Retrospective evaluation of cervical fusion with DTRAX (R) cervical cage

BackgroundCervical radiculopathy is a relatively common problem that often affects individuals in their 5th decade. Most cases resolve with conservative treatment, but when unsuccessful, many opt for surgical intervention. Anterior cervical discectomy and fusion is currently considered the gold standard for the surgical management of cervical radiculopathy. One promising alternative, the DTRAX facet system is minimally invasive and may significantly reduce or eliminate cervical radicular symptoms. This case series and literature review looks to investigate the safety and efficacy of the DTRAX facet system in treating cervical radiculopathy.MethodsThis retrospective analysis was performed by chart review of patients who underwent posterior cervical fusion and received the DTRAX spinal implant at University of California, Los Angeles within the last 8 years. Patient charts were located using the surgical cases report function of Epic electronic medical record, and patients were included in the study if they received a DTRAX implant during the stated time period. Data were compiled and analyzed using Microsoft Excel.ResultsA total of 14 patient charts were reviewed. Of the 14, there were no immediate postoperative complications. One international patient was subsequently lost to follow-up, and of the remaining 13, mean follow-up duration was 273 days, with a range of 15-660 days. All but one reported improvement of symptoms postoperatively, there were no device failures, and no reoperations were required. There were similar outcomes in patients who received single versus multilevel operations.ConclusionThe findings of this retrospective study of 14 patients who received the DTRAX facet system over the last 8 years support the conclusions of previous studies that DTRAX is safe and effective. In addition, this is the first study to look for differences in outcomes between single and multi-level DTRAX operations, of which there were none. Further investigation with larger cohorts should be conducted as DTRAX becomes more widely adopted in order to verify its safety and efficacy in various clinical scenarios

Chondrosarcoma of the Osseous Spine: An Analysis of Epidemiology, Patient Outcomes, and Prognostic Factors Using the SEER Registry From 1973 to 2012.

Study designRetrospective analysis.ObjectiveTo determine the epidemiology and prognostic indicators in patients with chondrosarcoma of the osseous spine.Summary of background dataChondrosarcoma of the spine is rare, with limited data on its epidemiology, clinicopathologic features, and treatment outcomes. Therapy centers on complete en bloc resection with radiotherapy reserved for subtotal resection or advanced disease.MethodsThe Surveillance, Epidemiology, and End Results Registry was queried for patients with chondrosarcoma of the osseous spine from 1973 to 2012. Study variables included age, sex, race, year of diagnosis, size, grade, extent of disease, and treatment modality.ResultsThe search identified 973 cases of spinal chondrosarcoma. Mean age at diagnosis was 51.6 years, and 627% of patients were males. Surgical resection and radiotherapy were performed in 75.2% and 21.3% of cases, respectively. Kaplan-Meier analysis demonstrated overall survival (OS) and disease-specific survival (DSS) of 53% and 64%, respectively, at 5 years. Multivariate Cox regression analysis showed that age (OS, P < 0.001; DSS, P = 0.007), grade (OS, P < 0.001; DSS, P < 0.001), surgical resection (OS, P < 0.001; DSS, P < 0.001), and extent of disease (OS, P < 0.001; DSS, P < 0.001) were independent survival determinants; tumor size was an independent predictor of OS (P = 0.006). For confined disease, age (P = 0.013), decade of diagnosis (P = 0.023), and surgery (P = 0.017) were independent determinants of OS. For locally invasive disease, grade (OS, P < 0.001; DSS, P = 0.003), surgery (OS, P = 0.013; DSS, P = 0.046), and size (OS, P = 0.001, DSS, P = 0.002) were independent determinants of OS and DSS. Radiotherapy was an independent indicator of worse OS for both confined (P = 0.004) and locally invasive disease (P = 0.002). For metastatic disease, grade (OS, P = 0.021; DSS, P = 0.012) and surgery (OS, P = 0.007; DSS, P = 0.004) were survival determinants for both OS and DSS, whereas radiotherapy predicted improved OS (P = 0.039).ConclusionSurgical resection confers survival benefit in patients with chondrosarcoma of the spine independent of extent of disease. Radiotherapy improves survival in patients with metastatic disease and worsens outcomes in patients with confined and locally invasive disease.Level of evidence4

Prognostic determinants and treatment outcomes analysis of osteosarcoma and Ewing sarcoma of the spine.

Background contextOsteosarcoma (OGS) and Ewing sarcoma (EWS) are the two classic primary malignant bone tumors. Due to the rarity of these tumors, evidence on demographics, survival determinants, and treatment outcomes for primary disease of the spine are limited and derived from small case series.PurposeTo use population-level data to determine the epidemiology and prognostic indicators in patients with OGS and EWS of the osseous spine.Study design/settingLarge-scale retrospective study.Patient samplePatients diagnosed with OGS and EWS of the spine in the Surveillance, Epidemiology, and End Results (SEER) registry from 1973 to 2012.Outcome measuresOverall survival (OS) and disease-specific survival (DSS).MethodsTwo separate queries of the SEER registry were performed to identify patients with OGS and EWS of the osseous spine from 1973-2012. Study variables included age, sex, race, year of diagnosis, tumor size, extent of disease (EOD), and treatment with surgery and/or radiation therapy. Primary outcome was defined as OS and DSS in months. Univariate survival analysis was performed using the Kaplan-Meier method and the log-rank test. Multivariate analysis was performed using Cox proportional hazards regression models.ResultsThe search identified 648 patients with primary OGS and 736 patients with primary EWS of the spine from 1973 to 2012. Mean age at diagnosis was 48.1 and 19.9 years for OGS and EWS, respectively, with OGS showing a bimodal distribution. The median OS and DSS were 1.3 and 1.7 years, respectively, for OGS, with OGS in Paget's disease having worse OS (0.7 years) relative to the mean (log-rank p=.006). The median OS and DSS for EWS were 3.9 and 4.3 years, respectively. Multivariate cox regression analysis showed that age (OS p<.001, DSS p<.001), decade of diagnosis (OS p=.049), surgical resection (OS p<.001, DSS p<.001), and EOD (OS p<.001, DSS p<.001) were independent positive prognostic indicators for spinal OGS; radiation therapy predicted worse OS (hazard ratio [HR] 1.48, confidence interval [CI] 1.05-2.10, p=.027) and DSS (HR 1.74, CI 1.13-2.66, p=.012) for OGS. For EWS, age (OS p<.001, DSS p<.001), surgical resection (OS p=.030, DSS p=.046), tumor size (OS p<.001, DSS p<.001), and EOD (OS p<.001, DSS p<.001) were independent determinants of improved survival; radiation therapy trended toward improved survival but did not achieve statistical significance for both OS (HR 0.76, CI 0.54-1.07, p=.113) and DSS (0.76, CI 0.54, 1.08, p=.126).ConclusionsAge, surgical resection, and EOD are key survival determinants for both OGS and EWS of the spine. Radiation therapy may be associated with worse outcomes in patients with OGS, and is of potential benefit in EWS. Overall prognosis has improved in patients with OGS of the spine over the last four decades

Chondrosarcoma of the Osseous Spine: An Analysis of Epidemiology, Patient Outcomes, and Prognostic Factors Using the SEER Registry From 1973 to 2012.

Study designRetrospective analysis.ObjectiveTo determine the epidemiology and prognostic indicators in patients with chondrosarcoma of the osseous spine.Summary of background dataChondrosarcoma of the spine is rare, with limited data on its epidemiology, clinicopathologic features, and treatment outcomes. Therapy centers on complete en bloc resection with radiotherapy reserved for subtotal resection or advanced disease.MethodsThe Surveillance, Epidemiology, and End Results Registry was queried for patients with chondrosarcoma of the osseous spine from 1973 to 2012. Study variables included age, sex, race, year of diagnosis, size, grade, extent of disease, and treatment modality.ResultsThe search identified 973 cases of spinal chondrosarcoma. Mean age at diagnosis was 51.6 years, and 627% of patients were males. Surgical resection and radiotherapy were performed in 75.2% and 21.3% of cases, respectively. Kaplan-Meier analysis demonstrated overall survival (OS) and disease-specific survival (DSS) of 53% and 64%, respectively, at 5 years. Multivariate Cox regression analysis showed that age (OS, P < 0.001; DSS, P = 0.007), grade (OS, P < 0.001; DSS, P < 0.001), surgical resection (OS, P < 0.001; DSS, P < 0.001), and extent of disease (OS, P < 0.001; DSS, P < 0.001) were independent survival determinants; tumor size was an independent predictor of OS (P = 0.006). For confined disease, age (P = 0.013), decade of diagnosis (P = 0.023), and surgery (P = 0.017) were independent determinants of OS. For locally invasive disease, grade (OS, P < 0.001; DSS, P = 0.003), surgery (OS, P = 0.013; DSS, P = 0.046), and size (OS, P = 0.001, DSS, P = 0.002) were independent determinants of OS and DSS. Radiotherapy was an independent indicator of worse OS for both confined (P = 0.004) and locally invasive disease (P = 0.002). For metastatic disease, grade (OS, P = 0.021; DSS, P = 0.012) and surgery (OS, P = 0.007; DSS, P = 0.004) were survival determinants for both OS and DSS, whereas radiotherapy predicted improved OS (P = 0.039).ConclusionSurgical resection confers survival benefit in patients with chondrosarcoma of the spine independent of extent of disease. Radiotherapy improves survival in patients with metastatic disease and worsens outcomes in patients with confined and locally invasive disease.Level of evidence4

Implications of sagittal alignment and complication profile with stand-alone anterior lumbar interbody fusion versus anterior posterior lumbar fusion

BackgroundAnterior lumbar interbody fusion (ALIF) is commonly utilized in lumbar degenerative pathologies. Standalone ALIF (ST-ALIF) systems were developed to avoid added morbidity, surgical time, and cost of anterior and posterior fusion (APF). Controversy exists in the literature about which of these two techniques yields superior clinical and radiographic outcomes, and few studies have directly compared them. This study seeks to compare ST-ALIF and APF in terms of sagittal correction and surgical complications.MethodsNinty-two consecutive ALIF cases performed from 2013-2018 were retrospectively reviewed and separated into 2 groups. Radiographic measurements were performed on pre- and post-operative radiographs, including segmental lordosis (SL), lumbar lordosis (LL), and pelvic incidence-lumbar lordosis mismatch (PI-LL). Surgical complications were determined. Statistical analysis was performed using chi-square test of homogeneity, Fisher's exact test, and independent sample t-test. Comparisons between groups were deemed statistically significant at the P<0.05 threshold.ResultsFifty-seven ST-ALIF, 35 APF were identified. There were no differences in age, gender, BMI, Charlson Comorbidity Index (CCI), preoperative diagnosis, or surgical level between the 2 cohorts. Bone Morphogenetic Protein (BMP) was utilized in 24.6% of ST-ALIF versus none of APF (P=0.001). No differences were detected in SL, LL, and PI-LL mismatch. ST-ALIF cohort had significantly greater risk of subsidence and revision surgery versus APF (12.3% vs. 0%, RD 95% CI: 3.8-20.8%, P=0.042). Recurrent spondylolisthesis occurred in 5 ST-ALIF cases, 3 cases with implant failure, and 2 nonunions versus none in the APF group.ConclusionsST-ALIF was associated with significantly greater subsidence and revision surgery versus APF. Careful patient selection is paramount when considering ST-ALIF. The potential for revision surgery may offset the potential benefit in avoiding posterior fusion. Despite the greater risk of subsidence, sagittal alignment was not significantly affected

Undenatured type II collagen (UC-II®) for joint support: a randomized, double-blind, placebo-controlled study in healthy volunteers

Abstract Background UC-II contains a patented form of undenatured type II collagen derived from chicken sternum. Previous preclinical and clinical studies support the safety and efficacy of UC-II in modulating joint discomfort in osteoarthritis and rheumatoid arthritis. The purpose of this study was to assess the efficacy and tolerability of UC-II in moderating joint function and joint pain due to strenuous exercise in healthy subjects. Methods This randomized, double-blind, placebo-controlled study was conducted in healthy subjects who had no prior history of arthritic disease or joint pain at rest but experienced joint discomfort with physical activity. Fifty-five subjects who reported knee pain after participating in a standardized stepmill performance test were randomized to receive placebo (n = 28) or the UC-II (40 mg daily, n = 27) product for 120 days. Joint function was assessed by changes in degree of knee flexion and knee extension as well as measuring the time to experiencing and recovering from joint pain following strenuous stepmill exertion. Results After 120 days of supplementation, subjects in the UC-II group exhibited a statistically significant improvement in average knee extension compared to placebo (81.0 ± 1.3º vs 74.0 ± 2.2º; p = 0.011) and to baseline (81.0 ± 1.3º vs 73.2 ± 1.9º; p = 0.002). The UC-II cohort also demonstrated a statistically significant change in average knee extension at day 90 (78.8 ± 1.9º vs 73.2 ± 1.9º; p = 0.045) versus baseline. No significant change in knee extension was observed in the placebo group at any time. It was also noted that the UC-II group exercised longer before experiencing any initial joint discomfort at day 120 (2.8 ± 0.5 min, p = 0.019), compared to baseline (1.4 ± 0.2 min). By contrast, no significant changes were seen in the placebo group. No product related adverse events were observed during the study. At study conclusion, five individuals in the UC-II cohort reported no pain during or after the stepmill protocol (p = 0.031, within visit) as compared to one subject in the placebo group. Conclusions Daily supplementation with 40 mg of UC-II was well tolerated and led to improved knee joint extension in healthy subjects. UC-II also demonstrated the potential to lengthen the period of pain free strenuous exertion and alleviate the joint pain that occasionally arises from such activities

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 contextWith 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.PurposeThe objective of this study was to determine the nationwide trends and relative complication rates associated with outpatient ACDF.Study design/settingThis is a large-scale retrospective case control study.Patient sampleThe patient sample included Humana-insured patients who underwent one- to two-level ACDF as either outpatients or inpatients from 2011 to 2016 OUTCOME MEASURES: The outcome measures included incidence and the adjusted odds ratio (OR) of postoperative medical and surgical complications within 1 year of the index surgery.Materials and methodsA retrospective review was performed of the PearlDiver Humana insurance records database to identify patients undergoing one- to two-level ACDF (Current Procedural Terminology [CPT]-22551 and International Classification of Diseases [ICD]-9-816.2) as either outpatients or inpatients from 2011 to 2016. The incidence of perioperative medical and surgical complications was determined by querying for relevant ICD and CPT codes. Multivariate logistic regression adjusting for age, gender, and Charlson Comorbidity Index was used to calculate ORs of complications among outpatients relative to inpatients undergoing ACDF.ResultsCohorts of 1,215 patients who underwent outpatient ACDF and 10,964 patients who underwent inpatient ACDF were identified. The median age was in the 65-69 age group for both cohorts. The annual relative incidence of outpatient ACDF increased from 0.11 in 2011 to 0.22 in 2016 (R2=0.82, p=.04). Adjusting for age, gender, and comorbidities, patients undergoing outpatient ACDF were more likely to undergo revision surgery for posterior fusion at both 6 months (OR 1.58, confidence interval [CI] 1.27-1.96, p<.001) and 1 year (OR 1.79, CI 1.51-2.13, p<.001) postoperatively. Outpatient ACDF was also associated with a higher likelihood of revision anterior fusion at 1 year postoperatively (OR 1.46, CI 1.26-1.70, p<.001). Among medical complications, postoperative acute renal failure was more frequently associated with outpatient ACDF than inpatient ACDF (OR 1.25, CI 1.06-1.49, p=.010). Adjusted rates of all other queried surgical and medical complications were comparable.ConclusionsOutpatient ACDF is increasing in frequency nationwide over the past several years. Nationwide data demonstrate a greater risk of perioperative surgical complications, including revision anterior and posterior fusion, as well as a higher risk of postoperative acute renal failure. Candidates for outpatient ACDF should be counseled and carefully selected to reduce these risks

Outpatient Posterior Lumbar Fusion

Study designA retrospective case-control study.ObjectiveThe aim of this study was to determine the nationwide trends and complication rates associated with outpatient posterior lumbar fusion (PLF).Summary of background dataOutpatient lumbar spine fusion is now possible secondary to minimally invasive techniques that allow for reduced hospital stays and analgesic requirements. Limited data are currently available regarding the clinical outcome of outpatient lumbar fusion.MethodsThe Humana administrative claims database was queried for patients who underwent one to two-level PLF (CPT-22612 or CPT-22633 AND ICD-9-816.2) as either outpatients or inpatients from Q1 2007 to Q2 2015. The incidence of perioperative medical and surgical complications was determined by querying for relevant International Classification of Diseases and Current Procedural Terminology codes. Multivariate logistic regression adjusting for age, gender, and Charlson Comorbidity Index was used to calculate odds ratios (ORs) of complications among outpatients relative to inpatients undergoing PLF.ResultsCohorts of 770 patients who underwent outpatient PLF and 26,826 patients who underwent inpatient PLF were identified. The median age was in the 65 to 69 years age group for both cohorts. The annual relative incidence of outpatient PLF remained stable across the study period (R = 0.03, P = 0.646). Adjusting for age, gender, and comorbidities, patients undergoing outpatient PLF had higher likelihood of revision/extension of posterior fusion [(OR 2.33, confidence interval (CI) 2.06-2.63, P < 0.001], anterior fusion (OR 1.64, CI 1.31-2.04, P < 0.001), and decompressive laminectomy (OR 2.01, CI 1.74-2.33, P < 0.001) within 1 year. Risk-adjusted rates of all other postoperative surgical and medical complications were statistically comparable.ConclusionOutpatient lumbar fusion is uncommonly performed in the United States. Data collected from a national private insurance database demonstrate a greater risk of postoperative surgical complications including revision anterior and posterior fusion and decompressive laminectomy. Surgeons should be cautious in performing PLF in the outpatient setting, as the risk of revision surgery may increase in these cases.Level of evidence3

Surgical treatment of metastatic spine disease: an update on national trends and clinical outcomes from 2010 to 2014

BACKGROUND CONTEXT: Metastatic spine disease (MSD) is becoming more prevalent as medical treatment for cancers advance and extend survival. More MSD patients are treated surgically to maintain neurological function, ambulation, and quality of life. PURPOSE: The purpose of this study was to use a large, nationally representative database to examine the trends, patient outcomes, and health-care resource utilization associated with surgical treatment of MSD. DESIGN: This was an epidemiologic study using national administrative data from the Nationwide Readmissions Database (NRD). PATIENT SAMPLE: All patients in the NRD from 2010 to 2014 who underwent spinal surgery were included in the study. OUTCOME MEASURES: Mortality, blood transfusion, complications, length of stay, cost, and discharge location during index hospitalization as well as hospital readmission and revision surgery within 90-days of surgery were analyzed. METHODS: International Classification of Diseases, Ninth Revision, (ICD-9) codes was used to identify patients of interest within the NRD from 2010 to 2014. Patients were separated into two cohorts - those with MSD and those without. Trends for surgical treatment of MSD were assessed and outcomes measures for both cohorts were analyzed and compared. RESULTS: The number of surgical treatments for MSD increased from 6,007 in 2010 to 7,032 in 2014 (p-trend<.0001) which represented a 17.1% increase. During index hospitalization, MSD patients had an increased risk of mortality (odds ratio [OR]=3.22, 95% confidence interval [CI]: 2.85-3.63, p<.0001), blood transfusion (OR=2.93, 95% CI: 2.66-3.23, p<.0001), any complication (OR=1.24, 95% CI: 1.18-1.31, p<.0001), and discharge to skilled nursing facility (OR=1.51, 95% CI:1.41-1.61, p<.0001). MSD patients had longer average length of stay (13.05 vs. 4.56 days, p<.0001) and cost ($49,421.75 vs.$26,190.37, p<.0001) during index hospitalization. Furthermore, MSD patients had an increased risk of hospital readmission (OR=2.82, 95% CI: 2.68-2.96, p<.0001), readmission for surgical site infection (OR=2.38, 95% CI: 2.20-2.58, p<.0001), and readmission with neurologic deficits (OR=1.62, 95% CI: 1.27- 2.06, p<.0001) despite a decreased risk of revision fusion (OR=0.71, 95% CI: 0.53- 0.96, p=.026). CONCLUSIONS: The number of MSD patients who undergo surgical treatments is increasing. Not only do these patients have worse outcomes during index hospitalization, but they are also at an increased risk of hospital readmission for surgical site infection and neurologic complications. These findings stress the need for multidisciplinary perioperative treatment plans that mitigate risks and facilitate quick, effective recovery in these unique, at-risk patients. Published by Elsevier Inc