Lumbar Degenerative Disc Disease Research Articles

Cortical bone trajectory screws in the treatment of lumbar degenerative disc disease in patients with osteoporosis.

Lumbar degenerative disc disease (DDD) in the elderly population remains a global health problem, especially in patients with osteoporosis. Osteoporosis in the elderly can cause failure of internal fixation. Cortical bone trajectory (CBT) is an effective, safe and minimally invasive technique for the treatment of lumbar DDD in patients with osteoporosis. In this review, we analyzed the anatomy, biomechanics, and advantages of the CBT technique in lumbar DDD and revision surgery. Additionally, the clinical trials and case reports, indications, advancements and limitations of this technique were further discussed and reviewed. Finally, we concluded that the CBT technique can be a practical, effective and safe alternative to traditional pedicle screw fixation, especially in DDD patients with osteoporosis.

Expanding access to microneurosurgery in low-resource settings: Feasibility of a low-cost exoscope in transforaminal lumbar interbody fusion.

Less than a quarter of the world population has access to microneurosurgical care within a range of 2 h. We introduce a simplified exoscopic visualization system for low-resource settings. We purchased a 48 megapixels microscope camera with a c-mount lens and a ring light at a total cost of US$ 125. Sixteen patients with lumbar degenerative disk disease were divided into an exoscope group and a microscope group. In each group, we performed four open and four minimally invasive transforaminal lumbar interbody fusions (TLIF). We conducted a questionnaire-based assessment of the user experience. The exoscope achieved similar outcomes with comparable blood loss and operating time as the microscope. It provided similar image quality and magnification. Yet, it lacked stereoscopic perception and the adjustability of the camera position was cumbersome. Most users strongly agreed the exoscope would significantly improve surgical teaching. Over 75% reported that they would recommend the exoscope to colleagues and all users saw its great potential for low-resource environments. Our low-budget exoscope is safe and feasible for TLIF and purchasable at a fraction of the cost of conventional microscopes. It may thus help expand access to neurosurgical care and training worldwide.

Post-operative tension spinal subdural extra-arachnoid hygroma of the lumbar spine: case series, literature review, and recommendations for clinical management

Objective Case series presentation and literature review of patient group suffering from symptomatic tension subdural extra-arachnoid hygroma following decompressive surgery for degenerative lumbar stenosis or disc disease. The purpose was to better understand this rare post-operative complication with a pathognomic radiological sign to help recommend optimal strategies for clinical management. Methods Retrospective case series comprising seven cases from one tertiary Neurosurgical centre spanning a 10-year period from 2011 to 2021. Patients included were those known to have undergone a spinal procedure and subsequently to have developed a symptomatic spinal subdural extra-arachnoid hygroma (SSEH). A literature review was conducted using PubMed, MEDLINE and EMBASE (keywords ‘subdural hygroma’, ‘lumbar CSF hygroma’, ‘extra arachnoid hygroma’, ‘extra-arachnoid CSF collection’, ‘CSF tension hygroma’, ‘lumbar extra arachnoid hygroma’, ‘lumbar spinal hygroma’, ‘post-operating spinal hygroma’, ‘post-operative spinal CSF collection’) and through reading references cited in relevant articles. Articles involving post-operative SSEH following lumbar spinal surgery were included. Results Rare complication with only five other cases in the literature. Dural breach described intra-operatively in only 5 of 12 total cases from our series and the literature. 5 patients in our series were managed surgically with 2 being managed conservatively. All patients in our series improved symptomatically and radiologically following surgical or conservative management. Conclusions This is a rare post-lumbar surgery complication that can cause rapidly deteriorating lower limb and sphincteric function. Surgical management with wide durotomy and arachnoid marsupialisation can lead to reversal of neurological deterioration and excellent clinical results. A delayed presentation with pseudomeningocele formation may be managed conservatively if neurology is stable or improving. It is a condition that it is important for the clinician to recognise in order to instigate appropriate management in a time-dependent fashion.

Validating the predictive precision of the dialogue support tool on Danish patient cohorts

BackgroundDespite advances in surgical techniques and diagnostics, some patients remain unsatisfied with the result following spine surgery. One way to improve patient satisfaction may be found in better alignment of expectations. Prognostic tools might prove useful in strengthening surgeon-patient communication prior to surgery. The purpose of this study is to assess the predictive capabilities of the Swedish based Dialogue Support (DS) tool for spine surgery on a Danish population. MethodsThe study included the diagnoses lumbar disc herniation, lumbar spinal stenosis, and lumbar degenerative disc disease. A total of 5.954 patients were retrieved from the Danish national spine registry (DaneSpine). For each group, 200 random cases with complete preoperative and 1 year follow-up data were selected. Two outcome measures were used: Global assessment of pain (GA pain) and satisfaction with outcome. Predictions were produced by manual entry in the DS application. Goodness of fit tests were used to compare the predicted distribution of proportions with successful outcomes (GA pain) to the actual distribution in the three samples. Binomial tests were performed to evaluate the predicted proportion of satisfied patients. Furthermore, ROC-curves, calibration plots, and metrics were calculated to assess the predictive performance. ResultsROC curves showed comparable AUC values with the values reported by the developing authors of the DS from 0.62 to 0.73 (GA pain) and 0.64 to 0.70 (satisfaction with outcome). The calibration plots, however, revealed a low degree of concordance. For GA pain sensitivity varied from 92.4% to 99.3%, and specificity from 1.5% to 13.4%. For satisfaction, sensitivity varied from 97.1% to 99.2% and specificity from 0.0% to 2.9%. ConclusionsThe predictive capabilities of the DS tool could not be generalized to the Danish sample cohorts. Further research on larger samples, provided full access to the underlying algorithms can be obtained, could produce a different result.

The Influence of Roussouly Type on the Prevalence, Subtype, and Distribution Characteristics of Modic Changes in Patients with Lumbar Degenerative Disc Disease

The relationship between Roussouly type and Modic changes (MC) is unknown. The aim of our study was to investigate the influence of Roussouly type on the characteristics of MC in patients with lumbar degenerative disc disease. This cross-sectional observational study from Huashan Hospital included 270 patients with lumbar degenerative disc disease. Subjects were divided into 4 groups according to the Roussouly classification. Prevalence, subtype, and distribution characteristics of MC from L1-L2 upper end plate to L5-S1 lower end plate were compared between 4 Roussouly types. Of 270 patients, 65 (24.1%) were Roussouly type I, 115 (42.6%) were Roussouly type II, 55 (20.4%) were Roussouly type III, and 35 (13.0%) were Roussouly type IV. MC were present in 45.9% (n= 270) of patients, 12.7% (n= 2700) of end plates, and 11.8% (n= 1350) of intervertebral discs. The prevalence rate of MC by subtype and intervertebral disc among the 4 Roussouly types was statistically different (P < 0.05), and the prevalence rate of MC by intervertebral disc in Roussouly type I was statistically higher than the other 3 Roussouly types. In Roussouly types I and IV, the prevalence rate of MC at L4-L5 level showed no significant differences compared with those at upper lumbar levels, while in Roussouly types II and III, the prevalence rate of MC at L4-L5 level was significantly higher than those at upper lumbar levels. Roussouly types can influence prevalence, subtype, and distribution characteristics of MC in patients with lumbar degenerative disc disease.

A Prospective, Observational, Open-Label, Non-Randomized, Multicenter Study Measuring Functional Outcomes in a Novel Interspinous Fusion Device in Subjects with Low Back Pain: REFINE Study.

Lumbar degenerative disease and the accompanying pain and dysfunction affect a significant number of patients in the USA and around the world. As surgery and innovation are moving towards minimally invasive treatments, this study looks to explore interspinous fixation as a standalone posterior approach to treat lumbar degenerative disc disease in the presence of neurogenic claudication and spinal stenosis. This study was approved by an institutional review board (IRB) and is actively enrolling in a single-arm, multicenter, prospective, open-label fashion. Patients are followed with reporting at 3months, and 12months for primary endpoint analysis of efficacy and safety based on improved composite endpoints relative to baseline, with success defined as greater than 20mm back pain reduction in Visual Analog Scale 100mm (VAS) while standing or walking, greater than 20mmleg pain reduction in VAS while standing or walking, Zurich Claudication Questionnaire (ZCQ) improvement of 0.5 or greater in two or three domains, Oswestry Disability Index (ODI) improvement of a least 10points and no reoperations or revisions at the index level(s). Secondary endpoints included a multidimensional assessment in the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 v2.1 and Patient Global Impression of Change (PGIC). In this interim 3-month analysis, 82% of patients reported they were improved from the procedure, while 65% of patients demonstrated clinical meaningful improvement in their pain and function, as defined by the VAS, ODI, and ZCQ. There was only one adverse event and no complications were identified at last clinic research follow-up visit. This interim analysis of the first 20% of the enrolled patients out to 3months was to determine safety of the procedure and report on adverse events, acknowledging the heterogeneity of surgical specialty. Further follow-up and greater numbers are needed as the study is ongoing. ClinicalTrials.gov identifier, NCT05504499.

CircRNA GRB10 is a Novel Biomarker for the Accurate Diagnosis of Lumbar Degenerative Disc Disease.

Lumbar degenerative disc disease (LDDD) is frequently misdiagnosed as other spine conditions, and the accurate diagnosis is challenging. This study was conducted to explore the role of circRNA GRB10 in the accurate diagnosis of LDDD. This study included 60 cases of LDDD, 60 cases of patients with sacroiliac joint pain (SJP), 60 cases of lumbar disc herniation (LDH), 60 cases of piriformis syndrome (PS), 60 cases of entrapment neuropathy (EN) and 60 cases of healthy controls (HCs). Plasma was obtained from each patient before and after treatment. Expression of GRB10 was studied with RT-qPCR. The role of plasma GRB10 in the accurate diagnosis of LDDD was analyzed by ROC curve analysis. Compared to HCs, decreased accumulation of GRB10 RNA was only observed in LDDD group, but not in SJP, LDH, PS and EN groups. With plasma expression level of GRB10 measured before treatment as a biomarker, LDDD patients were separated from SJP, LDH, PS, EN and HC groups. After treatment, increased expression levels of GRB10 were only observed in LDDD group, but not in other groups. Therefore, GRB10 was downregulated in LDDD and may serve as a biomarker for the accurate diagnosis of LDDD.

Comparative study between "Traditional Open" versus "Less Invasive" Transforaminal lumbar Interbody Fusion in the treatment of Degenerative Lumbar Disc Disease

Comparative study between "Traditional Open" versus "Less Invasive" Transforaminal lumbar Interbody Fusion in the treatment of Degenerative Lumbar Disc Disease

National trends in the utilization of lumbar disc replacement for lumbar degenerative disc disease over a 10-year period, 2010 to 2019.

BackgroundLumbar fusion (LF) is commonly performed to manage lumbar degenerative disc disease (LDDD) that has failed conservative measures. However, lumbar disc replacement (LDR) procedures are increasingly prevalent and designed to preserve motion in carefully selected patients.MethodsA retrospective cohort study was performed using the National Inpatient Sample (NIS), queried from 2010 to 2019 to identify patients undergoing single and double-level LF or LDR with a diagnosis of LDDD using International Classification of Diseases (ICD) 9th (ICD-9) and 10th (ICD-10) revision diagnostic and procedure codes. Propensity score matching (PSM) with a ratio of 2:1 was performed. All cost estimates reflect reported hospital costs adjusted to December 2019 United States Dollars.ResultsA total of 1,129,121 LF cases (99.3%) and 8,049 LDR cases (0.7%) were identified, with 364,637 (32.3%) and 712 (8.8%) comprising two-level surgeries, respectively. 1,712 LDRs were performed in 2010 (1.27% of all), decreasing to 565 in 2013 (0.52%), and increased slightly to 870 in 2019 (0.74%). LDR patients were significantly more likely to be younger (mean age 41.2 vs. 57.1, P<0.001) and healthier (mean ECI 0.88 vs. 1.80, P<0.001). On matched analysis, LDR hospital costs were $4,529 less (P<0.001) and length of stay was 0.65 days shorter (P<0.001) than LF patients. LDR patients had lower rates of any complication (7.0% vs. 13.2%, P<0.001), neurologic complication (3.0% vs. 4.2%, P=0.006), and blood transfusion (3.1% vs. 8.1%, P<0.001) compared to LF patients.ConclusionsThe prevalence of LDR procedures decreased from 2010–2017 but began to increase again in 2018 and 2019. Single-level LDR was associated with reduced costs and length of stay (LOS), and lower rates of blood transfusion compared to LF in patients with LDDD.

129. National trends in the utilization of lumbar disc replacement for lumbar degenerative disc disease over a 10-year period, 2010 to 2019

<h3>BACKGROUND CONTEXT</h3> In the treatment of lumbar degenerative disc disease (DDD) that has failed conservative measures, lumbar fusion (LF) remains the gold standard. Approved in 2004, lumbar disc replacement (LDR) is designed to preserve motion. Initial studies showed LDR was used in 2.7% of surgeries for DDD and spondylosis. <h3>PURPOSE</h3> We aim to analyze the trends, complications and costs associated with LDR compared to LF using a large national database. <h3>STUDY DESIGN/SETTING</h3> Restrospective, administrative database. <h3>PATIENT SAMPLE</h3> National Inpatient Sample, 2010-2019. <h3>OUTCOME MEASURES</h3> Cost, length of stay, discharge destination, index hospitalization complications. <h3>METHODS</h3> The National Inpatient Sample (NIS) was queried from 2010 to 2019 to identify patients undergoing single and double- level LF and LDR with a diagnosis of lumbar DDD using ICD-9 and ICD-10 diagnostic and procedure codes. Revision procedures were excluded. Propensity score matching (PSM) with a ratio of 2:1 was performed to compare health care utilization metrics and index hospital complications for patients undergoing single-level LF or LDR. <h3>RESULTS</h3> A total of 1,129,121 LF cases (99.3%) and 8,049 LDR cases (0.7%) we identified during the study period, with 364,637 (32.3%) and 712 (8.8%) comprising two-level procedures, respectively. 1,712 LDRs were performed in 2010 (1.27% of all), decreasing to 565 in 2013 (0.52%), and increased slightly to 870 in 2019 (0.74%). For single-level procedures, the proportion of LDR cases decreases from 1.41% in 2010 to 0.66% in 2013 (p <0.001), but then increased gradually to 1.17% in 2019 (p <0.001 for trend). The proportion of two-level LF and LDR procedures increased significantly over the study period from 15.7% in 2010 to 45.5% in 2019 (p <0.001 for trend). LDR patients were significantly more likely to be younger (mean age 41.2 vs 57.1, p <0.001), healthier (mean ECI 0.88 vs 1.80, p <0.001) and male (57.5% vs 47.1%, p <0.001). LDR patients were also more likely to have procedures paid for by private insurance (55.8% vs 43.7%, p <0.001) and reside in higher income areas (top quartile 30.0% vs 23.2%, p <0.001). On PSM analysis, a total of 1,343 single-level LDR patient records were matched to 2,686 single-level LF patient records, and 141 two-level LDR patient records were matched to 282 two-level LF patient records. Single-level LDR patients had significantly shorter LOS (2.45 vs 3.10 days, p <0.001), lower likelihood of discharge to facility (1.7% vs 3.4%, p=0.003), and lower costs overall ($27,714 vs $32,242, p <0.001) compared to matched LF patients. Single-level LDR patients had significantly lower rates of any complication (7.0% vs 13.2%, p <0.001), blood transfusion (3.1% and 8.1%, p <0.001) and neurologic complication (3.0% vs 4.8%, p=0.006). There were no differences with regard to VTE, pneumonia, renal, would or pulmonary complications. With regard to two-level procedures, there were no differences with regard to LOS and discharge to facility (p=0.38 and 0.21, respectively), while overall costs were significantly higher for LDR patients compared to LF ($53,270 to $44,721, p=0.005). There were no differences in rates of index hospitalization complications for two-level procedures. <h3>CONCLUSIONS</h3> The utilization of LDR procedures decreased from 2010-2017 but began to increase again in 2018 and 2019. After adjusting for demographic, medical and hospital variables, single-level LDR was associated with reduced costs and LOS, and lower rates of blood transfusion compared to single-level fusion in patients with lumbar DDD. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

173. Anterior lumbar spinal fusion perioperative morbidity and mortality utilizing the National Inpatient Sample (NIS): 2005-2013

<h3>BACKGROUND CONTEXT</h3> Minimally invasive approaches to the lumbar spine have become increasingly popular for the treatment of degenerative conditions and deformity correction. Anterior lumbar interbody fusion (ALIF) is one type of approach to the lumbar spine that has seen a massive increase in utilization over the past two decades. However, large scale studies evaluating the overall morbidity and mortality of this procedure are scarce. The National Inpatient Sample (NIS) serves as the single largest all-payer inpatient database in the United States and provides weights for nationally representative estimates. For this reason, it can be used to provide an approximation of the overall perioperative morbidity and mortality statistics for procedures such as ALIF. <h3>PURPOSE</h3> To evaluate the perioperative morbidity and mortality, as well as demographics, of patients undergoing lumbar spinal fusion via an anterior approach from 2005 to 2013. <h3>STUDY DESIGN/SETTING</h3> National Inpatient Sample Database Study <h3>PATIENT SAMPLE</h3> A total of 27,912 patients who underwent ALIF from 2005-2013 identified using the NIS database. <h3>OUTCOME MEASURES</h3> (1) Demographics (age, gender, hospital region and teaching status, insurance status, race/ethnicity, household income and Charlson Comorbidity Index [CCI] score); 2) frequencies of complications (pulmonary embolism [PE], deep venous thrombus [DVT], infection, cardiac, hematoma, durotomy); and 3) mortality rate. <h3>METHODS</h3> The NIS database was reviewed from 2005 to 2013. Patients undergoing elective lumbar fusion surgery via an anterior approach were identified by ICD-9 code. Indications specific to the lumbar spine, such as lumbar degenerative disc disease, herniated disc, stenosis or radiculopathy were also identified by their respective ICD-9 codes. Demographics including age, sex, hospital region and teaching status, insurance status, race/ethnicity, median household income and CCI score were assessed. Frequencies of complications including PE, DVT, infection, cardiac, hematoma, durotomy and mortality were also analyzed. Statistical analysis involved T tests, χ 2 analysis and binary logistic regression with p<0.001 denoting significance. <h3>RESULTS</h3> We identified 27,912 patients which represented an estimated 137,928 of weighted patients hospitalized for primary anterior lumbar spine fusion. Patients undergoing anterior lumbar fusion had a mean age of 55.4 (SD±14.3) with 55.3% female patients. The majority of patients were white (82.2%), privately insured (50.4%), had a median household income of $48,000-62,999 (27.1%) and had a CCI score of 0.44 (SD±0.8). The majority of procedures were performed in the South region (39.5%), in nonteaching hospitals (54.5%), in hospitals that were private or not-for-profit (70.4%). Bone morphogenic protein (BMP) was used in 43.4% of cases. The most common complication was durotomy (1.2%) followed by cardiac complications and hematoma (0.7%) with the least common being PE (0.1%). The mortality rate was 0.2% for this procedure. <h3>CONCLUSIONS</h3> This study provides valuable data on the patient demographics and complications of ALIF across the United States. ALIF has a low complication and mortality rate. We expect, with the advancements in instrumentation, success rate of fusions, and an aging population, that anterior fusion will continue to see an increase in utilization by spine surgeons across the country. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

26. Clinical outcome of lumbar hybrid surgery in a consecutive series of patients including long-term follow-up

<h3>BACKGROUND CONTEXT</h3> Many patients with symptomatic lumbar degenerative disc disease (DDD) are affected at more than one level. When nonoperative treatment fails to provide adequate relief, multilevel surgery may be considered. Lumbar total disc replacement (TDR) was introduced as an option to fusion. Some disc levels are not amenable to TDR and fusion is preferable at that level. Hybrid surgery, involving TDR at one level and fusion at the adjacent segment, has been introduced as an option to fusing multiple levels. <h3>PURPOSE</h3> The purpose of this study was to investigate the long-term clinical outcome of patients undergoing lumbar hybrid surgery for treating symptomatic lumbar DDD at more than one level. <h3>STUDY DESIGN/SETTING</h3> The study was a retrospective record review combined with a mailing and/or telephone calls to patients to collect current outcome data. <h3>PATIENT SAMPLE</h3> A consecutive series of 296 patients undergoing lumbar hybrid surgery was identified beginning with the first case experience in 2005. All patients were treated for painful disc degeneration unresponsive to nonoperative care and were at least two years postoperative. <h3>OUTCOME MEASURES</h3> The primary outcome measures were visual analog scales (VAS) separately assessing back and leg pain, and the Oswestry Disability Index (ODI). Data on re-operations were also collected. <h3>METHODS</h3> General descriptive data, surgical data and outcomes were collected for the consecutive series of hybrid patients. For patients who had not been seen recently in the clinic, mailing and/or telephone calls were conducted to collect VAS, ODI, and re-operation data. <h3>RESULTS</h3> The mean follow-up duration was 71.4 months with a maximum of 196 months. A total of 649 levels were operated with TDR implanted in 318 levels and 331 levels undergoing either stand-alone ALIF or combined anterior/posterior fusion. The most common combination for hybrid surgery was TDR at L4-5 and fusion at L5-S1. The mean blood loss was 99.1 ml. There were statistically significant improvements (p <0.001) in the mean values of all three clinical <h3>OUTCOME MEASURES</h3> VAS back pain scores improved from 6.7 to 3.2; VAS leg pain scores improved from 4.2 to 2.0; and ODI scores improved from 45.7 to 25.4. There were no significant differences in the pain and function scores for patients with minimum 10-year follow-up vs those with shorter follow-up duration. Re-operation occurred in 16.2% of patients. The most common reason for re-operation was the removal of painful posterior instrumentation at the fusion level of the hybrid (31.3% of re-operations; 6.1% of the study group). Re-operations involving the TDR level occurred in 9 patients (3.0%). These included 3 cases of TDR migration, 1 posterior fusion for facet joint arthrosis, 4 patients underwent decompression at the TDR and fusion levels, and one patient underwent re-operations at both hybrid levels related to multilevel deformity. One patient reported multiple re-operations on the returned mailing, but insufficient detail was provided to determine the procedure(s) performed. <h3>CONCLUSIONS</h3> The results of this study support that for many patients with symptomatic DDD arising from more than one disc, hybrid surgery is a viable surgical option. Significant improvement was demonstrated in pain and function scores with no difference in scores among patients with more than 10-year follow-up. The most commonly occurring re-operation was removal of painful posterior fixation, unrelated to the TDR. <h3>FDA DEVICE/DRUG STATUS</h3> Charite, ProDisc-L, activL (Not approved for this indication)

P82. The association of cannabis use disorder in patients undergoing primary 1- to 2- level lumbar fusion: an analysis of a nationwide claims database

<h3>BACKGROUND CONTEXT</h3> As the legalization of cannabis continues to increase nationwide, studies evaluating the association of cannabis use disorder (CUD) on outcomes following primary 1- to 2- level lumbar fusion (1-2LF) for lumbar degenerative disc disease (DDD) is of critical importance. <h3>PURPOSE</h3> Therefore, the aims of this study were to utilize a large nationwide administrative claims database to determine whether CUD patients undergoing 1-2LF for lumbar is associated with: 1) longer in-hospital lengths of stay (LOS); 2) medical complications; and 3) costs of care. <h3>STUDY DESIGN/SETTING</h3> Using a nationwide United States private payor database, a retrospective query from January 1, 2010 to December 31, 2018 was performed. Patients and complications were identified using International Classification of Disease, Ninth Revision (ICD-9), ICD-10, and Current Procedural Terminology (CPT) codes. <h3>PATIENT SAMPLE</h3> The inclusion criteria for the study group consisted of those patients undergoing primary 1-2LF for lumbar DDD who have CUD, while those patients without CUD served as the comparison cohort. Exclusions from the study were those patients undergoing spine surgery for traumatic causes, malignancy, infections, or more than 1- to 2- levels. To minimize any potential confounding bias, study group patients were 1:5 ratio matched to a comparison cohort by age, sex, and the following comorbid conditions - alcohol abuse, chronic obstructive pulmonary disease (COPD), diabetes mellitus, hyperlipidemia, hypertension, and obesity - defined as a body mass index greater than 30 kilograms per meter squared (kg/m2). Ratio matching was used to increase the overall sample size of the study. The aforementioned comorbid conditions were used as they have been associated with CUD. Following the random matching sequence, the query yielded 22,815 patients within the study (n = 3,805) and comparison (n = 19,010) cohort. <h3>OUTCOME MEASURES</h3> Primary endpoints of the study were to compare in-hospital LOS, 90-day medical complications, in addition to day of surgery and total global 90-day episode of care costs. <h3>METHODS</h3> Welch's t-tests were used to compare in-hospital LOS and costs of care, whereas a multivariate logistic regression model was used to calculate the odds-ratios (OR) and 95% confidence intervals (95%CI) on CUD on 90-day medical complications. Due to the ease of finding statistical significance with large database studies, a Bonferroni correction was performed to reduce the probability of a type I error. Thus, a p-value less than 0.001 was considered to be statistically significant. <h3>RESULTS</h3> CUD patients were found to have significantly longer in-hospital LOS compared to their counterparts (5- vs. 3- days, p < 0.0001). Additionally, CUD patients incurred significantly higher rates and odds of developing medical complications (31.88 vs. 18.01%; OR: 1.41, 95%CI: 1.29 to 1.54, p < 0.0001) such as deep vein thromboses (0.63 vs. 0.14%; OR: 3.07, 95%CI: 1.73 to 5.41, p < 0.0001), respiratory failures (0.81 vs. 0.22%: OR: 2.57, 95%CI: 1.58 to 4.13, p < 0.0001), myocardial infarctions (0.87 vs. 0.29%; OR: 2.08, 95%CI: 1.32 to 3.23, p < 0.0001), acute kidney injuries (4.05 vs. 1.62%; OR: 1.74, 95%CI: 1.41 to 2.14, p < 0.0001), pneumoniae (4.73 vs. 2.35%; OR: 1.51, 95%CI: 1.26 to 1.82, p < 0.0001), in addition to other complications (Table 2). CUD patients were also found to have significantly higher day of surgery ($54,196.00 vs. $52,717.26, p < 0.0001) and total global 90-day episode of care costs ($58,252.53 vs. $57,041.93, p < 0.0001). <h3>CONCLUSIONS</h3> As the number of states continue to decriminalize and legalize cannabis use, understanding the impact of CUD following surgical procedures is of critical importance. This study aimed to analyze the association of CUD on outcomes following 1-2LF for lumbar DDD. After adjusting for baseline covariates, this study of over 22,000 patients demonstrated CUD to be associated with longer in-hospital LOS, and higher rates of 90-day complications and healthcare expenditures. The study is vital as it can allow orthopedic surgeons and health care professionals to adequately educate patients on the outcomes of their procedure. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

40. Disc progenitor cell therapy improves pain, disability, and quality of life for patients with lumbar disc degeneration: results of an FDA-approved clinical trial

BACKGROUND CONTEXT Allogeneic disc progenitor cells derived from adult intervertebral disc tissue have demonstrated both immunomodulatory and regenerative properties in preclinical animal studies. This includes the ability to increase aggrecan and collagen production and restore disc histology. These cells have the potential to impact the pathophysiology of degenerative disc disease (DDD) and lead to lasting pain relief and improved quality of life for patients with symptomatic DDD. PURPOSE To report the results of an FDA-approved clinical trial of injectable allogeneic disc progenitor cells and a viscous carrier for the treatment of DDD vs carrier and saline controls. STUDY DESIGN/SETTING A randomized, double-blind, placebo-controlled study at 13 clinical sites. PATIENT SAMPLE Sixty subjects (mean age 38, 60% male) were enrolled. OUTCOME MEASURES Subjects were assessed using validated safety and efficacy parameters including low-back pain visual analog scale (VAS), Oswestry Disability Index (ODI) and EQ-5D. METHODS Subjects with early to moderate, symptomatic lumbar DDD were randomized to one of four treatment groups and received single intradiscal injections of either low-dose cells (3,000,000cells/mL; N=20), high-dose cells (9,000,000cells/mL; N=20), vehicle alone (N=10) or placebo (N=10). Subject outcomes were assessed over 52 weeks. RESULTS VAS scores in the high-dose cell group were statistically significantly improved over baseline at weeks 12 (-54.53% [-69.46, -39.60], p=0.0056), 26 (-50.94% [-66.10, -35.78], p=0.0140), and 52 (-62.79% [90% CI -77.13, -48.46], p=0.0005). The vehicle group achieved statistical significance in VAS at week 52 only (-52.83% [90%CI -74.73, -30.92], p=0.0443). Mean pain VAS improved from baseline after treatment but only achieved statistical significance at week 26 with low-dose cells (-48.49% [90% CI -61.03, -35.94], p=0.0101) and saline (-50.13% [-65.24, -35.02], p=0.0206); neither demonstrated statistical significance at week 52. Further analysis showed that only the high-dose cell group showed reduction from baseline in back pain VAS that was statistically significantly greater than a minimum clinically important difference (MCID) of -20mm at week 52 (-39.8 [-50.0, -29.6], p=0.0001). Only the high-dose cell group exhibited an improvement from baseline in ODI score at week 52 that was statistically significantly greater than a MCID of -10 points (-24.3[-31.2, -17.5], p <0.0001) and an EQ-5D index score that was statistically significantly greater than a MCID of 0.08 (0.194 [0.139, 0.250], p <0.0001). CONCLUSIONS High-dose allogeneic disc progenitor cells produced meaningful, statistically significant improvements in back pain VAS, ODI and EQ-5D at one-year post-intradiscal injection. FDA DEVICE/DRUG STATUS IDCT - Injectable Discogenic Cell Therapy (Investigational/Not Approved) Allogeneic disc progenitor cells derived from adult intervertebral disc tissue have demonstrated both immunomodulatory and regenerative properties in preclinical animal studies. This includes the ability to increase aggrecan and collagen production and restore disc histology. These cells have the potential to impact the pathophysiology of degenerative disc disease (DDD) and lead to lasting pain relief and improved quality of life for patients with symptomatic DDD. To report the results of an FDA-approved clinical trial of injectable allogeneic disc progenitor cells and a viscous carrier for the treatment of DDD vs carrier and saline controls. A randomized, double-blind, placebo-controlled study at 13 clinical sites. Sixty subjects (mean age 38, 60% male) were enrolled. Subjects were assessed using validated safety and efficacy parameters including low-back pain visual analog scale (VAS), Oswestry Disability Index (ODI) and EQ-5D. Subjects with early to moderate, symptomatic lumbar DDD were randomized to one of four treatment groups and received single intradiscal injections of either low-dose cells (3,000,000cells/mL; N=20), high-dose cells (9,000,000cells/mL; N=20), vehicle alone (N=10) or placebo (N=10). Subject outcomes were assessed over 52 weeks. VAS scores in the high-dose cell group were statistically significantly improved over baseline at weeks 12 (-54.53% [-69.46, -39.60], p=0.0056), 26 (-50.94% [-66.10, -35.78], p=0.0140), and 52 (-62.79% [90% CI -77.13, -48.46], p=0.0005). The vehicle group achieved statistical significance in VAS at week 52 only (-52.83% [90%CI -74.73, -30.92], p=0.0443). Mean pain VAS improved from baseline after treatment but only achieved statistical significance at week 26 with low-dose cells (-48.49% [90% CI -61.03, -35.94], p=0.0101) and saline (-50.13% [-65.24, -35.02], p=0.0206); neither demonstrated statistical significance at week 52. Further analysis showed that only the high-dose cell group showed reduction from baseline in back pain VAS that was statistically significantly greater than a minimum clinically important difference (MCID) of -20mm at week 52 (-39.8 [-50.0, -29.6], p=0.0001). Only the high-dose cell group exhibited an improvement from baseline in ODI score at week 52 that was statistically significantly greater than a MCID of -10 points (-24.3[-31.2, -17.5], p <0.0001) and an EQ-5D index score that was statistically significantly greater than a MCID of 0.08 (0.194 [0.139, 0.250], p <0.0001). High-dose allogeneic disc progenitor cells produced meaningful, statistically significant improvements in back pain VAS, ODI and EQ-5D at one-year post-intradiscal injection.

Genetic variants of interleukin 1B and 6 are associated with clinical outcome of surgically treated lumbar degenerative disc disease

BackgroundSuccessfully surgically treating degenerative disc diseases can be challenging to the spine surgeons, the long-term outcome relies on both the physical and mental status of the patient before and after treatment. Numerous studies underlined the role of inflammatory cytokines – like interleukin 1B and 6 – in the development of chronic diseases such as failed back surgery syndrome (FBSS) and major depressive disorder (MDD) which alter the outcome after spinal surgery. Our aim was to evaluate the associations of IL6 and IL1B gene polymorphisms with the long-term outcome of degenerative lumbar spine surgeries.MethodsAn international genetical database (GENODISC) was combined with our institute’s clinical database to create a large pool with long term follow up data. Altogether 431 patient’s data were analysed. Patient reported outcome measures and surgical outcome was investigated in association with IL1B and IL6 SNPs with the help of ‘SNPassoc’ R genome wide association package.ResultsInterleukin 1B variants analysis confirmed association with improvement of pain after surgery on individual SNP level and on haplotype level, moreover relationship with patient reported outcome and preoperative level of depression was found on individual SNP level. IL6 variants were associated with preoperative depression, somatization and with subsequent surgery.ConclusionUnderstanding the complexity of spinal surgery patients’ long-term well-being is crucial in effectively treating chronic debilitating somatic diseases and the associated mental illnesses. Further studies should investigate more comprehensively the linkage of chronic physical and mental illnesses focusing on their simultaneous treatment.

Study on the process of intervertebral disc disease by the theory of continuum damage mechanics

BackgroundRecently, more and more people suffer from low back pain triggered by lumbar degenerative disc disease. The mechanical factor is one of the most significant causes of disc degeneration. This study aims to explore the biomechanical responses of the intervertebral disc, and investigate the process of disc injury by the theory of continuum damage mechanics. MethodsA finite element model of the L4–L5 lumbar spine was developed and validated. The model not only considered changes in permeability coefficient with strain, but also included physiological factors such as osmotic pressure. Three loading conditions were simulated: (A) static loads, (B) vibration loads, (C) injury process. FindingsThe simulation results revealed that the facet joints shared massive stresses of the intervertebral discs, and prevented excessive lumbar spine movement. However, their asymmetrical position may have led to degeneration. The von Mises stress and pore pressure of annulus fibrosus showed significantly different trends under static loads and vibration loads. The von Mises stress of nucleus pulposus was not sensitive to vibration loads, but its pore pressure was conspicuously influenced by vibration loads. The injury first appeared at the posterior centre, and then, it gradually expanded along the edge of the intervertebral disc. With an increase in the loading steps, the damage rate of the intervertebral disc increased logarithmically. InterpretationThe variation in the biomechanical performance of the intervertebral disc could be attributed to the periodic movement of internal fluids. This study might be helpful for understanding the mechanism of intervertebral disc degeneration.

Vertebral endplate defects are associated with bone mineral density in lumbar degenerative disc disease.

Evidence has shown that lumbar vertebral endplate defects are clinically relevant and closely related to disc degeneration, but the relationship between endplate defects and bone mineral density (BMD) remains unclear. This study aimed to explore the association between endplate defects and BMD-related values in patients with lumbar degenerative disc disease (LDD). Three hundred and twenty-five Chinese adult subjects diagnosed with LDD underwent dual energy X-ray absorptiometry. Endplate defects were classified using lumbar MRI. Groups were subdivided based on the occurrence rates of defect endplates. BMD at the lumbar vertebral and bilateral femur necks was compared between groups, and the association between endplate defects and lumbar BMD-related values was analyzed and adjusted for confounders including age, sex, serum levels of 25-hydroxy vitamin D (25(OH)D), calcium (Ca) and phosphorus (P). Of 325 patients and 3250 endplates, 59.72% had defects, and 188 patients were divided into the higher defect rate group (occurrence rate > 50%). The higher defect rate group was associated with older age, more common postmenopausal females, higher osteoporosis rates and lower serum Ca and P levels. Lumbar BMD was greater than that at bilateral femur necks and was not equal to osteoporosis diagnosis. Endplate defects were more prevalent in lower segments. The occurrence of endplate defects was positively associated with lumbar BMD-related values in the partial correlation analysis. The association between endplate defects and lumbar BMD varies for subtypes and segments, with a trend of positive association in rim and erosive subtypes after adjusting for confounders. The present study demonstrated that the occurrence of endplate defects was associated with greater lumbar BMD values in patients with LDD. This association varies for different defect subtypes and segments. The results indicated that endplate defects should be taken into consideration in osteoporosis treatment to alleviate disc degeneration.

Single-Level Total Disc Replacement: Mid- to Long-Term Outcomes.

Total disc replacement (TDR) has been shown to be effective for the treatment of lumbar degenerative disc disease (DDD) in carefully selected patients. Previous studies have demonstrated high rates of patient satisfaction and improvement in patient-reported outcome measures (PROMs) compared with preoperative status but most have short-term follow-up or small cohort sizes only. The aim of this study is to report mid- to long-term PROMs from the treatment of symptomatic single-level lumbar DDD with TDR. Data collected prospectively concerning single-level TDR performed via an anterior approach were included for analysis. A preoperative assessment was obtained followed by postoperative follow-up assessments at 3, 6, and 12 months, and yearly follow-up thereafter. PROMs included patient satisfaction, visual analog score back and leg, Oswestry Disability Index, and Roland-Morris Disability Questionnaire. A total of 211 patients (118 men, 93 women) operated on between June 1997 and July 2015 were included in this study. Minimum follow-up was 4 years. The average age was 42.2 (range 24-87) years and median follow-up 96 interquartile range 72-132, range 48-120) months. The operative levels were L5-S1 (160, 75.8%) and L4-L5 (61, 24.2%). Both statistically and clinically significant improvements observed postoperatively were maintained at 10 years. In addition, 92% of patients reported either good (n = 29) or excellent satisfaction (n = 155) with treatment at final review. This study shows that single-level lumbar TDR used appropriately in selected patient results in clinically significant improvements in pain and function, well above the minimum clinically important difference, and good to excellent satisfaction in most patients. Further study to define long-term outcomes and survivorship is required. Statistically significant and clinically relevant improvements can be achieved by single-level lumbar TDR, in the treatment of single-level discogenic axial low back pain, with or without radiculopathy. These outcomes are sustained in the mid- to long-term followup periods.

Expanding Access to Microneurosurgery in Low-Resource Settings: Feasibility of a Low-Cost Exoscope in Transforaminal Lumbar Interbody Fusion

Abstract Objectives Less than a quarter of the world population has access to microneurosurgical care within a range of 2 hours. We introduce a simplified exoscopic visualization system to achieve optical magnification, illumination, and video recording in low-resource settings. Materials and Methods We purchased a 48 megapixels industrial microscope camera with a heavy-duty support arm, a wide field c-mount lens, and an LED ring light at a total cost of US$ 125. Sixteen patients with lumbar degenerative disk disease were divided into an exoscope group and a conventional microscope group. In each group we performed four open and four minimally invasive transforaminal lumbar interbody fusion procedures. We further conducted a questionnaire-based assessment of the user experience. Results The overall user experience was positive. The exoscope achieved similar postoperative improvement with comparable blood loss and operating time as the conventional microscope. It provided a similar image quality, magnification and illumination. Yet, the lack of stereoscopic perception and the cumbersome adjustability of the camera position and angle resulted in a shallow learning curve. Most users strongly agreed that the exoscope would significantly improve surgical teaching. Over 75% reported they would recommend the exoscope to colleagues and all users saw its great potential for low-resource environments. Conclusion Our low-budget exoscope is technically non-inferior to the conventional binocular microscope and purchasable at a significantly lower price. It may thus help expand access to neurosurgical care and training worldwide.

CLINICO- MRI PROFILE OF LUMBAR DISC HERNIATION ON SCIATIC LUMBAR PAIN IN BI-RIVER HOSPITAL SETTINGS (CASES OF KINSHASA AND BRAZZAVILLE)

I. Objective: to highlight the clinico-MRI prole of lumbar disc herniation on sciatic lumboradiculgia in bi- river hospital settings (cases of Kinshasa and Brazzaville). This was aII. Materials and methods: retrospective, documentary and multicenter study of 302 patients who performed lumbar MRI examinations in 18 months in hospitals in Kinshasa and Brazzaville. The mean age of patients was 53.4 years. The most represented age groupIII. Results: was 50 to 59 years old. The female sex was predominant (55.4%) with a ratio of 0.79. The majority of patients (68.2%) came from Kinshasa. Lumboradiculalgia was the most predominant indication with (49.3%), followed by low back pain (48%). The majority of MRI examinations (91.4%) were performed without injection of contrast product. T1 and T2 weightings were performed in 100% of patients. Diseased disc degeneration was found at (41.7%) and lumbar disc herniation at (27.2%). The MRI examination was normal in (47%) of the patients. Based on potentially clinically positive relevance, only 48.7% of our MRI diagnoses were clinically positive. Age (p=0.000), lumboradiculalgia (p=0.000) and specialist physician prescription (0.039) had a statistically signicant relationship with clinically positive diagnosis. HDL is a pathological reality in the hospitals ofIV. Conclusion: Kinshasa and Brazzaville. The MRI prole found mainly corroborates the observations of the literature. Lumbar disc herniation and degenerative disc disease remain the most frequently encountered pathologies on magnetic resonance imaging in hospitals in Kinshasa and Brazzaville. They are at the origin of the lumbar spinal syndrome and affect the young population. The posterolateral disc herniation remains the most frequently encountered subtype with predominance of damage to the oors: L4-L5 and L5-S1.