Streamlining the Journey of Research Into Clinical Practice: Making Your Patients and Practice Flourish Optimizing Management and Minimizing Risk of Osteoporotic Vertebral Fractures - Perspectives of the AO Spine KF Trauma and Infection Group Key Opinion Leaders.

STUDY DESIGN: Literature review with clinical recommendations. OBJECTIVE: To highlight important studies about osteoporotic spinal fractures (OF) that may be integrated into clinical practice based on the assessment of the AO Spine KF Trauma and Infection group key opinion leaders. METHODS: 4 important studies about OF that may affect current clinical practice of spinal surgeons were selected and reviewed with the aim of providing clinical recommendations to streamline the journey of research into clinical practice. Recommendations were graded as strong or conditional following the GRADE methodology. RESULTS: 4 studies were selected. Article 1: a validation of the Osteoporotic Fracture (OF)-score to treat OF fractures. Conditional recommendation to incorporate the OF score in the management of fractures to improve clinical results. Article 2: a randomized multicenter study comparing romosozumab/alendronate vs alendronate to decrease the incidence of new vertebral fractures. Strong recommendation that the group receiving romosozumab/alendronate had a decreased risk of new OF when compared with the alendronate only group only. Article 3: a systematic literature review of spinal orthoses in the management of. Conditional recommendation to prescribe a spinal orthosis to decrease pain and improve quality of life. Article 4: post-traumatic deformity after OF. A conditional recommendation that middle column injury and pre-injury use of steroids may lead to high risk of post-traumatic deformity after OF. CONCLUSIONS: Management of patients with OF is still complex and challenging. This review provides some recommendations that may help surgeons to better manage these patients and improve their clinical practice.

Expert Opinion, Real-World Classification, and Decision-Making in Thoracolumbar Burst Fractures Without Neurologic Deficits?

STUDY DESIGN: Retrospective analysis of prospectively collected data. OBJECTIVES: To compare decision-making between an expert panel and real-world spine surgeons in thoracolumbar burst fractures (TLBFs) without neurological deficits and analyze which factors influence surgical decision-making. METHODS: This study is a sub-analysis of a prospective observational study in TL fractures. Twenty two experts were asked to review 183 CT scans and recommend treatment for each fracture. The expert recommendation was based on radiographic review. RESULTS: Overall agreement between the expert panel and real-world surgeons regarding surgery was 63.2%. In 36.8% of cases, the expert panel recommended surgery that was not performed in real-world scenarios. Conversely, in cases where the expert panel recommended non-surgical treatment, only 38.6% received non-surgical treatment, while 61.4% underwent surgery. A separate analysis of A3 and A4 fractures revealed that expert panel recommended surgery for 30% of A3 injuries and 68% of A4 injuries. However, 61% of patients with both A3 and A4 fractures received surgery in the real world. Multivariate analysis demonstrated that a 1% increase in certainty of PLC injury led to a 4% increase in surgery recommendation among the expert panel, while a .2% increase in the likelihood of receiving surgery in the real world. CONCLUSION: Surgical decision-making varied between the expert panel and real-world treating surgeons. Differences appear to be less evident in A3/A4 burst fractures making this specific group of fractures a real challenge independent of the level of expertise.

The Surgical Algorithm for the AO Spine Sacral Injury Classification System.

STUDY DESIGN: Global cross-sectional survey. OBJECTIVE: To establish a surgical algorithm for sacral fractures based on the Arbeitsgemeinschaft für Osteosynthesefragen (AO) Spine Sacral Injury Classification System. SUMMARY OF BACKGROUND DATA: Although the AO Spine Sacral Injury Classification has been validated across an international audience of surgeons, a consensus on a surgical algorithm for sacral fractures using the Sacral AO Spine Injury Score (Sacral AOSIS) has yet to be developed. METHODS: A survey was sent to general orthopedic surgeons, orthopedic spine surgeons, and neurosurgeons across the five AO spine regions of the world. Descriptions of controversial sacral injuries based on different fracture subtypes were given, and surgeons were asked whether the patient should undergo operative or nonoperative management. The results of the survey were used to create a surgical algorithm based on each subtype's sacral AOSIS. RESULTS: An international agreement of 70% was decided on by the AO Spine Knowledge Forum Trauma experts to indicate a recommendation of initial operative intervention. Using this, sacral fracture subtypes of AOSIS 5 or greater were considered operative, while those with AOSIS 4 or less were generally nonoperative. For subtypes with an AOSIS of 3 or 4, if the sacral fracture was associated with an anterior pelvic ring injury (M3 case-specific modifier), intervention should be left to the surgeons' discretion. CONCLUSION: The AO Spine Sacral Injury Classification System offers a validated hierarchical system to approach sacral injuries. Through multispecialty and global surgeon input, a surgical algorithm was developed to determine appropriate operative indications for sacral trauma. Further validation is required, but this algorithm provides surgeons across the world with the basis for discussion and the development of standards of care and treatment.

Implementation of a Private Payer Bundled Payment Model While Maintaining High-Value Lumbar Spinal Fusion.

STUDY DESIGN: Retrospective single-institution cohort. OBJECTIVE: To evaluate the implementation of a commercial bundled payment model in patients undergoing lumbar spinal fusion. SUMMARY OF BACKGROUND DATA: BPCI-A caused significant losses for many physician practices, prompting private payers to establish their own bundled payment models. The feasibility of these private bundles has yet to be evaluated in spine fusion. METHODS: Patients undergoing lumbar fusion from October to December 2018 in BPCI-A before our institution's departure were included for BPCI-A analysis. Private bundle data was collected from 2018 to 2020. Analysis of the transition was conducted among Medicare-aged beneficiaries. Private bundles were grouped by calendar year (Y1, Y2, Y3). Stepwise multivariate linear regression was performed to measure independent predictors of net deficit. RESULTS: The net surplus was the lowest in Y1 ($2,395, P =0.03) but did not differ between our final year in BPCI-A and subsequent years in private bundles (all, P >0.05). AIR and SNF patient discharges decreased significantly in all private bundle years compared with BPCI. Readmissions fell from 10.7% (N=37) in BPCI-A to 4.4% (N=6) in Y2 and 4.5% (N=3) Y3 of private bundles ( P <0.001). Being in Y2 or Y3 was independently associated with a net surplus in comparison to the Y1 (ß: $11,728, P =0.001; ß: $11,643, P =0.002). Postoperatively, length of stay in days (ß: $-2,982, P <0.001), any readmission (ß: -$18,825, P =0.001), and discharge to AIR (ß: $-61,256, P <0.001) or SNF (ß: $-10,497, P =0.058) were all associated with a net deficit. CONCLUSIONS: Nongovernmental bundled payment models can be successfully implemented in lumbar spinal fusion patients. Constant price adjustment is necessary so bundled payments remain financially beneficial to both parties and systems overcome early losses. Private insurers who have more competition than the government may be more willing to provide mutually beneficial situations where cost is reduced for payers and health systems. LEVEL OF EVIDENCE: 3.

Reimbursement of Lumbar Fusion at an Orthopaedic Specialty Hospital Versus Tertiary Referral Center.

STUDY DESIGN: Retrospective Cohort Study. OBJECTIVE: To explore the differences in Medicare reimbursement for lumbar fusion performed at an orthopaedic specialty hospital (OSH) and a tertiary referral center and to elucidate drivers of Medicare reimbursement differences. SUMMARY OF BACKGROUND DATA: To provide more cost-efficient care, appropriately selected patients are increasingly being transitioned to OSHs for lumbar fusion procedures. There are no studies directly comparing reimbursement of lumbar fusion between tertiary referral centers (TRC) and OSHs. METHODS: Reimbursement data for a tertiary referral center and an orthopaedic specialty hospital were compiled through the Centers for Medicare and Medicaid Services. Any patient with lumbar fusions between January 2014 and December 2018 were identified. OSH patients were matched to TRC patients by demographic and surgical variables. Outcomes analyzed were reimbursement data, procedure data, 90-day complications and readmissions, operating room times, and length of stay (LOS). RESULTS: A total of 114 patients were included in the final cohort. The tertiary referral center had higher post-trigger ($13,554 vs. $8,541, P<0.001) and total episode ($49,973 vs. $43,512, P<0.010) reimbursements. Lumbar fusion performed at an OSH was predictive of shorter OR time (ß=0.77, P<0.001), shorter procedure time (ß=0.71, P<0.001), and shorter LOS (ß=0.53, P<0.001). There were no significant differences in complications (9.21% vs. 15.8%, P=0.353) or readmission rates (3.95% vs. 7.89%, P=0.374) between the 2 hospitals; however, our study is underpowered for complications and readmissions. CONCLUSION: Lumbar fusion performed at an OSH, compared with a tertiary referral center, is associated with significant Medicare cost savings, shorter perioperative times, decreased LOS, and decreased utilization of post-acute resources. LEVEL OF EVIDENCE: 3.

Assessment of a Private Payer Bundled Payment Model for Lumbar Decompression Surgery.

INTRODUCTION: Although bundled payment models are well-established in Medicare-aged individuals, private insurers are now developing bundled payment plans. The role of these plans in spine surgery has not been evaluated. Our objective was to analyze the performance of a private insurance bundled payment program for lumbar decompression and microdiskectomy. METHODS: A retrospective review was conducted of all lumbar decompressions in a private payer bundled payment model at a single institution from October 2018 to December 2020. 120-day episode of care cost data were collected and reported as net profit or loss regarding set target prices. A stepwise multivariable linear regression model was developed to measure the effect of patient and surgical factors on net surplus or deficit. RESULTS: Overall, 151 of 468 (32.2%) resulted in a deficit. Older patients (58.6 vs. 50.9 years, P < 0.001) with diabetes (25.2% vs. 13.9%, P = 0.004), hypertension (38.4% vs. 28.4%, P = 0.038), heart disease (13.9% vs. 7.57%, P = 0.030), and hyperlipidemia (51.7% vs. 35.6%, P = 0.001) were more likely to experience a loss. Surgically, decompression of more levels (1.91 vs. 1.19, P < 0.001), posterior lumbar decompression (86.8% vs. 56.5%, P < 0.001), and performing surgery at a tertiary hospital (84.8% vs. 70.3%, P < 0.001) were more likely to result in loss. All readmissions resulted in a loss (4.64% vs. 0.0%, P < 0.001). On multivariable regression, microdiskectomy (ß: $2,398, P = 0.012) and surgery in a specialty hospital (ß: $1,729, P = 0.096) or ambulatory surgery center (ß: $3,534, P = 0.055) were associated with cost savings. Increasing number of levels, longer length of stay, active smoking, and history of cancer, dementia, or congestive heart failure were all associated with degree of deficit. CONCLUSIONS: Preoperatively optimizing comorbidities and using risk stratification to identify those patients who may safely undergo surgery at a facility other than an inpatient hospital may help increase cost savings in a bundled payment model of working-age and Medicare-age individuals.

Are Clinical or Surgical Outcomes Different Based on Whether the Same Surgeon or Hospital System Performs the Spine Revision?

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To determine the effects of discontinuity in care by changing surgeons, health systems, or increased time to revision surgery on revision spine fusion surgical outcomes and patient-reported outcomes. SUMMARY OF BACKGROUND INFORMATION: Patients undergoing revision spine fusion experience worse outcomes than those undergoing primary lumbar surgery. Those requiring complex revisions are often transferred to tertiary or quaternary referral centers under the assumption that those institutions may be more accustomed at performing those procedures. However, there remains a paucity of literature assessing the impact of discontinuity of care in revision spinal fusions. METHODS: Patients who underwent revision 1-3 level lumbar spine fusion 2011-2021 were grouped based on (1) revision performed by the index surgeon versus a different surgeon, (2) revision performed within the same versus different hospital system as the index procedure, and (3) length of time from index procedure. Multivariate regression for outcomes controlled for confounding differences. RESULTS: A total of 776 revision surgeries were included. An increased time interval between the index procedure and the revision surgery was predictive of a lower risk for subsequent revision procedure (odds ratio: 0.57, P =0.022). Revision surgeries performed by the same surgeon predicted a reduced length of hospital stay (ß: -0.14, P =0.001). Neither time to revision nor undergoing by the same surgeon or same practice predicted 90-day readmission rates. Patients are less likely to report meaningful improvement in Mental Component Score-12 or Physical Component Score-12 if revision surgery was performed at a different hospital system. CONCLUSIONS: Patients who have revision lumbar fusions have similar clinical outcomes regardless of whether their surgeon performed the index procedure. However, continuity of care with the same surgeon may reduce hospital length of stay and associated health care costs. The length of time between primary and revision surgery does not significantly impact patient-reported outcomes. LEVEL OF EVIDENCE: Level III.

The Impact of Physical Therapy After Lumbar Fusion Surgery.

STUDY DESIGN: Retrospective Cohort. OBJECTIVE: To determine if outcomes varied between patients based on physical therapy (PT) attendance after lumbar fusion surgery. SUMMARY OF BACKGROUND DATA: The literature has been mixed regarding the efficacy of postoperative PT to improve disability and back pain, as measured by patient-reported outcome measures. Given the prevalence of PT referrals and lack of high-quality evidence, there is a need for additional studies investigating the efficacy of PT after lumbar fusion surgery to aid in developing robust clinical guidelines. METHODS: We retrospectively identified patients receiving lumbar fusion surgery by current procedural terminology codes and separated them into 2 groups based on whether PT was prescribed. Electronic medical records were reviewed for patient and surgical characteristics, PT utilization, and surgical outcomes. Patient-reported outcome measures (PROMs) were identified and compared preoperatively, at 90 days postoperatively and one year postoperatively. RESULTS: The two groups had similar patient characteristics and comorbidities and demonstrated no significant differences between readmission, complication, and revision rates after surgery. Patients that attended PT had significantly more fused levels (1.41 ± 0.64 vs. 1.32 ± 0.54, P =0.027), longer operative durations (234 ± 96.4 vs. 215 ± 86.1 min, P =0.012), and longer postoperative hospital stays (3.35 ± 1.68 vs. 3.00 ± 1.49 days, P =0.004). All groups improved similarly by Oswestry Disability Index, short form-12 physical and mental health subsets, and back and leg pain by Visual Analog Scale at 90-day and 1-year follow-up. CONCLUSION: Our data suggest that physical therapy does not significantly impact PROMs after lumbar fusion surgery. Given the lack of data suggesting clear benefit of PT after lumbar fusion, surgeons should consider more strict criteria when recommending physical therapy to their patients after lumbar fusion surgery. LEVEL OF EVIDENCE: Level-Ⅲ.

Comparison of Postoperative Opioid Use After Anterior Cervical Diskectomy and Fusion or Posterior Cervical Fusion.

INTRODUCTION: Posterior cervical fusion (PCF) and anterior cervical diskectomy and fusion (ACDF) are two main surgical management options for the treatment of cervical spondylotic myelopathy. Although ACDF is less invasive than PCF which should theoretically reduce postoperative pain, it is still unknown whether this leads to reduced opioid use. Our objective was to evaluate whether PCF increases postoperative opioid use compared with ACDF. METHODS: We retrospectively identified all patients undergoing 2-level to 4-level ACDF or PCF at a single center from 2017 to 2021. Our state's prescription drug-monitoring program was queried for filled opioid prescriptions using milligrams morphine equivalents (MMEs) up to 1 year postoperatively. In-hospital opioid use was collected from the electronic medical record. Bivariate statistics compared ACDF and PCF cohorts. Multivariate linear regression was done to assess independent predictors of in-hospital opioid use and short-term (0 to 30 days), subacute (30 to 90 days), and long-term (3 to 12 months) opioid prescriptions. RESULTS: We included 211 ACDF patients and 91 PCF patients. Patients undergoing PCF used more opioids during admission (126.7 vs. 51.0 MME, P < 0.001) and refilled more MMEs in the short-term (118.2 vs. 86.1, P = 0.001) but not subacute (33.6 vs. 19.7, P = 0.174) or long-term (85.6 vs. 47.8, P = 0.310) period. A similar percent of patients in both groups refilled at least one prescription after 90 days (39.6% vs. 33.2%, P = 0.287). PCF (ß = 56.7, P = 0.001) and 30-day preoperative MMEs (ß = 0.28, P = 0.041) were associated with greater in-hospital opioid requirements. PCF (ß = 26.7, P = 0.039), C5 nerve root irritation (ß = 51.4, P = 0.019), and a history of depression (ß = 40.9, P < 0.001) were independently associated with 30-day postoperative MMEs. CONCLUSIONS: PCF is initially more painful than ACDF but does not lead to persistent opioid use. Surgeons should optimize multimodal analgesia protocols to reduce long-term narcotic usage rather than change the surgical approach.Level of Evidence:III.

Effect of Clinical and Radiographic Degenerative Spondylolisthesis Classification on Patient-reported Outcomes and Spinopelvic Parameters for Patients With Single-level L4-L5 Degenerative Spondylolisthesis After Lumbar Fusion.

STUDY DESIGN: Retrospective cohort study. OBJECTIVES: To determine whether preoperative clinical and radiographic degenerative spondylolisthesis (CARDS) classification is associated with differences in patient-reported outcomes and spinopelvic parameters after posterior decompression and fusion for L4-L5 degenerative spondylolisthesis (DS). SUMMARY: The CARDS classification for lumbar DS, an alternative to the Meyerding system, considers additional radiographic findings such as disc space collapse and segmental kyphosis and stratifies DS into 4 radiographically distinct classes. Although CARDS has been shown to be a reliable and reproducible method for classifying DS, very few studies have assessed whether the CARDS types represent distinct clinical entities. PATIENTS AND METHODS: A retrospective cohort analysis was conducted on patients with L4-L5 DS who underwent posterior lumbar decompression and fusion. Changes in spinopelvic alignment and patient-reported outcomes measures, including recovery ratios and percentage of patients achieving the minimal clinically important difference, were compared among patients in each CARDS classification 1-year postoperatively using analysis of variance or Kruskal-Wallis H with Dunn post hoc analysis. Multiple linear regression determined whether CARDS groups significantly predicted patient-reported outcomes measures, lumbar lordosis (LL), and pelvic incidence-lumbar lordosis mismatch (PI-LL) while controlling for demographic and surgical characteristics. RESULTS: Preoperative type B spondylolisthesis predicted decreased improvement in "physical component and mental component score of the short form-12" compared with type A spondylolisthesis (ß-coefficient = -5.96, P = 0.031) at 1 year. Significant differences were found between CARDS groups with regards to ΔLL (A: -1.63 degrees vs B: -1.17 degrees vs C: 2.88 degrees vs D: 3.19 degrees, P = 0.010) and ΔPI-LL (A: 1.02 degrees vs B: 2.09 degrees vs C: -2.59 degrees vs D: -3.70 degrees, P = 0.012). Preoperative type C spondylolisthesis was found to predict increased LL (ß-coefficient = 4.46, P = 0.0054) and decreased PI-LL (ß-coefficient = -3.49, P = 0.025) at 1 year compared with type A spondylolisthesis. CONCLUSIONS: Clinical and radiographic outcomes differed significantly by preoperative CARDS classification type for patients undergoing posterior decompression and fusion for L4-L5 DS. LEVEL OF EVIDENCE: Level III.

Evaluation of Hospital Compliance With Federal Price Transparency Regulations and Variability of Negotiated Rates for Spinal Fusion.

INTRODUCTION: To improve price transparency, the Centers for Medicare & Medicaid Services (CMS) requires hospitals to post accessible pricing data for common elective procedures along with all third-party-negotiated rates. We aimed to evaluate hospital compliance with CMS regulations for both price estimators and machine-readable files for spinal fusions and to evaluate factors contributing to variability in hospital-negotiated pricing. METHODS: We reviewed the top 100 orthopaedic hospitals ranked by US News & World Report to assess compliance with CMS price transparency regulations for all spine diagnosis-related groups. We recorded gross inpatient charge, cash price, and deidentified maximum and minimum rates for the 11 spine diagnosis-related groups (DRGs). Variability was compared with geographic practice costs (GPCI), expected Medicare reimbursements, and poverty rate and median income ratio. RESULTS: Only 72% of hospitals were fully compliant in reporting spinal fusions on their price estimator, and 39% were fully compliant in reporting all mandatory rates for spinal fusions. The overall estimated cash price was $96,979 ± $56,262 and $62,595 ± $40,307 for noncervical and cervical fusion, respectively. Cash prices at top 50 hospitals were higher for both noncervical and cervical fusions ( P = 0.0461 and P = 0.0341, respectively). The average minimum negotiated rates ranged from 0.88 to 1.15 times the expected Medicare reimbursement, while maximum and cash prices were 3.41 to 3.90 and 2.53 to 4.08 times greater than Medicare reimbursement. GPCI demonstrated little to no correlation with DRG pricing. However, minimum negotiated rates and cash prices demonstrated weak positive correlations with the median income ratio and weak negative correlations with the poverty rate. DISCUSSION: Most US hospitals are not fully compliant with CMS price transparency regulations for spinal fusions despite increased overall utilization of price estimators and machine-readable files. Although higher ranked hospitals charged more for spinal fusions, DRG prices remain widely variable with little to no correlation with practice cost or socioeconomic parameters.

Patient-specific Risk Factors Increase Episode of Care Costs After Lumbar Decompression.

STUDY DESIGN: Retrospective cohort analysis. OBJECTIVE: To determine, which patient-specific risk factors increase total episode of care (EOC) costs in a population of Centers for Medicare and Medicaid Services beneficiaries undergoing lumbar decompression. SUMMARY OF BACKGROUND DATA: Lumbar decompression is an effective option for the treatment of central canal stenosis or radiculopathy in patients unresponsive to nonoperative management. Given that elderly Americans are more likely to have one or more chronic medical conditions, there is a need to determine, which, if any, patient-specific risk factors increase health care costs after lumbar decompression. METHODS: Care episodes limited to lumbar decompression surgeries were retrospectively reviewed on a Centers for Medicare and Medicaid Service reimbursement database at our academic institution between 2014 and 2019. The 90-day total EOC reimbursement payments were collected. Patient electronic medical records were then matched to the selected care episodes for the collection of patient demographics, medical comorbidities, surgical characteristics, and clinical outcomes. A stepwise multivariate linear regression model was developed to predict patient-specific risk factors that increased total EOC costs after lumbar decompression. Significance was set at P <0.05. RESULTS: A total of 226 patients were included for analysis. Risk factors associated with increased total EOC cost included increased age (per year) (ß = $324.70, P < 0.001), comorbid depression (ß = $4368.30, P = 0.037), revision procedures (ß = $6538.43, P =0.012), increased hospital length of stay (per day) (ß = $2995.43, P < 0.001), discharge to an inpatient rehabilitation facility (ß = $14,417.42, P = 0.001), incidence of a complication (ß = $8178.07, P < 0.001), and readmission (ß = $18,734.24, P < 0.001) within 90 days. CONCLUSIONS: Increased age, comorbid depression, revision decompression procedures, increased hospital length of stay, discharge to an inpatient rehabilitation facility, and incidence of a complication and readmission within 90 days were all associated with increased total episodes of care costs.

Validation of the Hierarchical Nature of the AO Spine Sacral Classification and the Development of the Sacral AO Spine Injury Score.

STUDY DESIGN: Global cross-sectional survey. OBJECTIVE: The objective of this study was to validate the hierarchical nature of the AO Spine Sacral Classification System and develop an injury scoring system. SUMMARY OF BACKGROUND DATA: Although substantial interobserver and intraobserver reliability of the AO Spine Sacral Classification System has been established, the hierarchical nature of the classification has yet to be validated. METHODS: Respondents numerically graded each variable within the classification system for severity. Based on the results, a Sacral AO Spine Injury Score (AOSIS) was developed. RESULTS: A total of 142 responses were received. The classification exhibited a hierarchical Injury Severity Score (ISS) progression (A1: 8 to C3: 95) with few exceptions. Subtypes B1 and B2 fractures showed no significant difference in ISS (B1 43.9 vs. B2 43.4, P =0.362). In addition, the transitions A3→B1 and B3→C0 represent significant decreases in ISS (A3 66.3 vs. B1 43.9, P <0.001; B3 64.2 vs. C0 46.4, P <0.001). Accordingly, A1 injury was assigned a score of 0. A2 and A3 received scores of 1 and 3 points, respectively. Posterior pelvic injuries B1 and B2 both received a score of 2. B3 received a score of 3 points. C0, C1, C2, and C3 received scores of 2, 3, 5, and 6 points, respectively. The scores assigned to neurological modifiers N0, N1, N2, N3, and NX were 0, 1, 2, 4, and 3, respectively. Case-specific modifiers M1, M2, M3, and M4 received scores of 0, 0, 1, and 2 points, respectively. CONCLUSIONS: The results of this study validate the hierarchical nature of the AO Spine Sacral Classification System. The Sacral AOSIS sets the foundation for further studies to develop a universally accepted treatment algorithm for the treatment of complex sacral injuries. LEVEL OF EVIDENCE: Level IV-Diagnostic.

Spine Surgical Subspecialty and Its Effect on Patient Outcomes: A Systematic Review and Meta-Analysis.

STUDY DESIGN: Systematic review and meta-analysis. OBJECTIVE: To perform a systematic review and meta-analysis to identify if intraoperative or postoperative differences in outcomes exist between orthopedic and neurological spine surgeons. SUMMARY OF BACKGROUND DATA: Spine surgeons may become board certified through orthopedic surgery or neurosurgical residency training, and recent literature has compared surgical outcomes between surgeons based on residency training background with conflicting results. MATERIALS AND METHODS: Using Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, a search of PubMed and Scopus databases was conducted and included articles comparing outcomes between orthopedic spine surgeons and neurosurgeons. The Newcastle-Ottawa scale was used to determine the quality of studies. Forest plots were generated using mean differences (MD) for continuous variables and odds ratios (OR) for binomial variables, and 95% CI was reported. RESULTS: Of 615 search term results, 16 studies were identified for inclusion. Evaluation of the studies found no differences in readmission rates [OR, ref: orthopedics: 0.99 (95% CI: 0.901, 1.09); I2 = 80%], overall complication rates [OR, ref: orthopedics: 1.03 (95% CI: 0.97, 1.10); I2 = 70%], reoperation rates [OR, ref: orthopedics: 0.91 (95% CI: 0.82, 1.00); I2 = 86%], or overall length of hospital stay between orthopedic spine surgeons and neurosurgeons [MD: -0.19 days (95% CI: -0.38, 0.00); I2 = 98%]. However, neurosurgeons ordered a significantly lower rate of postoperative blood transfusions [OR, ref: orthopedics: 0.49 (95% CI: 0.41, 0.57); I2 = 75%] while orthopedic spine surgeons had shorter operative times [MD: 14.28 minutes, (95% CI: 8.07, 20.49), I2 = 97%]. CONCLUSIONS: Although there is significant data heterogeneity, our meta-analysis found that neurosurgeons and orthopedic spine surgeons have similar readmission, complication, and reoperation rates regardless of the type of spine surgery performed.

Clinical Improvements in Myelopathy Result in Improved Patient-Reported Outcomes Following Anterior Cervical Discectomy and Fusion.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To determine if myelopathy severity predicted the magnitude of improvement in health-related quality of life metrics following anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA: Surgery for myelopathy is primarily performed to halt disease progression. However, it is still controversial if these patients can expect significant health-related quality-of life improvements following ACDF. We explore the relationship between modified Japanese Orthopaedic Association (mJOA) improvements and its effect on other health-related quality-of life metrics. MATERIALS AND METHODS: Patients undergoing ACDF for myelopathy were grouped based on preoperative mJOA scores into mild (15-17), moderate (12-14), and severe (<12) groups. Patients were subsequently categorized based on if they attained the minimum clinically detectable improvement (MCID) threshold for mJOA. Multivariate linear regression was performed to determine the magnitude of improvement in ∆patient-reported outcome measures. RESULTS: A total of 374 patients were identified for inclusion. Of those, 169 (45.2%) had mild myelopathy, 125 (33.4%) had moderate, and 80 (21.4%) had severe myelopathy. Only the moderate and severe groups had significant improvements in mJOA following surgery (mild: P =0.073, moderate: P <0.001, severe: P <0.001). There were no significant differences in the magnitude of improvement for any patient-reported outcome measure based on myelopathy severity, except for mJOA (mild: 0.27, moderate: 1.88, severe: 3.91; P <0.001). Patients meeting the MCID for mJOA had better ∆Short-Form 12 Mental Component Score (3.29 vs. -0.21, P =0.007), ∆Short-Form 12 Physical Component Score (6.82 vs. 1.96, P <0.001), ∆Visual Analog Scale Neck (-3.11 vs. -2.17, P =0.001), ∆Visual Analog Scale Arm (-2.92 vs. -1.48, P <0.001), ∆Neck Disability Index (-18.35 vs. -7.86, P <0.001), and ∆mJOA (3.38 vs. -0.56, P <0.001) compared with patients who did not. CONCLUSIONS: Worse baseline myelopathy severity predicts worse postoperative outcomes. However, baseline myelopathy severity is not predictive of the magnitude of postoperative improvement with the exception of mJOA. Patients who attain MCID improvement in mJOA had greater postoperative improvement for other health-related quality of life metrics.

Trends in Short Construct Lumbar Fusions Over the Past Decade at a Single Institution.

STUDY DESIGN: Retrospective cohort. OBJECTIVE: (1) To compare the rates of fusion techniques over the last decade; (2) to identify whether surgeon experience affects a surgeon's preferred fusion technique; (3) to evaluate differences in complications, readmissions, mortality, and patient-reported outcomes measures (PROMs) based on fusion technique. SUMMARY OF BACKGROUND DATA: Database studies indicate the number of lumbar fusions have been steadily increasing over the last two decades; however, insufficient granularity exists to detect if surgeons' preferences are altered based on additive surgical experience. METHODS: A retrospective review of continuously collected patients undergoing lumbar fusion at a single urban academic center was performed. Rates of lumbar fusion technique: posterolateral decompression fusion (PLDF), transforaminal lumbar interbody fusion (TLIF), anterior lumbar interbody fusion + PLDF (ALIF), and lateral lumbar interbody fusion + PLDF (LLIF) were recorded. Inpatient complications, 90-day readmission, and inpatient mortality were compared with χ 2 test and Bonferroni correction. The Δ 1-year PROMs were compared with the analysis of variance. RESULTS: Of 3938 lumbar fusions, 1647 (41.8%) were PLDFs, 1356 (34.4%) were TLIFs, 885 (21.7%) were ALIFs, and 80 (2.0%) were lateral lumbar interbody fusions. Lumbar fusion rates increased but interbody fusion rates (2012: 57.3%; 2019: 57.6%) were stable across the study period. Surgeons with <10 years of experience performed more PLDFs and less ALIFs, whereas surgeons with >10 years' experience used ALIFs, TLIFs, and PLDFs at similar rates. Patients were more likely to be discharged home over the course of the decade (2012: 78.4%; 2019: 83.8%, P <0.001). No differences were observed between the techniques in regard to inpatient mortality ( P =0.441) or Δ (postoperative minus preoperative) PROMs. CONCLUSIONS: Preferred lumbar fusion technique varies by surgeon preference, but typically remains stable over the course of a decade. The preferred fusion technique did not correlate with differences in PROMs, inpatient mortality, and patient complication rates. LEVELS OF EVIDENCE: 3-treatment.

Patient-Reported Outcomes Following Anterior and Posterior Surgical Approaches for Multilevel Cervical Myelopathy.

STUDY DESIGN: Retrospective cohort. OBJECTIVE: To compare health-related quality of life (HRQoL) outcomes between approach techniques for the treatment of multilevel degenerative cervical myelopathy (DCM). SUMMARY OF BACKGROUND DATA: Both anterior and posterior approaches for the surgical treatment of cervical myelopathy are successful techniques in the treatment of myelopathy. However, the optimal treatment has yet to be determined, especially for multilevel disease, as the different approaches have separate complication profiles and potentially different impacts on HRQoL metrics. MATERIALS AND METHODS: Retrospective review of a prospectively managed single institution database of patient-reported outcome measures after 3 and 4-level anterior cervical discectomy and fusion (ACDF) and posterior cervical decompression and fusion (PCDF) for DCM. The electronic medical record was reviewed for patient baseline characteristics and surgical outcomes whereas preoperative radiographs were analyzed for baseline cervical lordosis and sagittal balance. Bivariate and multivariate statistical analyses were performed to compare the two groups. RESULTS: We identified 153 patients treated by ACDF and 43 patients treated by PCDF. Patients in the ACDF cohort were younger (60.1 ± 9.8 vs . 65.8 ± 6.9 yr; P < 0.001), had a lower overall comorbidity burden (Charlson Comorbidity Index: 2.25 ± 1.61 vs . 3.07 ± 1.64; P = 0.002), and were more likely to have a 3-level fusion (79.7% vs . 30.2%; P < 0.001), myeloradiculopathy (42.5% vs . 23.3%; P = 0.034), and cervical kyphosis (25.7% vs . 7.69%; P = 0.027). Patients undergoing an ACDF had significantly more improvement in their neck disability index after surgery (-14.28 vs . -3.02; P = 0.001), and this relationship was maintained on multivariate analysis with PCDF being independently associated with a worse neck disability index (+8.83; P = 0.025). Patients undergoing an ACDF also experienced more improvement in visual analog score neck pain after surgery (-2.94 vs . -1.47; P = 0.025) by bivariate analysis. CONCLUSIONS: Our data suggest that patients undergoing an ACDF or PCDF for multilevel DCM have similar outcomes after surgery.

Evaluating Outcomes of Spinopelvic Fixation for Patients Undergoing Long Segment Thoracolumbar Fusion with a Prior Total Hip Arthroplasty.

INTRODUCTION: Understanding the relationship between spinal fusion and its effects on relative spinopelvic alignment in patients with prior total hip arthroplasty (THA) is critical. However, limited data exist on the effects of long spinal fusions on hip alignment in patients with a prior THA. Our objective was to compare clinical outcomes and changes in hip alignment between patients undergoing long fusion to the sacrum versus to the pelvis in the setting of prior THA. METHODS: Patients with a prior THA who underwent elective thoracolumbar spinal fusion starting at L2 or above were retrospectively identified. Patients were placed into one of two groups: fusion to the sacrum or pelvis. Preoperative, six-month postoperative, one-year postoperative, and delta spinopelvic and acetabular measurements were measured from standing lumbar radiographs. RESULTS: A total of 112 patients (55 sacral fusions, 57 pelvic fusions) were included. Patients who underwent fusion to the pelvis experienced longer length of stay (LOS) (8.31 vs. 4.21, P < 0.001) and less frequent home discharges (30.8% vs. 61.9%, P = 0.010), but fewer spinal revisions (12.3% vs. 30.9%, P = 0.030). No difference was observed in hip dislocation rates (3.51% vs. 1.82%, P = 1.000) or hip revisions (5.26% vs. 3.64%, P = 1.000) based on fusion construct. Fusion to the sacrum alone was an independent predictor of an increased spine revision rate (odds ratio: 3.56, P = 0.023). Patients in the pelvic fusion group had lower baseline lumbar lordosis (LL) (29.2 vs. 42.9, P < 0.001), six-month postoperative LL (38.7 vs. 47.3, P = 0.038), and greater 1-year ∆ pelvic incidence-lumbar lordosis (-7.98 vs. 0.21, P = 0.032). CONCLUSION: Patients with prior THA undergoing long fusion to the pelvis experienced longer LOS, more surgical complications, and lower rate of spinal revisions. Patients with instrumentation to the pelvis had lower LL preoperatively with greater changes in LL and pelvic incidence-lumbar lordosis postoperatively. No differences were observed in acetabular positioning, hip dislocations, or THA revision rates between groups.

Diversity in Orthopaedic Surgery Medical Device Clinical Trials: An Analysis of the Food and Drug Administration Safety and Innovation Act.

INTRODUCTION: Demographic factors contribute markedly to orthopaedic surgery outcomes. However, women and minorities have been historically excluded from clinical trials. The United States passed the Safety and Innovation Act (Food and Drug Administration Safety and Innovation Act [FDA-SIA]) in 2012 to increase study diversity and mandate reporting of certain demographics. The purpose of this study was to investigate demographic reporting and analysis among high-risk orthopaedic medical device trials and evaluate the effectiveness of the FDA-SIA in increasing diversity of study enrollment. METHODS: The premarket approval database was queried for all original submissions approved by the Orthopedic Advisory Committee from January 1, 2003, to July 1, 2022. Study demographics were recorded. Weighted means of race, ethnicity, and sex were compared before and after FDA-SIA implementation with the US population. RESULTS: We identified 51 orthopaedic trials with unique study data. Most Food and Drug Administration device trials reported age (98.0%) and sex (96.1%), but only 49.0% and 37.3% reported race and ethnicity, respectively. Only 23 studies analyzed sex, six analyzed race, and two analyzed ethnicity. Compared with the US population, participants were overwhelmingly White (91.36% vs. 61.63%, P < 0.001) with a significant underrepresentation of Black (3.65% vs. 12.41%, P = 0.008), Asian (0.86% vs. 4.8%, P = 0.030), and Hispanic participants (3.02% vs. 18.73%, P < 0.001) before 2013. The FDA-SIA increased female patient enrollment (58.99% vs. 47.96%, P = 0.021) but did not increase the enrollment of racial or ethnic minorities. CONCLUSION: Despite efforts to increase the generalizability of studies within the FDA-SIA, orthopaedic medical devices still fail to enroll diverse populations and provide demographic subgroup analysis. The study populations within these trials do not represent the populations for whom these devices will be indicated in the community. The federal government must play a stronger role in mandating study diversity, enforcing appropriate statistical analysis of the demographic subgroups, and executing measures to ensure compliance. LEVEL OF EVIDENCE: I.

Readmission and Resource Utilization in Patients From Socioeconomically Distressed Communities Following Lumbar Fusion.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To determine whether: (1) patients from communities of socioeconomic distress have higher readmission rates or postoperative healthcare resource utilization and (2) there are differences in patient-reported outcome measures (PROMs) based on socioeconomic distress. SUMMARY OF BACKGROUND DATA: Socioeconomic disparities affect health outcomes, but little evidence exists demonstrating the impact of socioeconomic distress on postoperative resource utilization or PROMs. METHODS: A retrospective review was performed on patients who underwent lumbar fusion at a single tertiary academic center from January 1, 2011 to June 30, 2021. Patients were classified according to the distressed communities index. Hospital readmission, postoperative prescriptions, patient telephone calls, follow-up office visits, and PROMs were recorded. Multivariate analysis with logistic, negative binomial regression or Poisson regression were used to investigate the effects of distressed communities index on postoperative resource utilization. Alpha was set at P <0.05. RESULTS: A total of 4472 patients were included for analysis. Readmission risk was higher in distressed communities (odds ratio, 1.75; 95% confidence interval, 1.06-2.87; P =0.028). Patients from distressed communities (odds ratio, 3.94; 95% confidence interval, 1.60-9.72; P =0.003) were also more likely to be readmitted for medical, but not surgical causes ( P =0.514), and distressed patients had worse preoperative (visual analog-scale Back, P <0.001) and postoperative (Oswestry disability index, P =0.048; visual analog-scale Leg, P =0.013) PROMs, while maintaining similar magnitudes of clinical improvement. Patients from distressed communities were more likely to be discharged to a nursing facility and inpatient rehabilitation unit (25.5%, P =0.032). The race was not independently associated with readmissions ( P =0.228). CONCLUSION: Socioeconomic distress is associated with increased postoperative health resource utilization. Patients from distressed communities have worse preoperative PROMs, but the overall magnitude of improvement is similar across all classes. LEVEL OF EVIDENCE: Level IV.