Perioperative Nutritional Supplementation Decreases Wound Healing Complications Following Elective Lumbar Spine Surgery: A Randomized Controlled Trial.

BACKGROUND: The prevalence of malnutrition in patients undergoing lumbar spine surgery ranges from 5% to 50% and is associated with higher rates of surgical site infections, medical complications, longer lengths of stay, and mortality. PURPOSE: To determine if perioperative nutritional intervention decreases wound healing complications in patients undergoing lumbar spine surgery. STUDY DESIGN/SETTING: A prospective randomized controlled trial. MATERIALS AND METHODS: Patients aged 55+ undergoing elective primary lumbar surgery were included. Patients with a preoperative albumin<3.5 g/dL were defined as malnourished. Intervention group received nutritional supplementation (protein shake) twice daily from postoperative day 0 to two weeks postdischarge. Control group was instructed to continue regular daily diets. Primary outcomes included minor in-hospital complications (wound drainage, electrolyte abnormalities, hypotension, ileus, deep venous thrombus) and wound healing complications within 90 days. Secondary outcomes included 90-day emergency room visits, readmissions, and return to the operating room. Baseline data were compared between groups using means comparison tests. Multivariable analysis evaluated association of outcomes with nutritional supplementation. Subanalysis of malnourished patients assessed effects of nutritional supplementation on outcomes. RESULTS: One hundred three patients were included. Thirty-seven (35.9%) were considered malnourished preoperatively. Forty-six (44.7%) received nutritional intervention and 57 (55.3%) served as controls. Adjusted analysis found patients receiving supplementation had lower rates of in-hospital minor complications (2.1% vs. 23.2%, P <0.01), and perioperative wound healing complications (3.4% vs. 17.9%, P <0.05). Subgroup analysis of 37 malnourished patients demonstrated that malnourished patients who received perioperative nutritional supplementation had lower rates of minor complications during admission (0.0% vs. 34.4%, P =0.01) and return to the operating room within 90 days (0.0% vs. 12.4%, P =0.04). CONCLUSIONS: Over one third of patients undergoing lumbar surgery were malnourished. Nutritional supplementation during the two-week perioperative period decreased rates of minor complications during admission and wound complications within 90 days. Malnourished patients receiving supplementation less often returned to the operating room. To our knowledge, this is the first study to investigate the effects of perioperative nutritional intervention on wound healing complications for patients undergoing elective lumbar spine surgery. LEVEL OF EVIDENCE: I.

Predictors of serious, preventable, and costly medical complications in a population of adult spinal deformity patients.

BACKGROUND CONTEXT: In 2008, the Centers for Medicare and Medicaid Services (CMS) established a list of hospital-acquired conditions (HACs) with significant deleterious effects on both patients and providers. Adult spinal deformity (ASD) surgery is complex and highly invasive, and as such may result in significant morbidity including these HACs. PURPOSE: Identify predictors for developing the most common HACs among adult spinal deformity (ASD) patients undergoing corrective surgery. STUDY DESIGN/SETTING: Retrospective analysis. PATIENT SAMPLE: One thousand one hundred and seventy-one ASD patients. OUTCOME MEASURES: HACs, Health-Related Quality of Life scores(HRQLs), Reoperation, Integrated Health State (IHS) METHODS: ASD pts undergoing surgery (>18 years, scoliosis ≥20°, SVA ≥5 cm, PT ≥25° and/or TK >60°) with complete data at BL and up to 2 years post-op were included. Patients were stratified by presence of >1 HAC, defined as at least one superficial/deep SSI, UTI, DVT, or PE within a 30-day post-op window. Random forest analysis generated 5,000 Conditional Inference Trees to compute a variable importance table for top predictors of HACs. An area-under-the-curve (AUC) methodology compared normalized HRQL scores between groups to determine an IHS with 2-year follow-up. RESULTS: Total of 1,171 pts (59.8 years, 76.2%F, 28.1kg/m2) underwent corrective ASD surgery, with 1,053 pts in the non-HAC group and 118 in the HAC group. Of these pts, 25.4% had UTI, 15.4% DVT, 19.2% superficial SSI, 20.8% deep SSI, and 19.2% PE. HAC pts were on average older (63.5 vs 59.3, p=.004) and more often frail (51.3 vs 39.7%, p=.021) than non-HAC pts. Postop LOS and reoperation were most associated with HAC groups: [1] LOS >7 days [2] reoperation. Patient-related predictors of HACs were [3] age >50 yerr, [4] frailty, and [13] BMI >31. Procedure-related predictors of HACs were [5] operative-time >405 minutes, [6] levels fused >9, EBL >1450 mL, and [11] decompression. BL radiographic predictors were [7] PT >20°, [9] PI-LL>6°, [10] TL Cobb angle >15°, [12] SVA C7-S1 >29 mm. No differences were observed between groups with regards to IHS ODI (0.73 vs 0.74, p=.863), SRS (1.3 vs1.3, p=.374), NRS Back (0.6 vs 0.6, p=.158). HAC had higher rates of reoperation than non-HAC (0.08 vs 0.01, p=.066), and any HAC within 30-days of index was a significant predictor of reoperation (OR: 2.448 [1.94-3.09], p<.001). CONCLUSIONS: In a population of ASD patients, HACs were associated with length of stay, reoperation, age, and frailty. Radiographic parameters such as pelvic tilt >20°, PI-LL >6°, & SVA >29 mm also increased odds of HACs, and should raise postoperative awareness for HAC development.

Predictors of Superior Recovery Kinetics in Adult Cervical Deformity Correction: An Analysis Using a Novel Area Under the Curve Methodology.

STUDY DESIGN: Retrospective review of a prospective database. OBJECTIVE: The aim of this study was to identify demographic, surgical, and radiographic factors that predict superior recovery kinetics following cervical deformity (CD) corrective surgery. SUMMARY OF BACKGROUND DATA: Analyses of CD corrective surgery use area under the curve (AUC) to assess health-related quality of life (HRQL) metrics throughout recovery. METHODS: Outcome measures were baseline (BL) to 1-year (1Y) health-related quality of life (HRQL) (Neck Disability Index [NDI]). CD criteria were C2-7 Cobb angle >10°, coronal Cobb angle >10°, C2-C7 sagittal vertical axis (cSVA) >4 cm, TS-CL >10°, or chin-brow vertical angle >25°. AUC normalization divided BL and postoperative outcomes by BL. Normalized scores (y axis) were plotted against follow-up (x axis). AUC was calculated and divided by cumulative follow-up length to determine overall, time-adjusted recovery (Integrated Health State [IHS]). IHS NDI was stratified by quartile, uppermost 25% being "Superior" Recovery Kinetics (SRK) versus "Normal" Recovery Kinetics (NRK). BL demographic, clinical, and surgical information predicted SRK using generalized linear modeling. RESULTS: Ninety-eight patients included (62 ±â€Š10 years, 28 ±â€Š6 kg/m2, 65% females, Charlson Comorbidity Index: 0.95), 6% smokers, 31% smoking history. Surgical approach was: combined (33%), posterior (49%), anterior (18%). Posterior levels fused: 8.7, anterior: 3.6, estimated blood loss: 915.9ccs, operative time: 495 minutes. Ames BL classification: cSVA (53.2% minor deformity, 46.8% moderate), TS-CL (9.8% minor, 4.3% moderate, 85.9% marked), horizontal gaze (27.4% minor, 46.6% moderate, 26% marked). Relative to BL NDI (Mean: 47), normalized NDI decreased at 3 months (0.9 ±â€Š0.5, P = 0.260) and 1Y (0.78 ±â€Š0.41, P < 0.001). NDI IHS correlated with age (P = 0.011), sex (P = 0.042), anterior approach (P = 0.042), posterior approach (P = 0.042). Greater BL pelvic tilt (PT) (SRK: 25.6°, NRK: 17°, P = 0.002), pelvic incidence-lumbar lordosis (PI-LL) (SRK: 8.4°, NRK: -2.8°, P = 0.009), and anterior approach (SRK: 34.8%, NRK: 13.3%; P = 0.020) correlated with SRK. 69.4% met MCID for NDI (<Δ-15) and 63.3% met substantial clinical benefit for NDI (<Δ-10); 100% of SRK met both MCID and substantial clinical benefit. The predictive model for SRK included (AUC = 88.1%): BL visual analog scale (VAS) EuroQol five-dimensional descriptive system (EQ5D) (odds rario [OR] 0.96, 95% confidence interval [CI]: 0.92-0.99), BL swallow sleep score (OR: 1.04, 95% CI: 1.01-1.06), BL PT (OR: 1.12, 95% CI: 1.03-1.22), BL modified Japanese Orthopedic Association scale (mJOA) (OR: 1.5, 95% CI: 1.07-2.16), BL T4-T12, BL T10-L2, BL T12-S1, and BL L1-S1. CONCLUSION: Superior recovery kinetics following CD surgery was predicted with high accuracy using BL patient-reported (VAS EQ5D, swallow sleep, mJOA) and radiographic factors (PT, TK, T10-L2, T12-S1, L1-S1). Awareness of these factors can improve decision-making and reduce postoperative neck disability.Level of Evidence: 3.

Baseline Frailty Status Influences Recovery Patterns and Outcomes Following Alignment Correction of Cervical Deformity.

BACKGROUND: Frailty severity may be an important determinant for impaired recovery after cervical spine deformity (CD) corrective surgery. OBJECTIVE: To evaluate postop clinical recovery among CD patients between frailty states undergoing primary procedures. METHODS: Patients >18 yr old undergoing surgery for CD with health-related quality of life (HRQL) data at baseline, 3-mo, and 1-yr postoperative were identified. Patients were stratified by the modified CD frailty index scale from 0 to 1 (no frailty [NF] <0.3, mild/severe fraily [F] >0.3). Patients in NF and F groups were propensity score matched for TS-CL (T1 slope [TS] minus angle between the C2 inferior end plate and the C7 inferior end plate [CL]) to control for baseline deformity. Area under the curve was calculated for follow-up time intervals determining overall normalized, time-adjusted HRQL outcomes; Integrated Health State (IHS) was compared between NF and F groups. RESULTS: A total of 106 CD patients were included (61.7 yr, 66% F, 27.7 kg/m2)-by frailty group: 52.8% NF, 47.2% F. After propensity score matching for TS-CL (mean: 38.1°), 38 patients remained in each of the NF and F groups. IHS-adjusted HRQL outcomes from baseline to 1 yr showed a significant difference in Euro-Qol 5 Dimension scores (NF: 1.02, F: 1.07, P = .016). No significant differences were found in the IHS Neck Disability Index (NDI) and modified Japanese Orthopedic Association between frailty groups (P > .05). F patients had more postop major complications (31.3%) compared to the NF (8.9%), P = .004, though DJK occurrence and reoperation between the groups was not significant. CONCLUSION: While all groups exhibited improved postop disability and pain scores, frail patients experienced greater amount of improvement in overall health state compared to baseline disability. This signifies that with frailty severity, patients have more room for improvement postop compared to baseline quality of life.

Does Patient Frailty Status Influence Recovery Following Spinal Fusion for Adult Spinal Deformity?: An Analysis of Patients With 3-Year Follow-up.

STUDY DESIGN: Retrospective review of a prospective database. OBJECTIVE: The aim of this study was to evaluate postop clinical recovery among adult spinal deformity (ASD) patients between frailty states undergoing primary procedures SUMMARY OF BACKGROUND DATA.: Frailty severity may be an important determinant for impaired recovery after corrective surgery. METHODS: It included ASD patients with health-related quality of life (HRQLs) at baseline (BL), 1 year (1Y), and 3 years (3Y). Patients stratified by frailty by ASD-frailty index scale 0-1(no frailty: <0.3 [NF], mild: 0.3-0.5 [MF], severe: >0.5 [SF]). Demographics, alignment, and SRS-Schwab modifiers were assessed with χ/paired t tests to compare HRQLs: Scoliosis Research Society 22-question Questionnaire (SRS-22), Numeric Rating Scale (NRS) Back/Leg Pain, Oswestry Disability Index (ODI). Area-under-the-curve (AUC) method generated normalized HRQL scores at baseline (BL) and f/u intervals (1Y, 3Y). AUC was calculated for each f/u, and total area was divided by cumulative f/u, generating one number describing recovery (Integrated Health State [IHS]). RESULTS: A total of 191 patients were included (59 years, 80% females). Breakdown of patients by frailty status: 43.6% NF, 40.8% MF, 15.6% SF. SF patients were older (P = 0.003), >body mass index (P = 0.002). MF and SF were significantly (P < 0.001) more malaligned at BL: pelvic tilt (NF: 21.6°; MF: 27.3°; SF: 22.1°), pelvic incidence and lumbar lordosis (7.4°, 21.2°, 19.7°), sagittal vertical axis (31 mm, 87 mm, 82 mm). By SRS-Schwab, NF were mostly minor (40%), and MF and SF markedly deformed (64%, 57%). Frailty groups exhibited BL to 3Y improvement in SRS-22, ODI, NRS Back/Leg (P < 0.001). After HRQL normalization, SF had improvement in SRS-22 at year 1 and year 3 (P < 0.001), and NRS Back at 1Y. 3Y IHS showed a significant difference in SRS-22 (NF: 1.2 vs. MF: 1.32 vs. SF: 1.69, P < 0.001) and NRS Back Pain (NF: 0.52, MF: 0.66, SF: 0.6, P = 0.025) between frailty groups. SF had more complications (79%). SF/marked deformity had larger invasiveness score (112) compared to MF/moderate deformity (86.2). Controlling for baseline deformity and invasiveness, SF showed more improvement in SRS-22 IHS (NF: 1.21, MF: 1.32, SF: 1.66, P < 0.001). CONCLUSION: Although all frailty groups exhibited improved postop disability/pain scores, SF patients recovered better in SRS-22 and NRS Back. Despite SF patients having more complications and larger invasiveness scores, they had overall better patient-reported outcomes, signifying that with frailty severity, patients have more room for improvement postop compared to BL quality of life. LEVEL OF EVIDENCE: 3.

Recovery kinetics following spinal deformity correction: a comparison of isolated cervical, thoracolumbar, and combined deformity morphometries.

BACKGROUND CONTEXT: The postoperative recovery patterns of cervical deformity patients, thoracolumbar deformity patients, and patients with combined cervical and thoracolumbar deformities, all relative to one another, is not well understood. Clear objective benchmarks are needed to quantitatively define a "good" versus a "bad" postoperative recovery across multiple follow-up visits, varying deformity types, and guide expectations. PURPOSE: To objectively define and compare the complete 2-year postoperative recovery process among operative cervical only, thoracolumbar only, and combined deformity patients using area-under-the-curve (AUC) methodology. STUDY DESIGN/SETTING: Retrospective review of 2 prospective, multicenter adult cervical and spinal deformity databases. PATIENT SAMPLE: One hundred seventy spinal deformity patients. OUTCOME MEASURES: Common health-related quality of life (HRQOL) assessments across both databases included the EuroQol 5-Dimension Questionnaire and Numeric Rating Scale (NRS) back pain assessment. In order to compare disability improvements, the Neck Disability Index (NDI) and the Oswestry Disability Index (ODI) were merged into one outcome variable, the ODI-NDI. Both assessments are gauged on the same scale, with minimal question deviation. Sagittal Radiographic Alignment was also assessed at pre- and all postoperative time points. METHODS: Operative deformity patients >18 years old with baseline (BL) to 2-year HRQOLs were included. Patients were stratified by cervical only (C), thoracolumbar only (T), and combined deformities (CT). HRQOL and radiographic outcomes were compared within and between deformity groups. AUC normalization generated normalized HRQOL scores at BL and all follow-up intervals (6 weeks, 3 months, 1 year, and 2 year). Normalized scores were plotted against follow-up time interval. AUC was calculated for each follow-up interval, and total area was divided by cumulative follow-up length, determining overall, time-adjusted HRQOL recovery (Integrated Health State, IHS). Multiple linear regression models determined significant predictors of HRQOL discrepancies among deformity groups. RESULTS: One hundred seventy patients were included (27 C, 27 T, and 116 CT). Age, BMI, sex, smoking status, osteoporosis, depression, and BL HRQOL scores were similar among groups (p >. 05). T and CT patients had higher comorbidity severities (CCI: C 0.696, T 1.815, CT 1.699, p = .020). Posterior surgical approaches were most common (62.9%) followed by combined (28.8%) and anterior (6.5%). Standard HRQOL analysis found no significant differences among groups until 1-year follow-up, where C patients exhibited comparatively greater NRS back pain (4.88 vs. 3.65 vs. 3.28, p = .028). NRS Back pain differences between groups subsided by 2-years (p>.05). Despite C patients exhibiting significantly faster ODI-NDI minimal clinically important difference (MCID) achievement (33.3% vs. 0% vs. 23.0%, p < .001), all deformity groups exhibited similar ODI-NDI MCID achievement by 2-years (51.9% vs. 59.3% vs. 62.9%, p = 0.563). After HRQOL normalization, similar results were observed relative to the standard analysis (1-year NRS Back: C 1.17 vs. T 0.50 vs. CT 0.51, p < .001; 2-year NRS Back: 1.20 vs. 0.51 vs. 0.69, p = .060). C patients exhibited a worse NRS back normalized IHS (C 1.18 vs. T 0.58 vs. CT 0.63, p = .004), indicating C patients were in a greater state of postoperative back pain for a longer amount of time. Linear regression models determined postoperative distal junctional kyphosis (adjusted beta: 0.207, p = .039) and osteoporosis (adjusted beta: 0.269, p = .007) as the strongest predictors of a poor NRS back IHS (model summary: R2 = 0.177, p = .039). CONCLUSIONS: Despite C patients exhibiting a quicker rate of MCID disability (ODI-NDI) improvement, they exhibited a poorer overall recovery of back pain with worse NRS back scores compared with BL status and other deformity groups. Postoperative distal junctional kyphosis and osteoporosis were identified as primary drivers of a poor postoperative NRS back IHS. Utilization of the IHS, a single number adjusting for all postoperative HRQOL visits, in conjunction with predictive modelling may pose as an improved method of gauging the effect of surgical details and complications on a patient's entire recovery process.

Recovery Kinetics: Comparison of Patients Undergoing Primary or Revision Procedures for Adult Cervical Deformity Using a Novel Area Under the Curve Methodology.

BACKGROUND: Limited data are available to objectively define what constitutes a "good" versus a "bad" recovery for operative cervical deformity (CD) patients. Furthermore, the recovery patterns of primary versus revision procedures for CD is poorly understood. OBJECTIVE: To define and compare the recovery profiles of CD patients undergoing primary or revision procedures, utilizing a novel area-under-the-curve normalization methodology. METHODS: CD patients undergoing primary or revision surgery with baseline to 1-yr health-related quality of life (HRQL) scores were included. Clinical symptoms and HRQL were compared among groups (primary/revision). Normalized HRQL scores at baseline and follow-up intervals (3M, 6M, 1Y) were generated. Normalized HRQLs were plotted and area under the curve was calculated, generating one number describing overall recovery (Integrated Health State). Subanalysis identified recovery patterns through 2-yr follow-up. RESULTS: Eighty-three patients were included (45 primary, 38 revision). Age (61.3 vs 61.9), gender (F: 66.7% vs 63.2%), body mass index (27.7 vs 29.3), Charlson Comorbidity Index, frailty, and osteoporosis (20% vs 13.2%) were similar between groups (P > .05). Primary patients were more preoperatively neurologically symptomatic (55.6% vs 31.6%), less sagittally malaligned (cervical sagittal vertical axis [cSVA]: 32.6 vs 46.6; T1 slope: 28.8 vs 36.8), underwent more anterior-only approaches (28.9% vs 7.9%), and less posterior-only approaches (37.8% vs 60.5%), all P < .05. Combined approaches, decompressions, osteotomies, and construct length were similar between groups (P > .05). Revisions had longer op-times (438.0 vs 734.4 min, P = .008). Following surgery, complication rate was similar between groups (66.6% vs 65.8%, P = .569). Revision patients remained more malaligned (cSVA, TS-CL; P < .05) than primary patients until 1-yr follow-up (P > .05). Normalized HRQLs determined primary patients to exhibit less neck pain (numeric rating scale [NRS]) and myelopathy (modified Japanese Orthopaedic Association) symptoms through 1-yr follow-up compared to revision patients (P < .05). These differences subsided when following patients through 2 yr (P > .05). Despite similar 2-yr HRQL outcomes, revision patients exhibited worse neck pain (NRS) Integrated Health State recovery (P < .05). CONCLUSION: Despite both primary and revision patients exhibiting similar HRQL outcomes at final follow-up, revision patients were in a greater state of postoperative neck pain for a greater amount of time.

Preoperative Assessment of Bone Quality in Spine Deformity Surgery: Correlation With Clinical Practice and Published Recommendations.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: The goals of this study were to (A) evaluate preoperative bone quality assessment and intervention practice over time and (B) review the current evidence for bone evaluation in spine fusion surgery. SUMMARY OF BACKGROUND DATA: Deformity spine surgery has demonstrated improved quality of life in patients; however, its cost has made it controversial. If preoperative bone quality can be optimized then potentially these treatments could be more durable; however, at present, no clinical practice guidelines have been published by professional spine surgical organizations. METHODS: A retrospective cohort review was performed on patients who underwent a minimum five-level primary or revision fusion. Preoperative bone quality metrics were evaluated over time from 2012 to 2017 to find potential trends. Subgroup analysis was conducted based on age, sex, preoperative diagnosis, and spine fusion region. RESULTS: Patient characteristics including preoperative rates of pseudarthrosis and junctional failure did not change. An increasing trend of physician bone health documentation was noted (P = 0.045) but changes in other metrics were not significant. A sex bias favored females who had higher rates of preoperative DXA studies (P = 0.001), Vitamin D 25-OH serum labs (P = 0.005), Vitamin D supplementation (P = 0.022), calcium supplementation (P < 0.001), antiresorptive therapy (P = 0.016), and surgeon clinical documentation of bone health (P = 0.008) compared with men. CONCLUSION: Our spine surgeons have increased documentation of bone health discussions but this has not affected bone quality interventions. A discrepancy exists favoring females over males in nearly all preoperative bone quality assessment metrics. Preoperative vitamin D level and BMD assessment should be considered in patients undergoing long fusion constructs; however, the data for bone anabolic and resorptive agents have less support. Clinical practice guidelines on preoperative bone quality assessment spine patients should be defined. LEVEL OF EVIDENCE: 4.

Recovery Kinetics of Radiographic and Implant-Related Revision Patients Following Adult Spinal Deformity Surgery.

BACKGROUND: Prior studies have observed similar health-related quality of life (HRQL) in revisions and nonrevision (NR) patients following adult spinal deformity (ASD) correction. However, a novel comparison approach may allow better comparisons in spine outcomes groups. OBJECTIVE: To determine if ASD revisions for radiographic and implant-related complications undergo a different recovery than NR patients. METHODS: Inclusion: ASD patients with complete HRQL (Oswestry Disability Index, Short-Form-36 version 2 (SF-36), Scoliosis Research Society [SRS]-22) at baseline, 6 wk, 1 yr, 2 yr. Generated revision groups: nonrevision (NR), revised-complete data (RC; with follow-up 2 yr after revision), and revised-incomplete data (RI; without 2-yr follow-up after revision). In a traditional analysis, analysis of variance (ANOVA) compared baseline HRQLs to follow-up changes. In a novel approach, integrated health state was normalized at baseline using area under curve analysis before ANOVA t-tests compared follow-up statuses. RESULTS: Two hundred fifty-eight patients were included with 50 undergoing reoperations (19.4%). Rod fractures (n = 15) and proximal joint kyphosis (n = 9) were most common. In standard HRQL analysis, comparing RC index surgery and RC revision surgery HRQLS revealed no significant differences throughout the 2-yr follow-up from either the initial index or revision procedure. Using normalized HRQL/integrated health state, RI displayed worse scores in SF-36 Physical Component Score, SRS activity, and SRS appearance relative to NR (P < .05), indicating less improvement over the 2-yr period. RC were significantly worse than RI in SF-36 Mental Component Score, SRS mental, SRS satisfaction, and SRS total (P < .05). CONCLUSION: ASD patients indicated for revisions for radiographic and implant-related complications differ significantly in their overall 2-yr recovery compared to NR, using a normalized integrated health state method. Traditional methods for analyzing revision patients' recovery kinetics may overlook delayed improvements.