A Comparison of Clinical Outcomes Between Anterior Cervical Discectomy and Fusion Versus Posterior Cervical Laminoplasty for Multilevel Cervical Myelopathy.

STUDY DESIGN: Retrospective Cohort. OBJECTIVE: To compare patient-reported outcomes and surgical outcomes after anterior cervical discectomy and fusion (ACDF) versus cervical laminoplasty for multilevel cervical spondylotic myelopathy. BACKGROUND: Treatment options for multilevel cervical spondylotic myelopathy include ACDF and cervical laminoplasty. Given that the literature has been mixed regarding the optimal approach, especially in patients without kyphosis, there is a need for additional studies investigating outcomes between ACDF and cervical laminoplasty. METHODS: A retrospective review was conducted of adult patients undergoing 3 or 4-level surgery. Patients with preoperative kyphosis based on C2-C7 Cobb angles were excluded. The electronic medical record and institutional databases were reviewed for baseline characteristics, surgical outcomes, and patient-reported outcomes. RESULTS: A total of 101 patients who underwent ACDF and 52 patients who underwent laminoplasty were included in the study. The laminoplasty cohort had a higher overall Charlson Comorbidity Index (3.10 ± 1.43 vs 2.39 ± 1.57, P = 0.011). Both groups had a comparable number of levels decompressed, C2-C7 lordosis, and diagnosis of myelopathy versus myeloradiculopathy. Patients who underwent laminoplasty had a longer length of stay (2.04 ± 1.15 vs 1.48 ± 0.70, P = 0.003) but readmission, complication, and revision rates were similar. Both groups had similar improvement in myelopathy scores (∆modified Japanese Orthopedic Association: 1.11 ± 3.09 vs 1.06 ± 3.37, P = 0.639). ACDF had greater improvement in Neck Disability Index (∆Neck Disability Index: -11.66 ± 19.2 vs -1.13 ± 11.2, P < 0.001), neck pain (∆Visual Analog Scale-neck: -2.69 ± 2.78 vs -0.83 ± 2.55, P = 0.003), and arm pain (∆Visual Analog Scale-arm: -2.47 ± 3.15 vs -0.48 ± 3.19, P = 0.010). These findings persisted in multivariate analysis except for Neck Disability Index. CONCLUSION: ACDF and cervical laminoplasty appear equally efficacious at halting myelopathic progression. However, patients who underwent ACDF had greater improvements in arm pain at 1 year postoperatively. Longitudinal studies evaluating the efficacy of laminoplasty to mitigate adjacent segment disease are indicated to establish a robust risk-benefit assessment for these 2 procedures. LEVEL OF EVIDENCE: III.

A Longitudinal Evaluation of Coronavirus Disease 2019 and Its Effects on Spinal Decompressions With or Without Fusion.

STUDY DESIGN: Retrospective cohort. OBJECTIVE: The objectives were to (1) compare the safety of spine surgery before and after the emergence of coronavirus disease 2019 (COVID-19) and (2) determine whether patients with a history of COVID-19 were at increased risk of adverse events. SUMMARY AND BACKGROUND DATA: The COVID-19 pandemic had a tremendous impact on several health care services. In spine surgery, elective cases were canceled and patients received delayed care due to the uncertainty of disease transmission and surgical outcomes. As new coronavirus variants arise, health care systems require guidance on how to provide optimal patient care to all those in need of our services. PATIENTS AND METHODS: A retrospective review of patients undergoing spine surgery between January 1, 2019 and June 30, 2021 was performed. Patients were split into pre-COVID or post-COVID cohorts based on local government guidelines. Inpatient complications, 90-day readmission, and 90-day mortality were compared between groups. Secondary analysis included multiple logistic regression to determine independent predictors of each outcome. RESULTS: A total of 2976 patients were included for analysis with 1701 patients designated as pre-COVID and 1275 as post-COVID. The pre-COVID cohort had fewer patients undergoing revision surgery (16.8% vs 21.9%, P < 0.001) and a lower home discharge rate (84.5% vs 88.2%, P = 0.008). Inpatient complication (9.9% vs 9.2%, P = 0.562), inpatient mortality (0.1% vs 0.2%, P = 0.193), 90-day readmission (3.4% vs 3.2%, P = 0.828), and 90-day mortality rates (0.8% vs 0.8%, P = 0.902) were similar between groups. Patients with positive COVID-19 tests before surgery had similar complication rates (7.7% vs 6.1%, P = 1.000) as those without a positive test documented. CONCLUSIONS: After the emergence of COVID-19, patients undergoing spine surgery had a greater number of medical comorbidities, but similar rates of inpatient complications, readmission, and mortality. Prior COVID-19 infection was not associated with an increased risk of postsurgical complications or mortality. LEVEL OF EVIDENCE: Level III.

Interpreting Meta-Analyses: A Guide to Funnel and Forest Plots.

Meta-analyses represent the best available medical evidence. Although a powerful tool, they are not without criticisms since any bias in the original studies are then compounded when they are pooled together for the meta-analysis. Funnel plots provide a useful graphical representation of the presence of bias, and forest plots represent the heterogeneity of findings within studies included in a meta-analysis. The purpose of this review is to help readers interpret these statistical tools to better understand the findings of a meta-analysis.

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.

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.

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.

Patients From Socioeconomically Distressed Communities Experience Similar Clinical Improvements Following Anterior Cervical Discectomy and Fusion.

STUDY DESIGN: Retrospective cohort. OBJECTIVES: The aim was to compare patient-reported outcome measures (PROMs) following anterior cervical discectomy and fusion (ACDF) when categorizing patients based on socioeconomic status. Secondarily, we sought to compare PROMs based on race. SUMMARY OF BACKGROUND DATA: Social determinants of health are believed to affect outcomes following spine surgery, but there is limited literature on how combined socioeconomic status metrics affect PROMs following ACDF. MATERIALS AND METHODS: The authors identified patients who underwent primary elective one-level to four-level ACDF from 2014 to 2020. Patients were grouped based on their distressed community index (DCI) quintile (Distressed, At-Risk, Mid-tier, Comfortable, and Prosperous) and then race (White or Black). Multivariate regression for ∆PROMs was performed based on DCI group and race while controlling for baseline demographics and surgical characteristics. RESULTS: Of 1204 patients included in the study, all DCI groups improved across all PROMs, except mental health component score (MCS-12) for the Mid-tier group ( P =0.091). Patients in the Distressed/At-Risk group had worse baseline MCS-12, visual analog scale (VAS) Neck, and neck disability index (NDI). There were no differences in magnitude of improvement between DCI groups. Black patients had significantly worse baseline VAS Neck ( P =0.002) and Arm ( P =0.012) as well as worse postoperative MCS-12 ( P =0.016), PCS-12 ( P =0.03), VAS Neck ( P <0.001), VAS Arm ( P =0.004), and NDI ( P <0.001). Multivariable regression analysis did not identify any of the DCI groupings to be significant independent predictors of ∆PROMs, but being White was an independent predictor of greater improvement in ∆PCS-12 (ß=3.09, P =0.036) and ∆NDI (ß=-7.32, P =0.003). CONCLUSIONS: All patients experienced clinical improvements regardless of DCI or race despite patients in Distressed communities and Black patients having worse preoperative PROMs. Being from a distressed community was not an independent predictor of worse improvement in any PROMs, but Black patients had worse improvement in NDI compared with White patients. LEVEL OF EVIDENCE: 3.