Effect of workers’ compensation status on pain, disability, quality of life, and return to work after anterior cervical discectomy and fusion: a 1-year propensity score–matched analysis

J Neurosurg Spine 39:822–830, 2023

Patients with workers’ compensation (WC) claims are reported to demonstrate poorer surgical outcomes after lumbar spine surgery. However, outcomes after anterior cervical discectomy and fusion (ACDF) in WC patients remain debatable. The authors aimed to compare outcomes between a propensity score–matched population of WC and non-WC patients who underwent ACDF.

METHODS Patients who underwent 1- to 4-level ACDF were retrospectively reviewed from the prospectively maintained Quality Outcomes Database (QOD). After propensity score matching, 1-year patient satisfaction, physical disability (Neck Disability Index [NDI]), pain (visual analog scale [VAS]), EQ-5D, and return to work were compared between WC and non-WC cohorts.

RESULTS A total of 9957 patients were included (9610 non-WC and 347 WC patients). Patients in the WC cohort were significantly younger (50 ± 9.1 vs 56 ± 11.4 years, p < 0.001), less educated, and were more frequently male, non-Caucasian, and active smokers (29.1% vs 18.1%, p < 0.001), with greater baseline VAS and NDI scores and poorer quality of life (p < 0.001). One-year postoperative improvements in VAS, NDI, EQ-5D, and return-to-work rates and satisfaction were all significantly worse for WC compared with non-WC patients. After adjusting for baseline differences via propensity score matching, WC versus non-WC patients continued to demonstrate worse 3- and 12-month VAS neck pain and NDI (p = 0.010), satisfaction (χ 2 = 4.03, p = 0.045), and delayed return to work (9.3 vs 5.7 weeks, p < 0.001).

CONCLUSIONS WC status was associated with greater 1-year residual disability and axial pain along with delayed return to work, without any difference in quality of life despite having fewer comorbidities and being a younger population. Further studies are needed to determine the societal impact that WC claims have on healthcare delivery in the setting of ACDF.

Comparison of clinical outcomes between cervical disc arthroplasty and anterior cervical discectomy and fusion for the treatment of single-level cervical spondylosis: a 10-year follow-up study

The Spine Journal 23 (2023) 361−368

The theoretical advantage of cervical disc arthroplasty includes preserved motion at the cervical level, which may reduce degeneration of the adjacent segments. The long-term follow-up results are still controversial.

PURPOSE: The present study aimed to retrospectively study the long-term efficacy and complications of cervical disc arthroplasty using a single commercially-available device in a single center.

STUDY DESIGN: This was a propensity-score matched cohort study.

PATIENT SAMPLE: This study enrolled 148 single-level cervical degenerative disease patients from January 2009 to March 2012. After 1:1 propensity score matching, 39 patients remained in the ACDF or ACDR groups.

OUTCOME MEASURES: The outcome measures were neurological functions (Neck Disability Index (NDI) and Japan Orthopedic Association (JOA) scores), radiographic evaluations (cervical curvature, operative segment range of motion, degenerative condition of adjacent segments, heterotopic ossification (HO) of the surgical segment), and complications.

METHODS: NDI and JOA scores were used to evaluate patient neurological functions. Cervical curvature (C2-C7 Cobb angle) and operative segment range of motion (ROM) were compared between the two groups. Grading criteria for osteophyte formation were used to evaluate the degenerative condition of adjacent segments. HO after ACDR was graded according to the McAfee grading method.

RESULTS: The average follow-up time was 119.3 §17.2 months. Satisfactory improvements in neurological function were obtained for both the ACDR and ACDF groups. There were no significant differences in VAS or NDI scores between the two groups. In the ACDR group, the ROM of the operative segment increased from 6.7 §4.3˚ before the operation to 8.9 §3.5˚ on the second day after the operation (p<.001). The ROM of the operative segment was 8.1 §4.0˚ at the 1-year follow-up, 7.2 §3.6˚ at the 2-year follow-up, 5.7 §4.5˚ at the 5-year follow-up and 4.3 §3.9˚ at the last follow-up. ASD was more likely to develop in the caudal adjacent segments and progressed with the follow-up time. At the last follow-up, HO was present in 27 patients (69.23%), while high-grade HO (McAfee scores III and IV) was detected in 6 patients (15.38%).

CONCLUSIONS: Through nearly 10 years of follow-up, ACDR was as effective as ACDF for treating single-level degenerative cervical disc disease. However, HO and the role of ACDR in the protection of ASD remains to be further observed and followed up.

Comparison of anterior cervical discectomy and fusion versus artificial disc replacement for cervical spondylotic myelopathy: a meta-analysis

J Neurosurg Spine 37:569–578, 2022

Anterior cervical discectomy and fusion (ACDF) has long been regarded as a gold standard in the treatment of cervical myelopathy. Subsequently, cervical artificial disc replacement (c-ADR) was developed and provides the advantage of motion preservation at the level of the intervertebral disc surgical site, which may also reduce stress at adjacent levels. The goal of this study was to compare clinical and functional outcomes in patients undergoing ACDF with those in patients undergoing c-ADR for cervical spondylotic myelopathy (CSM).

METHODS A systematic literature review and meta-analysis were performed using the Embase, PubMed, and Cochrane Central Register of Controlled Trials databases from database inception to November 21, 2021. The authors compared Neck Disability Index (NDI), SF-36, and Japanese Orthopaedic Association (JOA) scores; complication rates; and reoperation rates for these two surgical procedures in CSM patients. The Mantel-Haenszel method and varianceweighted means were used to analyze outcomes after identifying articles that met study inclusion criteria.

RESULTS More surgical time was consumed in the c-ADR surgery (p = 0.04). Shorter hospital stays were noted in patients who had undergone c-ADR (p = 0.04). Patients who had undergone c-ADR tended to have better NDI scores (p = 0.02) and SF-36 scores (p = 0.001). Comparable outcomes in terms of JOA scores (p = 0.24) and neurological success rate (p = 0.12) were noted after the surgery. There was no significant between-group difference in the overall complication rates (c-ADR: 18% vs ACDF: 25%, p = 0.17). However, patients in the ACDF group had a higher reoperation rate than patients in the c-ADR group (4.6% vs 1.5%, p = 0.02).

CONCLUSIONS At the midterm follow-up after treatment of CSM, better functional outcomes as reflected by NDI and SF-36 scores were noted in the c-ADR group than those in the ACDF group. c-ADR had the advantage of retaining range of motion at the level of the intervertebral disc surgical site without causing more complications. A large sample size with long-term follow-up studies may be required to confirm these findings in the future.

Use of zero-profile device for contiguous three-level anterior cervical discectomy and fusion: comparison with cage and plate construct

J Neurosurg Spine 35:219–226, 2021

The aim of this study was to compare a traditional cervical cage with a zero-profile (ZP) fixation device in patients who underwent three-level anterior cervical decompression and fusion (ACDF) in terms of patient-reported outcomes (visual analog scale [VAS], Japanese Orthopaedic Association [JOA], and Neck Disability Index [NDI] scores), radiographic findings (sagittal alignment 2 years after surgery and likelihood of fusion), and complications.

METHODS This study was a retrospective case series. Between January 2012 and December 2016, 58 patients with cervical spondylotic myelopathy (CSM) who required three-level ACDF procedures, as identified by spinal surgeons, were treated with three-level ACDF and an anterior cage-plate construct (ACPC) (n = 38) or a three-level stand-alone ZP device (n = 20). On the basis of patient choice, patients were divided into two groups (ACPC group and ZP group). All patients completed a minimum of 2 years of follow-up. Patient-reported outcome scores included VAS, JOA, and NDI scores. The radiographic findings included sagittal alignment and likelihood of fusion 2 years after surgery. Data related to patient-reported outcomes and sagittal alignment were collected preoperatively, postoperatively, and at the final follow-up. Intraoperative and postoperative complications were also documented and analyzed.

RESULTS The clinical outcomes, including VAS, JOA, and NDI scores, showed improvement in both groups, and no significant difference was observed between the two groups. Sagittal alignment and height of the fused segments were restored in all patients. However, the authors found no differences between the ZP and ACPC groups, and the groups exhibited similar fusion rates. The authors found no differences in complications, including dysphagia, adjacent-segment degeneration, and postoperative hematoma, between the groups.

CONCLUSIONS Use of ZP implants yielded satisfactory long-term clinical and radiological outcomes that were similar to those of the standard ACPC. Additionally, the rates of complications between the groups were not significantly different. Although the best surgical option for multilevel CSM remains controversial, the results of this work suggest that ACDF with the ZP device is feasible, safe, and effective, even for multilevel CSM.

Nonunion Rates After Anterior Cervical Discectomy and Fusion: Comparison of Polyetheretherketone vs Structural Allograft Implants

Neurosurgery 89:94–101, 2021

Although advances in implant materials, such as polyetheretherketone (PEEK), have been developed aimed to improve outcome after anterior cervical discectomy and fusion (ACDF), it is essential to confirm whether these changes translate into clinically important sustained benefits.

OBJECTIVE: To compare the radiographic and clinical outcomes of patients undergoing up to 3-level ACDF with PEEK vs structural allograft implants.

METHODS: In this cohort study, radiographic and symptomatic nonunion rates were compared in consecutive patients who underwent 1 to 3 level ACDF with allograft or PEEK implant. Prospectively collected clinical data and patient-reported outcome (PRO) scores were compared between the allograft and PEEK groups. Regression analysis was performed to determine the predictors of nonunion.

RESULTS: In total, 194 of 404 patients met the inclusion criteria (79% allograft vs 21% PEEK). Preoperative demographic variables were comparable between the 2 groups except for age. The rate of radiographic nonunion was higher with PEEK implants (39% vs 27%, P = .0035). However, a higher proportion of nonunion in the allograft cohort required posterior instrumentation (14% vs 3%, P = .039). Patients with multilevel procedures and PEEK implants had up to 5.8 times the risk of radiographic nonunion, whereas younger patients, active smokers, and multilevel procedures were at higher risk of symptomatic nonunion.

CONCLUSION: Along with implant material, factors such as younger age, active smoking status, and the number of operated levels were independent predictors of fusion failure. Given the impact of nonunion on PRO, perioperative optimization of modifiable factors and surgical planning are essential to ensure a successful outcome.

A single-center retrospective analysis of 3- or 4-level anterior cervical discectomy and fusion

J Neurosurg Spine 34:45–51, 2021

Anterior cervical discectomy and fusion (ACDF) is a safe and effective intervention to treat cervical spine pathology. Although these were originally performed as single-level procedures, multilevel ACDF has been performed for patients with extensive degenerative disc disease. To date, there is a paucity of data regarding outcomes related to ACDFs of 3 or more levels. The purpose of this study was to compare surgical outcomes of 3- and 4-level ACDF procedures.

METHODS The authors performed a retrospective chart review of patients who underwent 3- and 4-level ACDF at the University of Virginia Health System between January 2010 and December 2017. In patients meeting the inclusion/exclusion criteria, demographics, fusion rates, time to fusion, and reoperation rates were evaluated. Fusion was determined by < 1 mm of change in interspinous distance between individual fused vertebrae on lateral flexion/extension radiographs and lack of radiolucency between the grafts and vertebral bodies. Any procedure requiring a surgical revision was considered a failure.

RESULTS Sixty-six patients (47 with 3-level and 19 with 4-level ACDFs) met the inclusion/exclusion criteria of having at least one lateral flexion/extension radiograph series ≥ 12 months after surgery. Seventy percent of 3-level patients and 68% of 4-level patients had ≥ 24 months of follow-up. Ninety-four percent of 3-level patients and 100% of 4-level patients achieved radiographic fusion for at least 1 surgical level. Eighty-eight percent and 82% of 3- and 4-level patients achieved fusion at C3–4; 85% and 89% of 3- and 4-level patients achieved fusion at C4–5; 68% and 89% of 3- and 4-level patients achieved fusion at C5–6; 44% and 42% of 3- and 4-level patients achieved fusion at C6–7; and no patients achieved fusion at C7–T1. Time to fusion was not significantly different between levels. Revision was required in 6.4% of patients with 3-level and in 16% of patients with 4-level ACDF. The mean time to revision was 46.2 and 45.4 months for 3- and 4-level ACDF, respectively. The most common reason for revision was worsening of initial symptoms.

CONCLUSIONS The authors’ experience with long-segment anterior cervical fusions shows their fusion rates exceeding most of the reported fusion rates for similar procedures in the literature, with rates similar to those reported for short-segment ACDFs. Three-level and 4-level ACDF procedures are viable options for cervical spine pathology, and the authors’ analysis demonstrates an equivalent rate of fusion and time to fusion between 3- and 4-level surgeries.

 

Pseudarthrosis in anterior cervical discectomy and fusion with a self-locking, stand-alone cage filled with hydroxyapatite

J Neurosurg Spine 33:717–726, 2020

The goal of this study was to evaluate the incidence of pseudarthrosis after the treatment of cervical degenerative disc disease (CDDD) with anterior cervical discectomy and fusion (ACDF) in which self-locking, stand-alone intervertebral cages filled with hydroxyapatite were used.

METHODS The authors performed a retrospective cohort study of 49 patients who underwent 1- to 3-level ACDF with self-locking, stand-alone intervertebral cages without plates, with a minimum 2 years of follow-up. The following data were extracted from radiological and clinical charts: age, sex, time and type of pre- and postoperative signs and symptoms, pain status (visual analog scale [VAS]), functional status (Neck Disability Index [NDI]), history of smoking, bone quality (bone densitometry), and complications. Pseudarthrosis was diagnosed by a blinded neuroradiologist using CT scans. Clinical improvement was assessed using pre- and postoperative comparison of VAS and NDI scores. The Wilcoxon test for paired tests was used to evaluate statistical significance using a p value of < 0.05.

RESULTS Three patients (6%) developed symptomatic pseudarthrosis requiring reoperation, with only 1 patient showing clinical worsening due to pseudarthrosis, while the other 2 with pseudarthrosis had associated disc disease at an adjacent level. The rate of symptomatic pseudarthrosis according to the number of operated levels was 0% for 1 level, 8.7% (2/23 patients) for 2 levels, and 7.7% (1/13 patients) for 3 levels. The total pseudarthrosis rate (including both symptomatic and asymptomatic patients) was 16.4%. Considering the clinical outcomes, there was a significant improvement of 75.6% in neck pain and 95.7% in arm pain, as well as a 64.9% improvement in NDI scores. Complications were observed in 18.4% of patients, with adjacent-level degenerative disease being the most prevalent at 14.3%.

CONCLUSIONS ACDF with self-locking, stand-alone cages filled with a hydroxyapatite graft can be used for the surgical treatment of 1- to 3-level CDDD with clinical and radiological outcomes significantly improved after a minimum 2-year follow-up period. Comparative studies are necessary.

 

Lower Hounsfield units on CT are associated with cage subsidence after anterior cervical discectomy and fusion

J Neurosurg Spine 33:425–432, 2020

A consequence of anterior cervical discectomy and fusion (ACDF) is graft subsidence, potentially leading to kyphosis, nonunion, foraminal stenosis, and recurrent pain. Bone density, as measured in Hounsfield units (HUs) on CT, may be associated with subsidence. The authors evaluated the association between HUs and subsidence rates after ACDF.

METHODS A retrospective study of patients treated with single-level ACDF at the University of California, San Francisco, from 2008 to 2017 was performed. HU values were measured according to previously published methods. Only patients with preoperative CT, minimum 1-year follow-up, and single-level ACDF were included. Patients with posterior surgery, tumor, infection, trauma, deformity, or osteoporosis treatment were excluded. Changes in segmental height were measured at 1-year follow-up compared with immediate postoperative radiographs. Subsidence was defined as segmental height loss of more than 2 mm.

RESULTS A total of 91 patients met inclusion criteria. There was no significant difference in age or sex between the subsidence and nonsubsidence groups. Mean HU values in the subsidence group (320.8 ± 23.9, n = 8) were significantly lower than those of the nonsubsidence group (389.1 ± 53.7, n = 83, p < 0.01, t-test). There was a negative correlation between the HU values and segmental height loss (Pearson’s coefficient −0.735, p = 0.01). Using receiver operating characteristic curves, the area under the curve was 0.89, and the most appropriate threshold of HU value was 343.7 (sensitivity 77.1%, specificity 87.5%). A preoperative lower HU is a risk factor for postoperative subsidence (binary logistic regression, p < 0.05). The subsidence rate and distance between allograft and polyetheretherketone (PEEK) materials were not significantly different (PEEK 0.9 ± 0.7 mm, allograft 1.0 ± 0.7 mm; p > 0.05).

CONCLUSIONS Lower preoperative CT HU values are associated with cage subsidence in single-level ACDF. Preoperative measurement of HUs may be useful in predicting outcomes after ACDF.

The safety and efficacy of anterior versus posterior decompression surgery in degenerative cervical myelopathy: a prospective randomized trial

J Neurosurg Spine 33:288–296, 2020

The safety and efficacy of anterior and posterior decompression surgery in degenerative cervical myelopathy (DCM) have not been validated in any prospective randomized trial.

METHODS In this first prospective randomized trial, the patients who had symptoms or signs of DCM were randomly assigned to undergo either anterior cervical discectomy and fusion or posterior laminectomy with or without fusion. The primary outcome measures were the change in the visual analog scale (VAS) score, Neck Disability Index (NDI), and Nurick myelopathy grade 1 year after surgery. The secondary outcome measures were intraoperative and postoperative complications, hospital stay, and Odom’s criteria. The follow-up period was at least 1 year.

RESULTS A total of 68 patients (mean age 53 ± 8.3 years, 72.3% men) underwent prospective randomization. There was a significantly better outcome in the NDI and VAS scores in the anterior group at 1 year (p < 0.05). Nurick myelopathy grading showed nonsignificant improvement using the posterior approach group (p = 0.79). The mean operative duration was significantly longer in the anterior group (p < 0.001). No significant difference in postoperative complications was found, except postoperative dysphagia was significantly higher in the anterior group (p < 0.05). There was no significant difference in postoperative patient satisfaction (Odom’s criteria) (p = 0.52). The mean hospital stay was significantly longer in the posterior group (p < 0.001).

CONCLUSIONS Among patients with multilevel DCM, the anterior approach was significantly better regarding postoperative pain, NDI, and hospital stay, while the posterior approach was significantly better in terms of postoperative dysphagia and operative duration.

Asymptomatic ACDF Nonunions Underestimate the True Prevalence of Radiographic Pseudarthrosis

Spine 2020;45:E776–E780

Study Design. Secondary analysis of subjects in the control anterior cervical discectomy and fusion (ACDF) arm of Medtronic Investigational Device Exemption (IDE) trials for cervical disc arthroplasty (CDA).

Objectives. To compare patient-reported outcomes (PROs) in patients with radiographic nonunion to patients with a solid fusion. Summary of

Background Data. The true prevalence of nonunion after ACDF is unknown. Nonunion may be underreported, as some patients are not symptomatic enough to justify radiographic evaluation. Methods. Three hundred forty-five subjects enrolled in the control arm of IDE trials for CDA who had single-level ACDF with allograft and plate with 24 month data formed the study cohort. Using the 24-month postop evaluation, subjects were divided into those who had radiographic fusion and those who did not using strict study criteria. SF-36, NDI, Neck and Arm pain NRS scores were reported at 12, 24, 36, 60, and 84 months postop. For subjects who had secondary surgery failures, the last observations before the secondary surgery were carried forward to future visits for the analysis.

Results. Forty-four (13%) patients had radiographic nonunion and 301 (87%) were fused at 24 months postop. At 24 months, PROs were similar between the two groups. Seven patients in the Nonunion group (16%) and 10 (3%) in the Fused group had additional surgery at the index level prior to the 24 follow-up (P¼0.003). Over the 84-month follow-up a total of 9 patients in the Nonunion group (21%) and 22 (7%) in the Fused group had additional surgery at the index level (P¼0.009).

Conclusion. While the radiographic nonunion rate at 24 months was 13%, PROs show that many of the radiographic nonunions were asymptomatic. Although the majority of patients with radiographic nonunion did not undergo additional surgery, the rate of secondary surgeries at the index level was significantly higher in the radiographic nonunion group.

Level of Evidence: 2

Anterior Cervical Discectomy and Fusion in the Outpatient Ambulatory Surgery Setting: Analysis of 2000 Consecutive Cases

Neurosurgery 2019 DOI:10.1093/neuros/nyz514

In an effort to improve efficiency of care, ambulatory surgery centers (ASCs) have emerged as lower-cost options. Anterior cervical discectomy and fusion (ACDF) is one of the most prevalent spine surgeries performed and rarely requires overnight stays in the hospital, supporting its migration to the ASC. Recent analyses have called into question the safety of outpatient ACDF, potentially slowing its adoption. ASC-ACDF studies have largely been limited to small series, precluding an accurate assessment of safety.

OBJECTIVE: To analyze 2000 ASC-ACDF cases, describe patient selection and perioperative protocol, and report associated safety profile.

METHODS: A total of 2000 patients who underwent 1 to 3 level ACDF in a single ASC from 2006 to 2018 were included in this retrospective analysis. Patients were observed in a 4-h postanesthesia care unit (PACU) with a multimodal pain management regiment. Data were collected on patient demographics, comorbidities, operative details, and 30- and 90-d morbidity.

RESULTS: Of the 2000 patients, 10 (0.5%) required transfer to an inpatient setting within the 4-h observation. Reasons for transfer included hematoma (2), pain control (2), cerebrospinal fluid leak (1), and medical complications (5). Six patients (0.3%) underwent reoperation within 30 d. All-cause 30-d readmission was 1.9%.

CONCLUSION: An analysis of 2000 ACDF patients in an ASC setting with a standardized perioperative protocol demonstrates that surgical complications occur at a low rate (<1%) and can be appropriately diagnosed and managed in a 4-h PACU. In an effort to decrease healthcare costs, surgeons can safely perform ACDFs in an ASC utilizing patient selection criteria and perioperative management protocols similar to those reported here.

Safety of Outpatient Anterior Cervical Discectomy and Fusion: A Systematic Review and Meta-Analysis

Neurosurgery 86:30–45, 2020

Anterior cervical discectomy and fusion (ACDF) is being increasingly offered on an outpatient basis. However, the safety profile of outpatient ACDF remains poorly defined.

OBJECTIVE: To review the medical literature on the safety of outpatient ACDF.

METHODS: We systematically reviewed the literature for articles published before April 1, 2018, describing outpatient ACDF and associated complications, including incidence of reoperation, stroke, thrombolytic events, dysphagia, hematoma, and mortality. A random-effects analysis was performed comparing complications between the inpatient and outpatient groups.

RESULTS: We identified 21 articles that satisfied the selection criteria, of which 15 were comparative studies. Most of the existing studies were retrospective, with a lack of level I or II studies on this topic. We found no statistically significant difference between inpatient and outpatient ACDF in overall complications, incidence of stroke, thrombolytic events, dysphagia, and hematoma development. However, patients undergoing outpatient ACDF had lower reported reoperation rates (P < .001), mortality (P < .001), and hospitalization duration (P < .001).

CONCLUSION: Our meta-analysis indicates that there is a lack of high level of evidence studies regarding the safety of outpatient ACDF. However, the existing literature suggests that outpatient ACDF can be safe, with low complication rates comparable to inpatient ACDF in well-selected patients. Patients with advanced age and comorbidities such as obesity and significant myelopathy are likely not suitable for outpatient ACDF. Spine surgeons must carefully evaluate each patient to decide whether outpatient ACDF is a safe option. Higher quality, large prospective randomized control trials are needed to accurately demonstrate the safety profile of outpatient ACDF.

Two-level cervical disc arthroplasty versus anterior cervical discectomy and fusion: 10-year outcomes of a prospective, randomized investigational device exemption clinical trial

J Neurosurg Spine 31:508–518, 2019

The authors assessed the 10-year clinical safety and effectiveness of cervical disc arthroplasty (CDA) to treat degenerative cervical spine disease at 2 adjacent levels compared to anterior cervical discectomy and fusion (ACDF).

METHODS A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted comparing the low-profile titanium ceramic composite–based Prestige LP Cervical Disc (n = 209) at two levels with ACDF (n = 188). Ten-year follow-up data from a postapproval study were available on 148 CDA and 118 ACDF patients and are reported here. Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative follow-up intervals for up to 10 years. The primary endpoint was overall success, a composite variable that included key safety and efficacy considerations. Ten-year follow-up rates were 86.0% for CDA and 84.9% for ACDF.

RESULTS From 2 to 10 years, CDA demonstrated statistical superiority over ACDF for overall success, with rates at 10 years of 80.4% versus 62.2%, respectively (posterior probability of superiority [PPS] = 99.9%). Neck Disability Index (NDI) success was also superior, with rates at 10 years of 88.4% versus 76.5% (PPS = 99.5%), as was neurological success (92.6% vs 86.1%; PPS = 95.6%). Improvements from preoperative results in NDI and neck pain scores were consistently statistically superior for CDA compared to ACDF. All other study effectiveness measures were at least noninferior for CDA compared to ACDF through the 10-year follow-up period, including disc height. Mean angular ranges of motion at treated levels were maintained in the CDA group for up to 10 years. The rates of grade IV heterotopic ossification (HO) at the superior and inferior levels were 8.2% and 10.3%, respectively. The rate of severe HO (grade III or IV) did not increase significantly from 7 years (42.4%) to 10 years (39.0%). The CDA group had fewer serious (grade 3–4) implantrelated or implant/surgical procedure–related adverse events (3.8% vs 8.1%; posterior mean 95% Bayesian credible interval [BCI] of the log hazard ratio [LHR] -0.92 [-1.88, -0.01]). The CDA group also had statistically fewer secondary surgical procedures at the index levels (4.7%) than the ACDF group (17.6%) (LHR [95% BCI] -1.39 [-2.15, -0.61]) as well as at adjacent levels (9.0% vs 17.9%).

CONCLUSIONS The Prestige LP Cervical Disc, implanted at two adjacent levels, maintains improved clinical outcomes and segmental motion 10 years after surgery and is a safe and effective alternative to fusion.

Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)

Effects of smoking on cervical disc arthroplasty

J Neurosurg Spine 30:168–174, 2019

Cigarette smoking can adversely affect bone fusion in patients who undergo anterior cervical discectomy and fusion. However, there is a paucity of data on smoking among patients who have undergone cervical disc arthroplasty (CDA). The present study aimed to compare the clinical and radiological outcomes of smokers to those of nonsmokers following CDA.

METHODS The authors retrospectively reviewed the records of consecutive patients who had undergone 1- or 2-level CDA for cervical disc herniation or spondylosis and had a minimum 2-year follow-up. All patients were grouped into a smoking group, which consisted of those who had consumed cigarettes within 6 months prior to the CDA surgery, or a nonsmoking group, which consisted of those who had not consumed cigarettes at all or within 6 months of the CDA. Clinical outcomes were evaluated according to the visual analog scale for neck and arm pain, Neck Disability Index, Japanese Orthopaedic Association Scale, and Nurick Scale at each time point of evaluation. Radiological outcomes were assessed using radiographs and CT for multiple parameters, including segmental range of motion (ROM), neutral lordotic curve, and presence of heterotopic ossification (HO).

RESULTS A total of 109 patients completed at least 2 years of follow-up and were analyzed (mean follow-up 42.3 months). There were 89 patients in the nonsmoking group and 20 in the smoking group. The latter group was younger and predominantly male (both p < 0.05) compared to the nonsmoking group. The two groups had similar improvements in all clinical outcomes after CDA compared to preoperatively. Radiological evaluations were also very similar between the two groups, except for two factors. The smoking group had well-preserved segmental ROM after CDA at an average of 8.1° (both pre- and postoperation). However, while the nonsmoking group remained mobile, segmental ROM decreased significantly (8.2° to 6.9°, p < 0.05) after CDA. There was a trend toward more HO development in the nonsmoking group than in the smoking group, but the difference was without significance (59.6% vs 50.0%, p = 0.43).

CONCLUSIONS During an average 3.5 years of follow-up after 1- and 2-level CDA, cigarette smokers and nonsmokers had similar improvements in clinical outcomes. Moreover, segmental mobility was slightly better preserved in smokers. Since smoking status did not negatively impact outcomes, CDA may be a reasonable option for selected patients who have smoked.

Fivefold higher rate of pseudarthrosis with polyetheretherketone interbody device than with structural allograft used for 1-level anterior cervical discectomy and fusion

J Neurosurg Spine 30:46–51, 2019

Common interbody graft options for anterior cervical discectomy and fusion (ACDF) include structural allograft and polyetheretherketone (PEEK). PEEK has gained popularity due to its radiolucency and its elastic modulus, which is similar to that of bone. The authors sought to compare the rates of pseudarthrosis, a lack of solid bone growth across the disc space, and the need for revision surgery with the use of grafts made of allogenic bone versus PEEK.

METHODS The authors retrospectively reviewed 127 cases in which patients had undergone a 1-level ACDF followed by at least 1 year of radiographic follow-up. Data on age, sex, body mass index, tobacco use, pseudarthrosis, and the reoperation rate for pseudarthrosis were collected. These data were analyzed by performing a Pearson’s chi-square test.

RESULTS Of 127 patients, 56 had received PEEK implants and 71 had received allografts. Forty-six of the PEEK implants (82%) were stand-alone devices. There were no significant differences between the 2 treatment groups with respect to patient age, sex, or body mass index. Twenty-nine (52%) of 56 patients with PEEK implants demonstrated radiographic evidence of pseudarthrosis, compared to 7 (10%) of 71 patients with structural allografts (p < 0.001, OR 9.82; 95% CI 3.836–25.139). Seven patients with PEEK implants required reoperation for pseudarthrosis, compared to 1 patient with an allograft (p = 0.01, OR 10.00; 95% CI 1.192–83.884). There was no significant difference in tobacco use between the PEEK and allograft groups (p = 0.586).

CONCLUSIONS The results of this study demonstrate that the use of PEEK devices in 1-level ACDF is associated with a significantly higher rate of radiographically demonstrated pseudarthrosis and need for revision surgery compared with the use of allografts. Surgeons should be aware of this when deciding on interbody graft options, and reimbursement policies should reflect these discrepancies.

Comparison of Multilevel Cervical Disc Replacement and Multilevel Anterior Discectomy and Fusion: A Systematic Review of Biomechanical and Clinical Evidence

World Neurosurg. (2018) 116:94-104

OBJECTIVE: The aim of this study was to comprehensively compare the clinical and biomechanical efficiency of anterior cervical discectomy and fusion (ACDF) with anterior cervical disc replacement (ACDR) for treatment of multilevel cervical disc disease using a meta-analysis and systematical review.

METHODS: A literature search was performed using PubMed, MEDLINE, EMBASE, and the Cochrane Library for articles published between January 1960 and December 2017. Both clinical and biomechanical parameters were analyzed. Statistical tests were conducted by Revman 5.3. Nineteen studies including 10 clinical studies and 9 biomechanical studies were filtered out.

RESULTS: The pooled results for clinical efficiency showed that no significant difference was observed in blood loss (P [ 0.09; mean difference [MD], 7.38; confidence interval [CI], e1.16 to 15.91), hospital stay (P[ 0.33; MD, L0.25; CI, L0.76 to 0.26), Japanese Orthopaedic Association scores (P [ 0.63; MD, L0.11; CI, L0.57 to 0.34), visual analog scale (P [ 0.08; MD, L0.50; CI, L1.06 to 0.05), and Neck Disability Index (P [ 0.33; MD, L0.55; CI, L1.65 to 0.56) between the 2 groups. Compared with ACDF, ACDR did show increased surgical time (P [ 0.03; MD, 31.42; CI, 2.71e60.14). On the other hand, ACDR showed increased index range of motion (ROM) (P < 0.00001; MD, 13.83; CI, 9.28e 18.39), lower rates of adjacent segment disease (ASD) (P [ 0.001; odds ratio [OR], 0.27; CI, 0.13e0.59), complications (P [ 0.006; OR, 0.62; CI, 0.45e0.87), and rate of subsequent surgery (P < 0.00001; OR, 0.25; CI, 0.14e0.44). As for biomechanical performance, ACDR maintained index ROM and avoided compensation in adjacent ROM and tissue pressure.

CONCLUSIONS: Multilevel ACDR may be an effective and safe alternative to ACDF in terms of clinical and biomechanical performance. However, further multicenter and prospective studies should be conducted to obtain a stronger and more reliable conclusion.

Impact of local steroid application on dysphagia following an anterior cervical discectomy and fusion: results of a prospective, randomized single-blind trial

J Neurosurg Spine 29:10–17, 2018

Intraoperative local steroid application has been theorized to reduce swelling and improve swallowing in the immediate period following anterior cervical discectomy and fusion (ACDF). Therefore, the purpose of this study was to quantify the impact of intraoperative local steroid application on patient-reported swallow function and swelling after ACDF.

METHODS A prospective, randomized single-blind controlled trial was conducted. A priori power analysis determined that 104 subjects were needed to detect an 8-point difference in the Quality of Life in Swallowing Disorders (SWAL-QOL) questionnaire score. One hundred four patients undergoing 1- to 3-level ACDF procedures for degenerative spinal pathology were randomized to Depo-Medrol (DEPO) or no Depo-Medrol (NODEPO) cohorts. Prior to surgical closure, patients received 1 ml of either Depo-Medrol (DEPO) or saline (NODEPO) applied to a Gelfoam carrier at the surgical site. Patients were blinded to the application of steroid or saline following surgery. The SWAL-QOL questionnaire was administered both pre- and postoperatively. A ratio of the prevertebral swelling distance to the anteroposterior diameter of each vertebral body level was calculated at the involved levels ± 1 level by using pre- and postoperative lateral radiographs. The ratios of all levels were averaged and multiplied by 100 to obtain a swelling index. An air index was calculated in the same manner but using the tracheal air window diameter in place of the prevertebral swelling distance. Statistical analysis was performed using the Student t-test and chi-square analysis. Statistical significance was set at p < 0.05.

RESULTS Of the 104 patients, 55 (52.9%) were randomized to the DEPO cohort and 49 (47.1%) to the NODEPO group. No differences in baseline patient demographics or preoperative characteristics were demonstrated between the two cohorts. Similarly, estimated blood loss and length of hospitalization did not differ between the cohorts. Neither was there a difference in the mean change in the scaled total SWAL-QOL score, swelling index, and air index between the groups at any time point. Furthermore, no complications were observed in either group (retropharyngeal abscess or esophageal perforation).

CONCLUSIONS The results of this prospective, randomized single-blind study did not demonstrate an impact of local intraoperative steroid application on patient-reported swallowing function or swelling following ACDF. Neither did the administration of Depo-Medrol lead to an earlier hospital discharge than that in the NODEPO cohort. These results suggest that intraoperative local steroid administration may not provide an additional benefit to patients undergoing ACDF procedures.

 

What Is the Fate of Pseudarthrosis Detected 1 Year After Anterior Cervical Discectomy and Fusion?

Spine 2018;43:E23–E28

Objective. To investigate the consequences and appropriate management of pseudarthrosis after anterior cervical discectomy and fusion (ACDF).

Summary of Background Data. Pseudarthrosis is a frequent complication of ACDF and causes unsatisfactory results. Little is known about long-term prognosis of detecting pseudarthrosis 1 year after ACDF.

Methods. Eighty-nine patients with a minimum 2-year followup were included. ACDF surgery using allograft and plating was performed: single-level in 51 patients, two-level in 26 patients, and three-level in 12 patients. Presence of pseudarthrosis was evaluated 1 year postoperatively and then the nonunion segments were re-evaluated 2 years postoperatively. Demographic data were assessed to identify the risk factors associated with pseudarthrosis. A visual analogue scale for neck/arm pain and the Neck Disability Index were analyzed preoperatively and at 1 and 2 years postoperatively.

Results. Pseudarthrosis was detected in 29 patients (32.6%) 1 year postoperatively: 15of 51 patients after single-level surgery, 9 of 26 patients after two-level surgery, and 5 of 12 patients after three-level surgery. Only eight patients showed persistent nonunion at 2 years: 3 of 15 patients after single-level surgery, 3 of 9 after two-level surgery, and 2 of 5 after three-level surgery. The remaining 21 patients (72.4%) achieved bony fusion 2 years postoperatively without any intervention. Patients who underwent two-level or three-level ACDF had a significantly higher pseudarthrosis rate than those who underwent single-level ACDF, with odds ratios of 1.844 and 3.147, respectively. The improvements in visual analogue scale for neck pain and Neck Disability Index scores in the persistent nonunion group were significantly lower than those in the final union group at 2 years.

Conclusion. Patients with pseudarthrosis detected 1 year postoperatively may be observed without any intervention because approximately 70% of them will eventually fuse by the 2-year point. Early revision could, however, be considered if the pseudarthrosis is associated with considerable neck pain after multilevel ACDF.

Level of Evidence: 3

Predictors for Patient Discharge Destination After Elective Anterior Cervical Discectomy and Fusion

Spine 2017;42:1538–1544

Study Design. Retrospective study of prospectively collected data.

Objective. To identify risk factors for nonhome patient discharge after elective anterior cervical discectomy and fusion (ACDF).

Summary of Background Data. ACDF is one of the most performed spinal procedures and this is expected to increase in the coming years. To effectively deal with an increasing patient volume, identifying variables associated with patient discharge destination can expedite placement applications and subsequently reduce hospital length of stay.

Methods. The 2011 to 2014 ACS-NSQIP database was queried using Current Procedural Terminology (CPT) codes 22551 or 22554. Patients were divided into two cohorts based on discharge destination. Bivariate and multivariate logistic regression analyses were employed to identify predictors for patient discharge destination and extended hospital length of stay.

Results. A total of 14,602 patients met the inclusion criteria for the study of which 498 (3.4%) had nonhome discharge. Multivariate logistic regression found that Hispanic versus Black race/ ethnicity (odds ratio, OR¼0.21, 0.05–0.91, P¼0.037), American Indian or Alaska Native, Asian, Native Hawaiian or Pacific Islander versus Black race/ethnicity (OR¼0.52, 0.34–0.80, p-value¼0.003), White versus Black race/ethnicity (OR¼0.55, 0.42–0.71), elderly age 65 years (OR¼3.32, 2.72–4.06), obesity (OR¼0.77, 0.63–0.93, P¼0.008), diabetes (OR¼1.32, 1.06–1.65, P¼0.013), independent versus partially/totally dependent functional status (OR¼0.11, 0.08–0.15), operation time 4hours (OR¼2.46, 1.87–3.25), cardiac comorbidity (OR ¼1.38, 1.10– 1.72, P ¼0.005), and ASA Class 3 (OR¼2.57, 2.05–3.20) were predictive factors in patient discharge to a facility other than home. In addition, multivariate logistic regression analysis also found nonhome discharge to be the most predictive variable in prolonged hospital length of stay.

Conclusion. Several predictive factors were identified in patient discharge to a facility other than home, many being preoperative variables. Identification of these factors can expedite patient discharge applications and potentially can reduce hospital stay, thereby reducing the risk of hospital acquired conditions and minimizing health care costs.

Level of Evidence: 3

Cervical disc arthroplasty with the Prestige LP disc versus anterior cervical discectomy and fusion, at 2 levels: results of a prospective, multicenter randomized controlled clinical trial at 24 months

J Neurosurg Spine 26:653–667, 2017

The authors compared the efficacy and safety of arthroplasty using the Prestige LP cervical disc with those of anterior cervical discectomy and fusion (ACDF) for the treatment of degenerative disc disease (DDD) at 2 adjacent levels.

METHODS Patients from 30 investigational sites were randomized to 1 of 2 groups: investigational patients (209) underwent arthroplasty using a Prestige LP artificial disc, and control patients (188) underwent ACDF with a cortical ring allograft and anterior cervical plate. Patients were evaluated preoperatively, intraoperatively, and at 1.5, 3, 6, 12, and 24 months postoperatively. Efficacy and safety outcomes were measured according to the Neck Disability Index (NDI), Numeric Rating Scales for neck and arm pain, 36-Item Short-Form Health Survey (SF-36), gait abnormality, disc height, range of motion (investigational) or fusion (control), adverse events (AEs), additional surgeries, and neurological status. Treatment was considered an overall success when all 4 of the following criteria were met: 1) NDI score improvement of ≥ 15 points over the preoperative score, 2) maintenance or improvement in neurological status compared with preoperatively, 3) no serious AE caused by the implant or by the implant and surgical procedure, and 4) no additional surgery (supplemental fixation, revision, or nonelective implant removal). Independent statisticians performed Bayesian statistical analyses.

RESULTS The 24-month rates of overall success were 81.4% for the investigational group and 69.4% for the control group. The posterior mean for overall success in the investigational group exceeded that in the control group by 0.112 (95% highest posterior density interval = 0.023 to 0.201) with a posterior probability of 1 for noninferiority and 0.993 for superiority, demonstrating the superiority of the investigational group for overall success. Noninferiority of the investigational group was demonstrated for all individual components of overall success and individual effectiveness end points, except for the SF-36 Mental Component Summary. The investigational group was superior to the control group for NDI success. The proportion of patients experiencing any AE was 93.3% (195/209) in the investigational group and 92.0% (173/188) in the control group, which were not statistically different. The rate of patients who reported any serious AE (Grade 3 or 4) was significantly higher in the control group (90 [47.9%] of 188) than in the investigational group (72 [34.4%] of 209) with a posterior probability of superiority of 0.996. Radiographic success was achieved in 51.0% (100/196) of the investigational patients (maintenance of motion without evidence of bridging bone) and 82.1% (119/145) of the control patients (fusion). At 24 months, heterotopic ossification was identified in 27.8% (55/198) of the superior levels and 36.4% (72/198) of the inferior levels of investigational patients.

CONCLUSIONS Arthroplasty with the Prestige LP cervical disc is as effective and safe as ACDF for the treatment of cervical DDD at 2 contiguous levels and is an alternative treatment for intractable radiculopathy or myelopathy at 2 adjacent levels.

Clinical trial registration no.: NCT00637156 (clinicaltrials.gov)