Faculty Bibliography

BACKGROUND CONTEXT: Often patients with cervical deformity (CD) require extensive fusions that extend into the thoracic spine. However, factors that influence the treatment approach and level selection are poorly understood. PURPOSE: To examine if there are significant differences between patients with CD who have a lowest instrumented vertebrae (LIV) to the upper thoracic (UT) vs the midthoracic (MT) spine. STUDY DESIGN/SETTING: Comparative cohort study. PATIENT SAMPLE: Prospective adult cervical deformity database. OUTCOME MEASURES: NDI, mJOA, SWAL-QOL.
METHOD(S): A prospective CD database was analyzed for the following inclusion criteria: LIV between C7-T5 and a UIV of C2, and 1 yr min follow-up (f/u). Patient demographics, operative details, radiographic parameters and clinical outcomes were compared between those with a LIV from C7-T2 (UT) vs T3-T5 (MT). X2 and independent samples T-Tests were performed for statistical analysis RESULTS: A total of 64 patients met inclusion criteria for the study and 46 were included in the analysis (avg. age 62, 58% female, avg 1yr f/u) with 22 in UT vs 24 in the MT groups. No differences were seen in age or revision case prevalence, EBL, operative time or surgical approach (anterior, posterior, combined) types between groups. MT patients had a higher pre-op cSVA, TS-CL, Max Kyphosis and T9PA and were treated with a larger number of PSOs (p<0.01). There was a larger correction in Cervical Lordosis (CL) seen in the MT group (29 vs 17, p=0.04) and larger changes in T4-T12 (9.6 vs 0.0, p<0.01). No differences were seen in DJK (p=0.22) or rates of revision surgery (5% vs 21%, p=0.19,

BACKGROUND CONTEXT: Choosing the surgical approach and osteotomy type is challenging when surgically treating cervical deformity. Preoperative assessment of flexibility and final alignment would be useful for surgeons treating this complex problem. Currently extension lateral XR are inconstantly taken for the management of cervical deformity for planning purposes. PURPOSE: Investigate the relationship of surgical procedure choice and the pre-operative flexibility of the cervical spine. Determine if extension lateral XR (ELXR) can also predict the final postoperative alignment. STUDY DESIGN/SETTING: Retrospective review of prospective, consecutively enrolled multicenter cervical deformity database PATIENT SAMPLE: A total of 106 cervical deformity patients OUTCOME MEASURES: Surgical treatment, radiographic alignment parameters (SS, T1S-CL, cSVA, C2 slope, T1 slope) METHODS: A prospective database of operative cervical deformity patients was analyzed. Inclusion was cervical kyphosis>10degree, cervical scoliosis>10degree, C2-C7 SVA>4cm or chin-brow vertical angle>25degree. Patients were excluded if they did not have neutral and ELXR or did not have deformity limited to the cervical or cervicothoracic spine. The ELXR was compared to preoperative neutral lateral, and 3 mo alignment XR and type of surgical osteotomy based upon the Ames Classification. Statistical analysis included t-test and chi-squared.
RESULT(S): A total of 106 from 164 patients met the inclusion criteria. Mean age of 60 yo, with 58% females. Of the study population, 43.4% of patients had prior cervical surgery. The evaluation of ELXR in patients who received grade 1-2 osteotomies (as compared to those who received grade 5,6 or 7), shows they have statistically lower T1S (23.06 vs 35.46; p=.021), lower T1S-CL (20.90 vs 36.29; p=.033), lower cSVA (24.66 vs 48.35; p<.001) and lower C2Slope (18.69 vs 37.46; p=.008). Subsequent analysis revealed the anterior approach chosen over the post approach when, in extension, patients achieved more normal radiographic alignment T1S (21.17 vs 31.59; p=.018), lower cSVA (11.18 vs 36.44; p<.001), lower T1S-CL (13.68 vs 28.13; p=.014) and lower C2 slope (8.49 vs 28.28; p<.001). Patients were more likely to have a post approach when they had larger than normativeT1S-CL>17 in the ELXR (46.77% vs 36.36%; p=.033). Overall, while surgery created a significant change in all radiographic parameters; the 3 month lateral XR and baseline ELXR were statistically similar for T1S-CL (26.04 vs 24.83; p=.542) and C2Slope (23.27 vs 22.87; p=.839).
CONCLUSION(S): Preoperative ELXR had a significant association with surgical approach and grade of osteotomy. The ELXR was statistically similar to the post-operative 3-month lateral XR and should be used to predict final cervical alignment. Obtaining ELXR is a critical alignment tool, and should be obtained as a part of the preoperative surgical plan. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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BACKGROUND CONTEXT: The Patient-Reported Outcomes Measurement Information System (PROMIS) is a comprehensive self-report measurement tool with patient functions, symptoms, behaviors, and mental health outcomes. Little work has been done correlating PROMIS physical health domain metrics with established adult spinal deformity (ASD) classifications such as SRS-Schwab. PURPOSE: To correlate sagittal alignment components via the SRS-Schwab classification system with established PROMIS domains in a cohort of ASD patients. STUDY DESIGN/SETTING: Retrospective review of a single-center stereoradiographic database. PATIENT SAMPLE: A total of 41 ASD patients with complete baseline radiographic and PROMIS data. OUTCOME MEASURES: PROMIS physical health domain metrics (Pain Intensity [PI], Physical Function [PF], Pain Interference [Interference]), SRS-Schwab modifiers (SVA, PI-LL, PT) METHODS: Surgical ASD patients (SVA>=5cm, PT>=25degree or TK >=60degree) >=18 years old with available baseline (BL) radiographic and PROMIS data were isolated in the single-center comprehensive Spine Quality Database (Quality). Patients were classified according to SRS-Schwab deformity modifiers(0,+,++) for SVA, PI-LL and PT. Descriptives and univariate analyses compared population-weighted PROMIS scores for PI, PF and Interference across ASD deformity modifiers. Conditional Tree Analysis (CTA) with logistic regression sampling established cut-off points for PROMIS scores predicting severe malalignment (++) at BL compared to mild or moderate (0,+).
RESULT(S): A total of 41 patients (58.95 yrs,75.6%F,29.1kg/m2) met inclusion criteria. BL SRS modifiers were as follows: SVA 51.2%, 2.4%, 46.3% (0,+,++); PI-LL 27.3%, 12.1%, 60.6%(0,+,++); PT 18.2%, 36.4%, 45.5% (0,+,++). Mean cohort PI score was 94.2+/-6.0, mean PF score 8.95+/-10.1, mean Inter score 57.84+/-5.46. PF and Interference differed significantly across low and high SVA groups, with low SVA having significantly higher PF (13.50 vs 3.68,p<0.001) and lower Inter (59.62 vs 56.30, p=0.05). PI did not differ across SVA groups (p>0.05). Low PI-LL pts had significantly higher PF than pts with ++PI-LL (19.3 vs 4.15,p=0.001) and trended lower PI and Inter without significance. No significant differences in PI, PF or Inter were found across PT groups (all p>0.05). CTA found a PI score>98 or PF score <6 were independent predictors of Severe (++) SVA as opposed to Mild/Moderate SVA. For example, a PF score<6 increased odds of ++SVA by at least 2.7x compared to 0/+SVA. Similarly, significant thresholds for PI (>98) and PF (<8) scores were found for ++PI-LL, but not ++PT (p>0.05). Pain Interference did not predict SRS metrics to a significant degree (all p>0.05).
CONCLUSION(S): Inferior PROMIS scores of pain intensity and physical function predicted increasingly severe SRS sagittal modifiers at baseline, specifically severe sagittal vertical axis and lumbopelvic mismatch. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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BACKGROUND CONTEXT: The opioid crisis in the US is currently catastrophic. A large number of patients use opioids preoperatively. PURPOSE: The goal of this study is to look at a group of patients who were on opioids prior to adult spinal deformity surgery, and compare outcomes in those who ceased and those who continued opioid use post operatively. We also aim to identify factors associated with postoperative opioid cessation. STUDY DESIGN/SETTING: Retrospective review of a prospective multicenter database of ASD patients. PATIENT SAMPLE: A total of 296 surgical ASD patients who were using opioids (daily or weekly) prior to surgical intervention. OUTCOME MEASURES: Post-operative opioid cessation or decreased use, HRQOL (SF-36, ODI, back pain, leg pain), and patient satisfaction.
METHOD(S): A multicenter prospective database of surgical ASD patients was reviewed. Opioid use was measured using the SRS-22r Q11. We included all surgical ASD patients who using opioids pre-operatively (daily or weekly) and completed 2-year follow up. Patients were divided based on 2-year opioid use: decreased/ceased vs continued. Groups were compared in regards to demographics, radiographic parameters, HRQL, invasiveness of surgery, complications, re-operations, and satisfaction.
RESULT(S): Our database had a total of 1,281 surgical patients, out of which 760 were eligible for 2-year follow up. Of those eligible, 578 (76.05%) completed their 2-year follow up. A total of 547 of these patients answered SRS22R-Q11 at baseline at 2-years (with the remainder choosing to not answer this question). There were 296 (54.11%) of 547 ASD patients undergoing surgery reported using opioids preoperatively. Of those, 171 (57.8%) had decreased or ceased opioids 2 years after surgical intervention. Those who decreased/ceased had a higher proportion of females (83.83% vs 72.00%, p=0.014). There was no other statistically significant difference in demographics (BMI, co-morbidities, age, prior spine surgery, smoking) or radiographic parameters (PI-LL, SVA, PT). Those who decreased/ceased opioids had higher baseline SF-36 M

BACKGROUND CONTEXT: The Adult Spinal Deformity Frailty Index (ASD-FI), a validated modality for quantifying frailty, stratifies patients into categories not frail (NF), frail (F) and severely frail (SF). However, the cost of treating each frailty state is unknown. PURPOSE: Investigate the cost utility of treating not frail versus frail or severely frail ASD patients. STUDY DESIGN/SETTING: Retrospective review of a prospective single center adult spinal deformity database. PATIENT SAMPLE: A total of 79 operative and non operative ASD patients >=18 years old, with baseline and 2Y ASD-FI and Oswestry Disability Index (ODI) scores. OUTCOME MEASURES: ODI, SF-6D, Cost per quality adjusted life years (QALY), Incremental Cost Effectiveness, Ratio (ICER).
METHOD(S): Inclusion criteria was surgical ASD (scoliosis>=20degree, SVA>=5cm, PT>=25degree, or thoracic kyphosis >=60degree) patients >18 years with available frailty and ODI data at BL and 2-years post op. Independent T-Tests assessed baseline radiographic differences in PT, PI-LL, and Schwab SVA modifier status between NF vs. F/SF patients. Utility data was calculated using the ODI converted to the SF-6D using published conversion methods. QALYs utilized a 3% discount rate to account for residual decline to life expectancy (78.7 years). Costs were calculated using the PearlDiver database. After accounting for complications, LOS, revisions, and death, cost per QALY at 2Y and life expectancy were calculated for NF, and F/SF patients. ICER was compared between non op and operative NF and F/SF patients at 2Y and life expectancy.
RESULT(S): Seventy-nine ASD patients met inclusion criteria. Descriptive statistics for the cohort were: age 51.0+/-6.8, 76% women, BMI 26.7+/-6.8, 54% osteotomy, 54% decompression, and 11.6+/-4.2 average levels fused. At BL, there were 48 NF, 26 F, and 4 SF pts. The average BL frailty for NF pts was 0.13+/-0.08, 0.39+/-0.06 for F, and 0.59+/-0.08 for SF pts. There were no differences in PT, PI-LL, or severe SVA Schwab modifier grades between NF or F/SF pts (all p>0.05). At 2-year follow up, there was no difference in the average cost of ASD surgery, $91,068.98 for NF patients and $90,888.53 for F/SF pts (p>0.05). The cost per QALY was higher for NF pts at 2 years vs F/SF pts ($464,239.62 vs. $321,107.89, p<0.05). If the utility gained was sustained to life expectancy, the cost per QALY was $70,796.43 for NF and $48,968.88 for F/SF (p<0.05). When compared to non op ASD pts, the ICER was $447,943.96 vs. $313,211.01 for NF and F/SF at 2 years, and $68,311.35 vs. $47,764.61 for NF and F/SF at life expectancy.
CONCLUSION(S): Frail and severely frail patients had lower cost per QALY compared to not frail patients at 3 years and life expectancy. In addition, when compared to a non operative cohort of ASD patients, frail and severely frail patients had lower ICER values. While these results support operative correction of frail and severely frail patients, it is important to note that these patients are often at worse baseline disability, which is closely related to frailty scores, and have more opportunity to improve postoperatively. In addition, there may be a threshold of frailty that is not operable due to the risk of severe complications that is not captured by this analysis. While future research should investigate economic outcomes at extended follow-up times, these findings support the cost effectiveness of ASD surgery at all frailty states. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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BACKGROUND CONTEXT: Much research has focused on the etiology of PJK and with the evolution of our knowledge, there have been modifications to surgical techniques and radiographic aims in an attempt to minimize the risk for PJK development. PURPOSE: To examine if rates of PJK are lower today compared to a historical cohort. STUDY DESIGN/SETTING: Retrospective. PATIENT SAMPLE: Multicenter adult spinal deformity database. OUTCOME MEASURES: PJK incidence, radiographic outcomes, revision rates.
METHOD(S): A multicenter database of Adult Spinal Deformity patients was analyzed for the following inclusion criteria: fusions >5 levels, LIV S1/Ilium with at least 6 weeks follow up (f/u) for the assessment of PJK. A historical cohort of patients from 2009-2011 (Group P) were compared to those from 2016-2018 (Group T) for the rates of PJK. Patient demographics, operative details, radiographic and clinical outcomes were compared between groups. Unpaired T-Tests were utilized followed by a multivariate analysis to eliminate confounding variables.
RESULT(S): A total of 504 patients were included for analysis (Group P, n=210 vs. Group T, n=294). Group T were older patients (65 vs. 62, p<0.01), with a higher CCI and ASA compared to Group P (p<0.01) with a larger PI-LL mismatch (24 vs. 20, p=0.02) and TPA (28 vs. 26, p=0.03) at baseline. Statistically significant differences in the surgical strategies were noted between cohorts, with a higher number of ALIFs, LLIFs, Allograft and BMP usage in the T group versus P (all p<0.05) and a lower prevalence of 3CO utilization (17.7% vs. 29.5%, p<0.01). There were no differences in the rates of PJK or in the PJK angle between groups (P 38% vs. T 34%, p=0.43; P 13.8 deg+/-9.8 vs. T 14.5 deg+/-9.0, p=0.39). No differences were noted in the radiographic outcomes post-operatively. When controlling for confounding variables (age, CCI and ASA, surgical strategies and 3CO), there were no significant differences in PJK rates between the cohorts (p=0.2). The prevalence of revision cases for PJK was also similar between time points (25 vs 23)
CONCLUSION(S): In a study of over 500 patients comparing PJK rates from 2009-2011 versus 2016-2018, no differences were noted in the rate of PJK or in the PJK angles through time (38% vs 34%, 13.8 deg+/-9.8 vs 14.5 deg+/-9.0, respectively). While there were differences in operative techniques and strategies evidenced by the utilization of different interbody techniques, osteotomies and bone graft products through time, PJK incidence has stayed the same. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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BACKGROUND CONTEXT: Flattening of the thoracic spine is a common biomechanical compensatory mechanism for adult spinal deformity (ASD). The literature shows that younger ASD patients recruit more thoracic flattening than older patients. It is hypothesized that differences in muscle quality between younger and older ASD patients explains this difference in the recruitment of thoracic compensation. PURPOSE: Investigate the relationship between paraspinal muscle degeneration and recruitment of thoracic compensation. STUDY DESIGN/SETTING: Retrospective review of a prospective database. PATIENT SAMPLE: ASD patients from a prospective database. OUTCOME MEASURES: Posterior paraspinal muscle fat infiltration, thoracic kyphosis between T4 and T12 (TK) and pelvic retroversion (PT).
METHOD(S): ASD patients with spino-pelvic deformity (defined as SRS-Schwab PI-LL modifier of + or ++) and available pre-op CT imaging were identified from a retrospective database. Patients with previous fusion of the thoracic spine were excluded. Erector spinae and multifidus measurements were manually contoured on CT imagesat three vertebral levels (T2, T10, and L3), at three locations per level: immediately inferior to the superior end plate, in the middle of the vertebral body, and superior to the inferior end plate. Fat infiltration (Fat) within each muscle was defined as the number of voxels with a Hounsfield unit (HU) corresponding to fat (-190 to 0) divided by the total number of voxels. The maximum fat infiltration (MaxFat) was determined by taking the muscle with the highest percentage of Fat. After a Pearson correlation analysis, the cohort was separated into 2 groups: high Fat (HFat) and Low Fat (LFat) based on MaxFat threshold of 35%. Demographics and radiographic parameters including TK and PT were compared between groups.
RESULT(S): Of the 57 patients (mean age 61 yrs, 75% F, BMI 28) that met inclusion, 26% had a fused lumbar spine. Assessed by +/++ SRS-Schwab modifiers, 90% of patients had severe PT malalignment and 75% a severe SVA malalignment. Breakdown of Fat and area by vertebral level was: T2 (35% and 1332mm2), T10 (30% and 1910mm2), L3 (38% and 3915mm2). TK correlated significantly with Fat at all levels from T2 to L3 (r=-0.498, r=-0.519, r=-0.472), FatMax (r=-0.470) and area at T10 (r=-0.341). PT correlated significantly with FatMax (r=0.333) and T10 Fat(r=0.548). After grouping, 31 pts were HFat, and 25 pts were LFat. HFat pts were older (64.2 vs 56.3, p=0.047) and had a greater BMI (30.1 vs 25, p=0.002). The groups did not differ in sex or rates of lumbar fusion. In terms of spinal alignment, HFat pts had a higher T1 pelvic angle (30.7degree vs 23.7degree), a higher TK (-34.6degree vs -22.9degree), and a higher PT (30.1degree vs 25.2degree), without difference in lumbar deformity or other sagittal parameters.
CONCLUSION(S): Patients with higher fat infiltration in paraspinal muscles show less compensation with the thoracic spine than patients with leaner musculature, despite having similar lumbar deformities. Consequently, patients with degenerative paraspinal musculature have more pelvic retroversion, causing greater gait disruption due to limitation in hip extension. The assessment of fatty infiltration in posterior paraspinal muscles could help identify patient compensatory profile and aid in surgical planning. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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BACKGROUND CONTEXT: Numerous advances have been made in the field of spine fusion, such as minimally invasive (MIS) or robotic assisted spine surgery. However, it is unknown how these advances have impacted the cost of care. PURPOSE: Compare the economic outcomes of lumbar spine fusion between open, MIS and robotic assisted surgery patients. STUDY DESIGN/SETTING: Retrospective review of a single center spine surgery database. PATIENT SAMPLE: A total of 360 propensity matched patients. OUTCOME MEASURES: Costs, EuroQol-5D (EQ5D), Cost per quality adjusted life years (QALY).
METHOD(S): Inclusion criteria: surgical patients >18 years undergoing lumbar fusion surgery. Patients were categorized into 3 groups based on procedure type: open, MIS or robotic. Open patients undergoing poster spinal fusion were considered as the control group. MIS patients included those undergoing transforaminal or lateral lumbar interbody fusion with percutaneous screws. Robotic patients were those undergoing robot assisted fusion. Propensity score matching was performed between all groups for the number of levels fused. Costs were calculated using the PearlDiver database, which reflects both private insurance and Medicare reimbursement claims for ICD-9 codes. For robot cases, costs were reflective of operational fees and initial purchase cost. Complications and comorbidities (CC) and major complications and comorbidities (MCC) were assessed according to CMS.gov manual definitions. QALYs and cost per QALY were calculated using a 3% discount rate to account for residual decline to life expectancy (78.7 years). Costs per QALY were calculated for both 1 year and life expectancy, assuming no loss of benefit.
RESULT(S): A total of 360 propensity matched patients (120 open, 120 MIS, 120 robot) met inclusion. Descriptive statistics for the cohort were: age 58.8+/-13.5, 50% women, BMI 29.4+/-6.3, op time 294.4+/-119.0, LOS 4.56+/-3.31 days, EBL 515.9+/-670.0 cc, and 2.3+/-2.2 average levels fused. Rates of postop complications were significantly higher in robotic cases versus open and MIS (43% vs. 21% and 22% for open and MIS, p<0.05). However, revision rates were comparable between all groups (3% open, 3% MIS, 5% robotic, p>0.05). After factoring in complications, revisions, and purchasing and operating fees, the costs of robotic cases was significantly higher than both open and MIS surgery ($60,047.01 vs. $42,538.98 open and $41,471.21 MIS). In a sub analysis of 42 patients with BL and 1Y EQ5D data, the cost per QALY at 1Y for open, MIS, and robot assisted cases was $296,624.48, $115,911.69, and $592,734.30. If utility gained was sustained to life expectancy, the cost per QALY was $14,905.75, $5,824.71, $29,785.64 for open, MIS, and robot assisted cases.
CONCLUSION(S): Numerous advances have been made in the field of spine surgery, however, there has been limited discussion of the effect these advances have on economic outcomes. When matched for levels fused, robot assisted surgery patients had significantly higher rates of complications and 30% higher costs of surgery compared to minimally invasive and open spine surgery patients. While 1 year economic outcomes weren't optimal for robotic surgery cases, the projected costs per quality adjusted life years at life expectancy were well below established acceptable thresholds. FDA DEVICE/DRUG STATUS: This abstract does not discuss or include any applicable devices or drugs.
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BACKGROUND CONTEXT: Psychiatric diagnoses (PD) present a significant burden on elective surgery patients and may have potentially dramatic impacts on outcomes. As ailments of the spine can be particularly debilitating, the effect of PD on outcomes was compared between elective spine surgery patients and other common elective orthopedic surgery procedures. PURPOSE: Investigate the rates of PD in elective orthopedic procedures. STUDY DESIGN/SETTING: Retrospective review of the National Inpatient Database 2007-2013. PATIENT SAMPLE: A total of 15,434,393 weighted hospital discharges. OUTCOME MEASURES: Rates of PD, post-operative complications, length of stay (LOS), cost to charge (CCR), discharge location, and death.
METHOD(S): Inclusion criteria: elective orthopedic surgery procedures from 2007-2013 as defined by ICD-9-CM codes. Exclusion criteria: emergency, trauma, or non-elective surgery. Patients were grouped as shoulder, elbow, hand, spine, hip, knee, or foot/ankle. Descriptive statistics assessed demographics. Rates of DSM-IV PD, as classified by single-level C

BACKGROUND CONTEXT: Although epidural steroid injection (ESI) has been shown to provide adequate pain relief for degenerative spondylolisthesis patients in treatment regimens up to months, it remains unclear whether the use of ESI affects the rate of crossover from nonoperative to operative management. PURPOSE: Investigate the relationship between epidural steroid injections and rates of surgical crossover for degenerative spondylolisthesis patients. STUDY DESIGN/SETTING: Retrospective review of prospectively collected data from 13 spine centers. PATIENT SAMPLE: Degenerative spondylolisthesis patients from both the randomized and concurrent observational cohorts of the Spine Patient Outcomes Research Trial (SPORT). OUTCOME MEASURES: Primary: Surgical crossover rates. Secondary: health related quality of life outcome (HRQL) measures (SF-36, ODI, Sciatica and Leg Pain Bothersomeness Indices), self-reported improvement METHODS: Included: surgical candidates >18yrs with degenerative spondylolisthesis. Excluded: patients receiving ESI before enrollment. Those who received ESI within 3 months of enrollment (ESI) and those who did not (no-ESI) were compared for differences in baseline characteristics. Outcomes at 1-year, 2-year, 3-year, and 4-year intervals following enrollment were assessed within operative and nonoperative groups using longitudinal mixed-effect models with random subject intercept term to account for correlations between repeated measurements. Treatment comparisons were performed at follow-up intervals. Area under the curve analysis for all time points assessed global significance of treatment.
RESULT(S): Included: 266 patients (192 no-ESI, 74 ESI). Patient groups did not differ in age, sex, BMI, or comorbidity burden (all p>0.05). No-ESI had greater baseline SF-36 body-pain scores (38+/-20 vs 30+/-16, p=0.002) and self-reported surgical preference (38% vs 11%, p<0.001). There were no differences in surgical rates within 4-years of enrollment between no-ESI and ESI patients (61% vs 62%, p=0.97). Surgical ESI and no-ESI patients did not differ in op-time, blood loss, rates of decompression, multilevel fusion or levels decompressed (all p>0.05). Surgical ESI and no-ESI patients showed no differences in postoperative HRQL changes at any follow-up interval, or in 4-year average HRQL outcomes. Non-operative no-ESI patients showed greater 4-year average improvement in SF-36 body pain (no-ESI: 17.8, ESI: 7.8, p=0.004) and physical function (no-ESI: 13.1, ESI: 4.3, p=0.005) than non-operative ESI patients. These improvements in SF-36 body pain were greater for non-operative no-ESI patients at 1-year (p=0.002) and 3-years (p=0.005); improvements in SF-36 physical function were greater for non-operative no-ESI patients at 1-year (p=0.030) and 2-years (p=0.002). Of patients that were initially non-operative, there was no difference between ESI and no-ESI groups in surgical crossover rates (ESI: 52%, no-ESI: 39%, p=0.15). For operative patients, crossover rates to non-operative treatment did not differ between ESI and no-ESI groups (ESI: 23%, no-ESI: 16%, p=0.38).
CONCLUSION(S): For surgical degenerative spondylolisthesis patients, there was no relationship between ESI and improved clinical outcomes over a 4-year study. For nonoperative patients, ESI was associated with inferior pain reduction through 3 years of follow-up; however, this was confounded by higher levels of baseline pain. ESI showed little relationship with surgical crossover. FDA DEVICE/DRUG STATUS: Unavailable from authors at time of publication.
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