Stand-alone Cage Research Articles

Stand-alone anterior cervical decompression and fusion surgery: A cohort study evaluating a shaped cage without plates or screws.

BackgroundThe anterior approach to the cervical spine is the most commonly used surgery with effective decompression and less surgical trauma. Anterior plate construct (APC) is considered a standard technique. However, it appears to cause implant failure and postoperative dysphagia. Due to these reasons, locking stand-alone cages (LSCs) without the addition of an anterior plate have been developed and gained popularity in the past decade. In theory, an LSC could provide immediate load-bearing support to the anterior column of the cervical spine and may enhance the rate of arthrodesis. However, screw skiving and backing off are known complications of LSC. Given the characteristic shape of cervical discs, we wondered whether there may be a role for a shape-conforming cage without screws and plates to achieve desired outcomes, i.e., a true stand-alone cage (TSC). A single surgeon cohort using the cage in a heterogenic set of indications was evaluated.MethodsA total of 45 patients with degenerative cervical conditions who underwent surgery using TSC using CoRoent Small Contoured peek cage (Nuvasive, San Diego, CA) and Orthoblend™ (Medtronics, Memphis, TN) were retrospectively reviewed. Comparisons between preoperative and postoperative Numeric Rating Scale (NRS), the modified AAOS-Modems disability outcome, Neck Disability Index (NDI) scores, and Short Form 36 were evaluated. Operative time, the occurrence rate of fusion, lordosis change of cervical spine, and occurrence rate of complications were evaluated.ResultsThere were one-level (n = 15), two-level (n = 24), and three-level (n = 6) cases making a total of 81 cages implanted and studied. The mean operative time was 132.7 min. The group demonstrated significant improvements in NRS, AAOS-Modems disability outcome, and NDI scores after surgery (mean follow-up 12 months). The cervical lordosis at pre- and last follow-up period was 8.7 ± 2.2° and 8.3 ± 3.2°, respectively. The complication rate was 21.2%.ConclusionsTSC yielded satisfactory long-term clinical and radiological outcomes; this preliminary report can form the basis of a cost–benefit analysis study either prospectively or by way of meta-modeling comparing APC, LSC to TSC.

Comparing Clinical and Radiographic Outcomes Between the Self-locking Stand-alone Cage and Conventional Cage-plate Construct: A Five-year Retrospective Cohort Study.

A retrospective cohort study. To evaluate the clinical efficacy of the self-locking stand-alone (SA) cage and conventional cage-plate construct (CPC) in treating degenerative cervical spondylosis with a five-year follow-up. The SA approach was designed to reduce complications associated with traditional anterior cervical discectomy and fusion. These techniques have been shown to have satisfactory short-term clinical outcomes. Literature describing the mid-term clinical outcomes of SA cage is limited. We retrospectively analyzed patients with cervical spondylosis who had received an SA device or CPC between 2014 and 2016 at the Xijing Hospital. Participants were matched for sex, age, and operative level. Differences in clinical and radiographic outcomes and the occurrence of postoperative complications between the two groups were analyzed. In total, 207 patients were included (101 with SA and 106 with CPC), the median follow-up for both groups were 60.2 and 60.9 months. Both groups exhibited significant improvements in all measured values compared with the preoperative values. The SA group had a shorter operation time, less intraoperative blood loss, and a significantly lower incidence of dysphagia after surgery than the CPC group ( P <0.05). At the last visit, cage subsidence was 6.9% and 3.8% in the SA and CPC groups, respectively ( P =0.365). The radiographic adjacent segment degeneration (ASD) was significantly lower in the SA group than in the CPC group (6.9% vs. 27.4%, P <0.01). No symptomatic ASD was observed in the SA group, and six (5.7%) cases occurred in the CPC group ( P =0.029). In this study, the SA cage showed similar efficacy to that of the conventional CPC in treating cervical spondylosis using anterior cervical discectomy and fusion, with a significant reduction in the incidence of immediate postoperative dysphagia and mid-term ASD.

A randomized controlled study of two different fixations in anterior cervical discectomy of multilevel cervical spondylotic myelopathy.

Background: To compare the efficacy of anterior cervical discectomy and hybrid fusion (ACDHF) with short-segment plate plus self-locking, stand-alone intervertebral cages versus traditional anterior cervical discectomy and fusion (ACDF) with long-segment plate for multilevel cervical spondylotic myelopathy (MCSM). Methods: All the patients were randomly divided into two groups. 30 cases underwent ACDHF with short-segment plate and self-locking stand-alone cages (hybrid group), while the other 30 cases received ACDF with long-segment plate (control group). In patients meeting the inclusion and exclusion criteria, operation time, blood loss, postoperative drainage volume, length of stay (LOS), visual analogue scale for neck pain (VASNP) scores, Japanese Orthopaedic Association (JOA) score, and the cervical lordosis before and after the operation (5 days, 3, 6, 12 months after operation and final follow-up) were evaluated. The postoperative complications were analyzed as well. Results: All operations were performed uneventfully with followed-up. Compared with ACDF, ACDHF showed a shorter operation time, less intraoperative blood loss and postoperative drainage (p < 0.05). There were no significant difference in LOS between two groups (p ˃ 0.05). Both approaches significantly improved the JOA scores, VASNP scores and the cervical lordosis (p < 0.05). Based on Bazaz grading system, hybrid group had a lower incidence of dysphagia than control group in follow-up periods of 5 days, 3 and 6 months (p < 0.05). Conclusion: ACDF and ACDHF are both effective methods of restoring cervical lordosis following MCSM, but hybrid surgery minimizes intraoperative injury and postoperative dysphagia, making it a viable treatment option for the disorder.

33. Comparison of the biomechanics of lumbar spine instrumented with standalone interbody fixation constructs vs interbody with supplemental fixation: a finite element investigation

<h3>BACKGROUND CONTEXT</h3> Low fusion rates and cage subsidence have been reported as the main drawbacks of lumbar fixation with static interbody cages. Although several clinical and biomechanical studies have evaluated the efficacy of 360 interbody fixation constructs (anterior cage plus posterior fixation), no study has reported the biomechanical comparison between such constructs and more novel techniques which use standalone fixation implants. A cadaver validated computational model of lumbar spine was used to compare the biomechanics of spine instrumented with 360 fixations vs standalone cage and screw and cage with lateral plate systems. <h3>PURPOSE</h3> To compare the mechanical stability of different interbody fixation techniques in lumbar spinal segments with standalone interbody vs static cage with posterior fixation or lateral plate system. <h3>STUDY DESIGN/SETTING</h3> Finite element modeling. <h3>OUTCOME MEASURES</h3> Range of motion across instrument segments and load sharing on vertebral endplate. <h3>METHODS</h3> An experimentally validated finite element (FE) model of L1-pelvic segment was used to simulate ALIF and LIF lumbar fixation techniques including: ALIF cage at L5-S1 plus posterior screw-rod fixation (360 construct) vs ALIF standalone (screw through the cage). LIF cage at L4-L5 vs LIF cage with integrated two-hole lateral plate system. 4WEB Medical's Truss ALIF (27mm x 25mm), Lateral Truss (22mm X 5mm) cages and 2-hole integrated plate systems were used for simulation of the surgical procedure. For 360 constructs, a generic posterior rod and screw system was used. All models were subjected to a 400N compressive pre-load followed by an 8Nm moment to simulation flexion-extension, left and right bending and axial rotation motions. The segmental kinematics and the load sharing at the inferior endplate were compared among cases. <h3>RESULTS</h3> The segmental motion in standalone ALIF construct was 1.1°(Flex-Ext), 0.9° (LB) and 0.4° vs 0.8°, 0.8° and 0.6° in 360 ALIF in the same planes of motion. When comparing lateral cases, the motions were 1.2° (Flex-Ext), 1.4° (LB) and 0.5° (AR) in lateral cage with plate vs 0.9°, 1.0° and 0.8° in the 360 lateral construct for the same loads. The peak stresses in extension for the LIF stand-alone cage were somewhat higher than the posterior instrumented cases, but not significant. When comparing the mechanical stress on the inferior endplate of the index segment, the standalone ALIF had almost 20% higher peak stress compared to the 360 ALIF. In the lateral construct, the cage-plate segment experienced 15% lower stresses on the endplate compared to the 360 lateral construct. <h3>CONCLUSIONS</h3> Our data suggest that standalone ALIF cage with screw through the cage is able to provide kinematic stability in the fixation construct comparable to the cage plus posterior fixation, although the 360 construct is able to provide slightly more stability in the sagittal plane. Also, the standalone cage results in higher stresses applied to the endplate compared the cage in 360 constructs. The lateral cage with integrated plate had superior stability in axial rotation compared to the 360 lateral construct. The loads on the endplate were also slightly lower compared to the 360-fixation case. Standalone ALIF and LIF with lateral plate are biomechanically effecient alternatives to 360-fixation constructs at least under the controlled conditions analyzed in the present study. Clinical data are required to support the findings and define the further role and application of standalone cages. <h3>FDA DEVICE/DRUG STATUS</h3> 4WEB ALIF Truss System (Approved for this indication), 4WEB Lateral Plate System (Approved for this indication), 4WEB Lateral Truss System (Approved for this indication)

Clinical and Radiological Outcome in a Series of Patients Treated by Anterior Cervical Discectomy and Fusion: Retrospective Controlled Study With 2 Different Stand-Alone Cages.

Cervical spine balance and alignment targets after cervical spine surgery are poorly established in patients with cervical spine degenerative disease surgically treated by anterior cervical discectomy and fusion (ACDF). The objective of the study is to determine the correlation between radiological and clinical outcomes in patients surgically treated by ACDF with 2 different stand-alone cervical cages. Clinical outcomes were evaluated using visual analog scale (VAS), Neck Disability Index (NDI), Nurick Scale, and Japanese Orthopedic Association score for myelopathy. Radiological evaluation included cervical and segmental Cobb angles, cervical sagittal vertical axis (cSVA), T1 slope (T1s), C0-C2 angle, fusion rates, adjacent segment degeneration, and cage subsidence. A total of 80 patients were included with an average age of 53 years. There was a statistically significant improvement in both clinical and radiological evaluations. There was a statistical significant correlation between cervical pain on cervical VAS and cSVA. There was a significant correlation between postoperative T1s and cSVA, related to the improvement in cervical angles. There was no significant difference in rates of fusion, adjacent segment changes, or reoperation between both cervical cages, and there was a higher rate of subsidence in the Aleutian group. There were significant differences between both groups on postoperative NDI and VAS, but this difference is not maintained during follow-up. Cervical sagittal balance is directly related to clinical outcome in patients with cervical spine degenerative disease. Both cervical implants analyzed were comparable in clinical and radiological outcomes. There are important clinical and radiological parameters that should be taken into account for the analysis of the surgical outcome of patients treated by ACDF; this is one of the few studies that report the results with 2 different cervical cage designs.

P23. Inline axial forces associated with implantation of ALIF interbody devices with integrated supplemental fixation

<h3>BACKGROUND CONTEXT</h3> Anterior lumbar interbody fusion (ALIF) allows for an optimal sized interboy device while providing correction for lumbar lordosis, restoration of disc height and indirect decompression. Spinal interbody devices with integrated fixation through blades, screws or other supplemental anchoring components mitigate the need for supplemental instrumentation, thus reducing OR time and preserving the stability of the functional spinal unit. Unfortunately, interbody devices have failed at the bone implant interface resulting in complications including implant migration and expulsion. Gaining a better understanding of the biomechanics associated with interbody placement may help to prevent these complications in the future. The aim of present study is to determine the magnitude and effect of axial forces during the deployment of an interbody device with supplemental integrated fixation. <h3>PURPOSE</h3> To understand the axial loading imparted to the functional spinal unit during lumbar interbody fusion surgery. <h3>STUDY DESIGN/SETTING</h3> Biomechanical axial load mesaurement in cadaveric functional spinal units during lumbar disc preparation and spinal interbody device implant procedures. <h3>METHODS</h3> Cadaveric functional spinal units, levels L2-L3, L3-L4, L4-L5, and L5-S1, were decorticated to the osteoligamentous structures. Posterior elements were removed to allow for MicroCT imaging of each specimen at a voxel size of 27 micron before and after instrumentation. A custom test fixture was used to apply 50N compressive force to stabilize the specimen and also record inline axial forces associated with the deployment of anchor plates during instrumentation procedures. A Chatillon DFS II force gauge was used to record axial forces during implantation of ENZA 1.0 and ENZA 2.0 interbody devices. Axial forces resulting from implant trialing, device insertion and anchor deployment were recorded. MicroCT scans were repeated to allow for quantification of damage to bony structures as a result of implantation procedures. <h3>RESULTS</h3> L2-L3 and L3-L4 force outputs are similar for both insertion, 218.82 N, 219.89 N, and deployment forces, 34.58 N, 44.88 N respectively. Insertion forces throughout all spinal levels were larger than both deployment and removal forces. Insertion forces were larger in the proximal levels, 218.82 N, 219.89 N, when compared to the distal levels, 178.96 N, 113.76 N. However, deployment force was larger in the distal levels, 99.03 N, 77.76 N, when compared to proximal 34.58 N, 44.88 N. <h3>CONCLUSIONS</h3> As evidence mounts for the cost-effectiveness of standalone cages with integrated supplemental fixation, it is imperative that design requirements of these devices continue to improve. Previous studies have shown that the vertebral endplate is susceptible to fracture under compressive loading, with the weakest area of the vertebrae being the center region. In 2001, Hasegawa et al showed a cylindrical-shaped implant caused endplate fracture between 510N and 1335N and that implant size is inversely related to the force required to cause fracture. Endplate fracture is difficult to detect with standard imaging modalities and leaves the patient vulnerable to implant subsidence and reduces segmental stability as a result of changes in load transfer. Furthermore, endplate failure may be a contributor to low back pain, further reducing the chance of a successful outcome. Our study showed interbody devices with integrated fixation plates could safely be inserted and deployed in the disc space without causing endplate fracture. The implant-endplate interface should be investigated in greater detail to allow for design of standalone interbody devices which do not cause unintended distraction or worse, damage to the vertebrae. <h3>FDA DEVICE/DRUG STATUS</h3> ENZA Lumbar Interbody Fusion Device (Approved for this indication).

Evaluation of Anterior Lumbar Interbody Fusion Performed Using a Stand-Alone, Integrated Fusion Cage.

Anterior lumbar interbody fusion (ALIF) has been performed for many years. Often, posterior supplemental fixation has been used to provide additional stability to the operated segment. Interbody implants have evolved to incorporate unique designs, polyetheretherketone, integrated screws, and surface texture. With these changes, the need for supplemental posterior fixation has been debated. The purpose of this study was to evaluate the clinical outcome of stand-alone ALIF. A surgery log was reviewed to identify the consecutive series of 58 patients undergoing ALIF using a STALIF stand-alone cage from March 2011 (first case) to December 2018 (minimum 24 months postoperative) with a mean follow-up of 30.6 months. All patients were treated for symptomatic degenerative conditions. Charts were reviewed to collect general patient information, operative data, and patient-reported outcomes, including the Oswestry Disability Index (ODI), visual analog scales (VAS) separately assessing back pain and leg pain, and re-operations. For patients who were not seen recently in clinic for follow-up, current outcome data were collected through mailings. The mean operative blood loss was 52.1 mL. There was a statistically significant improvement in mean ODI scores from 41.7 preoperatively to 21.0 at follow-up (P < 0.01). There was also significant improvement (P < 0.01) in VAS back pain (6.0-2.5) and leg pain (4.1-1.3). Subsequent surgery was performed on 9 patients. Reasons for re-operation were pseudoarthrosis (n = 3), progressive cage subsidence (n = 1), foraminal stenosis at the index level (n = 1), metal allergy reaction (n = 2), adjacent segment degeneration (n = 1), and ongoing pain (n = 1). There were no cases of device failure, vertebral body fracture, or screws backing out of the implant. Stand-alone ALIF was associated with statistically significant improvements in ODI scores, back pain, and leg pain. The re-operation rate for clear pseudoarthrosis or cage subsidence was 6.8%. These results support that stand-alone ALIF produces good outcomes in patients treated for symptomatic disc degeneration while avoiding the use of posterior fixation and its complication risk and cost. The results of this study support that stand-alone ALIF is a viable procedure for the treatment of symptomatic disc degeneration unresponsive in patients who have failed nonoperative care and who do not have specific indications for supplemental posterior instrumentation.

Assessing Postoperative Pseudarthrosis in Anterior Cervical Discectomy and Fusion (ACDF) on Dynamic Radiographs Using Novel Angular Measurements.

A retrospective review of operative patients at a single institution. The aim was to validate a novel method of detecting pseudarthrosis on dynamic radiographs. A common complication after anterior cervical discectomy and fusion is pseudarthrosis. A previously published method for detecting pseudarthrosis identifies a 1mm difference in interspinous motion (ISM), which requires calibration of images and relies on anatomic landmarks difficult to visualize. An alternative is to use angles between spinous processes, which does not require calibration and relies on more visible landmarks. ISM was measured on dynamic radiographs using the previously published linear method and new angular method. Angles were defined by lines from screw heads to dorsal points of spinous processes. Angular cutoff for fusion was calculated using a regression equation correlating linear and angular measures, based on the 1mm linear cutoff. Pseudarthrosis was assessed with both cutoffs. Sensitivity, specificity, inter-reliability and intrareliability of angular and linear measures used postoperative computed tomography (CT) as the reference. A total of 242 fused levels (81 allograft, 84 polyetheretherketone, 40 titanium, 37 standalone cages) were measured in 143 patients (mean age 52.0±11.5, 42%F). 36 patients (66 levels) had 1-year postoperative CTs; 13 patients (13 levels) had confirmed pseudarthrosis. Linear and angular measurements closely correlated ( R =0.872), with 2.3° corresponding to 1mm linear ISM. Potential pseudarthroses was found in 28.0% and 18.5% levels using linear and angular cutoffs, respectively. Linear cutoff had 85% sensitivity, 87% specificity; angular cutoff had 85% sensitivity, 96% specificity for detecting CT-validated pseudarthrosis. Interclass correlation coefficients were 0.974 and 0.986 (both P <0.001); intrarater reliability averaged 0.953 and 0.974 ( P <0.001 for all) for linear and angular methods, respectively. The angular measure for assessing potential pseudarthrosis is as sensitive as and more specific than published linear methods, has high interobserver reliability, and can be used without image calibration. 3.

Standalone cage versus anchored cage for anterior cervical discectomy and fusion: a comparative analysis of clinical and radiological outcomes.

The use of standalone cages (SAC) and anchored cages (AC) in anterior cervical discectomy and fusion surgery (ACDF) has shown advantage of reduced operative time and lower incidence of dysphagia. However, there is limited literature available comparing the clinical and radiological outcomes of SAC and AC. We conducted a prospective study for patients undergoing ACDF for cervical radiculopathy or myelopathy. Patient were classified based on the cage used into SAC group and the AC group. Clinical outcomes were assessed using the modified Japanese Orthopedic Association (mJOA) for myelopathy and Neck Disability Index (NDI) and Visual Analogue Scale (VAS) for radiculopathy. Dysphagia was graded as per Bazaz score. Radiologically, global cervical lordosis, segmental lordosis, cage subsidence, and migration were assessed. We analyzed 31 patients in each group with a minimum twoyear follow-up. The mean VAS improved from 7.9 to 4.56, mean NDI score improved from 27.6 to 19.8, and mean mJOA improved from 10.8 to 11.7 which were statistically significant (p < 0.05); however, no significant difference was noted between the SAC and AC groups. Mean global lordosis improved from 14.4 to 20.3° and mean segmental lordosis improved from 6 to 10.1° at sixmonths and plateaued to 6.9° at final follow up without any significant difference between the groups. The subsidence was statistically more in 12.9% (4/31) in SAC than 6.4% (2/31) in AC. AC showed of lower rates of subsidence while both SAC and AC had comparable clinical outcomes and radiological alignment outcomes.

Single-Level Anterior Cervical Discectomy and Interbody Fusion: A Comparison between Porous Tantalum and Polyetheretherketone Cages.

Background: Anterior cervical discectomy and interbody fusion (ACDF) may be performed with different kinds of stand-alone cages. Tantalum and polyetheretherketone (PEEK) are two of the most commonly used materials in this procedure. Few comparisons between different stand-alone implants for ACDF have been reported in the literature. Methods: We performed a comparison between patients who underwent ACDF with either a porous tantalum or a PEEK stand-alone cage, in two spine surgery units for single-level disc herniation. Clinical outcome [Neck Disability Index (NDI), Visual Analog Scale (VAS) for pain, Short Form-36 (SF-36)] and radiological outcome (lordosis, fusion and subsidence) were measured before surgery and at least one year after surgery in both groups. Results: Thirty-eight patients underwent ACDF with a porous tantalum cage, and thirty-one with a PEEK cage. The improvement of NDI and SF-36 was significantly superior in the PEEK group (p = 0.002 and p = 0.049 respectively). Moreover, the variation of the Cobb angle for the cervical spine was significantly higher in the PEEK group (p < 0.001). Conclusions: In a retrospective analysis of two groups of patients with at least one year of follow-up, a stand-alone PEEK cage showed superior clinical results, with improved cervical lordosis, compared to a stand-alone porous tantalum cage. Further studies are needed to confirm these data.

Biomechanical analysis of stand-alone lumbar interbody cages versus 360° constructs: an in vitro and finite element investigation.

Low fusion rates and cage subsidence are limitations of lumbar fixation with stand-alone interbody cages. Various approaches to interbody cage placement exist, yet the need for supplemental posterior fixation is not clear from clinical studies. Therefore, as prospective clinical studies are lacking, a comparison of segmental kinematics, cage properties, and load sharing on vertebral endplates is needed. This laboratory investigation evaluates the mechanical stability and biomechanical properties of various interbody fixation techniques by performing cadaveric and finite element (FE) modeling studies. An in vitro experiment using 7 fresh-frozen human cadavers was designed to test intact spines with 1) stand-alone lateral interbody cage constructs (lateral interbody fusion, LIF) and 2) LIF supplemented with posterior pedicle screw-rod fixation (360° constructs). FE and kinematic data were used to validate a ligamentous FE model of the lumbopelvic spine. The validated model was then used to evaluate the stability of stand-alone LIF, transforaminal lumbar interbody fusion (TLIF), and anterior lumbar interbody fusion (ALIF) cages with and without supplemental posterior fixation at the L4-5 level. The FE models of intact and instrumented cases were subjected to a 400-N compressive preload followed by an 8-Nm bending moment to simulate physiological flexion, extension, bending, and axial rotation. Segmental kinematics and load sharing at the inferior endplate were compared. The FE kinematic predictions were consistent with cadaveric data. The range of motion (ROM) in LIF was significantly lower than intact spines for both stand-alone and 360° constructs. The calculated reduction in motion with respect to intact spines for stand-alone constructs ranged from 43% to 66% for TLIF, 67%-82% for LIF, and 69%-86% for ALIF in flexion, extension, lateral bending, and axial rotation. In flexion and extension, the maximum reduction in motion was 70% for ALIF versus 81% in LIF for stand-alone cases. When supplemented with posterior fixation, the corresponding reduction in ROM was 76%-87% for TLIF, 86%-91% for LIF, and 90%-92% for ALIF. The addition of posterior instrumentation resulted in a significant reduction in peak stress at the superior endplate of the inferior segment in all scenarios. Stand-alone ALIF and LIF cages are most effective in providing stability in lateral bending and axial rotation and less so in flexion and extension. Supplemental posterior instrumentation improves stability for all interbody techniques. Comparative clinical data are needed to further define the indications for stand-alone cages in lumbar fusion surgery.

Zero-Profile Anchored Spacer (ROI-C) in the Treatment of Cervical Adjacent Segment Disease.

Background Self-locking stand-alone cages have increasingly been used in anterior cervical discectomy and fusion (ACDF) cervical degenerative disc disease. We studied clinical and radiological outcomes of patients who underwent zero-profile anchored spacer (ROI-C)–assisted ACDF without anterior plate fixation in cervical adjacent segment disease. Materials and Methods Fifteen patients suffering from cervical adjacent segment disease with various symptoms, such as radiculopathy, myelopathy, or both, were retrospectively evaluated. The cervical adjacent segment disease was confirmed by plain radiographs and magnetic resonance imaging. The patients underwent radiological evaluation to assess cervical curvature, intervertebral height, fusion, and subsidence. Clinical assessment was graded using a visual analog scale, Modified Japanese Orthopedic Association score, and the Neck Disability Index. Results There were 19 levels of operation. Single-level ACDF was performed in 11 patients and two level in 4 patients. In the postoperative period, our study revealed significant improvement in the clinical outcome. The cervical curvature and intervertebral height were significantly improved at 12-months follow-up ( p < 0.05). The fusion rate was 100%, whereas subsidence occurred in 5.3% but produced no symptoms. Of the 19 operated segment, 2 (5.3%) from 38 VerteBRIDGE plates had breakage. There was only one case of mild dysphagia, which resolved in less than 2 weeks. Conclusion This study indicates that zero-profile anchored spacer (ROI-C) in the treatment of cervical adjacent segment disease provides improvement of clinical outcomes, restoration of lordosis, high fusion rate, and low incidence of dysphagia. However, subsidence and breakage of VerteBRIDGE plate occurred in 5.3% cases, but did not cause clinical symptoms.

Response to: A Randomized Control Trial Comparing Local Autografts and Allografts in Single Level Anterior Cervical Discectomy and Fusion Using a Stand-Alone Cage.

See the letter "Letter to the Editor: A Randomized Control Trial Comparing Local Autografts and Allografts in Single Level Anterior Cervical Discectomy and Fusion Using a Stand-Alone Cage" on page 311.

Letter to the Editor: A Randomized Control Trial Comparing Local Autografts and Allografts in Single Level Anterior Cervical Discectomy and Fusion Using a Stand-Alone Cage.

See the reply "Response to: A Randomized Control Trial Comparing Local Autografts and Allografts in Single Level Anterior Cervical Discectomy and Fusion Using a Stand-Alone Cage" on page 313.

Stand-Alone Cage Versus Anterior Plating for 1-Level and 2-Level Anterior Cervical Discectomy and Fusion: A Randomized Controlled Trial.

Prospective, randomized controlled trial. The aim was to compare perioperative and radiographic outcomes between stand-alone and anterior plated 1 and 2-level anterior cervical discectomy and fusion (ACDF). ACDF with interbody spacer and separate plate/screw construct (PLATE) may be associated with a higher incidence of postoperative dysphagia, increased operative time, and other complications. Therefore, some have opted to utilize an interbody cage with integrated screws and no plate (CAGE) with good results. Patients with 1-level to 2-level degenerative disease were prospectively enrolled and randomized into 1 of 2 treatment arms consisting of either PLATE or CAGE reconstruction. Patients were followed for a minimum of 1 year postoperatively. Primary endpoints included improvement on patient-reported outcome metrics, construct integrity, cervical alignment, successful arthrodesis, and subsequent revision surgeries. Forty-six patients were included: 12 with 1-level PLATE, 12 with 1-level CAGE, 12 with 2-level PLATE, and 10 with 2-level CAGE. For 1-level ACDF, PLATE patients reported worse swallow function on Swallowing Quality of Life Questionnaire at 6 weeks (P=0.050) and 6 months (P=0.042). Pseudarthrosis requiring revision was observed in one PLATE patient. For 2-level ACDF CAGE patients reported worse disability on neck disability index (P=0.037) at 6 weeks, as well as worse neck disability index (P=0.017) and visual analog scale neck (P=0.010) at 6 months. However, PLATE patients reported worse swallow function on Swallowing Quality of Life Questionnaire at 6 weeks (P=0.038). There were no differences in the rates of fusion, loss of disc height correction, subsidence, or in sagittal parameters between cohorts for both 1-level and 2-level ACDF. There was greater incidence of transient postoperative dysphagia in both single and 2-level PLATE cohorts. However, early postoperative outcomes were worse for 2-level CAGE in certain patient-reported metrics. This suggests that although anterior instrumentation may be associated with a higher likelihood of dysphagia, it may also lead to higher short-term stability and improved patient-reported outcomes for 2-level fusion.

When to Consider Stand-Alone Lateral Lumbar Interbody Fusion: Is There a Role for a Comeback With New Implants?

To perform a comprehensive review of the literature about the role of stand-alone lateral lumbar interbody fusion (LLIF). A MEDLINE review was conducted including studies about stand-alone LLIF for any condition. The opinions of the authors were also considered. Studies that included biomechanical, cadaveric, or clinical aspects of stand-alone cages were revised to obtain data about the pros, cons, and limitations of the technique. Comparative studies with 360° (lateral + posterior) fusions were also analyzed. A total of 36 studies were identified. After reviewing the abstracts, 18 full articles of interest for the objective of this review were analyzed. Recommendations based on the literature were made. Although most of the recommendations in the literature were about augmentation with pedicle screws, there may be a role for stand-alone LLIF in some particular cases. Specific technical aspects should be considered to reduce the failure rate. Although there might be some specific indications for stand-alone LLIF, it should be considered an exception rather than the rule.

Anterior Cervical Discectomy and Fusion Surgery: Results with Zero-Profile Spacer/Cage

Objective: Study provides proof to support the promised benefits of employing stand-alone zero-profile cages in multilevel ACDF procedures, as the stand-alone zero-profile device has proven safety and a reduction of the risk of dysphagia in single-level ACDF surgeries.&#x0D; Materials and Methods: This is a retrospective descriptive study, conducted at the Punjab Institute of Neurosciences, Lahore, Pakistan. Data of 36 patients evaluated for post-operative dysphagia and fusion, who had multi-level ACDF surgery employing stand-alone zero-profile cages.&#x0D; Results: Total of 36 patients underwent ACDF surgeries. 86.1% (31/36) patients operated for 2 levels and 13.9% (5/36) patients operated for 3 levels. Dysphagia developed postoperatively in 2 (5.6%) patients in which zero-profile stand-alone cages were used. Fusion was achieved in 94.4% (34/36) patients.&#x0D; Conclusion: Stand-alone zero-profile cages in multi-level ACDF surgeries have a good outcome in terms of post-operative less dysphagia and higher fusion rates.&#x0D; Keywords: Anterior Cervical Discectomy (Decompression) And Fusion (ACDF), Zero-Profile Cages, Cervical Spondylotic Myelopathy.

Thorough Comparative Analysis of Stand-Alone Cage and Anterior Cervical Plate for Anterior Cervical Discectomy and Fusion in the Treatment of Cervical Degenerative Disease: A Systematic Review and Meta-analysis.

In this systematic review and meta-analysis, we aim to thoroughly describe and objectively compare the efficacy of anterior cervical plate (ACP) and stand-alone cage (SAC). Although recognized as an effective procedure for cervical degenerative disease (CDD), a debate between the methods of anterior cervical discectomy and fusion exists. ACP provides stability to the fusion construct; however, some complications have been reported, such as dysphagia, adjacent disc disease, and soft tissue injury. To overcome these complications, a SAC was later introduced. A systematic search was conducted on the basis of PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines to identify relevant studies through PubMed, Google Scholar, and Cochrane database. A total of 14 studies (960 patients) were included in the meta-analysis. Twenty outcomes were clinically and radiologically compared between the two procedures. ACP and SAC were comparable in terms of dysphasia rate, loss of segmental angle, loss of disc height, the Odom criteria, Robinson's criteria, hospital stay, Japanese Orthopaedic Association score, Neck Disability Index, Visual Analog Scale, and fusion time. However, SAC was superior in terms of shorter operation time, less blood loss, lower dysphagia rate, and lower rate of adjacent level disease, whereas ACP was advantageous in terms of lower subsidence rate, better maintenance of the cervical global and segmental angles and disc height, and higher fusion rate. Both procedures can be used in patients with CDD, although it might be more beneficial to choose ACP in patients with multi-level pathologies, wherein better mechanical stability is provided. However, SAC may be more beneficial to use in patients with comorbidities, anemia, or swelling problems because it offers lower complication rates.

Do evoked potentials matter? Pre-pathologic signal change and clinical outcomes with expandable cages in lateral lumbar interbody fusion surgery

Minimally Invasive Lateral Lumbar Interbody Fusion (MIS LLIF) is a reliable technique for treatment of degenerative disk disease, foraminal stenosis and spinal deformity. The retroperitoneal transpsoas approach risks lumbar plexus injury that may result in anterior thigh pain, sensory loss and weakness. A prospective study of 64 consecutive patients undergoing MIS LLIF with expandable cages (23 standalone, 41 integrated with lateral plate) using multimodal electrophysiological monitoring was performed. We measured sequential retraction times, complications, patient reported outcome scores and electrophysiologic findings with a minimum 12-month follow-up. Incidence of evoked potential and electromyographic signal change was moderate, and rarely resulted in post-operative neurologic deficit. Evoked potential signal changes were frequently resolved by the un-breaking of the surgical table or repositioning of the retractor. Average retraction times were 24 (15–41) minutes for standalone cages and 30 (15–41) minutes for integrated cages. At follow-up, the vast majority (97%) of patients reported significant clinical improvement post-operatively with only 2 patients reporting postoperative neurologic symptoms and subsequent recovery at 12-months. The present study shows that evoked potentials combined with electromyography is a more sensitive measure of pre-pathologic lumbar plexopathy in LLIF compared to electromyography alone, especially at L3/4 and L4/5 levels. Based on our findings, there is limited clinical indication for routine neural monitoring at rostral lumbar levels. The routine inclusion of multimodal electrophysiological monitoring in lateral transpsoas surgery is recommended to minimise the risk of neural injury by enabling optimal patient and retractor positioning and continued surveillance throughout the procedure.

Anterior cervical corpectomy and fusion with stand-alone cages in patients with multilevel degenerative cervical spine disease is safe

BackgroundIn case of spinal cord compression behind the vertebral body, anterior cervical corpectomy and fusion (ACCF) proves to be a more feasible approach than cervical discectomy. The next step was the placement of an expandable titanium interbody in order to restore the vertebral height. The need for additional anterior plating with ACCF has been debatable and such technique has been evaluated by very few studies. The objective of the study is to evaluate radiographic and clinical outcomes in patients with multilevel degenerative cervical spine disease treated by stand-alone cages for anterior cervical corpectomy and fusion (ACCF).MethodsThirty-one patients (66.5 ± 9.75 years, range 53–85 years) were analyzed. Visual Analog Scale (VAS) and the 10-item Neck Disability Index (NDI) were assessed preoperatively and during follow-up on a regular basis after surgery and after one year at least. Assessment of radiographic fusion, subsidence, and lordosis measurement of Global cervical lordosis (GCL); fusion site lordosis (FSL); the anterior interbody space height (ant. DSH); the posterior interbody space height (post. DSH); the distance of the cage to the posterior wall of the vertebral body (CD) were done retrospectively. Mean clinical and radiographic follow-up was 20.0 ± 4.39 months.ResultsVAS-neck (p = 0.001) and VAS-arm (p < 0.001) improved from preoperatively to postoperatively. The NDI improved at the final follow-up (p < 0.001). Neither significant subsidence of the cages nor significant loss of lordotic correction were seen. All patients showed a radiographic union of the surgically addressed segments at the last follow up.ConclusionsApplication of a stand-alone expandable cage in the cervical spine after one or two-level ACCF without additional posterior fixation or anterior plating is a safe procedure that results in fusion. Neither significant subsidence of the cages nor significant loss of lordotic correction were seen.Trial registrationRetrospectively registered. According to the Decision of the ethics committee, Jena on 25th of July 2018, that this study doesn’t need any registration. https://www.laek-thueringen.de/aerzte/ethikkommission/registrierung/.