Visual Analog Scale Leg Scores Research Articles

120. The clinical and operative impact of lumbar epidural steroid injections prior to spine surgery for lumbar spinal stenosis

<h3>BACKGROUND CONTEXT</h3> Lumbar spinal stenosis is a common finding in the adult population. Lumbar epidural steroid injections (ESIs) are often used in management of this condition, with conflicting evidence regarding their efficacy. Previous research has suggested a negative impact of ESIs on the operative times and postoperative outcomes when ESIs are administered preoperatively prior to spine surgery in this population. Our retrospective study was performed to gain greater insight into the impact of preoperative ESIs on postoperative outcomes following spine surgery in management of lumbar stenosis. <h3>PURPOSE</h3> Our objective is to determine how preoperative ESIs impact postoperative outcomes following spine surgery in management of lumbar stenosis. <h3>STUDY DESIGN/SETTING</h3> Retrospective cohort involving patients who underwent surgical management of lumbar stenosis. Data for patients with preoperative ESI was compared to those without preoperative ESI administration. <h3>PATIENT SAMPLE</h3> Patient data for this retrospective cohort was retrieved solely from a patient database of a medical institution in north Texas, US. Patients were included in the study if they underwent surgical management of lumbar spinal stenosis between January 2016 and December 2020. The inclusion criteria required an active diagnosis of lumbar spinal stenosis. Patients who received an ESI within three months prior to the spine surgery were included in the "ESI" group, while those who did not receive a lumbar ESI within three months prior to the spine surgery were included in the "Non-ESI" group. <h3>OUTCOME MEASURES</h3> Primary outcome measures were ODI (Oswestry Disability Index) back, NDI (Neck Disability Index) back, VAS (Visual Analog Scale) leg pain, VAS back pain, PROMIS (Patient-Reported Outcomes Measurement Information System) pain, PROMIS pain interference, PROMIS satisfaction, PROMIS physical function at time of spine surgery (baseline) and at three months after surgery. <h3>METHODS</h3> This study was conducted at a medical institution in north Texas, US, utilizing the institution's spine center database. The institutional review board approved the standardized protocol. This study included a retrospective cohort. All results were collated on a Microsoft Excel file as retrieved from a patient registry of a medical institution in north Texas based on exclusion and inclusion criteria above. Statistical analysis was performed using IBM SPSS software, with t-test and ANOVA used to determine significance. P-value less than 0.05 was considered statistically significant. <h3>RESULTS</h3> Patients receiving an ESI in the preoperative period had shorter operative times (ESI 157 minutes vs Non-ESI 187 minutes, p=.10) during spine surgery than did patients in the Non-ESI group. Both ESI and Non-ESI groups showed significant improvements in VAS leg, VAS back, ODI and PROMIS pain scores at three months after surgery, with the ESI group showing a significantly larger improvement compared to the Non-ESI group in PROMIS pain scores. <h3>CONCLUSIONS</h3> Regardless of preoperative ESI administration, this study demonstrated improvement in pain and disability scores in the postoperative period following surgical management of lumbar stenosis. Patients who received ESI in the preoperative course had shorter operative times and greater improvements in PROMIS pain scores in the postoperative course compared to those who did not receive ESI. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

P137. Preliminary analysis on the influence of workers’ compensation status on outcomes of anterior lumbar interbody fusion at L5-S1

<h3>BACKGROUND CONTEXT</h3> Few studies have focused on outcomes among Workers' Compensation (WC) claimants undergoing anterior lumbar interbody fusion (ALIF). <h3>PURPOSE</h3> To determine the influence of WC on perioperative outcomes, patient-reported outcome measures (PROMs) and attainment rates of minimal clinically important difference (MCID) among patients undergoing single-level ALIF at L5S1. <h3>STUDY DESIGN/SETTING</h3> Retrospective. <h3>PATIENT SAMPLE</h3> A retrospective surgical database of an attending spine surgeon was utilized to identify patients with WC insurance undergoing single-level ALIF at L5S1. One-hundred and nine patients were included, with 82 in the non-WC and 27 in the WC cohort. <h3>OUTCOME MEASURES</h3> PROM data for visual analog scale (VAS) back/leg, Oswestry Disability Index (ODI), 12-Item Short Form (SF-12) Physical Composite Score (PCS) and Patient Reported Outcome Measurement Information System physical function (PROMIS-PF) was obtained preoperatively and at 6-weeks, 12-weeks, 6-months, 1-year and 2-years following ALIF. <h3>METHODS</h3> Patients were divided into groups based on insurance status: WC vs non-WC (including patients with private insurance or Medicare/Medicaid). Demographic and perioperative information was evaluated between insurance groups using student's t-test for independent samples for continuous variables and chi-squared test for categorical variables. Mean PROMs were compared with student's t-test for independent samples. Comparisons of preoperative and postoperative PROM values were evaluated with paired sample t-tests. Patients who achieved an improvement in PROM score greater than or equal to established threshold values were marked as achieving MCID. WC and non-WC groups were compared in MCID attainment rates across PROMs with chi-squared analyses. <h3>RESULTS</h3> A greater proportion of the non-WC cohort were Caucasian, while a significantly greater proportion of the WC cohort were African American and Hispanic (p=0.001). Significantly more patients in the WC cohort were smokers (p<0.001). Non-WC patients improved significantly from preoperative to postoperative timepoints of 6-months through 2-years for PROMIS-PF and SF-12 PCS, 6 weeks through 1 year for VAS back, 6 months/1 year for VAS leg and 12 weeks through 1-year for ODI (p≤0.048, all). WC patients improved significantly at postoperative timepoints for PROMIS-PF at 6 weeks (p=0.029), SF-12 PCS at 12 weeks (p=0.018), VAS back from 6 weeks to 6 months, and VAS leg at 6 months, only (p≤0.029, all). Mean VAS back scores were significantly greater in the WC cohort at 6 months and 1 year (p≤0.013, both), mean VAS leg scores were significantly greater in the WC cohort at 1 year (p=0.029), and mean ODI scores were significantly higher in the WC cohort at preoperative through 1 year (p≤0.040, all). With the exception of higher MCID achievement for VAS back at 12 weeks (p=0.037), no other differences in attainment rates were observed for any PROM at any time point or for the overall postoperative period. <h3>CONCLUSIONS</h3> Among patients receiving ALIF, WC insurance was more prevalent among patients identifying as Hispanic and African American, along with smokers. While physical function scores were similar between groups, long-term pain and disability (throughout the entire postoperative period) were significantly higher among patients with WC. MCID achievement, however, was largely comparable for all PROMs between WC and non-WC study groups. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Effect of Preoperative Parameters on Outcomes of Lumbar Microdiscectomy: A Retrospective Analysis.

Objective The objective of this study was to characterize the effect of preoperative variables on outcomes after minimally invasive lumbar microdiscectomy. Materials and Methods This study was done from January 2019 to May 2020. This included medical records of all patients who were diagnosed with lumbar disc herniation and treated surgically by microdiscectomy. The medical records of such patients from January 2016 to January 2018 were included in this study. Postoperative outcomes were analyzed by Oswestry Disability Index (ODI), visual analog scale (VAS) leg, and VAS back scores, that were noted at preoperative, immediate postoperative, 6 months postoperative, and 1 year after operation. Difference in each outcomes score was calculated postoperatively with respect to the preoperative readings. Minimal clinically important difference was further calculated for each outcome score. Results On analyzing the ODI, VAS leg, and VAS back scores across various age groups, genders, body mass indexes, addictions, comorbidities, preoperative epidural steroid injection and physiotherapy, and levels of disc herniation, and it was found that there was no statistically significant difference across these categories. However, the ODI scores (∼ ODI) at all time points showed greater difference in the younger age group, that is, 18 to 30 years, males, nonsmokers, those with symptom duration of less than 6 weeks, and with disc herniation at L3 to L4. Conclusion The findings of this study will help to properly counsel patients with regard to the factors mentioned above so as to set realistic expectations, to help improve the outcomes, and for appropriate surgical decision making, that is, at which point should a surgical intervention be made.

No correlation identified between the proportional size of a prolapsed intravertebral disc with disability or leg pain.

The aim of the study was to determine if there was a direct correlation between the pain and disability experienced by patients and size of their disc prolapse, measured by the disc's cross-sectional area on T2 axial MRI scans. Patients were asked to prospectively complete visual analogue scale (VAS) and Oswestry Disability Index (ODI) scores on the day of their MRI scan. All patients with primary disc herniation were included. Exclusion criteria included recurrent disc herniation, cauda equina syndrome, or any other associated spinal pathology. T2 weighted MRI scans were reviewed on picture archiving and communications software. The T2 axial image showing the disc protrusion with the largest cross sectional area was used for measurements. The area of the disc and canal were measured at this level. The size of the disc was measured as a percentage of the cross-sectional area of the spinal canal on the chosen image. The VAS leg pain and ODI scores were each correlated with the size of the disc using the Pearson correlation coefficient (PCC). Intraobserver reliability for MRI measurement was assessed using the interclass correlation coefficient (ICC). We assessed if the position of the disc prolapse (central, lateral recess, or foraminal) altered the symptoms described by the patient. The VAS and ODI scores from central and lateral recess disc prolapses were compared. A total of 56 patients (mean age 41.1 years (22.8 to 70.3)) were included. A high degree of intraobserver reliability was observed for MRI measurement: single measure ICC was 0.99 (95% confidence interval (CI) from 0.97 to 0.99 (p < 0.001)). The PCC comparing VAS leg scores with canal occupancy for herniated disc was 0.056. The PCC comparing ODI for herniated disc was 0.070. We found 13 disc prolapses centrally and 43 lateral recess prolapses. There were no foraminal prolapses in this group. The position of the prolapse was not found to be related to the mean VAS score or ODI experienced by the patients (VAS, p = 0.251; ODI, p = 0.093). The results of the statistical analysis show that there is no direct correlation between the size or position of the disc prolapse and a patient's symptoms. The symptoms experienced by patients should be the primary concern in deciding to perform discectomy. Cite this article: Bone Joint J2022;104-B(6):715-720.

Endoscopic decompression for the treatment of lumbar spinal stenosis: an updated systematic review and meta-analysis.

Lumbar stenosis treatment has evolved with the introduction of minimally invasive surgery (MIS) techniques. Endoscopic methods take the concepts applied to MIS a step further, with multiple studies showing that endoscopic techniques have outcomes that are similar to those of more traditional approaches. The aim of this study was to perform an updated meta-analysis and systematic review of studies comparing the outcomes between endoscopic (uni- and biportal) and microscopic techniques for the treatment of lumbar stenosis. Following PRISMA guidelines, a systematic search was performed using the Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Ovid Embase, and PubMed databases from their dates of inception to December 14, 2020. All identified articles were then systematically screened against the following inclusion criteria: 1) studies comparing endoscopic (either uniportal or biportal) with minimally invasive approaches, 2) patient age ≥ 18 years, and 3) diagnosis of lumbar spinal stenosis. Bias was assessed using quality assessment criteria and funnel plots. Meta-analysis using a random-effects model was used to synthesize the metadata. From a total of 470 studies, 14 underwent full-text assessment. Of these 14 studies, 13 comparative studies were included for quantitative analysis, totaling 1406 procedures satisfying all criteria for selection. Regarding postoperative back pain, 9 studies showed that endoscopic methods resulted in significantly lower pain scores compared with MIS (mean difference [MD] -1.0, 95% CI -1.6 to -0.4, p < 0.01). The length of stay data were reported by 7 studies, with endoscopic methods associated with a significantly shorter length of stay versus the MIS technique (MD -2.1 days, 95% CI -2.7 to -1.4, p < 0.01). There was no significant difference with respect to leg visual analog scale scores, Oswestry Disability Index scores, blood loss, surgical time, and complications, and there were not any significant quality or bias concerns. Both endoscopic and MIS techniques are safe and effective methods for treating patients with symptomatic lumbar stenosis. Patients who undergo endoscopic surgery seem to report less postoperative low-back pain and significantly reduced hospital stay with a trend toward less perioperative blood loss. Future large prospective randomized trials are needed to confirm the findings in this study.

What Can Legacy Patient-Reported Outcome Measures Tell Us About Participation Bias in Patient-Reported Outcomes Measurement Information System Scores Among Lumbar Spine Patients?

ObjectivePatient-Reported Outcomes Measurement Information System (PROMIS) is a validated tool for assessing patient-reported outcomes in spine surgery. However, PROMIS is vulnerable to nonresponse bias. The purpose of this study is to characterize differences in patient-reported outcome measure scores between patients who do and do not complete PROMIS physical function (PF) surveys following lumbar spine surgery. MethodsA prospectively maintained database was retrospectively reviewed for primary, elective lumbar spine procedures from 2015 to 2019. Outcome measures for Patient Health Questionnaire-9 (PHQ-9), visual analogue scale (VAS) back & leg, Oswestry Disability Index (ODI), and 12-item Short Form health survey physical composite summary (SF-12 PCS) were recorded at both preoperative and postoperative (6 weeks, 12 weeks, 6 months, 1 year, 2 years) timepoints. Completion rates for PROMIS PF surveys were recorded and patients were categorized into groups based on completion. Differences in mean scores at each timepoint between groups was determined. ResultsEight hundred nine patients were included with an average age of 48.1 years. No significant differences were observed for all outcome measures between PROMIS completion groups preoperatively. Postoperative PHQ-9, VAS back, VAS leg, and ODI scores differed significantly between groups through 1 year (all p < 0.05). SF-12 PCS differed significantly only at 6 weeks (p = 0.003). ConclusionPatients who did not complete PROMIS PF surveys had significantly poorer outcomes than those that did in terms of postoperative depressive symptoms, pain, and disability. This suggests that patients completing PROMIS questionnaires may represent a healthier cohort than the overall lumbar spine population.

Unilateral Dynamic Stabilization in Recurrent Lumbar Disc Herniation.

To evaluate the effectiveness and outcomes of unilateral dynamic stabilization in patients with recurrent lumbar disc herniation (RLDH). Patients requiring an operation due to RLDH at the L4?5 level were included in the study.They divided into the following two groups: SD group who had only revision discectomy (n=20) and DD group who had unilateral dynamic rod stabilization with discectomy (n=20). Low back and leg pain were evaluated with the visual analog scale (VAS), and functional results were evaluated with the Oswestry disability index (ODI). The VAS scores were evaluated in two different regions as VAS Low Back (VASLB) and VAS Leg (VASL). The results of each patient were evaluated preoperatively and at 1 and 12 months postoperatively. The anterior disc height (ADH), posterior disc height (PDH), and segmental angle (SA) were measured on the sagittal computed tomography (CT) scans of each patient?s lumbar spine. Modified Pfirrmann grades in the operated and adjacent segments on lumbar magnetic resonance imaging (MRI) were assessed preoperatively and at 12 months postoperatively. A total of, 40 patients (17 women and 23 men; mean age, 47.9 years) were enrolled. There was no statistically significant difference in the VASLB scores between the two groups (p=0.42). The decrease in VASL scores was statistically significant between groups (p < 0.05). A statistically significant decrease in ODI scores was also observed (p < 0.05). When ADH and PDH obtained preoperatively and postoperatively were compared for the SD group, the differences were not statistically significant. Significant differences were found for ADH and PDH obtained preoperatively and postoperatively in the DD group (p < 0.05). However, for SA, the difference was not significant between the two groups (p=0.28). Unilateral dynamic stabilization for RLDH leads to fewer surgical complications and provides sufficient stability by preserving segmental movements.

Efficacy and safety of percutaneous transforaminal endoscopic surgery (PTES) compared with MIS-TLIF for surgical treatment of lumbar degenerative disease in elderly patients: A retrospective cohort study.

To evaluate the efficacy and safety of PTES for surgical treatment of lumbar degenerative disease (LDD) including lumbar disc herniation, lateral recess stenosis, intervertebral foraminal stenosis and central spinal canal stenosis in elderly patients compared with MIS-TLIF. From November 2016 to December 2018, 84 elderly patients (>70years old) of single-level LDD with neurologic symptoms underwent the surgical treatment. 45 patients were treated using PTES under local anesthesia in group 1 and 39 patients treated using MIS-TLIF in group 2. Preoperative, postoperative back and leg pain were evaluated using Visual analog scale (VAS) and the results were determined with Oswestry disability index (ODI) at 2-year follow-up. All complications were recorded. PTES group shows significantly less operation time (55.6 ± 9.7 min vs. 97.2 ± 14.3 min, P < 0.001), less blood loss [11(2-32) ml vs. 70(35-300) ml, P < 0.001], shorter incision length (8.4 ± 1.4 mm vs. 40.6 ± 2.7 mm, P < 0.001), less fluoroscopy frequency [5(5-10) times vs. 7(6-11) times, P < 0.001] and shorter hospital stay[3(2-4) days vs. 7(5-18) days, P < 0.001] than MIS-TLIF group does. Although there was no statistical difference of leg VAS scores between two groups, back VAS scores in PTES group were significantly lower than those in MIS-TLIF group during follow-ups after surgery (P < 0.001). ODI of PTES group was also significantly lower than that of MIS-TLIF group at 2-year follow-up (12.3 ± 3.6% vs. 15.7 ± 4.8%, P < 0.001). Both PTES and MIS-TLIF show favorable clinical outcomes for LDD in elderly patients. Compared with MIS-TLIF, PTES has the advantages including less damage of paraspinal muscle and bone, less blood loss, faster recovery, lower complication rate, which can be performed under local anesthesia.

P141. Do age adjusted parameters influence patient reported outcomes after lumbar decompression?

<h3>BACKGROUND CONTEXT</h3> The impact of sagittal malalignment after lumbar fusion has been well described. However, few studies have examined the impact of sagittal alignment on outcomes after lumbar decompression. The existing literature has focused exclusively on normative measures of alignment (e.g., pelvic incidence lumbar lordosis mismatch [PI-LL] > 10) but has not considered age-adjusted alignment. <h3>PURPOSE</h3> To determine if age-adjusted sagittal malalignment (PI-LL or pelvic tilt [PT]), influences postoperative patient reported outcomes (PROs) after lumbar decompression surgery. <h3>STUDY DESIGN/SETTING</h3> Retrospective review of 62 patients who underwent lumbar decompression. <h3>PATIENT SAMPLE</h3> A total of 62 patients. <h3>OUTCOME MEASURES</h3> Oswestry disability index (ODI), Visual analog scale (VAS) Back, VAS leg <h3>METHODS</h3> Patients with >3 months follow-up who underwent one to four level lumbar decompression at a single institution were included. Patients were stratified into three groups based on achievement of age-adjusted thresholds in PI-LL and PT postoperatively. The first group included patients within the age-adjusted threshold ±10 years (MATCHED), and the other groups included those who were outside of the age-adjusted threshold ±10 years as over corrected (OVER), and under corrected (UNDER). The equations used to determine their age-adjusted sagittal parameters included: PT = [(Age-55)/3] + 20, and PI-LL = [(Age-55)/2] +3. Oswestry Disability Index (ODI), Visual Analog Scale (VAS) Back, and VAS Leg were evaluated. The percent of patients achieving MCID at final follow-up was calculated. <h3>RESULTS</h3> A total of 62 patients (mean 66 years, 50% female) were included with a mean follow-up of 368 days (range, 40 to 1,401). Groups for postoperative age-adjusted PI-LL included 12 MATCHED patients, 30 OVER patients and 20 UNDER patients. Groups for postoperative age-adjusted PT included 16 MATCHED patients, 27 OVER patients and 19 UNDER patients. For the entire cohort, there was a significant decrease in PI-LL (preop 8.7° vs postop 5.5°, p=0.001). There was no significant change in PT for the entire group (preop 22.5° vs postop 23.1°, p=0.39). There was no significant preoperative to postoperative PI-LL difference in the MATCHED (10.5° vs 7.9°, p=0.08) or UNDER patients (22.2° vs 19.3°, p=0.08), but PI-LL significantly decreased in the OVER group (preop -0.9°vs postop -4.7°, p=0.02). There were no significant differences in the preoperative to postoperative PT in the MATCHED (22.0° vs 22.8°, p=0.22), UNDER (28.4° vs 31.3°, p=0.11) or OVER groups (18.7° vs 17.5°, p=0.12). All groups exhibited significant improvements postoperatively for VAS Back, VAS Leg, and ODI scores (p<0.05). With respect to preoperative PROs, postoperative PROs and improvement in PROs, there was no difference between the MATCHED, UNDER or OVER groups. There were no significant differences between the groups in the percent that met MCID for ODI, VAS Back or VAS Leg scores. However, there was a trend towards increased PI-LL mismatch and increased ODI (p=0.09) and VAS-back scores (p=0.07). <h3>CONCLUSIONS</h3> Patients with postoperative age-adjusted spinopelvic abnormalities after lumbar decompression surgery had similar PROs when compared to patients without age-adjusted spinopelvic abnormalities. Therefore, isolated decompression is a viable treatment strategy in patients with sagittal malalignment. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

The Influence of Sex on Clinical Outcomes in Minimally Invasive Lumbar Decompression.

Research focused on postoperative outcomes among men and women undergoing minimally invasive lumbar decompression (MIS LD) spine surgery is sparse. This study aims to assess the influence of sex on postoperative patient-reported outcome measure (PROM) evaluations and achievement of a minimum clinically important difference (MCID). A prospectively maintained surgical database was retrospectively queried for patients undergoing primary or revision, single or multilevel LD procedures from 2011 to 2019. Patients with incomplete visual analog scale (VAS) leg or back surveys were excluded. Demographic and operative variables were recorded, and a chi-squared analysis or t tests were used to compare by sex. PROMs were evaluated from preoperative to postoperative time points. PROM score differences and postoperative improvement were evaluated between sexes by a t test. Achievement of MCID by sex was compared using chi-squared analysis. The study cohort (n = 572) was 70% male (n = 398), had an average age of 47 years, and 42% were obese. Sexes differed in preoperative VAS leg, Oswestry Disability Index (ODI), and 12-item short form (SF-12)-physical composite score (PCS) scores (all P < .05) and in ODI at 6 and 12 weeks (P = .048; P = .001) and VAS back and leg scores at 6 months (P = .039; P = .019). Both sexes significantly improved (P < .050) all PROMs at all time points except for VAS back at 1 year for women and ODI at 6 weeks and 6 months for men. The only significant difference in achievement of MCID was for ODI at 6 months (P = .008). Significant preoperative differences were observed among sexes with ODI, SF-12-PCS, and VAS leg scores. By 1 year, there were no significant sex differences for any PROM or for achievement of MCID. MIS LD has an equivalent role for both sexes in achieving MCID. 3. Results demonstrate no sex difference in PROMs following LD.

The Synergistic Effect of Combined Transforaminal and Caudal Epidural Steroid Injection in Recurrent Lumbar Disc Herniations.

BackgroundRecurrent lumbar disc herniation (RLDH) is one of the most common causes of chronic low back and leg pain. Although surgical treatment has high success rates in primary lumbar disc herniations, recurrence is not an uncommon clinic condition after the surgery. Considering the recurrent surgeries have lower success rates and higher risks, such as dural tear and nerve injury, alternative treatment modalities are needed for RLDH patients. Epidural steroid injections (ESI), particularly transforaminal steroid injection (TFESI) and caudal steroid injection (CESI), which are the alternative treatments to surgery, have not shown reasonable results in RLDH separately. In this study, we aimed to investigate the effects of combined TFESI and CESI (TFESI + CESI) treatment, which has been found successful in primary lumbar disc herniation (PLDH) and on pain control and quality of life in RLDH patients for the first time.Materials and methodsA total of 71 patients, who had ESI treatment as only TFESI or TFESI + CESI because of RLDH in our clinic between March 2017 and February 2020, were investigated retrospectively. The visual analog scale (VAS) leg, VAS back, and Oswestry disability index (ODI) were used to assess leg pain, low back pain, and limitation of daily routine activities. Each assessment was done before the intervention and repeated at the third week, the third month, and the sixth month of injection, and the results were noted.ResultsOut of 71 patients, 38 were female and 33 male. Patients were divided into two subgroups according to the applied ESI methods as only TFESI (n = 32) and TFESI + CESI (n = 39). In the only TFESI group, the mean VAS leg score was 7.84, 4.63, 5.40, and 6.19 before, at the third week, the third month, and the sixth month of the injection, respectively. Also, in this group, the mean VAS back score was 8.06, 4.16, 4.88, and 5.97; the mean ODI score was 55.81, 34.31, 37.5, and 49.04 in the same respect. In the TFESI + CESI group, the mean VAS leg score was 8.20, 2.87, 3.64, 4.23; mean VAS back score 8.03, 3.05, 3.90, 4.08; mean ODI score 56.56, 28.05, 30.21, 33.64 before, at the third week, third month, and sixth month of the injection, respectively. The mean of the initial VAS leg, VAS back, and ODI scores was not found to be statistically significantly different between the two groups. The mean of all VAS leg, VAS back, and ODI scores was found to be lower in the TFESI + CESI group than the only TFESI group at each third-week, third-month, and sixth-month controls, and these differences were statistically significant. (p<0.0001 at each controls for VAS leg; p = 0.001 at third week, p = 0.002 at third month and p <0.0001 at sixth month for VAS back; p= 0.0003 at third week, p<0.0001 at third month, p<0.0001 at sixth month for ODI)ConclusionOur study demonstrates that TFESI + CESI treatment is an effective non-surgical treatment for RLDH. Considering the higher risks and lower success rates of recurrent surgeries, TFESI + CESI can be a potential treatment option for RLDH patients.

Evaluation of Percutaneous Transforaminal Endoscopic Discectomy in the Treatment of Lumbar Disc Herniation: A Retrospective Study.

ObjectiveThe objective of the present study was to evaluate the safety and efficacy of percutaneous transforaminal endoscopic discectomy (PTED) and open fenestration discectomy (OFD) in the treatment of lumbar disc herniation (LDH).MethodsPatients in our hospital with LDH who received PTED (n = 71) and OFD (n = 39) from 2013 to 2014 were retrospectively studied. Patient information, including age, gender, visual analogue scale (VAS) score for low back pain and leg pain, body weight, height, Oswestry disability index (ODI), Japanese Orthopedic Association (JOA), and recurrence, was collected. The patients in the two groups were followed up for an average of 63 months after surgery.ResultsA total of 136 patients completed the operation and 110 patients were followed up completely. There was no significant difference in baseline data between the two groups (P > 0.05). The postoperative low back pain, leg pain, ODI, and JOA of the two groups were better than those preoperatively (P < 0.05). One week after surgery, the recovery of PTED patients was better than that of OFD. The ODI score of the PTED group was lower than that of the OFD group (10 [8, 12] vs 14 [11, 16]; P < 0.05), the waist VAS score of the PTED group was lower than that of the OFD group (2 [2, 3] vs 3 [2, 4]; P < 0.05), the leg VAS score of the PTED group was lower than that of the OFD group (1 [0,1] vs 1 [1, 2]; P < 0.05), while the JOA score of the PTED group was higher than that of OFD group [19(16, 20) vs 12(10, 17); P < 0.05]. There were no significant differences in ODI, JOA, waist and leg VAS scores between the two groups at 1 month after surgery and at subsequent follow‐up (P > 0.05). At the end of the follow up, 89.7% (35/39) of patients in the OFD group had excellent improvement in the JOA score, and 88.7% (63/71) of patients in the PTED group had an excellent improvement. There was no significant difference between the two (P > 0.05). There was also no significant difference in the recurrence rate between the two groups [(5/71) vs (3/39); P > 0.05]. [Correction added on 05 March 2021, after first online publication: “3/29” was amended to “3/39” in the preceding sentence.]ConclusionBoth PTED and OFD can achieve good mid‐term efficacy in the treatment of LDH but PTED has certain advantages, including the small incision, a shorter hospital stay, and quicker, earlier recovery. However, prospective randomized controlled studies with a larger sample size are needed.

Facet Arthrodesis with the FFX Device: One-Year Results from a Prospective Multicenter Study.

Facet osteosynthesis can be performed to treat facet syndrome (FS) and reduce spinal instability following laminectomy in patients with lumbar spinal stenosis (LSS). The present study evaluated clinical and radiological outcomes following facet osteosynthesis with the FFX device. Patients with FS or LSS were prospectively enrolled in a single-arm, multicenter study. The device was placed at affected levels with or without concomitant posterior lumbar interbody fusion (PLIF) procedures. The visual analog scale (VAS) for back and leg pain and Oswestry Disability Index (ODI) were evaluated preoperatively and postoperatively. Computed tomography scans to assess fusion and migration were performed 1 year following surgery. Fifty-three patients (26 men/27 women) with a mean age of 65.0 ± 9.6 years (range: 37-83 years) were enrolled. A total of 205 FFX devices were implanted with 15 patients undergoing concurrent PLIF procedures. There were no intraoperative or postoperative surgical complication reported, and no patient required revision surgery. Mean VAS leg and back pain scores significantly improved from 5.57 to 2.09 (P < .001) and 5.74 to 3.13 (P < .001), respectively, between the preoperative and 1 year follow-up assessments. Mean ODI scores also significantly improved from 44.7% to 24.0% (P < .001) during the same time period. Facet fusion occurred with 86.3% of device placements after 12 months. There was 1 (0.5%) asymptomatic device migration. Eight devices (3.9%) were considered misplaced. The use of the FFX device is associated with a significant reduction in both pain and disability following surgery with a high facet joint fusion rate. 4. This is the first study reporting clinical experience using the FFX device to facilitate facet osteosynthesis. The ability of the device to relieve pain, reduce disability, and enhance lumbar facet fusion with a low rate of device misplacement and migration was demonstrated.

Safety Profile and Radiographic and Clinical Outcomes of Stand-Alone 2-Level Anterior Lumbar Interbody Fusion: A Case Series of 41 Consecutive Patients.

Objective: The use of stand-alone 2-level anterior lumbar interbody fusion (ALIF) for degenerative lumbar disease has been increasing as an alternative to routinely augmenting these constructs with posterior fixation or fusion. Despite the potential benefits of a stand-alone approach (decreased cost and operative time, decreased pain and early mobilization), there is a paucity of information regarding these operations in the literature. This investigation aimed to determine the safety profile, radiographic outcomes including fusion rates, improvement in preoperative pain, and spinopelvic parameter modification, for patients undergoing stand-alone 2-level ALIF.Methods: This retrospective case series involved a chart review of all patients undergoing 2-level stand-alone ALIF at a single tertiary hospital from 2008 to 2018. Data included patient demographics, hospitalization, complications and radiological studies. Visual analog scale (VAS) back and leg scores were measured via patient-administered surveys preoperatively and up to 18 weeks postoperatively.Results: Forty-one patients who underwent L4-S1 stand-alone ALIF were included. Sixteen (39%) of patients had undergone previous posterior lumbar surgery. Length of stay averaged 4.2 days. Complication rates were comparable to 1-level ALIF. Two patients required reoperation. Fusion rates were 100% for L4-5 and 94.4% for L5-S1. There was no significant change in lumbar lordosis (LL) or LL-pelvic incidence (PI), but there was improved segmental lordosis (SL) and disc height at L4-S1 on final follow-up imaging. There was also modest but statistically significant improvement in VAS back and leg scores.Conclusions: Stand-alone 2-level ALIF is an option for a surgeon to perform in the absence of significant instability, even in the setting of prior posterior surgery. These procedures increase SL and disc height, but do not have the same effect on LL or LL-PI.

Endoscopic Surgical Resection of the Retropulsed S1 Vertebral Endplate in L5-S1 Spondylolisthesis: Case Series

Background A severe grade I and grade II spondylolisthesis at L5-S1 creates an anatomic distortion that can compress the traversing S1 nerve with a retropulsed S1 vertebral body endplate and (sometimes) herniated disc. Objectives To evaluate the feasibility for awake, endoscopic treatment of symptomatic radiculopathy secondary to the deformity that results from the retropulsed superior endplate of S1 in grade I/II L5-S1 spondylolisthesis in patients with and without previous fusion surgery. Study design Retrospective chart review. Setting This study took place in a single-center, academic hospital. Methods In 325 patients over 4 years there were 19 patients (8 with previous L5-S1 fusions and 11 without) treated with transforaminal endoscopic spine surgery for decompression of the neural foramen at L5-S1 in the setting of spondylolisthesis (at least 5 mm) and a retropulsed superior vertebral endplate of S1. Results The average preoperative Visual Analog Scale (VAS) back and leg scores were 6.1 and 6.7, and the average preoperative Oswestry Disability Index (ODI) score was 50.4. The average 1-year VAS back and leg scores were 2.2 and 2.2, and the average 1-year postoperative ODI score was 20.5. There was no statistically significant difference between the fusion and nonfusion groups. Patients treated were patients who presented with an S1 or L5 and S1 radiculopathy as their primary complaint and a L5-S1 spondylolisthesis of 5 mm or greater. Patients treated had no instability on flexion-extension x-rays. Eleven patients had not had fusions at L5-S1, and 8 patients had previous fusions at L5-S1 but still had a spondylolisthesis of at least 5 mm. The average slip for nonfusion patients was 8.4 mm, and the average slip for fusion patients was 8.8 mm. At 1-year follow-up the improvement in VAS back scores was 44% in the nonfusion group and 49% in the fusion group, and the improvement in VAS leg scores was 84% in the nonfusion group and 58% in the fusion group. At 1-year follow-up the improvement in ODI scores was 63% in the nonfusion group and 54% in the fusion group. Limitations Retrospective case series. Conclusions Awake, endoscopic surgery for the treatment of radiculopathy in the setting of a grade I/II L5-S1 spondylolisthesis is a viable minimally invasive treatment option for patients with radiculopathy in the setting of a stable L5-S1 spondylolisthesis with foraminal narrowing caused by a retropulsed superior endplate of the S1 vertebral body.

Age as a Predictor for Complications and Patient-reported Outcomes in Multilevel Transforaminal Lumbar Interbody Fusions: Analyses From the Michigan Spine Surgery Improvement Collaborative (MSSIC).

Retrospective review of a multi-institutional data registry. The authors sought to determine the association between age and complications & patient-reported outcomes (PRO) in patients undergoing multilevel transforaminal interbody lumbar fusion (MTLIF). Elderly patients undergoing MTLIF are considered high risk. However, data on complications and PRO are lacking. Additionally, safety of multilevel lumbar fusion in the elderly remains uncertain. Patients ≥50-year-old who underwent MTLIF for degenerative lumbar spine conditions were analyzed. Ninety-day complications and PROs (baseline, 90-d, 1-y, 2-y) were queried using the MSSIC database. PROs were measured by back & leg visual analog scale (VAS), Patient-reported Outcomes Measurement Information System (PROMIS), EuroQol-5D (EQ-5D), and North American Spine Society (NASS) Patient Satisfaction Index. Univariate analyses were used to compare among elderly and complication cohorts. Generalized estimating equation (GEE) was used to identify predictors of complications and PROs. A total of 3120 patients analyzed with 961 (31%) ≥ 70-y-o and 2159 (69%) between 50-69. A higher proportion of elderly experienced postoperative complications (P = .003) including urinary retention (P = <.001) and urinary tract infection (P = .002). Multivariate analysis demonstrated that age was not independently associated with complications. Number of operative levels was associated with any (P = .001) and minor (P = .002) complication. Incurring a complication was independently associated with worse leg VAS and PROMIS scores (P = <.001). Preoperative independent ambulation was independently associated with improved PROMIS, and EQ5D (P = <.001). Within the elderly, preoperative independent ambulation and lower BMI were associated with improved PROMIS (P = <.001). Complications had no significant effect on PROs in the elderly. Age was not associated with complications nor predictive of functional outcomes in patients who underwent MTLIF. Age alone, therefore, may not be an appropriate surrogate for risk. Furthermore, baseline preoperative independent ambulation was associated with better clinical outcomes and should be considered during preoperative surgical counseling.Level of Evidence: 3.

Early Clinical Outcomes of Percutaneous Endoscopic Lumbar Discectomy for L4-5 Highly Down-Migrated Disc Herniation: Interlaminar Approach Versus Transforaminal Approach

This study is a retrospective evaluation of patients with L4-5 highly down-migrated lumbar disc herniation (LDH) operated with interlaminar endoscopic lumbar discectomy (IELD) versus transforaminal endoscopic lumbar discectomy (TELD). From January 2015 to December 2018, 77 patients with L4-5 highly down-migrated LDH were divided into 2 groups according to different surgical approaches. There were 40 patients who underwent IELD, and 37 patients who underwent TELD. The operation time, hospital stay, Oswestry Disability Index, clinical outcome according with modified MacNab criteria, Visual Analog Scale (VAS) scores, and complications were compared between the IELD and TELD groups. Seventy-seven patients were included, 40 and 37 patients underwent IELD and TELD, respectively. The IELD and TELD groups both achieved a significant improvement in Oswestry Disability Index, back and leg VAS scores, and clinical outcome postoperation. Mean operating and x-ray times during operation were significantly shorter in the IELD group than in the TELD group (41.8 vs. 50.3, 1.8 vs. 13.7). There were 3 patients who experienced recurrence in the IELD group and 2 in the TELD group. In the TELD group, there were 3 patients who required revision surgery due to incompletely removed disc fragment. All patients in the IELD group were treated successfully. There was no other complication in these cases. Both IELD and TELD could be a good alternative option for highly down-migrated LDH in L4-L5. IELD may have advantages in operation time and x-ray times during operation compared with TELD.

75. Prospective, randomized study of lumbar facet replacement and lumbar interbody fusion for spondylolisthesis

BACKGROUND CONTEXT The surgical treatment for lumbar spondylolisthesis has remained somewhat controversial. Posterior lumbar arthroplasty with facet replacement is a novel alternative to lumbar decompression and fusion. There are currently no FDA-approved devices for facet replacement. The TOPS System is a robust, pedicle screw-based biomechanical device intended to replace the facets and posterior elements following aggressive decompression. PURPOSE Lumbar facet replacement is a novel motion-preserving procedure that can be used to treat spondylolisthesis with stenosis. There is an ongoing multicenter, prospective, randomized, controlled US Food and Drug Administration (FDA) Investigation Device Exemption (IDE) trial evaluating the clinical and radiographic outcomes of an investigational facet replacement device and lumbar fusion with interbody fusion with pedicle screw fixation. STUDY DESIGN/SETTING Multicenter, prospective, randomized, US FDA Investigation Device Exemption trial. PATIENT SAMPLE The results of five high enrolling investigational sites from the prospective, randomized IDE trial comparing facet replacement (TOPS) and lumbar interbody fusion (TLiF) in the treatment of Grade I degenerative spondylolisthesis and stenosis were combined to evaluate clinical outcomes. OUTCOME MEASURES The primary clinic outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) as well as re-operation rate. Patients were 2:1 randomized to artificial facet replacement vs TLIF using a monolithic PEEK interbody spacer and pedicle screw fixation. A minimum of 12 months follow-up was required for inclusion in this study. METHODS The results of five high enrolling investigational sites from the prospective, randomized IDE trial comparing facet replacement (TOPS) and lumbar interbody fusion (TLiF) in the treatment of Grade I degenerative spondylolisthesis and stenosis were combined to evaluate clinical outcomes. The primary clinic outcome measures included the Oswestry Disability Index (ODI) and visual analog scale (VAS) as well as re-operation rate. Patients were 2:1 randomized to artificial facet replacement vs TLIF using a monolithic PEEK interbody spacer and pedicle screw fixation. A minimum of 12 months follow-up was required for inclusion in this study. RESULTS A total of 129 patients have been enrolled and randomly assigned to either TOPS (n=90) or to TLIF (n= 39). A total of 63 patients were available for follow-up of at least 12 months (TOPS=47, TLIF=16). The reoperation rate for revision, removal or supplemental fixation (RRSF) for facet replacement and TLIF control was 6.7% and 12.8%, respectively. There was no significant difference between groups in baseline mean ODI (TOPS=57; TLIF=56) or VAS Back (TOPS=68; TLIF=68) and Leg scores (TOPS=83; TLIF=84). Both groups showed significant improvement in ODI (TOPS=13; TLIF=14) and VAS Back (TOPS=12; TLIF=14) and VAS Leg (TOPS=12; TLIF=10) from baseline to 12-month follow-up. At 12-month follow-up, 89% of TOPS patients and 81% of TLIF patients showed both a minimum of 15-point ODI improvement and no RRSF reoperation. CONCLUSIONS The preliminary results of this prospective, randomized study are encouraging for both TOPS and TLIF. Both lumbar facet replacement and interbody fusion groups have shown good clinical outcomes with relatively low re-operation rates. There was a trend toward lower reoperation rates with lumbar arthroplasty that did not reach clinical significance. There was no statistically significant difference between the groups in clinic outcome measures. There was a statistically significant level of improvement from baseline and last follow-up in ODI and VAS (Back and Leg) in both treatment groups. Lumbar facet replacement and lumbar interbody fusion both appear to be viable options for treatment of one-level lumbar stenosis due to degenerative spondylolisthesis. Continued enrollment with long-term follow-up is required to validate these early findings as well as to evaluate for any differences between rigid and dynamic stabilization on adjacent level disease. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

The Therapeutic Evaluation of Spinal Canal Decompression by Using the TBEIS Technique in the Treatment of Lumbar Spinal Stenosis.

Objective To evaluate the clinical efficacy of the percutaneous endoscopic Transforaminal Broad Easy Immediate Surgery (TBEIS) technology in elderly patients with lumbar spinal stenosis (LSS). Methods From February 2016 to May 2018, 35 elderly patients with LSS were treated with the TBEIS technique. There were 23 males and 12 females, aged from 53 to 72 years with a median age of 63.1 years. Preoperative, 1 day, and 1 and 12 months postoperative visual analogue scale (VAS) scores and Oswestry Disability Index (ODI) were statistically analyzed. The modified MacNab criterion was used to assess the clinical effects. The radiological outcomes were evaluated by X-ray and computed tomography (CT). Results All of the operations were successful. The operative time ranged from 120 to 170 min with a median time of 148 min. All of the patients were followed up for 12 to 38 months with a median follow-up of 18 months. Preoperative, 1 day, and 1 and 12 months postoperative VAS leg scores were 6.91 ± 0.98, 1.69 ± 0.68, 1.23 ± 0.59, and 0.91 ± 0.61, respectively, and the VAS back scores improved from 4.51 ± 0.82 to 0.66 ± 0.68. The ODI scores were 63.82 ± 7.59, 38.79 ± 6.36, 24.79 ± 3.90, and 11.33 ± 3.92, respectively. Postoperative scores of VAS and ODI were obviously improved (P < 0.01). According to the modified MacNab criteria used to evaluate the clinical effects, 11 cases achieved excellent results, 18 cases achieved good results, 4 cases achieved fair results, and 2 cases achieved poor results. There were no neurovascular injury and other complications. Conclusions Treatment of LSS in the elderly patients by the TBEIS technology has good clinical efficacy, and the technique is safe and minimally invasive.

Influence of positioning of L4-5 disc prostheses on functional outcomes and sagittal balance: 2-year follow-up of a cohort of 38 patients.

The main objective of this study was to evaluate the influence of L4-5 total disc replacement (TDR) positioning on functional outcome at the 2-year follow-up. The secondary objective was to assess its influence on sagittal balance. Prospective data were compiled for 38 single-level L4-5 ProDisc-O TDRs. Anteroposterior placement (APP) was the distance between the center of the implant and the center of the L5 endplate divided by the total length of the L5 endplate. This ratio was expressed as a percentage (APP 0%-49%, anterior off-centering; 50%, perfect centering; and 51%-100%, posterior off-centering). The patients were divided into 3 groups depending on the APP and using quartile values: group 1, anterior placement (APP 0%-46%); group 2, central placement (APP 46.1%-52%, the 2 central quartiles); and group 3, posterior placement (APP 52.1%-100%). The sagittal balance parameters assessed were overall lordosis, segmental lordosis, and pelvic incidence. Adequate lordosis was defined for each patient according to their pelvic incidence. The Oswestry Disability Index and visual analog scale (VAS) scores for back and leg pain were assessed. The average APP was 48% (range 40%-64%). There were 10 patients in group 1, 18 in group 2, and 10 in group 3. There was a significant difference in functional outcomes among the 3 groups. APP influenced the VAS back (p = 0.04) and VAS leg (p = 0.05) scores. Group 1 consistently showed the highest performance scores. No significant association between APP and the sagittal balance parameters was found. Patients who had preoperative sagittal imbalance or those who significantly modified their balance after the surgery had the poorest outcomes. Disc prostheses at L4-5 seem to provide better functional outcome when they are positioned anteriorly to the center of the vertebral body.