How Do Functional Comorbidities Affect PROMIS-PF Scores Following Lumbar Fusion Surgery?

STUDY DESIGN: A retrospective review. OBJECTIVE: The purpose of this study is to trend PROMIS PF scores following lumbar fusion surgery, and to investigate how the presence of functional comorbidities affects PROMIS PF scores. Additionally, we compare trends in PROMIS PF scores to the Oswestry Disability Index (ODI) and to PROMIS Pain Interference (PI) scores. SUMMARY OF BACKGROUND DATA: National Institute of Health's (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) domain has been validated in spine surgery. However, little is known about how PROMIS-PF scores are affected by functional comorbidities and how these scores change in patients recovering from lumbar fusion surgery over time. In this study, we hypothesize that functional comorbidities negatively affect recovery. METHODS: We retrospectively identified 1,893 patients who underwent thoracolumbar, lumbar, or lumbosacral fusion for degenerative conditions between 01/02/2014 and 01/07/2022. We summarized PF at 3-month intervals for 2 years following surgery between those with and without functional comorbidity, defined as the presence of congestive heart failure (HF), chronic obstructive pulmonary disease (COPD), cerebrovascular disease (CVD), or paraplegia. Mixed effects multivariable regressions were used to model between group trends in PF through 2 years post-operatively controlling for age, gender, indication, and surgical invasiveness. The minimally clinically important difference (MCID) was defined as 5+ point improvement from baseline in PF. RESULTS: The cohort includes 1,224 (65%) patients without functional comorbidity and 669 (35%) with functional comorbidity. The mean age was 65.0 and Charlson index was 1.0 in the cohort without functional comorbidity compared to 65.4 and 3.8 in the cohort with functional comorbidity (P=0.552 and P<0.001 respectively). The groups were otherwise similar with respect to surgical invasiveness index, vertebral levels, and spine diagnosis (all P>0.05). At 24 months post operatively, the functional comorbidity group had a 2.5 point lower absolute PF score and a 1.3 point less improvement from baseline (P=0.012 and 0.190 respectively). 19.3% of patients in the functional comorbidity group achieved the MCID compared to 80.9% in patients without a functional comorbidity (P<0.001). CONCLUSION: Based on PROMIS PF scores, patients with functional comorbidities do not recover to the same extent and are less likely to achieve an MCID compared to patients without baseline functional comorbidities. PROMIS-PF can help benchmark patients along their recovery, and other metrics may be needed to better understand the recovery of patients with functional comorbidities.

Transthyretin amyloidosis in spinal canal stenosis: A systematic review.

We systematically review literature regarding the contribution of transthyretin amyloidosis to spinal stenosis. Amyloidosis is a protein misfolding condition that causes systemic deposition of amyloid and commonly leads to heart failure and nephropathy. A growing body of literature suggests that amyloid deposits within the ligamentum flavum are frequently associated with spinal stenosis with subsequent myelopathy. Our search identified 67 publications from the PubMed database for literature review. After evaluating the inclusion and exclusion criteria, a total of 18 articles were included in the review. Each article was evaluated for country, study type, sample size, amyloidosis subtype, spinal level, systemic symptoms, treatment, patient outcome, and conclusions. Many studies concluded that lumbar ligamentum flavum hypertrophy is more severe in patients with amyloidosis due to associated amyloid deposition. Additionally, patients with systemic amyloidosis are more likely to have recurrence of spinal stenosis. Multiple studies encourage routine screening be performed on spinal stenosis patients to target those needing cardiac surveillance. Amyloid deposition is frequently associated with spinal stenosis, and its presence may provide an earlier opportunity to diagnose or predict systemic amyloidosis. Surgeons should consider obtaining intraoperative biopsy to identify amyloidosis and inform screening postoperatively. Finally, physicians should be aware of this association and counsel patients accordingly on the risks and treatment options available for amyloidosis.

Factors Related to Clinical Performance in Spine Surgery Fellowship: Can We Predict Success.

INTRODUCTION: The factors most important in the spine fellowship match may not ultimately correlate with quality of performance during fellowship. This study examined the spine fellow applicant metrics correlated with high application rank compared with the metrics associated with the strongest clinical performance during fellowship. METHODS: Spine fellow applications at three academic institutions were retrieved from the San Francisco Match database (first available to 2021) and deidentified for application review. Application metrics pertaining to research, academics, education, extracurriculars, leadership, examinations, career interests, and letter of recommendations were extracted. Attending spine surgeons involved in spine fellow selection at their institutions were sent a survey to rank (1) fellow applicants based on their perceived candidacy and (2) the strength of performance of their previous fellows. Pearson correlation assessed the associations of application metrics with theoretical fellow rank and actual performance. RESULTS: A total of 37 spine fellow applications were included (Institution A: 15, Institution B: 12, Institution C: 10), rated by 14 spine surgeons (Institution A: 6, Institution B: 4, Institution C: 4). Theoretical fellow rank demonstrated a moderate positive association with overall research, residency program rank, recommendation writer H-index, US Medical Licensing Examination (USMLE) scores, and journal reviewer positions. Actual fellow performance demonstrated a moderate positive association with residency program rank, recommendation writer H-index, USMLE scores, and journal reviewer positions. Linear regressions identified journal reviewer positions (ß = 1.73, P = 0.002), Step 1 (ß = 0.09, P = 0.010) and Step 3 (ß = 0.10, P = 0.002) scores, recommendation writer H-index (ß = 0.06, P = 0.029, and ß = 0.07, P = 0.006), and overall research (ß = 0.01, P = 0.005) as predictors of theoretical rank. Recommendation writer H-index (ß = 0.21, P = 0.030) and Alpha Omega Alpha achievement (ß = 6.88, P = 0.021) predicted actual performance. CONCLUSION: Residency program reputation, USMLE scores, and a recommendation from an established spine surgeon were important in application review and performance during fellowship. Research productivity, although important during application review, was not predictive of fellow performance. LEVEL OF EVIDENCE: III. STUDY DESIGN: Cohort Study.

Riluzole for Degenerative Cervical Myelopathy: A Secondary Analysis of the CSM-PROTECT Trial.

Importance: The modified Japanese Orthopaedic Association (mJOA) scale is the most common scale used to represent outcomes of degenerative cervical myelopathy (DCM); however, it lacks consideration for neck pain scores and neglects the multidimensional aspect of recovery after surgery. Objective: To use a global statistical approach that incorporates assessments of multiple outcomes to reassess the efficacy of riluzole in patients undergoing spinal surgery for DCM. Design, Setting, and Participants: This was a secondary analysis of prespecified secondary end points within the Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-PROTECT) trial, a multicenter, double-blind, phase 3 randomized clinical trial conducted from January 2012 to May 2017. Adult surgical patients with DCM with moderate to severe myelopathy (mJOA scale score of 8-14) were randomized to receive either riluzole or placebo. The present study was conducted from July to December 2023. Intervention: Riluzole (50 mg twice daily) or placebo for a total of 6 weeks, including 2 weeks prior to surgery and 4 weeks following surgery. Main Outcomes and Measures: The primary outcome measure was a difference in clinical improvement from baseline to 1-year follow-up, assessed using a global statistical test (GST). The 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS), arm and neck pain numeric rating scale (NRS) scores, American Spinal Injury Association (ASIA) motor score, and Nurick grade were combined into a single summary statistic known as the global treatment effect (GTE). Results: Overall, 290 patients (riluzole group, 141; placebo group, 149; mean [SD] age, 59 [10.1] years; 161 [56%] male) were included. Riluzole showed a significantly higher probability of global improvement compared with placebo at 1-year follow-up (GTE, 0.08; 95% CI, 0.00-0.16; P = .02). A similar favorable global response was seen at 35 days and 6 months (GTE for both, 0.07; 95% CI, -0.01 to 0.15; P = .04), although the results were not statistically significant. Riluzole-treated patients had at least a 54% likelihood of achieving better outcomes at 1 year compared with the placebo group. The ASIA motor score and neck and arm pain NRS combination at 1 year provided the best-fit parsimonious model for detecting a benefit of riluzole (GTE, 0.11; 95% CI, 0.02-0.16; P = .007). Conclusions and Relevance: In this secondary analysis of the CSM-PROTECT trial using a global outcome technique, riluzole was associated with improved clinical outcomes in patients with DCM. The GST offered probability-based results capable of representing diverse outcome scales and should be considered in future studies assessing spine surgery outcomes.

Postoperative C5 Palsy after Anterior or Posterior Decompression for Degenerative Cervical Myelopathy: A Subgroup Analysis of the Multicenter, Prospective, Randomized, Phase III, CSM-Protect Clinical Trial.

STUDY DESIGN: Retrospective cohort study of prospectively accrued data. OBJECTIVE: To evaluate a large, prospective, multicentre dataset of surgically treated degenerative cervical myelopathy (DCM) cases on the contemporary risk of C5 palsy with surgical approach. SUMMARY OF BACKGROUND DATA: The influence of surgical technique on postoperative C5 palsy after decompression for DCM is intensely debated. Comprehensive, covariate-adjusted analyses are needed using contemporary data. METHODS: Patients with moderate to severe DCM were prospectively enrolled in the multicenter, randomized, Phase III CSM-Protect clinical trial and underwent either anterior or posterior decompression between Jan 31, 2012 and May 16, 2017. The primary outcome was the incidence of postoperative C5 palsy, defined as the onset of muscle weakness by at least one grade in manual muscle test at the C5 myotome with slight or absent sensory disruption after cervical surgery. Two comparative cohorts were made based on the anterior or posterior surgical approach. Multivariate hierarchical mixed-effects logistic regression was used to estimate odds ratios (OR) with 95% confidence intervals (CI) for C5 palsy. RESULTS: A total of 283 patients were included, and 53.4% underwent posterior decompression. The total incidence of postoperative C5 palsy was 7.4% and was significantly higher in patients who underwent posterior decompression compared with anterior decompression (11.26% vs. 3.03%, P =0.008). After multivariable regression, the posterior approach was independently associated with greater than four times the likelihood of postoperative C5 palsy ( P =0.017). Rates of C5 palsy recovery were comparable between the two surgical approaches. CONCLUSION: The odds of postoperative C5 palsy are significantly higher after posterior decompression compared to anterior decompression for DCM. This may influence surgical decision-making when there is equipoise in deciding between anterior and posterior treatment options for DCM. LEVEL OF EVIDENCE: Therapeutic Level-II.

Does Operative Level Impact Dysphagia Severity After Anterior Cervical Discectomy and Fusion?: A Multicenter Prospective Analysis.

STUDY DESIGN: Prospective multicenter cohort study. OBJECTIVE: To explore the association between operative level and postoperative dysphagia after anterior cervical discectomy and fusion (ACDF). BACKGROUND: Dysphagia is common after ACDF and has several risk factors, including soft tissue edema. The degree of prevertebral soft tissue edema varies based on the operative cervical level. However, the operative level has not been evaluated as a source of postoperative dysphagia. PATIENTS AND METHODS: Adult patients undergoing elective ACDF were prospectively enrolled at 3 academic centers. Dysphagia was assessed using the Bazaz Questionnaire, Dysphagia Short Questionnaire, and Eating Assessment Tool-10 (EAT-10) preoperatively and at 2, 6, 12, and 24 weeks postoperatively. Patients were grouped based on the inclusion of specific surgical levels in the fusion construct. Multivariable regression analyses were performed to evaluate the independent effects of the number of surgical levels and the inclusion of each particular level on dysphagia symptoms. RESULTS: A total of 130 patients were included. Overall, 24 (18.5%) patients had persistent postoperative dysphagia at 24 weeks and these patients were older, female, and less likely to drink alcohol. There was no difference in operative duration or dexamethasone administration. Patients with persistent dysphagia were significantly more likely to have C4-C5 included in the fusion construct (62.5% vs . 34.9%, P = 0.024) but there were no differences based on the inclusion of other levels. On multivariable regression, the inclusion of C3-C4 or C6-C7 was associated with more severe EAT-10 (ß: 9.56, P = 0.016 and ß: 8.15, P = 0.040) and Dysphagia Short Questionnaire (ß: 4.44, P = 0.023 and (ß: 4.27, P = 0.030) at 6 weeks. At 12 weeks, C3-C4 fusion was also independently associated with more severe dysphagia (EAT-10 ß: 4.74, P = 0.024). CONCLUSION: The location of prevertebral soft tissue swelling may impact the duration and severity of patient-reported dysphagia outcomes at up to 24 weeks postoperatively. In particular, the inclusion of C3-C4 and C4-C5 into the fusion may be associated with dysphagia severity.

Development and validation of a large animal ovine model for implant-associated spine infection using biofilm based inocula.

Postoperative implant-associated spine infection remains poorly understood. Currently there is no large animal model using biofilm as initial inocula to study this challenging clinical entity. The purpose of the present study was to develop a sheep model for implant-associated spine infection using clinically relevant biofilm inocula and to assess the in vivo utility of methylene blue (MB) for visualizing infected tissues and guiding debridement. This 28-day study used five adult female Rambouillet sheep, each with two non-contiguous surgical sites- in the lumbar and thoracic regions- comprising randomized positive and negative infection control sites. A standard mini-open approach to the spine was performed to place sterile pedicle screws and Staphylococcus aureus biofilm-covered (positive control), or sterile (negative control) spinal fusion rods. Surgical site bioburden was quantified at the terminal procedure. Negative and positive control sites were stained with MB and staining intensity quantified from photographs. Specimens were analyzed with x-ray, micro-CT and histologically. Inoculation rods contained ∼10.44 log10 colony forming units per rod (CFU/rod). Biofilm inocula persisted on positive-control rod explants with ∼6.16 log10 CFU/rod. There was ∼6.35 log10 CFU/g of tissue in the positive controls versus no identifiable bioburden in the negative controls. Positive controls displayed hallmarks of deep spine infection and osteomyelitis, with robust local tissue response, bone resorption, and demineralization. MB staining was more intense in infected, positive control sites. This work presents an animal-efficient sheep model displaying clinically relevant implant-associated deep spine infection.

Evaluating Dysphagia Duration and Severity After ACDF in Patients With Underlying Dysphagia - A Prospective, Multicenter Study.

STUDY DESIGN: Prospective Cohort Study. OBJECTIVES: The purpose of this study was to prospectively evaluate the impact of preoperative dysphagia on the postoperative incidence and severity of dysphagia in patients undergoing ACDF at multiple institutions. METHODS: After IRB approval, patients over 18 years of age who underwent an elective ACDF for degenerative conditions were prospectively enrolled at two academic centers from 2018 to 2021. Preoperative dysphagia was self-reported by patients through a pre-operative questionnaire on a binary basis. Patients completed dysphagia surveys (Bazaz, Dysphagia Short Questionnaire, 10-item Eating Assessment Tool) to assess dysphagia severity during their preoperative visit, and these dysphagia surveys were repeated immediately postoperatively, at two weeks and again at six, 12, and 24 weeks postoperatively. Patients were stratified into three subgroups based on dysphagia status preoperatively and immediately postoperatively and compared using ANOVA tests or Kruskal-Wallis tests for continuous variables and Pearson chi-square analysis or Fisher's Exact test for categorical variables. RESULTS: A total of 168 patients (23 with preoperative dysphagia, 145 without preoperative dysphagia) met study criteria and were enrolled in the study. Patients with preoperative dysphagia had less frequent alcohol consumption (23.8% vs 53.7%, P = .0210), and higher rates of dysphagia at 2-weeks (77.8% vs 38.7%, P = .004) and 24-weeks (43.8% vs 14.8%, P = .010) postoperatively. These patients also had higher severity scores for dysphagia on the Bazaz (P = .001), DSQ (P = .012), EAT10 (P = .022) questionnaires at the 2-week follow-up period, higher DSQ scores (P = .036) at the 6-week follow-up period, higher EAT-10 scores (P = .009) at the 12-week follow-up period, and higher Bazaz (P = .001), DSQ (P = .002), and EAT-10 (P = .005) scores at the 24-week follow-up period. There were no differences in demographic, medical history, surgical variables, rates of ENT consultation, length of stay, or other in-hospital events between groups. CONCLUSIONS: Patients undergoing ACDF who had preoperative dysphagia have prolonged postoperative dysphagia and greater dysphagia severity. Surgeons should be aware of the risk of prolonged dysphagia severity that may persist past 24 weeks after surgery when discussing clinical decisions with patients.

Safety and Efficacy of Riluzole in Acute Spinal Cord Injury Study (RISCIS): A Multi-Center, Randomized, Placebo-Controlled, Double-Blinded Trial.

Riluzole is a sodium-glutamate antagonist that attenuates neurodegeneration in amyotrophic lateral sclerosis (ALS). It has shown favorable results in promoting recovery in pre-clinical models of traumatic spinal cord injury (tSCI) and in early phase clinical trials. This study aimed to evaluate the efficacy and safety of riluzole in acute cervical tSCI. An international, multi-center, prospective, randomized, double-blinded, placebo-controlled, adaptive, Phase III trial (NCT01597518) was undertaken. Patients with American Spinal Injury Association Impairment Scale (AIS) A-C, cervical (C4-C8) tSCI, and <12 h from injury were randomized to receive either riluzole, at an oral dose of 100 mg twice per day (BID) for the first 24 h followed by 50 mg BID for the following 13 days, or placebo. The primary efficacy end-point was change in Upper Extremity Motor (UEM) scores at 180 days. The primary efficacy analyses were conducted on an intention to treat (ITT) and completed cases (CC) basis. The study was powered at a planned enrolment of 351 patients. The trial began in October 2013 and was halted by the sponsor on May 2020 (and terminated in April 2021) in the face of the global COVID-19 pandemic. One hundred ninety-three patients (54.9% of the pre-planned enrolment) were randomized with a follow-up rate of 82.7% at 180 days. At 180 days, in the CC population the riluzole-treated patients compared with placebo had a mean gain of 1.76 UEM scores (95% confidence interval: -2.54-6.06) and 2.86 total motor scores (CI: -6.79-12.52). No drug-related serious adverse events were associated with the use of riluzole. Additional pre-planned sensitivity analyses revealed that in the AIS C population, riluzole was associated with significant improvement in total motor scores (estimate: standard error [SE] 8.0; CI 1.5-14.4) and upper extremity motor scores (SE 13.8; CI 3.1-24.5) at 6 months. AIS B patients had higher reported independence, measured by the Spinal Cord Independence Measure score (45.3 vs. 27.3; d: 18.0 CI: -1.7-38.0) and change in mental health scores, measured by the Short Form 36 mental health domain (2.01 vs. -11.58; d: 13.2 CI: 1.2-24.8) at 180 days. AIS A patients who received riluzole had a higher average gain in neurological levels at 6 months compared with placebo (mean 0.50 levels gained vs. 0.12 in placebo; d: 0.38, CI: -0.2-0.9). The primary analysis did not achieve the predetermined end-point of efficacy for riluzole, likely related to insufficient power. However, on pre-planned secondary analyses, all subgroups of cervical SCI subjects (AIS grades A, B and C) treated with riluzole showed significant gains in functional recovery. The results of this trial may warrant further investigation to extend these findings. Moreover, guideline development groups may wish to assess the possible clinical relevance of the secondary outcome analyses, in light of the fact that SCI is an uncommon orphan disorder without an accepted neuroprotective treatment.

Representativeness of the American Spine Registry: a comparison of patient characteristics with the National Inpatient Sample.

OBJECTIVE: The American Spine Registry (ASR) is a collaborative effort between the American Academy of Orthopaedic Surgeons and the American Association of Neurological Surgeons. The goal of this study was to evaluate how representative the ASR is of the national practice with spinal procedures, as recorded in the National Inpatient Sample (NIS). METHODS: The authors queried the NIS and the ASR for cervical and lumbar arthrodesis cases performed during 2017-2019. International Classification of Diseases, 10th Revision and Current Procedural Terminology codes were used to identify patients undergoing cervical and lumbar procedures. The two groups were compared for the overall proportion of cervical and lumbar procedures, age distribution, sex, surgical approach features, race, and hospital volume. Outcomes available in the ASR, such as patient-reported outcomes and reoperations, were not analyzed due to nonavailability in the NIS. The representativeness of the ASR compared to the NIS was assessed via Cohen's d effect sizes, and absolute standardized mean differences (SMDs) of < 0.2 were considered trivial, whereas > 0.5 were considered moderately large. RESULTS: A total of 24,800 arthrodesis procedures were identified in the ASR for the period between January 1, 2017, and December 31, 2019. During the same time period, 1,305,360 cases were recorded in the NIS. Cervical fusions comprised 35.9% of the ASR cohort (8911 cases) and 36.0% of the NIS cohort (469,287 cases). The two databases presented trivial differences in terms of patient age and sex for all years of interest across both cervical and lumbar arthrodeses (SMD < 0.2). Trivial differences were also noted in the distribution of open versus percutaneous procedures of the cervical and lumbar spine (SMD < 0.2). Among lumbar cases, anterior approaches were more common in the ASR than in the NIS (32.1% vs 22.3%, SMD = 0.22), but the discrepancy among cervical cases in the two databases was trivial (SMD = 0.03). Small differences were illustrated in terms of race, with SMDs < 0.5, and a more significant discrepancy was identified in the geographic distribution of participating sites (SMDs of 0.7 and 0.74 for cervical and lumbar cases, respectively). For both of these measures, SMDs in 2019 were smaller than those in 2018 and 2017. CONCLUSIONS: The ASR and NIS databases presented a very high similarity in proportions of cervical and lumbar spine surgeries, as well as similar distributions of age and sex, and distribution of open versus endoscopic approach. Slight discrepancies in anterior versus posterior approach among lumbar cases and patient race, and more significant discrepancies in geographic representation were also identified, yet decreasing trends in differences suggested the improving representativeness of the ASR over the course of time and its progressive growth. These conclusions are important to underline the external validity of quality investigations and research conclusions to be drawn from analyses in which the ASR is used.

Surgeon input can increase the value of registry data: early experience from the American Spine Registry.

OBJECTIVE: Clear diagnostic delineation is necessary for the development of a strong evidence base in lumbar spinal surgery. Experience with existing national databases suggests that International Classification of Diseases, Tenth Edition (ICD-10) coding is insufficient to support that need. The purpose of this study was to assess agreement between surgeon-specified diagnostic indication and hospital-reported ICD-10 codes for lumbar spine surgery. METHODS: Data collection for the American Spine Registry (ASR) includes an option to denote the surgeon's specific diagnostic indication for each procedure. For cases treated between January 2020 and March 2022, surgeon-delineated diagnosis was compared with the ICD-10 diagnosis generated by standard ASR electronic medical record data extraction. For decompression-only cases, the primary analysis focused on the etiology of neural compression as determined by the surgeon versus that determined on the basis of the related ICD-10 codes extracted from the ASR database. For lumbar fusion cases, the primary analysis compared structural pathology, which may have required fusion, as determined by the surgeon versus that determined on the basis of the extracted ICD-10 codes. This allowed for identification of agreement between surgeon delineation and extracted ICD-10 codes. RESULTS: In 5926 decompression-only cases, agreement between the surgeon and ASR ICD-10 codes was 89% for spinal stenosis and 78% for lumbar disc herniation and/or radiculopathy. Both the surgeon and database indicated no structural pathology (i.e., none) suggesting the need for fusion in 88% of cases. In 5663 lumbar fusion cases, agreement was 76% for spondylolisthesis but poor for other diagnostic indications. CONCLUSIONS: Agreement between surgeon-specified diagnostic indication and hospital-reported ICD-10 codes was best for patients who underwent decompression only. In the fusion cases, agreement with ICD-10 codes was best in the spondylolisthesis group (76%). In cases other than spondylolisthesis, agreement was poor due to multiple diagnoses or lack of an ICD-10 code that reflected the pathology. This study suggested that standard ICD-10 codes may be inadequate to clearly define the indications for decompression or fusion in patients with lumbar degenerative disease.

Response to Preoperative Steroid Injections Predicts Surgical Outcomes in Patients Undergoing Fusion for Isthmic Spondylolisthesis.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: The decision to pursue operative intervention for patients with isthmic spondylolisthesis is complex. Although steroid injections are a well-accepted therapeutic modality that may delay or obviate surgery, little is known regarding their ability to predict surgical outcomes. SUMMARY OF BACKGROUND DATA: Here, we examine whether improvement after preoperative steroid injections can accurately predict clinical outcomes after surgery. METHODS: A retrospective cohort analysis was performed on adult patients undergoing primary posterolateral lumbar fusion for isthmic spondylolisthesis between 2013 and 2021. Data were stratified into a control (no preoperative injection) group and an injection group (received a preoperative diagnostic and therapeutic injection). We collected demographic data, peri-injection visual analog pain scores (VAS) pain scores, PROMIS pain interference and physical function scores, Oswestry Disability Index, and VAS pain (back and leg). Student t test was utilized to compare baseline group characteristics. Linear regression was performed comparing changes in peri-injection VAS pain scores and postoperative measures. RESULTS: Seventy-three patients did not receive a preoperative injection and were included in the control group. Fifty-nine patients were included in the injection group. Of patients who received an injection, 73% had >50% relief of their preinjection VAS pain score. Linear regression revealed a positive interaction between the injection efficacy and postoperative pain relief as measured by VAS leg scores ( P <0.05). There was also an association between injection efficacy and back pain relief, though this did not achieve statistical significance ( P =0.068). No association was found between injection efficacy and improvement in Oswestry Disability Index or PROMIS measures. CONCLUSIONS: Steroid injections are often utilized in the nonoperative therapeutic management of patients with lumbar spine disease. Here, we demonstrate the diagnostic value of steroid injections in predicting postoperative leg pain relief in patients undergoing posterolateral fusion for isthmic spondylolisthesis.

Hypoalbuminemia as a Predictor of Mortality, Disability, and Readmission in Patients Undergoing Spine Surgery: A Retrospective Analysis.

STUDY DESIGN: This was a retrospective cohort study. OBJECTIVE: The objective of this study was to clarify the association between preoperative albumin status and mortality and morbidity in lumbar spine surgery. SUMMARY OF BACKGROUND DATA: Hypoalbuminemia is a known marker of inflammation and is associated with frailty. Hypoalbuminemia is an identified risk factor for mortality following spine surgery for metastases, yet has not been well studied among spine surgical cohorts outside of metastatic cancer. MATERIALS AND METHODS: We identified patients with preoperative serum albumin laboratory values who underwent lumbar spine surgery at a US public university health system between 2014 and 2021. Demographic, comorbidity, and mortality data were collected along with preoperative and postoperative Oswestry Disability Index (ODI) scores. Any cause readmission within 1 year of surgery was recorded. Hypoalbuminemia was defined as <3.5 g/dL in serum. We examined the Kaplan-Meier survival plots based on serum albumin. Multivariable regression models were used to identify the association between preoperative hypoalbuminemia with mortality, readmission, and ODI, while controlling for age, sex, race, ethnicity, procedure, and Charlson Comorbidity Index. RESULTS: Of 2573 patients, 79 were identified as hypoalbuminemic. Hypoalbuminemic patients had a significantly greater adjusted risk of mortality through 1 year (odds ratio=10.2; 95% CI: 3.1-33.5; P <0.001), and 7 years (hazard ratio=4.18; 95% CI: 2.29-7.65; P <0.001). Hypoalbuminemic patients had ODI scores 13.5 points higher (95% CI: 5.7-21.4; P <0.001) at baseline. Adjusted readmission rates were not different between groups through 1 year (odds ratio=1.15; 95% CI: 0.5-2.62; P =0.75) or through full surveillance (hazard ratio=0.82; 95% CI: 0.44-1.54; P =0.54). CONCLUSIONS: Preoperative hypoalbuminemia was strongly associated with postoperative mortality. Hypoalbuminemic patients did not have demonstrably worse outcomes in their functional disability beyond 6 months. Within the first 6 months following surgery, the hypoalbuminemic group improved at a similar rate to the normoalbuminemic group despite having a greater preoperative disability. However, causal inference is limited in this retrospective study.

Evaluating the Effect of Gastroesophageal Reflux Disease on Postoperative Dysphagia Following Anterior Cervical Spine Surgery-A Prospective, Multicenter Study.

STUDY DESIGN: Prospective cohort study. OBJECTIVES: The purpose of this study was to prospectively evaluate the impact of a preoperative diagnosis of gastroesophageal reflux disease on the incidence and severity of postoperative dysphagia in a multicenter population. METHODS: After Institutional Review Board approval, written informed consent was obtained from all participating patients. Patients over 18 years of age who underwent an elective anterior cervical discectomy and fusion for a degenerative condition were prospectively enrolled at two academic centers from the years 2018 to 2020. Patients were separated into two groups: those with and without a preoperative diagnosis of GERD. Continuous variables were assessed using either an independent t-test or Mann Whitney U-test for parametric and non-parametric data. All categorical variables were compared using a chi-square test. RESULTS: A total of 116 patients met study criteria and were subsequently enrolled. Overall rates of postoperative dysphagia increased to 47.3% (n = 53) at 2-weeks but eventually decreased towards the preoperative prevalence of 25.0% at the 24-week mark. Patients with preoperative diagnosis of GERD had lower dysphagia severity scores on a continuous variable analysis in both the DSQ and EAT-10 surveys at 2-week follow-up in addition to the Bazaz survey at 24-week follow-up. Our follow up at 24-weeks was 85.7%. CONCLUSIONS: Our study shows that having a preoperative diagnosis of GERD has no significant effect on the incidence of dysphagia following ACDF. Nevertheless, having a preoperative diagnosis of GERD does seem to provide some protective effect on the severity of dysphagia that this patient population develops at multiple intervals over a 24-week postoperative period.

Preoperative Fluoroscopically Guided Regional Erector Spinae Plane Blocks Reduce Opioid Use, Increase Mobilization, and Reduce Length of Stay Following Lumbar Spine Fusion.

STUDY DESIGN: Retrospective review. OBJECTIVE: To determine the effectiveness of erector spinae plane (ESP) blocks at improving perioperative pain control and function following lumbar spine fusions. METHODS: A retrospective analysis was performed on patients undergoing < 3 level posterolateral lumbar fusions. Data was stratified into a control group and a block group. We collected postop MED (morphine equivalent dosages), physical therapy ambulation, and length of stay. PROMIS pain interference (PI) and physical function (PF) scores, ODI, and VAS were collected preop and at the first postop visit. Chi-square and student's t-test (P = .05) were used for analysis. We also validated a novel fluoroscopic technique for ESP block delivery. RESULTS: There were 37 in the block group and 39 in the control group. There was no difference in preoperative opioid use (P = .22). On postop day 1, MED was reduced in the block group (32 vs 51, P < .05), and more patients in the block group did not utilize any opioids (22% vs 5%, P < .05). The block group ambulated further on postop day 1 (312 ft vs 204 ft, P < .05), and had reduced length of stay (2.4 vs 3.2 days, P < .05). The block group showed better PROMIS PI scores postoperatively (58 vs 63, P < .05). The novel delivery technique was validated and successful in targeting the correct level and plane. CONCLUSIONS: ESP blocks significantly reduced postop opioid use following lumbar fusion. Block patients ambulated further with PT, had reduced length of stay, and had improved PROMIS PI postoperatively. Validation of the block demonstrated the effectiveness of a novel fluoroscopic delivery technique. ESP blocks represent an underutilized method of reducing opioid consumption, improving postoperative mobilization and reducing length of stay following lumbar spine fusion.

Postoperative ileus risk after posterior thoracolumbar fusion performed with total intravenous anesthesia versus inhaled anesthesia.

OBJECTIVE: There has been an increase in the use of total intravenous anesthesia (TIVA) for intraoperative neuromonitoring during thoracolumbar posterior spinal fusion (PSF). Although prior studies have identified risk factors for postoperative ileus (PI) after PSF, to the authors' knowledge, PI rates in patients receiving inhaled anesthetic versus TIVA have not been evaluated. In this study the authors analyzed whether TIVA is associated with greater risk of PI in PSF patients. METHODS: In this retrospective single-institution cohort study, all patients undergoing PSF at the authors' tertiary academic institution from May 2014 to December 2020 were included. Patients undergoing anterior/lateral approaches or who had concurrent abdominal procedures unrelated to ileus in the same admission were excluded. PI was defined using radiographic and/or clinical diagnoses (postoperative radiographs, abdominal CT, and/or ICD-9 or -10 codes) and was confirmed via chart review. The use of TIVA or inhaled anesthetic was captured from the anesthesia record; patients were excluded if they were missing anesthesia technique data. Postoperative occurrence of PI was compared between patients who had TIVA or inhaled anesthetics while controlling for collected demographic, clinical, and surgical variables. RESULTS: Of the 2819 patients meeting inclusion criteria, 283 (10.0%) had PI (mean ± SD age 59.3 ± 15.8 years; 155 [54.8%] male). The mean patient length of stay was 7.7 ± 5.0 days, which was significantly longer than that of patients without PI (4.9 ± 3.9 days, p < 0.001). Patients with PI had more levels fused (46% of PI patients with ≥ 5 levels fused vs 25% of non-PI patients, p < 0.001) and longer operations (6.0 ± 2.2 vs 5.4 ± 1.9 hours, p < 0.001). TIVA patients were more likely than inhalation-only patients to experience PI, but this finding did not reach significance on univariate analysis (11.0% PI rate vs 8.9%, p = 0.06). After propensity matching 125 non-PI patients and 50 PI patients by age, sex, operative time, and number of levels fused, there was a significant difference in intraoperative opiate dosing between TIVA and inhalational patients (275.7 ± 187.5 intravenous morphine milligram equivalents vs 120.9 ± 155.5, p < 0.001). On multivariate analysis of PI outcome, TIVA was an independently significant predictor (OR 1.45, p = 0.02), as was anesthesia time (OR per hour increase: 1.09, p = 0.03) and ≥ 8 levels fused (OR 1.86, p = 0.01). CONCLUSIONS: In a large cohort of PSF patients, TIVA was associated with a higher rate of PI compared with inhaled anesthetic. This effect is likely due to higher intraoperative opiate use in these patients.

Risk Factors for Postoperative Ileus in Patients Undergoing Spine Surgery.

STUDY DESIGN: Retrospective Cohort Study. OBJECTIVES: Postoperative ileus (POI) is a common complication following elective spinal surgeries. The aim of this study was to determine the incidence of POI and identify demographic and surgical risk factors for developing POI after elective instrumented fusion of the thoracolumbar spine. METHODS: The University of Utah Institutional Review Board (IRB) approved this retrospective study. The study does not require informed consent given the data reviewed was deidentified and collected in accordance with the institution's standard of care. A designated IRB committee determined that study is exempt under exemption category 7. IRB approval number 00069703. Patients undergoing instrumented thoracolumbar fusion for one or more levels were retrospectively identified from an internal spine surgery database. Cases performed for trauma, infection, or tumors were excluded. Demographics, medical comorbidities, surgical variables, and opioid medication administration (morphine milligram equivalents, MME) were abstracted from the electronic medical record. Univariate analysis was used to identify variables associated with POI. These variables were then tested for independent association with POI using multivariate logistic regression. RESULTS: 418 patients were included in the current study. The incidence of POI was 9.3% in this cohort. There was no significant relationship between development of POI and patient age, gender, BMI, diabetes mellitus, thyroid dysfunction, lung disease, CKD, GERD, smoking status, alcohol abuse, anemia, or prior abdominal surgery. Univariate analysis demonstrated significant association between POI and fusion ≥7 levels compared to fusions of fewer levels (P = .001), as well as intraoperative sufentanil compared to other opioids (35.9% vs 20.1%, P = .02). POI was not significantly associated with total intraoperative MME, approach, use of interbody cage, or osteotomy. Multivariate logistic regression confirmed total 24-hour postoperative MME as an independent risk factor for POI (OR 1.004, P = .04), however, intraoperative sufentanil administration was not an independent risk factor for POI when controlling for other variables. CONCLUSIONS: This retrospective cohort study demonstrates that greater postoperative MME is an independent risk factor for POI after thoracolumbar spine fusion when accounting for demographic, medical, and surgical variables with multiple logistic regression. Prospective studies are warranted to evaluate clinical measures to decrease the risk of POI among patients undergoing instrumented thoracolumbar spinal fusions.

Summary of the FDA virtual public workshop on spinal device clinical review held on September 17, 2021.

The mission of Food and Drug Administration (FDA)'s Center for Devices and Radiological Health is to protect and promote public health. It assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products by providing meaningful and timely information about the products we regulate and the decisions we make. On September 17, 2021, an FDA workshop was held to provide information to stakeholders, including members of the spine community, device manufacturers, regulatory affairs professionals, clinicians, patients, and the general public regarding FDA regulations, guidance and regulatory pathways related to spinal device clinical review. It was not intended to communicate any new policies, processes, or interpretations regarding medical device marketing authorizations. This workshop consisted of individual presentations, group discussions, question and answer sessions, and audience surveys. Information-sharing included discussions related to patient-reported outcomes, clinician-reported outcomes, observer-reported outcomes, and performance outcomes. Discussions involving external subject matter experts covered topics related to spinal device clinical studies including definition of a target population, enrollment criteria, strategies for inclusion of under-represented patient groups, reporting of adverse event and secondary surgical procedures, clinical study endpoints, and clinical outcome assessments. A meeting transcript and webcast workshop link are currently posted on the FDA website. Important related issues and challenges were discussed, and an exciting range of new ideas and concepts were shared which hold promise to advance regulatory science, patient care and future innovation related to spinal devices.

How Do PROMIS Scores Correspond to Common Physical Abilities?

BACKGROUND: The Patient-Report Outcomes Measurement Information System (PROMIS) is increasingly used as a general-purpose tool for measuring orthopaedic surgery outcomes. This set of questionnaires is efficient, precise, and correlates well with specialty-specific measures, but impactful implementation of patient-specific data, especially at the point of care, remains a challenge. Although clinicians may have substantial experience with established patient-reported outcome measures in their fields, PROMIS is relatively new, and the real-life meaning of PROMIS numerical summary scores may be unknown to many orthopaedic surgeons. QUESTIONS/PURPOSES: We aimed to (1) identify a small subset of important items in the PROMIS Physical Function (PF) item bank that are answered by many patients with orthopaedic conditions and (2) graphically display characteristic responses to these items across the physical function spectrum in order to translate PROMIS numerical scores into physical ability levels using clinically relevant, familiar terms. METHODS: In a cross-sectional study, 97,852 PROMIS PF assessments completed by 37,517 patients with orthopaedic conditions presenting to a tertiary-care academic institution were pooled and descriptively analyzed. Between 2017 and 2020, we evaluated 75,354 patients for outpatient orthopaedic care. Of these, 67% (50,578) were eligible for inclusion because they completed a PROMIS version 2.0 physical function assessment; 17% (12,720) were excluded because they lacked information in the database on individual item responses, and another < 1% (341) were excluded because the assessment standard error was greater than 0.32, leaving 50% of the patients (37,517) for analysis. The PROMIS PF is scored on a 0-point to 100-point scale, with a population mean of 50 and SD of 10. Anchor-based minimum clinically important differences have been found to be 8 to 10 points in a foot and ankle population, 7 to 8 points in a spine population, and approximately 4 points in a hand surgery population. The most efficient and precise means of administering the PROMIS PF is as a computerized adaptive test (CAT), whereby an algorithm intelligently tailors each follow-up question based on responses to previous questions, requiring only a few targeted questions to generate an accurate result. In this study, the mean PROMIS PF score was 41 ± 9. The questions most frequently used by the PROMIS CAT software were identified (defined in this study as any question administered to > 0.1% of the cohort). To understand the ability levels of patients based on their individual scores, patients were grouped into score categories: < 18, 20 ± 2, 25 ± 2, 30 ± 2, 35 ± 2, 40 ± 2, 45 ± 2, 50 ± 2, 55 ± 2, 60 ± 2, and > 62. For each score category, the relative frequency of each possible response (ranging from "cannot do" to "without any difficulty") was determined for each question. The distribution of responses given by each score group for each question was graphically displayed to generate an intuitive map linking PROMIS scores to patient ability levels (with ability levels represented by how patients responded to the PROMIS items). RESULTS: Twenty-eight items from the 165-question item bank were used frequently (that is, administered to more than 0.1% of the cohort) by the PROMIS CAT software. The top four items constituted 63% of all items. These top four items asked about the patient's ability to perform 2 hours of physical labor, yard work, household chores, and walking more than 1 mile. Graphical displays of responses to the top 28 and top four items revealed how PROMIS scores correspond to patient ability levels. Patients with a score of 40 most frequently responded that they experienced "some difficulty" with physical labor, yard work, household chores, and walking more than 1 mile, compared with "little" or "no" difficulty for patients with a score of 50 and "cannot do" for patients with a score of 30. CONCLUSION: We provided a visual key linking PROMIS numerical scores to physical ability levels using clinically relevant, familiar terms. Future studies might investigate whether using similar graphical displays as a patient education tool enhances patient-provider communication and improves the patient experience. CLINICAL RELEVANCE: The visual explanation of PROMIS scores provided by this study may help new users of the PROMIS understand the instrument, feel empowered to incorporate it into their practices, and use it as a tool for counseling patients about their scores.

Is Discretionary Care Associated with Safety Among Medicare Beneficiaries Undergoing Spine Surgery?

BACKGROUND: Spine surgery and its corresponding costs have increased in recent years and are variable across geographic regions. Discretionary care is the component of spending variation that is independent of illness severity, age, and regional pricing. It is unknown whether greater discretionary care is associated with improved safety for patients undergoing spine surgery, as we would expect from value-based health care. METHODS: We conducted an analysis of 5 spine surgery cohorts based on Medicare claims from 2013 to 2017. Patients were grouped into quintiles based on the Dartmouth Atlas End-of-Life Inpatient Care Index (EOL), reflecting regional spending variation attributed to discretionary care. Multivariable regression examined the association between discretionary care and safety measures while controlling for age, sex, race, comorbidity, and hospital features. RESULTS: We observed a threefold to fourfold variation in 90-day episode-of-care cost across regions, depending on the cohort. Spine-specific spending was correlated with EOL quintile, confirming that spending variation is due more to discretionary care than it is to pricing, age, or illness severity. Greater spending across EOL quintiles was not associated with improved safety, and, in fact, was associated with poorer safety in some cohorts. For example, all-cause readmission was greater in the high-spending EOL quintile relative to the low-spending EOL quintile among the "fusion, except cervical" cohort (14.2% vs. 13.1%; OR = 1.10; 95% CI = 1.05 to 1.20), the "complex fusion" cohort (28.0% vs. 25.4%; OR = 1.15; 95% CI = 1.01 to 1.30), and the "cervical fusion" cohort (15.0% vs. 13.6%; OR = 1.12; 95% CI = 1.05 to 1.20). CONCLUSIONS: Wide variation in spending was not explained by differences in illness severity, age, or pricing, and increased discretionary care did not enhance safety. These findings point to inefficient use of health-care resources, a potential focus of reform. LEVEL OF EVIDENCE: Economic and Decision Analysis Level IV. See Instructions for Authors for a complete description of levels of evidence.