The Fragility of Statistical Findings in Cervical Disc Arthroplasty: a Systematic Review of Randomized Controlled Trials.

PURPOSE: This study employs both the fragility index (FI) and fragility quotient (FQ) to assess the level of robustness in the cervical disc arthroplasty (CDA) literature. We hypothesize that dichotomous outcomes involving CDA would exhibit statistical vulnerability. METHODS: A PubMed search was conducted to evaluate dichotomous data for randomized controlled trials (RCTs) in CDA literature from 2000 to 2023. The FI of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by the study sample size. The interquartile range (IQR) was also calculated for the FI and FQ. RESULTS: Of the 1561 articles screened, 111 met the search criteria, with 35 RCTs evaluating CDA included for analysis. Six hundred and ninety-three outcome events with 130 significant (P < 0.05) outcomes and 563 nonsignificant (P ≥ 0.05) outcomes were identified. The overall FI and FQ for all 693 outcomes were 5 (IQR 3-7) and 0.019 (IQR 0.011-0.043). Fragility analysis of statistically significant outcomes and nonsignificant outcomes both revealed an FI of 5. All of the studies reported loss to follow-up (LTF) data where 65.7% (23) did not report or reported an LTF greater or equal to 5. CONCLUSIONS: The literature regarding CDA RCTs lacks statistical robustness and may misrepresent the conclusions with the sole use of the P value. By implementing the FI and FQ along with the P value, we believe the interpretation and contextualization of the clinical data surrounding CDA will be better understood.

The iliac kickstand screw: anatomic CT analysis of screw trajectory and osseous corridor for screw placement.

INTRODUCTION: The 'kickstand screw-rod' technique has been recently described for correction of coronal malalignment. This technique utilizes powerful 'construct-to-ilium' distraction between a fixed multi-screw thoracic construct and the ilium, facilitated by a novel 'iliac kickstand screw'. The 'iliac kickstand screw' traverses a previously undescribed osseous corridor in the ilium. OBJECTIVE: Using a radiographic CT study, the objective is to describe a large osseous corridor within the ilium to accommodate the novel iliac kickstand screw. METHODS: 50 consecutive patients with pelvic CTs at an academic medical center were queried. Simulated iliac kickstand screw trajectories for the left and right hemipelvis were analyzed with 3D visualization software. Maximal screw lengths and dimensions, and trajectories in the osseous corridor were measured. RESULTS: 50 patients' (31 female, 19 male) pelvic CTs were measured with a total of 100 simulated screws. The mean age was 52.4 years and BMI 28.1 ± 7.9. The average length is 119.7 ± 6.6 mm (range 98.7 - 135.3). The narrowest width (maximum potential screw diameter) is 17.8 ± 2.9 mm (coronal) and 20.8 ± 5.3 mm (sagittal). The starting point to the top of the iliac crest is 66.4 mm lateral to midline, and 15.9° caudal in the sagittal and 6.1° lateral in the coronal planes. CONCLUSIONS: The novel iliac kickstand screw traverses a consistent and large osseous corridor within the ilium. The average simulated screw length is 119.7 mm and maximum potential diameter of 17.8 mm. Starting points relative to the iliac crest are identified.

Patient Perspectives on Artificial Intelligence in Healthcare Decision Making: A Multi-Center Comparative Study.

Objective: Investigate the patient opinion on the use of Artificial Intelligence (AI) in Orthopaedics. Methods: 397 orthopaedic patients from a large urban academic center and a rural health system completed a 37-component survey querying patient demographics and perspectives on clinical scenarios involving AI. An average comfort score was calculated from thirteen Likert-scale questions (1, not comfortable; 10, very comfortable). Secondary outcomes requested a binary opinion on whether it is acceptable for patient healthcare data to be used to create AI (yes/no) and the impact of AI on: orthopaedic care (positive/negative); healthcare cost (increase/decrease); and their decision to refuse healthcare if cost increased (yes/no). Bivariate and multivariable analyses were employed to identify characteristics that impacted patient perspectives. Results: The average comfort score across the population was 6.4, with significant bivariate differences between age (p = 0.0086), gender (p = 0.0001), education (p = 0.0029), experience with AI/ML (p < 0.0001), survey format (p < 0.0001), and four binary outcomes (p < 0.05). When controlling for age and education, multivariable regression identified significant relationships between comfort score and experience with AI/ML (p = 0.0018) and each of the four binary outcomes (p < 0.05). In the final multivariable model gender, survey format, perceived impact of AI on orthopaedic care, and the decision to refuse care if it were to increase cost remained significantly associated with the average AI comfort score (p < 0.05). Additionally, patients were not comfortable undergoing surgery entirely by a robot with distant physician supervision compared to close supervision. Conclusion: The orthopaedic patient appears comfortable with AI joining the care team.

Implementing a pragmatic clinical trial to tailor opioids for acute pain on behalf of the IGNITE ADOPT PGx investigators.

Opioid prescribing for postoperative pain management is challenging because of inter-patient variability in opioid response and concern about opioid addiction. Tramadol, hydrocodone, and codeine depend on the cytochrome P450 2D6 (CYP2D6) enzyme for formation of highly potent metabolites. Individuals with reduced or absent CYP2D6 activity (i.e., intermediate metabolizers [IMs] or poor metabolizers [PMs], respectively) have lower concentrations of potent opioid metabolites and potentially inadequate pain control. The primary objective of this prospective, multicenter, randomized pragmatic trial is to determine the effect of postoperative CYP2D6-guided opioid prescribing on pain control and opioid usage. Up to 2020 participants, age ≥8 years, scheduled to undergo a surgical procedure will be enrolled and randomized to immediate pharmacogenetic testing with clinical decision support (CDS) for CYP2D6 phenotype-guided postoperative pain management (intervention arm) or delayed testing without CDS (control arm). CDS is provided through medical record alerts and/or a pharmacist consult note. For IMs and PM in the intervention arm, CDS includes recommendations to avoid hydrocodone, tramadol, and codeine. Patient-reported pain-related outcomes are collected 10 days and 1, 3, and 6 months after surgery. The primary outcome, a composite of pain intensity and opioid usage at 10 days postsurgery, will be compared in the subgroup of IMs and PMs in the intervention (n = 152) versus the control (n = 152) arm. Secondary end points include prescription pain medication misuse scores and opioid persistence at 6 months. This trial will provide data on the clinical utility of CYP2D6 phenotype-guided opioid selection for improving postoperative pain control and reducing opioid-related risks.

Postoperative C5 Palsy Following Cervical Laminectomy With Instrumented Fusion Versus Cervical Laminoplasty With Reconstruction: Single Surgeon and National Inpatient Cohort Analyses.

STUDY DESIGN: This was a retrospective cohort study. OBJECTIVE: The objective of this study was to investigate whether cervical laminectomy with instrumented fusion (LF) and cervical laminoplasty with reconstruction (LP) are associated with different rates C5 palsy (C5P) at 1-month follow-up in a single surgeon and nationally representative cohort. SUMMARY OF BACKGROUND DATA: LF and LP both carry a well-known risk of nerve root injury that most commonly presents as C5P which can reduce patient satisfaction, patient function, and impede patient recovery. The procedure type that is more frequently associated with C5P remains largely unclear. METHODS: We identified patients undergoing primary LF or LP procedures for the treatment of cervical myelopathy in both a single-surgeon series cohort (2004-2018; Mount Sinai Hospital) and a nationally representative cohort drawn from the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) database (2006-2017). For the single-surgeon cohort, C5P within 1 month of surgery was recorded. For the NSQIP cohort, peripheral nerve injury (PNI) within 1 month of surgery was recorded and used as a proxy for C5P. Postoperative complications including C5P were compared between cohorts. Multivariable logistic regression was used to evaluate the association between procedure type and postoperative C5P or PNI. RESULTS: Without adjusting for covariates, LF patients had a higher rate of 1-month C5P in the single-surgeon cohort (8% vs. 0%, P=0.01). An adjusted odds ratio could not be obtained due to the absence of C5P in the LP group. In the national cohort, LP patients had a significantly higher rate of 1-month PNI on unadjusted analysis (11% vs. 16%, P<0.001). After adjusting for covariates, we found no significant difference in odds of 1-month PNI between LF and LP (adjusted odds ratio=0.84, P=0.07). CONCLUSIONS: Overall, the single-surgeon series suggest that cervical LF is associated with significantly higher rates of postoperative C5P as compared with LP. These findings are not corroborated by nationally representative data, which showed no difference in PNI rates between LF and LP. A surgeon's training and experience likely contribute to which procedure has a higher propensity for a C5P as a complication. Regardless, both LF and LP patients should be closely monitored for new-onset C5P during follow-up visits. LEVEL OF EVIDENCE: Level III.

Accelerometry Data Delineate Phases of Recovery and Supplement Patient-Reported Outcome Measures Following Lumbar Laminectomy.

BACKGROUND: Patient-reported outcome measures (PROMs) are traditionally used to track recovery of patients after spine surgery. Wearable accelerometers have adjunctive value because of the continuous, granular, and objective data they provide. We conducted a prospective study of lumbar laminectomy patients to determine if time-series data from wearable accelerometers could delineate phases of recovery and compare accelerometry data to PROMs during recovery tracking. METHODS: Patients with lumbar stenosis for whom lumbar laminectomy was indicated were prospectively recruited. Subjects wore accelerometers that recorded their daily step counts from at least 1 week preoperatively to 6 months postoperatively. Subjects completed the Oswestry Disability Index and the 12-Item Short Form Health Survey preoperatively and at 2 weeks, 1 month, 3 months, and 6 months postoperatively. Daily aggregate median steps and individual visit-specific median steps were calculated. The Pruned Linear Exact Time method was used to segment aggregate median steps into distinct phases. Associations between visit-specific median steps and PROMs were identified using Spearman rank correlation. RESULTS: Segmentation analysis revealed 3 distinct postoperative phases: step counts rapidly increased for the first 40 days postoperatively (acute healing), then gained more slowly for the next 90 days (recovery), and finally plateaued at preoperative levels (stabilization). Visit-specific median steps were significantly correlated with PROMs throughout the postoperative period. PROMs significantly exceeded baseline at 6 months postoperatively, while step counts did not (all P < 0.05). CONCLUSIONS: Continuous data from accelerometers allowed for identification of 3 distinct stages of postoperative recovery after lumbar laminectomy. PROMs remain necessary to capture subjective elements of recovery.

Safe Spine Surgery During the COVID-19 Pandemic.

Safe spine surgery is possible during the COVID-19 pandemic. Certain urgent procedures must still be performed during this challenging time to prevent permanent long-term disability or death for patients. Precautions must be taken in the operating room to optimize safety, including the use of personal protective equipment and appropriate room setup and anesthesia and equipment optimization. Evidence-based guidelines to create a safe operative paradigm for use in future viral outbreaks are paramount.

How do C2 tilt and C2 slope correlate with patient reported outcomes in patients after anterior cervical discectomy and fusion?

BACKGROUND/CONTEXT: C2 tilt and C2 slope are quick and easy measurements to obtain on lateral radiographs and may be used to determine overall cervical sagittal alignment; however, the influence of these measurements on patient outcomes has not been well established in literature. PURPOSE: To determine if C2 tilt and/or C2 slope predict patient outcomes better compared with conventional radiographic measures after an anterior cervical discectomy and fusion (ACDF). STUDY DESIGN/SETTING: Retrospective cohort study. PATIENT SAMPLE: A total of 249 patients who underwent 1 to 3 level ACDF to address radiculopathy and/or myelopathy at a single academic institution between 2011 and 2015 were identified. Patients with less than 1 year of follow-up were excluded. OUTCOME MEASURES: Patient Reported Outcomes: Neck Disability Index (NDI), Physical Component Score-12 (PCS-12), and Mental Component Score (MCS-12), Visual Analog Score (VAS) Neck and Arm scores Cervical radiographic measurements: C2 tilt, C2 slope, C2-C7 lordosis, cervical SVA, T1 slope, T1 slope minus cervical lordosis (TS-CL), and C2-C7 ROM METHODS: Pearson correlation tests were performed to assess for significant associations between radiographic measurements and patient outcomes. Multiple linear regression models were developed adjusting for demographics and radiographic parameters to determine which factors were predictive of patient outcomes. RESULTS: C2 tilt and TS-CL correlated with all postoperative physical outcome scores (NDI, PCS-12, VAS Neck and ARM; p<.05), however no association was seen between C2 slope and postoperative outcomes. After accounting for the presence of subaxial deformity, C2 tilt and TS-CL remained strongly correlated to patient outcome scores. With multiple linear regression, C2 tilt was a significant predictor for NDI, whereas TS-CL was a significant predictor for PCS-12, VAS Neck and VAS Arm. CONCLUSIONS: C2 tilt significantly correlated with well-described conventional cervical parameters as well as postoperative physical outcomes measures, especially NDI, on multivariate analysis. C2 tilt may provide an easy and practical tool for predicting physical outcomes after ACDF.

Consensus on Wound Care of SSI in Spine Surgery.

In July of 2018, the Second International Consensus Meeting on Musculoskeletal Infection convened in Philadelphia, PA to discuss issues regarding infection in orthopedic patients and to provide consensus recommendations on these issues to practicing orthopedic surgeons. During this meeting, attending delegates divided into subspecialty groups to discuss topics specifics to their respective fields, which included the spine. At the spine subspecialty group meeting, delegates discussed and voted upon the recommendations for 63 questions regarding the prevention, diagnosis, and treatment of infection in spinal surgery. Of the 63 questions, 7 focused on wound care, for which this article provides the recommendations, voting results, and rationales.

General Principles in the Consensus of SSI Management After Spine Surgery.

In July of 2018, the Second International Consensus Meeting (ICM) on Musculoskeletal Infection convened in Philadelphia, PA was held to discuss issues regarding infection in orthopedic patients and to provide consensus recommendations on these issues to practicing orthopedic surgeons. During this meeting, attending delegates divided into subspecialty groups to discuss topics specifics to their respective fields, which included the spine. At the spine subspecialty group meeting, delegates discussed and voted upon the recommendations for 63 questions regarding the prevention, diagnosis, and treatment of infection in spinal surgery. Of the 63 questions, 8 questions focused on general principles in spine surgery, for which this article provides the recommendations, voting results, and rationales.

Consensus on Risk Factors and Prevention in SSI in Spine Surgery.

In July of 2018, the Second International Consensus Meeting (ICM) on Musculoskeletal Infection convened in Philadelphia, PA to discuss issues regarding infection in orthopedic patients and to provide consensus recommendations on these issues to practicing orthopedic surgeons. During this meeting, attending delegates divided into subspecialty groups to discuss topics specifics to their respective fields, which included the spine. At the spine subspecialty group meeting, delegates discussed and voted upon the recommendations for 63 questions regarding the prevention, diagnosis, and treatment of infection in spinal surgery. Of the 63 questions, 11 focused on risk factors and prevention questions in spine surgery, for which this article provides the recommendations, voting results, and rationales.

Consensus on Implants in Infections After Spine Surgery.

In July of 2018, the Second International Consensus Meeting (ICM) on Musculoskeletal Infection convened in Philadelphia, PA was held to discuss issues regarding infection in orthopedic patients and to provide consensus recommendations on these issues to practicing orthopedic surgeons. During this meeting, attending delegates divided into subspecialty groups to discuss topics specifics to their respective fields, which included the spine. At the spine subspecialty group meeting, delegates discussed and voted upon the recommendations for 63 questions regarding the prevention, diagnosis, and treatment of infection in spinal surgery. Of the 63 questions, 9 focused on implants questions in spine surgery, for which this article provides the recommendations, voting results, and rationales.

Consensus on the Role of Antibiotic Use in SSI Following Spinal Surgery.

In July of 2018, the Second International Consensus Meeting (ICM) on Musculoskeletal Infection convened in Philadelphia, PA was held to discuss issues regarding infection in orthopedic patients and to provide consensus recommendations on these issues to practicing orthopedic surgeons. During this meeting, attending delegates divided into subspecialty groups to discuss topics specifics to their respective fields, which included the spine. At the spine subspecialty group meeting, delegates discussed and voted upon the recommendations for 63 questions regarding the prevention, diagnosis, and treatment of infection in spinal surgery. Of the 63 questions, 17 focused on the use of antibiotics in spine surgery, for which this article provides the recommendations, voting results, and rationales.

The C2 "Parsicle" Screw: Introduction of a Novel Posterior Surgical Technique For Upper Cervical Fixation.

The instrumentation of C2 is technically challenging given the anatomic complexity of the upper cervical spine. Although the placement of C2 pedicle screws may be safer than transarticular screw placement, the inconsistent location of the transverse foramen and vertebral artery precludes placement of such screws in up to 26% of patients. In cases where vertebral artery anatomy prevents the safe placement of a pedicle screw, a pars screw is an excellent alternative. However, pars screws must stop short of the vertebral foramen, limiting the typical length of these screws to only 14-18 mm. The associated purchase and rigidity are compromised compared with the pedicle screw. A modified C2 fixation technique was developed by our group which we have named the C2 "parsicle" screw reflecting the hybrid nature of the screw incorporating aspects of pars and pedicle screw fixation.

Role of Imaging, Tissue Sampling, and Biomarkers for Diagnosis of SSI in Spine Surgery.

In July 2018, the Second International Consensus Meeting on Musculoskeletal Infection convened in Philadelphia, PA to discuss issues regarding infection in orthopedic patients and to provide consensus recommendations on these issues to practicing orthopedic surgeons. During this meeting, attending delegates divided into subspecialty groups to discuss topics specifics to their respective fields, which included the spine. At the spine subspecialty group meeting, delegates discussed and voted upon the recommendations for 63 questions regarding the prevention, diagnosis, and treatment of infection in spinal surgery. Of the 63 questions, 15 focused on the use of imaging, tissue sampling, and biomarkers in spine surgery, for which this article provides the recommendations, voting results, and rationales.

Management of Type II Odontoid Fractures in Adults.

Fractures of the odontoid represent as much as 20% of cervical spine fractures in adults, and they are the most common spine fracture in patients over 80 years of age. Despite their prevalence, the management of these fractures remains highly controversial. In particular, there is much debate concerning the management of type II fractures, or fractures occurring about the waist of the odontoid. We will review the epidemiology, evaluation, management-both operative and non-operative-and outcomes of adults with type II odontoid fractures. We will particularly focus on debates concerning hard collar versus halo, anterior versus posterior surgery, the management of odontoid nonunions, as well as questions about risks and benefits of surgery in the very elderly.

Lack of Cost Savings for Lumbar Spine Fusions After Bundled Payments for Care Improvement Initiative: A Consequence of Increased Case Complexity.

STUDY DESIGN: Retrospective analysis of Medicare claims and procedure details from a single institution participation in the Bundled Payments for Care Improvement (BPCI) program. OBJECTIVE: To analyze the effects of the BPCI program on patient outcome metrics and cost data. SUMMARY OF BACKGROUND DATA: The BPCI program was designed to improve the value of care provided to patients, but the financial consequences of this system remain largely unknown. We present 2 years of data from participation in the lumbar spine fusion bundle at a large, urban, academic institution. METHODS: In 2013 and 2014, all Medicare patients undergoing lumbar spine fusions for DGR 459 (spinal fusion except cervical with major complication or comorbidity [MCC]) and 460 (without MCC) at our institution were enrolled in the BPCI program. We compared the BPCI cohort to a baseline cohort of patients under the same diagnosis related groups (DRGs) from 2009 to 2012 from which the target price was established. RESULTS: Three hundred fifty patients were enrolled into the BPCI program, while the baseline group contained 518 patients. When compared with the baseline cohort, length of stay decreased (4.58 ±â€Š2.51 vs. 5.13 ±â€Š3.75; P = 0.009), readmission rate was unchanged, and discharges with home health aid increased. Nonetheless, we were unable to effect an episode-based cost savings ($52,655 ±â€Š27,028 vs. $48,913 ±â€Š24,764). In the larger DRG 460 group, total payments increased in the BPCI group ($51,105 ±â€Š26,347 vs. $45,934 ±â€Š19,638, P = 0.001). Operative data demonstrated a more complex patient mix in the BPCI cohort. The use of interbody fusions increased from 2% to 16% (P < 0.001), and the percentage of complex spines increased from 23% to 45% (P < 0.001). CONCLUSION: Increased case complexity was responsible for increasing costs relative to the negotiated baseline target price. This payment system may discourage advancement in spine surgery due to the financial penalty associated with novel techniques and technologies. LEVEL OF EVIDENCE: 3.

S1 Pedicle Subtraction Osteotomy for Fixed Sagittal Imbalance and Lumbosacral Kyphosis.

S1 pedicle subtraction osteotomies (PSOs) are indicated in patients with fixed, high-grade L5-S1 spondylolisthesis or kyphosis secondary to a sacral fracture, who present with severe sagittal imbalance. Unlike lumbar PSOs, sacral osteotomies are rare, and there is a paucity of literature outlining techniques. Here, we present the indications, planning, technique, and outcomes for S1 PSOs.

Correction of dropped head deformity through combined anterior and posterior osteotomies to restore horizontal gaze and improve sagittal alignment.

OBJECTIVE: The aim of this study is to present our technique for a large focal correction of a partially flexible dropped head deformity through combined anterior and posterior osteotomies, as well as anterior soft tissue releases. METHODS: One patient with dropped head deformity underwent an anterior and posterior osteotomy with anterior soft tissue release. RESULTS: The patient recovered well, with postoperative radiographs demonstrating significant improvement in coronal and sagittal alignment. His C2-C7 sagittal vertical axis improved from 7.5 cm preoperatively to less than 4 cm postoperatively and his C2-C7 sagittal Cobb improved from 35° of kyphosis to 10° of lordosis. CONCLUSION: In this report, we present our technique for a large focal correction of a partially flexible dropped head deformity through combined anterior and posterior osteotomies and anterior soft tissue releases. These more conservative osteotomies permitted gradual deformity correction and alleviated the need for pedicle subtraction osteotomy. We were able to restore horizontal gaze and improve sagittal malalignment. Although the technique we present here is one of many possible options for managing the deformity, we believe this combined approach is safe and effective and well tolerated by patients.