy. Facet blocks with combinations of local anesthetic and corticosteroid may also be employed to evaluate for facet arthropathy. Additionally, patients with a kyphotic deformity of over 15° should be carefully considered for this operation, as this deformity is usually seen in conjunction with a posterior spinal pathology. Lastly, anterior soft tissue abnormalities or anomalies including tracheal or esophageal abnormalities or history of radiation may be a general contraindication to any anteriorly based cervical spine procedure [22].


Currently, there are 7 total cervical disc replacement devices approved by the FDA for single-level disc arthroplasty [2329]. These include the Bryan cervical disc (Medtronic Sofamor Danek USA Inc.), Mobi-C cervical disc (Zimmer Biomet Inc.), PCM cervical disc (NuVasive Inc.), Prestige LP and Prestige ST cervical discs (Medtronic Sofamor Danek), ProDisc-C total disc replacement device (Synthes Spine), and Secure-C cervical artificial disc (Globus Medical Inc.) Among these, only Prestige LP and Mobi-C have approval for two-level disc arthroplasty.


Surgical Management


Preoperative Evaluation and Imaging


Preoperative imaging for cervical disc arthroplasty involves plain radiographs and more advanced imaging techniques. Anteroposterior, odontoid, neutral lateral, and flexion-extension lateral radiographic views should be obtained. The flexion-extension lateral views can be used to assess the preoperative mobility of the cervical spine. MRI or CT scans offer a more comprehensive evaluation of the index surgical level, particularly regarding the presence of conditions such as spondylosis, neurologic compression, and pre-existing facet arthropathy. Myelography can be incorporated to gain additional information. These imaging studies could also reveal contraindications for this procedure.


Technique


The anterior cervical spine is approached as discussed in Chap. 1. A nasogastric tube can be placed for easier identification and protection of the esophagus. The neutral to slightly lordotic position is preferred, which can be created with the use of a small towel bump under the neck rather than between the shoulders or under the thoracic spine, which can cause a hyperlordotic position. A donut pillow is placed under the head to prevent it from rolling. Taping of the shoulders can additionally stabilize the operative field and may be utilized in order to obtain light traction. A right or left Smith-Robinson approach is used to expose the levels of interest and adequate decompression is completed. Of note, in comparison to an anterior cervical discectomy and fusion, a more rigorous decompression is often necessary with cervical disc replacement. The posterior longitudinal ligament should always be removed to maximize the biomechanics of the device. A wide foraminotomy should also be performed as the level will continue to remove and any foraminal stenosis can lead to recurrent radicular symptoms. Meticulous hemostasis should be maintained in an effort to keep a clear operative field and minimize the risk of heterotopic ossification.


Prior to endplate preparation, exact sagittal position of the vertebrae should be confirmed with lateral fluoroscopic imaging. Anteroposterior views should place spinous processes at the target level centered between pedicles to ensure coronal plane alignment. Next, sizing of the device should be assessed. The largest diameter disc possible for the prepared space should be utilized. This can be accomplished with preoperative templates, radiographs, and CT. Intraoperatively, trials along with fluoroscopy confirm or allow for adjustment of the final device implanted. Endplate preparation is generally implant-specific. Milling of the endplate is required for the Bryan system and creating a bony trough is required for the Prodisc-C’s endplate keel. Regardless of manufacturer-specific endplate preparation, subchondral bone should be preserved as much as possible to prevent subsidence. After the endplate is prepared, centering and neurologic decompression should again be checked.


The artificial disc device is then implanted, with the appropriate depth based on implant design. Fluoroscopic imaging ensures appropriate coronal and sagittal plane positioning. The prosthesis should cover the endplates on both fluoroscopic views [30]. Lastly, implants are fixed with any implant-specific instrumentation and final imaging is performed. Wound closure should proceed with meticulous hemostasis to prevent postoperative wound complications and heterotopic ossification.


Postoperative Care


Postoperative immobilization is not required. Plain films may be obtained in the PACU and typically consist of anteroposterior and lateral views but upright flexion-extension views may also be obtained for comparison to follow-up films. Imaging studies obtained postoperatively provide an opportunity to evaluate the device placement and motion. Plain radiographs, specifically lateral bending and flexion-extension views, are relatively easy to obtain, reduce radiation exposure compared to CT or CT myelography, and allow for motion of the spine to be analyzed. MRI is an alternative imaging technique to CT myelography that can be used to assess postoperative neurologic status. A comparison of several devices regarding image artifact and visualization of neural elements at index and adjacent sites suggested that this modality is particularly useful in devices containing titanium alloy [31]. Fayyazi et al. observed that the amount of artifact was similar when any of four titanium devices (ProDisc-C Ti, Prestige LP, Discover, and Bryan) were used and increased significantly following implantation of the Prestige-ST, a stainless steel device. Visualization of the index and adjacent levels was easily performed with the titanium devices. The ProDisc-C Cobalt Chrome implant produced an image where only the index level was obscured by the artifact, while visualization could not be performed at the index and adjacent levels following implantation of the Prestige-ST. These differences necessitate that preoperative selection of a device considers the imaging studies that might be completed postoperatively.


Outcomes and Complications


Recent studies have assessed the long term results of total disc arthroplasty (TDA) using a specific device, analyzed the outcomes of ACDF versus TDA, and described differences between cervical arthroplasty devices. One meta-analysis examined surgical parameters, functional indicators, and the need for secondary surgery in patients with cervical degenerative disc disease undergoing TDA using the Prestige, Bryan, Kineflex C, Mobi-C, and ProDisc-C devices compared to recipients of ACDF [32]. ACDF was significantly associated with reduced operation time and decreased blood loss compared to any of the TDA procedures. TDA using the Bryan and Prestige discs demonstrated improved neurological success compared to ACDF, with the Bryan disc also resulting in better neck disability index (NDI) scores. ACDF had a higher rate of reoperation and secondary surgery at the adjacent and index levels than TDA using the Mobi-C disc. Patient satisfaction was not significantly different between ACDF and TDA.


A second meta-analysis compared the clinical outcomes 24 months postoperatively of TDA using the Bryan, Prestige, ProDisc-C, and PCM devices to those for patients undergoing ACDF [33]. Metrics including neurological success, survivorship, and overall success revealed a statistically significant difference in patient outcomes, suggesting that TDA is superior to ACDF. While the four devices differed in how they scored in these categories, conclusions on this data could not be drawn as no statistical analysis was undertaken to compare the devices.


Prestige


Burkus et al. [34] reported the 7-year postoperative clinical outcomes of ACDF compared to those for patients receiving TDA with the Prestige Cervical Disc. Neurological status was improved or maintained in 88.2% TDA patients and 79.7% ACDF patients. Rates of additional surgical procedures was also reduced in patients undergoing TDA versus ACDF at 4.6% and 11.9%, respectively. NDI scores, success, work status, rate of adverse events, and adjacent segment motion were similar between both groups.


Peng et al. [35] completed a prospective study looking at clinical and radiographic outcomes for patients that underwent ACDF and TDA with the Prestige LP Cervical Disc. Follow-up time was an average of 2.9 years with a minimum of 2 years. Significant improvement in metrics for neck and limb pain, neurogenic symptoms, myelopathy, and quality of life was observed for all patients, although no statistically significant difference was noted between patients in the ACDF and TDA groups. Physiologic motion was maintained at the surgical level for TDA and no significant difference in motion was exhibited at the adjacent segments. This finding contrasted ACDF which resulted in increased motion at adjacent levels; these changes in motion patterns have been implicated in adjacent level degeneration.


PCM Disc Prosthesis


Phillips et al. [36] conducted a study to assess the 5-year postoperative outcomes of ACDF versus TDA with the PCM disc. Scores for NDI, neck and arm pain, patient satisfaction, rates of dysphagia, and a general health summary for patients receiving TDA were significantly superior to those with ACDF. Radiological findings mirrored these results, as degeneration at the superior disc level was seen in 33.1% of the TDA patients compared to 50.9% ACDF patients. People in the TDA group also had fewer secondary surgeries and maintained range of motion at the 5-year follow-up with an average flexion-extension value of 5.2°.


ProDisc-C


Zigler et al. [37] compared the 5-year postoperative clinical outcomes of ACDF and a cervical total disc replacement using ProDisc-C . Neurological status, patient satisfaction, and number of adverse events were not significantly different between these two groups. However, patients who underwent TDA reported less neck pain intensity and frequency and had lower rates of secondary surgery (2.9% for TDA patients and 11.3% for ACDF patients). Range of motion was also maintained in the ProDisc-C patients at the 5-year follow-up.


Adjacent segment motion was evaluated by Kelly et al. [38] following ACDF versus TDA using the ProDisc-C prosthesis . Flexion-extension films were obtained of the 199 patients to assess range of motion 2 years following surgery. Both cranial and caudal adjacent segments demonstrated a statistically significant increase in motion for the ACDF patients, although there was no difference observed between the ACDF and TDA groups.


Mobi-C


Radcliff et al. [39] recently reported on the long-term outcomes of a multicenter randomized clinical trial with 7-year follow-up comparing ACDF to TDA. Interestingly, this analysis demonstrated clinical superiority of two-level TDA over two-level ACDF and non-inferiority of single-level TDA versus single-level ACDF. The overall success rates of two-level TDA and two-level ACDF patients were 60.8% and 34.2%, respectively. Success rates of single-level TDA and single-level ACDF were similar between cohorts. Both the single- and two-level TDA and ACDF groups showed significant improvement in NDI scores, pain scores, and SF-12 MCS/PCS scores. In the single-level cohort, there was an increased percentage of TDA patients who reported themselves as “very satisfied” (90.9% vs. 77.8%). There was a lower rate of adjacent level secondary surgery in the single-level TDA patients (3.7%) versus the ACDF patients (13.6%). In the two-level TDA group, the NDI success rate was significantly greater (79% vs. 58%), as was the rate of patients who were “very satisfied” with treatment (85.9% vs. 73.9%). The rate of subsequent surgery at the index level was significantly lower in the two-level TDA group compared to the ACDF group (4.4% vs. 16.2%). The rate of adjacent level secondary surgery was significantly lower in the two-level TDA (4.4%) patients compared to the ACDF (11.3%) patients.


An assessment of the occurrence of heterotopic ossification (HO) in patients presenting with extremity radiculopathy receiving TDA using the Mobi-C was completed by Park et al. [40]. Mean follow-up time was 40 months for the 75 patients. NDI scores and neck and arm pain levels all improved significantly between preoperative and postoperative evaluation. HO occurred in 67 levels at 12 months, and then at 80 levels by 24 months following the procedure , out of a total of 85 surgical levels. A univariate and multivariate logistic regression indicated that anterior HO was significantly associated with surgical technique, although the study was limited by follow-up time and number of patients enrolled.


Bryan Cervical Disc


Quan et al. [41] analyzed the clinical and radiological outcomes of a Bryan cervical disc arthroplasty at 8 years postoperative. None of the 21 patients required revision surgery and 19 reported an ability to perform daily activities without limitations. Motion was maintained to an average range of 10.6 +/− 4.5 degrees in 78% of the cases. Evidence of HO was seen in nearly half of the patients, many presenting with grades 3 and 4 HO. Four patients developed adjacent segment degeneration, although this only occurred in patients who exhibited signs of degenerative disc changes prior to their operation.


In a similar study, Dejaegher et al. [42] provided a 10-year follow-up to TDA with the Bryan prosthesis. Neurological success was achieved in 89% of the 72 patients, and over 80% of the prostheses had mobility of at least 2 degrees. Adverse events, specifically cases of radiculopathy and myelopathy, were reported by 24% of the patients, of which 8% required additional surgery to address new or recurrent symptoms . In an FDA IDE trial, Sasso et al. [43] conducted a prospective, randomized controlled trial of the Bryan cervical disc arthroplasty compared to ACDF and followed patients for 10 years. At this time point, arthroplasty demonstrated a significantly improved NDI (8 vs. 16) and a lower reoperation rate (9% vs. 32%).


Secure-C


Vaccaro et al. [29] compared the 2-year patient outcomes of using TDA with the Secure-C to ACDF. A total of 380 patients were included in this study. Mean surgery time was significantly shorter with ACDF. NDI reduction and improvement in neck and arm pain were seen at a higher rate in TDA patients; patient satisfaction and neurologic status were also better for this group. Radiological assessments indicated that 84.6% of TDA patients were range of motion successes at 24 months, with mean flexion-extension of 9.7°. It was also observed that 89.1% of patients who received ACDF had successful fusion at 24 months.



Pearls and Pitfalls






  • Cervical TDA is a viable FDA-approved tool in the armamentarium of the spine surgeon, but indications and contraindications should be seriously considered after obtaining patient history and preoperative diagnostics.



  • Patients with single-level and two-level cervical disease should be assessed for infection, osteoporosis, allergies, severe spondylosis or instability, facet arthropathy, and axial neck pain prior to considering TDA since these are all contraindications to the procedure.



  • Although there are no gold-standard diagnostics to assess facet arthropathy, consider CT, MRI, and facet blocks to aid in diagnosis.



  • Generally speaking, patients with less than 3 mm of disc space or greater than 15° of kyphotic deformity are poor candidates for cervical TDA.

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Oct 22, 2020 | Posted by in ORTHOPEDIC | Comments Off on Disc Arthroplasty

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