Are preoperative depression and anxiety associated with patient-reported outcomes,health care payments,and opioid use after anterior discectomy and fusion?

BACKGROUND CONTEXTDepression and anxiety are common psychiatric conditions among US adults, and anterior cervical discectomy and fusion (ACDF) is one of the most commonly performed spinal surgeries. Mental health conditions can affect physical health, and thus have the potential to contribute to adverse outcomes after spine surgery; however, a comprehensive assessment of long-term outcomes and the additive economic burden of these conditions in patients undergoing ACDF has not been well described.PURPOSEOur goal was to assess the associations between depression/anxiety and adverse outcomes and health-resource utilization after anterior cervical discectomy and fusion (ACDF).STUDY DESIGNRetrospective database study.PATIENT SAMPLEWe retrospectively analyzed a private administrative health claims database to identify patients who underwent ACDF in the United States from 2010 to 2013. A total of 16,306 patients met our inclusion criteria. Mean (± standard deviation) patient age was 50±7.9 years. Approximately 4,800 patients (30%) had a depression diagnosis and 4,000 (25%) had a diagnosis of anxiety.OUTCOME MEASURESThe primary outcomes of interest were intensive care unit admission, multiday hospitalization, discharge disposition, 30- and 90-day hospital readmission, 1- and 2-year rates of revision surgery, and chronic postoperative opioid use. Secondary outcomes were 1- and 2-year total cumulative health care payments and cumulative postoperative opioid consumption.METHODSRegression models controlled for demographic and medical covariates, alpha=0.05.RESULTSA preoperative diagnosis of depression was associated with higher odds of multiday hospitalization (odds ratio [OR] 1.09, 95% confidence interval [CI] 1.01–1.19), 90-day readmission (OR 1.71, 95% CI 1.46–2.02), revision surgery within 2 years (OR 1.43 95% CI 1.16–1.76), and chronic postoperative opioid use (OR 1.58, 95% CI 1.45–1.72) and an increase of $5,915 in adjusted 2-year health care payments (p<.001). Patients with a preoperative diagnosis of anxiety had higher odds of multiday hospitalization (OR 1.15, 95% CI 1.06–1.25), revision surgery within 2 years (OR 1.33, 95% CI 1.07–1.65), and chronic postoperative opioid use (OR 1.62, 95% CI 1.48–1.77) and an increase of $4,471 in adjusted 2-year health care payments (p<.001). Neither anxiety nor depression was associated with intensive care unit admission, discharge disposition, 30-day readmission, revision surgery within 1 year, 1-year cumulative health care payments, or cumulative postoperative opioid consumption.CONCLUSIONSPatients with preoperative diagnoses of depression or anxiety have a greater likelihood of adverse outcomes, increased opioid consumption, and increased cumulative health care payments after ACDF compared with patients without depression or anxiety.     

Comparison of revision surgeries for one- to two-level cervical TDR and ACDF from 2002 to 2011

Background contextCervical total disc replacement (TDR) and anterior cervical discectomy and fusion (ACDF) provide comparable outcomes for degenerative cervical pathology. However, revisions of these procedures are not well characterized.PurposeThe purpose of this study is to examine the rates, epidemiology, perioperative complications, and costs between the revision procedures and to compare these outcomes with those of primary cases.Study designThis study is a retrospective database analysis.Patient sampleA total of 3,792 revision and 183,430 primary cases from the Nationwide Inpatient Sample (NIS) database from 2002 to 2011 were included.Outcome measuresIncidence of revision cases, patient demographics, length of stay (LOS), in-hospital costs, mortality, and perioperative complications.MethodsPatients who underwent revision for either one- to two-level cervical TDR or ACDF were identified. SPSS v.20 was used for statistical analysis with χ² test for categorical data and independent sample t test for continuous data. The relative risk for perioperative complications with revisions was calculated in comparison with primary cases using a 95% confidence interval. An alpha level of less than 0.05 denoted statistical significance.ResultsThere were 3,536 revision one- to two-level ACDFs and 256 revision cervical TDRs recorded in the NIS database from 2002 to 2011. The revision cervical TDR cohort demonstrated a significantly greater LOS (3.18 vs. 2.25, p<.001), cost ($16,998 vs. $15,222, p=.03), and incidence of perioperative wound infections (13.6 vs. 5.3 per 1,000, p<.001) compared with the ACDF revision cohort (p<.001). There were no differences in mortality between the revision surgical cohorts. Compared with primary cases, both revision cohorts demonstrated a significantly greater LOS and cost. Furthermore, patients who underwent revision demonstrated a greater incidence and risk for perioperative wound infections, hematomas, dysphagia, and neurologic complications relative to the primary procedures.ConclusionsThis study demonstrated a significantly greater incidence of perioperative wound infection, LOS, and costs associated with a TDR revision compared with a revision ACDF. We propose that these differences are by virtue of the inherently more invasive nature of revising TDRs. In addition, compared with primary cases, revision procedures are associated with greater costs, LOS, and complications including wound infections, dysphagia, hematomas, and neurologic events. These additional risks must be considered before opting for a revision procedure.     

The use of bone morphogenetic protein in thoracolumbar spine procedures: analysis of the MarketScan longitudinal database

Background contextThe use of recombinant human bone morphogenetic protein (BMP) in the thoracolumbar spine remains controversial, with many questioning the risks and benefits of this new biologic.PurposeTo describe national trends, incidence of complications, and revision rates associated with BMP use in thoracolumbar spine procedures.Study design/settingAdministrative database study.Patient sampleA matched cohort of 52,259 patients undergoing thoracolumbar fusion surgery from 2006 to 2010 were identified in the MarketScan database. Patients without BMP treatment were matched 2:1 to patients receiving intraoperative BMP.Outcome measuresRevision rates and postoperative complications.MethodsThe MarketScan database was used to select patients undergoing thoracolumbar fusion procedures, with and without intraoperative BMP. We ascertained outcome measures using either International Classification of Disease, ninth revision, or Current Procedural Terminology coding, and matched groups were evaluated using a bivariate and multivariate analyses. Kaplan-Meier estimates of fusions failure rates were also calculated.ResultsPatients receiving intraoperative BMP underwent fewer refusions, decompressions, posterior and anterior revisions, or any revision procedure (single level 4.53% vs. 5.85%, p<.0001; multilevel 5.02% vs. 6.83%, p<.0001; overall cohort 4.73% vs. 6.09%, p<.0001). After adjusting for comorbidities, demographics, and levels of procedure, BMP was not associated with the postoperative development of cancer (odds ratio 0.92). Bone morphogenetic protein use was associated with an increase in any complication at 30 days (15.8% vs. 14.9%, p=.0065), which is only statistically significant among multilevel procedures (19.74% vs. 18.02%, p=.0013). Thirty-day complications in multilevel procedures associated with BMP use included new dysrhythmia (4.68% vs. 4.01%, p=.0161) and delirium (1.08% vs. 0.69%, p=.0024). A new diagnosis of chronic pain was associated with BMP use in both single-level (2.74% vs. 2.15%, p=.0019) and multilevel (3.7% vs. 2.52%, p<.0001) procedures. Bone morphogenetic protein was negatively associated with infection in single-level procedures (2.12% vs. 2.64%, p=.0067) and wound dehiscence in multilevel procedures (0.84% vs. 1.18%, p=.0167).ConclusionsIn national data analysis of thoracolumbar procedures, we found that BMP was associated with decreased incidence of revision spinal surgery and with a slight increased risk of overall complications at 30 days. Although no BMP-associated increased risk of malignancy was found, lack of long-term follow-up precludes detection of between-group differences in malignancies and other rare events that may not appear until later.     

Patient Characteristics Influence Revision Rate of Total Hip Arthroplasty: American Society of Anesthesiologists Score and Body Mass Index Were the Strongest Predictors for Short-Term Revision After Primary Total Hip Arthroplasty

BackgroundOutcome and survival after primary total hip arthroplasty (THA) can be affected by patient characteristics. We examined the effect of case-mix on revision after primary THA using the Dutch Arthroplasty Register.MethodsOur cohort included all primary THAs (n = 218,214) performed in patients with osteoarthritis in the Netherlands between 2007 and 2018. Multivariable logistic regression analysis was used to calculate the difference in survivorship in patients with different patient characteristics (age, gender, American Society of Anesthesiologists [ASA] score, body mass index [BMI], Charnley score, smoking, and previous operations to the hip).ResultsCase-mix factors associated with an increased risk for revision 1 year after THA were the following: a high ASA score (II and III-IV) (odds ratio [OR] 1.5, 95% confidence interval [CI] 1.1-2.0 and OR 3.0, 95% CI 1.7-5.3), a higher BMI (30-40 and >40) (OR 1.4, 95% CI 1.2-1.5 and OR 2.0, 95% CI 1.4-1.7), age ≥75 years (OR 1.5, 95% CI 1.1-2.0), and male gender (OR 1.3, 95% CI 1.2-1.4). A similar model for 3-year revision showed comparable results. High BMI (OR 1.9, 95% CI 1.3-2.9), a previous hip operation (OR 1.8, 95% CI 1.3-2.5), ASA III-IV (OR 1.2, 95% CI 1-1.6), and Charnley score C (OR 1.5, 95% CI 1.1-2.2) were associated with increased risk for revision. Main reasons for revision in obese and ASA II-IV patients were infection, dislocation, and periprosthetic fracture. Patients with femoral neck fracture and late post-traumatic pathology were more likely to be revised within 3 years, compared to osteoarthritis patients (OR 1.5, 95% CI 1.3-1.7 and OR 1.5, 95% CI 1.2-1.7).ConclusionThe short-term risk for revision after primary THA is influenced by case-mix factors. ASA score and BMI (especially >40) were the strongest predictors for 1-year revision after primary THA. After 3 years, BMI and previous hip surgery were independent risk factors for revision. This will help surgeons to identify and counsel high-risk patients and take appropriate preventive measures.     

Factors affecting reoperations after anterior cervical discectomy and fusion within and outside of a Federal Drug Administration investigational device exemption cervical disc replacement trial

Background contextThe excellent clinical re.sults of five US Federal Drug Administration (FDA) trials approved for cervical total disc replacement (TDR) (Prestige [Medtronic Sofamor Danek, Memphis, TN, USA], Bryan [Medtronic Sofamor Danek], ProDisc-C [Synthes, West Chester, PA, USA], Kineflex|C [SpinalMotion, Mountain View, CA, USA], and Mobi-C [LDR Spine, Austin, TX, USA]) have recently been published. In these prospective randomized studies, superiority or equivalency of TDR was claimed, citing an 8.7% (23/265), 9.5% (21/221), 8.5% (9/106), 12.2% (14/115), and 6.2% (5/81) (mean=9.02%) rate of additional related cervical surgical procedures within 2 years in control anterior cervical discectomy and fusion (ACDF) patients, respectively, compared with 1.8% (5/276), 5.8% (14/242), 1.9% (2/103), 11% (15/136), and 1.2% (2/164) (mean=4.34%) in patients receiving the cervical TDR. The rate of reoperation within 2 years after ACDF seems unusually high.PurposeTo assess the rate of and specific indications for early reoperation after ACDF in a cohort of patients receiving the ACDF as part of their customary care. These results are contrasted with similar patients receiving ACDF as the control arm of five FDA investigational device exemption (IDE) studies.Study designMultisurgeon retrospective clinical series from a single institution.Patient sampleOne hundred seventy-six patients with spondylotic radiculopathy or myelopathy underwent ACDF by three surgeons between 2001 and 2005 as part of their clinical practices. All patients had at least 2 years of follow-up with final follow-up within 6 months of completion of this study.Outcome measuresCervical reoperation rates at 2-year follow-up and at 3.5-year follow-up.MethodsReview of medical records and telephone conversations were completed to determine the number of patients who had undergone a revision cervical procedure.ResultsAt final follow-up, complete data were available for 159 ACDF patients. Of the 48 patients who underwent single-level ACDF and met criteria for inclusion in the IDE studies, one patient (2.1%) required additional surgery (adjacent-segment degeneration) within 2 years, the duration of follow-up of the five published IDE studies. Of the 159 patients who received single or multilevel ACDF at a mean follow-up of 3.5 years, 12 patients (7.6%) had undergone revision cervical surgery, with three patients (1.9%) undergoing same-level revisions (posterior fusion) and nine patients (5.7%) undergoing adjacent anterior level fusions. Patients who underwent revision same-level surgery typically had the intervention within the first year (mean, 11 months), whereas those requiring adjacent-level fusions typically had surgery later (mean, 29 months).ConclusionsThe present study identifies a 2.1% rate of repeat surgery within 2 years of a single-level ACDF performed during routine clinical practice, which is lower than that reported in the control arm of the Prestige, ProDisc-C, Bryan, Kineflex|C, and Mobi-C FDA trials (mean=9%). Even with longer follow-up including multilevel cases, our reoperation rate (7.6%) compared favorably with the IDE rates. This discrepancy may reflect different thresholds for reoperation in the control arm of a device IDE study compared with routine clinical practice. Additionally, patients enrolled in the single-level-only IDE trial may have received multilevel procedures outside of the study. This factor could result in a higher rate of subsequent surgeries at adjacent levels not addressed at the index procedure. These data suggest that we need to better understand factors driving treatment and, in particular, decisions to reoperate both in and outside of a device trial.     

Perioperative complications of inpatient and outpatient single-level posterior cervical foraminotomy: a comparative retrospective study

BACKGROUND CONTEXTPosterior cervical foraminotomy (PCF) is a relatively safe procedure for the treatment of cervical radiculopathy. Though most often performed as an inpatient procedure, there is an increasing number of patients treated in an outpatient setting.PURPOSEThis study aimed to compare the perioperative complication rates associated with inpatient and outpatient single-level PCF.STUDY DESIGN/SETTINGRetrospective database study.PATIENT SAMPLEPatients with cervical radiculopathy who underwent inpatient or outpatient single-level PCF between 2007 to the first quarter of 2016.OUTCOME MEASURESCharlson Comorbidity Index (CCI) was used as a broad measure of comorbidity. Surgical complications included cervical nerve root injury, dural tear, wound complications, infection, dysphagia, cervicalgia, and revision surgery. Medical complications included pulmonary embolism and lower limb deep vein thrombosis, acute myocardial infarction, acute respiratory failure, pneumonia, sepsis, and urinary complications.METHODSThis study was a retrospective review of patients who received single-level PCF from 2007 to the first quarter of 2016 as either outpatients or inpatients using the Humana subset of the PearlDiver Patient Record Database. The incidence of perioperative medical and surgical complications was queried using relevant International Classification of Diseases (ICD-9-CM and ICD-10-CM) and Current Procedural Terminology codes. Multivariate logistic regression analysis, adjusted for age, gender, and CCI, was performed to calculate odds ratios (ORs) of complications among inpatients relative to outpatients treated with PCF. Propensity score matching was done, and comparisons were made for postoperative complications.RESULTSThroughout the time period, 1,469 and 1,192 patients received inpatient and outpatient single-level PCF, respectively. The mean CCIs±standard deviation of inpatient and outpatient groups undergoing PCF were 2.83±3.11 and 1.46±2.21, respectively (p<.001). After propensity score matching, patients who received PCF in an inpatient setting showed significantly higher rates of wound complications (OR=1.53, 95% confidence interval [CI]=1.04–2.23; p=.029), infection (OR=1.91, CI=1.15–3.15; p=.012), acute respiratory failure (OR=2.50, CI=1.23–5.08; p=.011), and urinary tract infections and incontinence (OR=2.11, CI=1.32–3.38; p=.002).CONCLUSIONSOutpatient single-level PCF was associated with a lower rate of perioperative medical and surgical complications. The PCF in the outpatient setting can potentially be a safe procedure for the treatment of cervical radiculopathy with appropriate patient selection.     

Leveraging HFRS to assess how frailty affects healthcare resource utilization after elective ACDF for CSM

BACKGROUND CONTEXTFrailty is a common comorbidity associated with worsening outcomes in various medical and surgical fields. The Hospital Frailty Risk Score (HFRS) is a recently developed tool which assesses frailty using 109 International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) comorbidity codes to assess severity of frailty. However, there is a paucity of studies utilizing the HFRS with patients undergoing anterior cervical discectomy and fusion (ACDF) for cervical spondylotic myelopathy (CSM).PURPOSEThe aim of this study was to investigate the impact of HFRS on health care resource utilization following ACDF for CSM.STUDY DESIGNA retrospective cohort study was performed using the Nationwide Inpatient Sample (NIS) database from 2016-2019.PATIENT SAMPLEAll adult (≥18 years old) patients undergoing primary, ACDF for CSM were identified using the ICD-10 CM codes.OUTCOME MEASURESWeighted patient demographics, comorbidities, perioperative complications, LOS, discharge disposition, and total admission costs were assessed.METHODSThe 109 ICD-10 codes with pre-assigned values from 0.1 to 7.1 pertaining to frailty were queried in each patient, with a cumulative HFRS ≥5 indicating a frail patient. Patients were then categorized as either Low HFRS (HFRS<5) or Moderate to High HFRS (HFRS≥5). A multivariate stepwise logistic regression was used to determine the odds ratio for risk-adjusted extended LOS, non-routine discharge disposition, and increased hospital cost.RESULTSA total of 29,305 patients were identified, of which 3,135 (10.7%) had a Moderate to High HFRS. Patients with a Moderate to High HFRS had higher rates of 1 or more postoperative complications (Low HFRS: 9.5% vs. Moderate-High HFRS: 38.6%, p≤.001), significantly longer hospital stays (Low HFRS: 1.8±1.7 days vs. Moderate-High HFRS: 4.4 ± 6.0, p≤.001), higher rates of non-routine discharge (Low HFRS: 5.8% vs. Moderate-High HFRS: 28.2%, p≤.001), and increased total cost of admission (Low HFRS: $19,691±9,740 vs. Moderate-High HFRS: $26,935±22,824, p≤.001) than patients in the Low HFRS cohort. On multivariate analysis, Moderate to High HFRS was found to be a significant independent predictor for extended LOS [OR: 3.19, 95% CI: (2.60, 3.91), p≤.001] and non-routine discharge disposition [OR: 3.88, 95% CI: (3.05, 4.95), p≤.001] but not increased cost [OR: 1.10, 95% CI: (0.87, 1.40), p=.418].CONCLUSIONSOur study suggests that patients with a higher HFRS have increased total hospital costs, a longer LOS, higher complication rates, and more frequent nonroutine discharge compared with patients with a low HFRS following elective ACDF for CSM. Although frail patients should not be precluded from surgical management of cervical spine pathology, these findings highlight the need for peri-operative protocols to medically optimize patients to improve health care quality and decrease costs.     

Socioeconomic disparities in the utilization of spine augmentation for patients with osteoporotic fractures: an analysis of National Inpatient Sample from 2011 to 2015

BACKGROUND CONTENTVertebral augmentation procedures are used for treatment of osteoporotic compression fractures. Prior studies have reported disparities in the treatment of patients with osteoporotic vertebral fractures, particularly with regards to the use of vertebroplasty and kyphoplasty.PURPOSEThe purpose of this study is to report updates in racial and health insurance inequalities of spine augmentation procedures in patients with osteoporotic fractures.METHODSWith the use of the National Inpatient Sample, we identified hospitalized patients with osteoporotic fractures between the period of 2011 and 2015. Patients with spine augmentation, defined by the utilization of vertebroplasty and kyphoplasty, were also identified. Our primary outcome was defined as the utilization of spine augmentation procedures across ethnic (white, hispanic, black, and asian/pacific islander) and insurance (self-pay, private insurance, Medicare, and Medicaid) groups. Variables were identified from the NIS database using International Classification of Diseases, Ninth and Tenth diagnosis codes. Univariate and multivariate regression analysis was used for statistical analysis with p value <.05 considered significant. A subgroup analysis was performed across the utilization of kyphoplasty, vertebroplasty, and Medicare coverage.RESULTSWe identified a total of 110,028 patients with a primary diagnosis of vertebral fracture between 2011 and 2015 (mean age: 74.4±13.6 years, 68% women). About 16,237 patients (14.8%) underwent any type of spine augmentation with over 75% of the patients receiving kyphoplasty. Multivariate analysis showed that black patients (odds ratio [OR]=0.64, 95% confidence interval [CI]: 0.58–0.70, p<.001), Hispanic patients (OR=0.79, 95% CI: 0.73–0.86, p<.001), and Asian/Pacific Islander (OR=0.79, 95% CI: 0.70–0.89, p<.001) had significantly lower odds for receiving any spine augmentation compared with white patients. Patients with Medicaid (OR=0.59, 95% CI: 0.53–0.66, p<.001), private insurance (OR=0.90, 95% CI: 0.85–0.96, p=.001), and those who self-pay (OR=0.57, 95% CI: 0.47–0.69, p<.001) had significantly lower odds of spine augmentation compared with those with Medicare. Comparative use of kyphoplasty was not significantly different between white and black patients (OR=0.85, 95% CI: 0.70–1.04, p=.12). However, Hispanic patients (OR=0.84, 95% CI: 0.71–0.99, p=.04) and Asian/Pacific Islander patients (OR=0.73, 95% CI: 0.58–0.92, p=.007) had significantly lower use of kyphoplasty compared with white patients. The comparative use of kyphoplasty among patients receiving spine augmentation was not significantly different across each insurances status when compared with patients with Medicare.CONCLUSIONSOur study suggests that racial and socioeconomic disparities continue to exist with the utilization of spine augmentation procedures in hospitalized patients with osteoporotic fractures.     

Ambulatory anterior cervical discectomy and fusion is associated with a higher risk of revision surgery and perioperative complications: an analysis of a large nationwide database

Background Context

With the changing landscape of health care, outpatient spine surgery is being more commonly performed to reduce cost and to improve efficiency. Anterior cervical discectomy and fusion (ACDF) is one of the most common spine surgeries performed and demand is expected to increase with an aging population.

Trends in resource utilization and rate of cervical disc arthroplasty and anterior cervical discectomy and fusion throughout the United States from 2006 to 2013

Background Context

The typically accepted surgical procedure for cervical disc pathology has been the anterior cervical discectomy and fusion (ACDF), although recent trials have demonstrated equivalent or improved outcomes with cervical disc arthroplasty (CDA). Trends for these two procedures regarding utilization, revision procedures, and other demographic information have not been sufficiently explored.

Preoperative characteristics are associated with increased likelihood of low early postoperative mobility after adult spinal deformity surgery

BACKGROUND CONTEXTLow early postoperative mobility (LEPOM) has been shown to be associated with increased length of hospital stay, complication rates, and likelihood of nonhome discharge. However, few studies have examined preoperative characteristics associated with LEPOM in adult spinal deformity (ASD) patients.PURPOSETo investigate which preoperative patient characteristics may be associated with LEPOM after ASD surgery.DESIGNRetrospective review.PATIENT SAMPLEIncluded were 86 ASD patients with fusion of ≥5 levels for whom immediate-postoperative AM-PAC Basic Mobility Inpatient Short Form (6-Clicks) scores had been obtained.OUTCOME MEASURESThe primary outcome of this study was the likelihood of LEPOM, defined as an AM-PAC score ≤15, which is associated with inability to stand for more than 1 minute.METHODSSignificant cutoffs for preoperative characteristics associated with LEPOM were determined via threshold linear regression. Multivariable logistic regression was used to assess the impact of preoperative characteristics on the likelihood of LEPOM.RESULTSLEPOM was recorded in 38 patients (44.2%). Threshold regression identified the following cutoffs to be associated with LEPOM: preoperative Patient Reported Outcomes Measurement Information System (PROMIS) scores of ≥68 for Pain, <28.3 for Physical Function, and ≥63.4 for Anxiety; preoperative Oswestry disability index (ODI) score of ≥60; and body mass index (BMI) of ≥35.2. On multivariate analysis, preoperative PROMIS scores of ≥68 for Pain (odds ratio [OR] 5.3, confidence interval [CI] 1.2–22.8, p=.03), <28.3 for Physical Function (OR 10.1, CI 1.8–58.2, p=.01), and ≥63.4 for Anxiety (OR 4.7, CI 1.1–20.8, p=.04); preoperative ODI score ≥60 (OR 38.8, CI 4.0–373.6, p=.002); BMI ≥35.2 (OR 14.2, CI 1.3–160.0, p=.03), and male sex (OR 5.4, CI 1.2–23.7, p=.03) were associated with increased odds of LEPOM.CONCLUSIONSPreoperative PROMIS Pain, Physical Function, and Anxiety scores; ODI score; BMI; and male sex were associated with LEPOM. Several of these characteristics are modifiable risk factors and thus may be candidates for optimization before surgery.LEVEL OF EVIDENCEIII     

Comparison of adverse events between cervical disc arthroplasty and anterior cervical discectomy and fusion: a 10-year follow-up

BACKGROUND CONTEXTCervical disc arthroplasty (CDA) has been advocated as an alternative to anterior cervical discectomy and fusion (ACDF) with the added potential to reduce the risk of adjacent level disc degeneration and segmental instability. However, the long-term adverse events of arthroplasty have yet to be fully reported.PURPOSETo investigate the 10-year follow-up adverse events rates between CDA and ACDF.STUDY DESIGN/SETTINGThe study was a randomized, prospective, multicenter Investigational Device Exemption (IDE) trial and its continued follow-up as a postapproval study (PAS). Single level surgeries were performed for cervical disc pathologies between May 2002 and October 2004.PATIENT SAMPLEn=463 patients.OUTCOME MEASURESAdverse events comparison of CDA and ACDF from self-reported and physiologic measures.METHODSAt each evaluation time point, subjects were queried for adverse events since their last visit; and all adverse events were documented, regardless of whether or not they appeared related to the surgery or device. Adverse events were recorded, categorized, and assessed for severity and relationship to the study device and/or surgical procedure. The 10-year cumulative rates for each type of adverse events were summarized using a life-table method for the time-to-event analysis. A log-rank test was used to compare the two treatment groups.RESULTSA total of 242 patients received CDA and 221 patients received ACDF. At 10-year follow-up, 54% (130/242) of CDA patients and 47% (104/221) of the ACDF subjects were evaluated. At up to 10-year follow-up, 231 patients in the CDA group (cumulative rate 98.4%) and 199 patients in the ACDF group (cumulative rate 98.7%) had at least one adverse event. Overall, the difference in the cumulative rate of all adverse events over 10 years was not statistically different (p=0.166). The cumulative rates of the following adverse events were not different between the two groups for cancer, cardiovascular, death, dysphonia/dysphagia, gastrointestinal, infection, urogenital, respiratory, implant displacement/loosening, implant malposition, neck and arm pain, neurological, other pain, spinal events, and intraoperative vascular injury. However, there were more adverse events in the CDA group resulting from trauma (p=.012) and more spinal events at the index level (p=.006). The ACDF group had significantly more nonunion events (p=.019), and nonunion outcome pending (p=.034), adjacent level spinal events (p=.033), and events that fell into the “other” category (p=.015).CONCLUSIONSThe cumulative rates of patients who had any adverse events were not different between the artificial cervical disc and the anterior cervical arthrodesis groups. In addition, the cumulative rates were not different between the two groups for the majority of categories as well.     

Cervical kinematics and radiological changes after Discover artificial disc replacement versus fusion

Background contextThe cervical disc arthroplasty has emerged as a promising alternative to the anterior cervical discectomy and fusion (ACDF) in patients with radiculopathy or myelopathy with disc degeneration disease. The advantages of this technique have been reported to preserve the cervical mobility and possibly reduce the adjacent segment degeneration. However, no studies have compared the clinical outcomes and radiological results in patients treated with Discover artificial disc replacement to those observed in matched group of patients that have undergone ACDF.PurposeWe conducted this clinical study to compare the cervical kinematics and radiographic adjacent-level changes after Discover artificial disc replacement with ACDF.Study designAnalysis and evaluation of data acquired in a comparative clinical study.Patient sampleThe number of patients in the Discover and ACDF group were 149 and 196, respectively.Outcome measuresThe Neck Disability Index (NDI) and visual analog scale (VAS) pain score were evaluated. The range of movement (ROM) by the shell angle, the functional segment unit and global angles were measured, and the postoperative radiological changes at adjacents levels were observed.MethodsA total of 149 patients with symptomatic single or two-level cervical degenerative diseases received the Discover cervical artificial disc replacement from November 2008 to February 2010. During the same period, there were a total of 196 patients undergoing one or two-level ACDF. The average follow-up periods of the Discover disc group and ACDF group were 22.1 months and 22.5 months, respectively. Before surgery, patients were evaluated using static and dynamic cervical spine radiographs in addition to computerized tomography and magnetic resonance imaging. Static and dynamic cervical spine radiographs were obtained after surgery and then at 3- and 6-month follow-up. Then, the subsequent follow-up examinations were performed at every 6-month interval. The clinical results in terms of NDI and VAS scores, the parameters of cervical kinematics, postoperative radiological changes at adjacent levels, and complications in the two groups were statistically analyzed and compared. No funding was received for this study, and the authors report no potential conflict of interest–associated biases in the text.ResultsAlthough the clinical improvements in terms of NDI and VAS scores were achieved in both the Discover and ACDF group, no significant difference was found between the two groups for both single- (VAS p=.13, NDI p=.49) and double-level surgeries (VAS p=.28, NDI p=.21). Significant differences of cervcial kinematics occurred between the Discover and the ACDF group for both the single- and double-level surgeries at the operative segments (p<.001). Except the upper adjacent levels for the single-level Discover and ACDF groups (p=.33), significant increases in adjacent segment motion were observed in the ACDF group compared with the minimal ROM changes in adjacent segment motion noted in the Discover group, and the differences between the two groups for both single and double-level procedures were statistically significant (p<.05). There were significant differences in the postoperative radiological changes at adjacent levels between the Discover and ACDF groups for the single-level surgery (p<.001, χ²=18.18) and the double-level surgery (p=.007, χ²=7.2). No significant difference of complications was found between the Discover and ACDF groups in both single (p=.25, χ²=1.32) and double-level cases (p=.4, χ²=0.69).ConclusionsThe adjacent segment ROM and the incidence of radiographic adjacent-level changes in patients undergoing ACDF were higher than those undergoing Discover artificial disc replacement. The cervical mobility was relatively well maintained in the Discover group compared with the ACDF group, and the Discover cervical disc arthroplasty can be an effective alternative to the fusion technique.     

Incidence of complications associated with cervical spine surgery and post-operative physical therapy and implications for timing of initiation of post-operative physical therapy: a retrospective database study

Purpose

To describe the incidence of complications associated with cervical spine surgery and post-operative physical therapy (PT), and to identify if the timing of initiation of post-operative PT impacts the incidence rates.

Methods

MOrtho PearlDiver database was queried using billing codes to identify patients who had undergone Anterior Cervical Discectomy and Fusion (ACDF), Posterior Cervical Fusion (PCF), or Cervical Foraminotomy and post-operative PT from 2010–2019. For each surgical procedure, patients were divided into three 12-week increments for post-operative PT (starting at post-operative weeks 2, 8, 12) and then matched based upon age, gender, and Charlson Comorbidity Index score. Each group was queried to determine complication rates and chi-square analysis with adjusted odds ratios, 95% confidence intervals, and p-values were used.

Results

Following matching, 3,609 patients who underwent cervical spine surgery at one or more levels and had post-operative PT (ACDF:1784, PCF:1593, and cervical foraminotomy:232). The most frequent complications were new onset cervicalgia (2–14 weeks, 8–20 weeks, 12–24 weeks): ACDF (15.0%, 14.0%, 13.0%), PCF (18.8%, 18.0%, 19.9%), cervical foraminotomy (16.8%, 16.4%, 19.4%); revision: ADCF (7.9%, 8.2%, 7.4%), PCF (9.3%, 10.6%, 10.2%), cervical foraminotomy (11.6%, 10.8% and 13.4%); wound infection: ACDF (3.3%, 3.4%, 3.1%), PCF (8.3%, 8.0%,7.7%), cervical foraminotomy (5.2%, 6.5%, < 4.7%). None of the comparisons were statistically significant.

Conclusion

The most common post-operative complications included new onset cervicalgia, revision and wound infection. Complications rates were not impacted by the timing of initiation of PT whether at 2, 8, or 12 weeks post-operatively.

     

Safety and accuracy of robot-assisted placement of pedicle screws compared to conventional free-hand technique: a systematic review and meta-analysis

BACKGROUND CONTEXTThe introduction and integration of robot technology into modern spine surgery provides surgeons with millimeter accuracy for pedicle screw placement. Coupled with computer-based navigation platforms, robot-assisted spine surgery utilizes augmented reality to potentially improve the safety profile of instrumentation.PURPOSEIn this study, the authors seek to determine the safety and efficacy of robotic-assisted pedicle screw placement compared to conventional free-hand (FH) technique.STUDY DESIGN/SETTINGWe conducted a systematic review of the electronic databases using different MeSH terms from 1980 to 2020.OUTCOME MEASURESThe present study measures pedicle screw accuracy, complication rates, proximal-facet joint violation, intraoperative radiation time, radiation dosage, and length of surgery.RESULTSA total of 1,525 patients (7,379 pedicle screws) from 19 studies with 777 patients (51.0% with 3,684 pedicle screws) in the robotic-assisted group were included. Perfect pedicle screw accuracy, as categorized by Gerztbein-Robbin Grade A, was significantly superior with robotic-assisted surgery compared to FH-technique (Odds ratio [OR]: 1.68, 95% confidence interval [CI]: 1.20–2.35; p=.003). Similarly, clinically acceptable pedicle screw accuracy (Grade A+B) was significantly higher with robotic-assisted surgery versus FH-technique (OR: 1.54, 95% CI: 1.01–2.37; p=.05). Furthermore, the complication rates and proximal-facet joint violation were 69% (OR: 0.31, 95% CI: 0.20–0.48; p<.00001) and 92% less likely (OR: 0.08, 95% CI: 0.03–0.20; p<.00001) with robotic-assisted surgery versus FH-group. Robotic-assisted pedicle screw implantation significantly reduced intraoperative radiation time (MD: ?5.30, 95% CI: ?6.83–3.76; p<.00001) and radiation dosage (MD: ?3.70, 95% CI: ?4.80–2.60; p<.00001) compared to the conventional FH-group. However, the length of surgery was significantly higher with robotic-assisted surgery (MD: 22.70, 95% CI: 6.57–38.83; p=.006) compared to the FH-group.CONCLUSIONThis meta-analysis corroborates the accuracy of robot-assisted pedicle screw placement.     

Choice of plate may affect outcomes for single versus multilevel ACDF: results of a prospective randomized single-blind trial

Background contextConflicting views exist according to the individual philosophy about various plate designs that can be used in anterior cervical discectomy and fusion (ACDF) to achieve clinical and radiological improvement within shortest time period. No prospective randomized study has ever been conducted to clarify the relationship between clinical outcomes, fusion rates, and the choice of plate (static vs. dynamic design).PurposeTo compare the clinical and radiological outcomes of patients treated with one-level or multiple levels ACDF using cervical plates of dynamic (slotted-holes) versus static (fixed-holes) design.Study designSingle masked, prospective, randomized study.Patient sampleOver a 4-year period, 66 patients (M:F=37:29) had ACDF using either dynamic (n=33) or static (n=33) plates for intractable radiculopathy as the result of degenerative cervical spine disease. Overall, 28 patients had single-level fusion and 38 had two or three levels fused.Outcome measuresVisual Analogue Pain scores (VASs), Neck Disability Index (NDI), and radiological criteria of established fusion.MethodsThe qualifying subjects were randomized to receive ACDF using either fixed-holes (static) or the slotted-holes (dynamic) anterior cervical plates. Clinical and radiographic data were collected and analyzed. Paired-sample t test was used to correlate clinical and radiological outcomes and General Linear Model Analysis of Variance (GLM ANOVA) with repeated measures was used to detect outcome differences between the two groups for single and multiple fusions.ResultsAt a mean follow-up of 16 months (range, 12–24), 49 patients (73.7%) had clinical success and 56 (85%) showed radiological fusion. Although clinical success was a predictor of fusion (p=.043), the reverse was not true (p=.61). In single-level fusion, no statistical difference of outcome was observed between the two groups but multilevel fusions with dynamic plate showed significantly lower VAS and NDI than those with static plates (p=.050).ConclusionsAlthough clinical improvement is a good predictor of successful ACDF, radiological evidence of fusion alone is not reliable as a parameter of success. The design of plate does not affect the outcomes in single-level fusions but statistics indicate that multiple-level fusions may have better clinical outcome when a dynamic plate design is used.     

Complications,revision fusions,readmissions, and utilization over a 1-year period after bone morphogenetic protein use during primary cervical spine fusions

Background contextNationwide estimates examining bone morphogenetic protein (BMP) use with cervical spine fusions have been limited to perioperative outcomes.PurposeTo determine the 1-year risk of complications, cervical revision fusions, hospital readmissions, and health care services utilization.Study designA retrospective cohort study from 2002 to 2009 using a nationwide claims database.Patient sampleThere were 61,937 primary cervical spine fusions of which 1,677 received BMP.Outcome measuresComplications, revision fusions, 30-day hospital readmission, and health care utilization.MethodsData for these analyses come from the Thomson Reuters MarketScan Commercial Claims and Encounters Database 2010. Patients were aged 18 to 64 years, receiving and not receiving BMP with a primary (C2–C7) cervical spine fusion. All outcomes were defined by International Classification of Diseases, 9th edition Clinical Modification and Current Procedural and Terminology, 4th edition codes. Complications were analyzed as any complication and stratified by nervous system, wound, and dysphagia or hoarseness. Cervical revision fusions were determined in the 1-year follow-up. Hospital readmission discharge records defined 30-day hospital readmission and reason for the readmission. The utilization of at least one health care service of cervical spine imaging, epidural usage or rehabilitation service was examined. Poisson regression models were used to estimate the relative risk and 95% confidence interval (CI). Linear regression was used to determine the time to hospital readmission. Results were stratified by anterior or posterior and circumferential approaches.ResultsPatients receiving BMP were 29% more likely to have a complication (adjusted relative risk [aRR]=1.29 [95% CI, 1.14–1.46]) and a nervous system complication (aRR=1.42 [95% CI, 1.10–1.83]). Cervical revision fusions were more likely among patients receiving BMP (aRR=1.69 [95% CI, 1.35–2.13]). The risk of 30-day readmission was greater with BMP use (aRR=1.37 [95% CI, 1.07–1.73]) and readmission occurred 27.4% sooner on an average. Patients receiving BMP were more likely to receive computed tomography scans (aRR=1.34 [95% CI, 1.06–1.70]) and epidurals with anterior surgical approaches (aRR=1.29 [95% CI, 1.00–1.65]).ConclusionsThese findings question both the safety and effectiveness of off-label BMP use in primary cervical spine fusions.     

Revision risk after pediatric spinal deformity surgery: a nationwide study with 2-year follow-up

BACKGROUND CONTEXTRevision risk after pediatric spine surgery is not well established and varies between deformity etiologies.PURPOSETo report the 2-year revision risk following surgery for primary pediatric spinal deformity in a nationwide cohort and to evaluate potential risk factors and reasons for revision surgery.DESIGNRetrospective nationwide cohort study.PATIENT SAMPLEA national registry study of all pediatric spinal deformity patients undergoing surgery during 2006–2015 (n=1310).OUTCOME MEASURESTwo-year revision risk.METHODSAll patients ≤21 years of age undergoing spinal deformity surgery in Denmark during 2006–2015 were identified by procedure and diagnosis codes in the Danish National Patient Registry (DNPR). Data on revision surgery were retrieved from the DNPR. Patients were categorized in six groups according to etiology. Medical records were reviewed for reason for revision in all patients. Potential risk factors for revision were assessed with multiple logistic regression analyses and included age, etiology, sex, Charlson comorbidity index (CCI), and growth-preserving treatment.RESULTSPatients were categorized according to etiology: idiopathic deformity (53%), neuromuscular deformity (23%), congenital/structural deformity (9%), spondylolisthesis (7%), Scheuermann's kyphosis (5%), and syndromic deformity (3%). Of 1,310 included patients, 9.2% underwent revision surgery within 2 years and 1.5% was revised more than once. Median time to revision was 203 (interquartile range 35–485) days. The multivariable logistic regression found significantly higher odds ratio (OR) for revision in patients with growth-preserving treatment (OR=5.1, 95% confidence interval [CI] 2.6–10.1), congenital deformity (OR=2.7, 95% CI 1.3–5.3), spondylolisthesis (OR=3.5, 95% CI 1.9–6.7), Scheuermann kyphosis (OR=3.9, 95% CI 1.9–8.3), and CCI score ≥3 (OR=2.5 95% CI 1.1–5.6). The most common reason for revision was implant failure (32.5%) followed by residual deformity and/or curve progression (15.8%).CONCLUSIONSIn this nationwide study, the 2-year revision risk after primary pediatric spinal deformity surgery is 9.2%. Risk factors for revision are etiology of congenital deformity, spondylolisthesis, Scheuermann kyphosis as well as patients with growth-preserving treatment and higher CCI. The most common reason for revision is implant failure.