At the present time there are no consistently satisfactory treatment options for some challenging bone loss scenarios. We have previously reported on the properties of a novel 3D‐printed hydroxyapatite‐composite material in a pilot study, which demonstrated osteoconductive properties but was not tested in a rigorous, clinically relevant model. We therefore utilized a rat critical‐sized femoral defect model with a scaffold designed to match the dimensions of the bone defect. The scaffolds were implanted in the bone defect after being loaded with cultured rat bone marrow cells (rBMC) transduced with a lentiviral vector carrying the cDNA for BMP‐2. This experimental group was compared against 3 negative and positive control groups. The experimental group and positive control group loaded with rhBMP‐2 demonstrated statistically equivalent radiographic and histologic healing of the defect site (p > 0.9), and significantly superior to all three negative control groups (p < 0.01). However, the healed defects remained biomechanically inferior to the unoperated, contralateral femurs (p < 0.01). When combined with osteoinductive signals, the scaffolds facilitate new bone formation in the defect. However, the scaffold alone was not sufficient to promote adequate healing, suggesting that it is not substantially osteoinductive as currently structured. The combination of gene therapy with 3D‐printed scaffolds is quite promising, but additional work is required to optimize scaffold geometry, cell dosage and delivery.
Background: Modifiable risk factors (MRFs) represent patient variables associated with increased complication rates that may be prevented. There exists a paucity of studies that comprehensively analyze MRF subgroups and their independent association with postoperative complications in patients undergoing cervical spine surgery. Therefore, the purpose of this study is to compare outcomes between patients receiving cervical spine surgery with reported MRFs. Methods: Retrospective analysis of the Nationwide Readmissions Database (NRD) from the years 2016 and 2017, a publicly available and purchasable data source, to include adult patients undergoing cervical fusion. MRF cohorts were separated into three categories: substance abuse (alcohol, tobacco/nicotine, opioid abuse); vascular disease (hypertension, dyslipidemia); and dietary factors (malnutrition, obesity). Three-way nearest-neighbor propensity score matching for demographics, hospital, and surgical characteristics was implemented. Findings: We identified 9601 with dietary MRFs (D-MRF), 9654 with substance abuse MRFs (SA-MRF), and 9503 with vascular MRFs (V-MRF). Those with D-MRFs had significantly higher rates of medical complications (9.3%), surgical complications (8.1%), and higher adjusted hospital costs compared to patients with SA-MRFs and V-MRFs. Patients with D-MRFs (16.3%) and V-MRFs (14.0%) were independently non-routinely discharged at a significantly higher rate compared to patients with SA-MRFs (12.6%) (p<0.0001 and p = 0.0037). However, those with substance abuse had the highest readmission rate and were more commonly readmitted for delayed procedure-related infections. Interpretation: A large proportion of patients who receive cervical spine surgery have potential MRFs that uniquely influence their postoperative outcomes. A thorough understanding of patient-specific MRF subgroups allows for improved preoperative risk stratification, tailored patient counseling, and postoperative management planning.
Study Design: Prospective single-cohort analysis. Objectives: To compare the outcomes/complications of 2 robotic systems for spine surgery. Methods: Adult patients (≥18-years-old) who underwent robot-assisted spine surgery from 2016-2019 were assessed. A propensity score matching (PSM) algorithm was used to match Mazor X to Renaissance cases. Preoperative CT scan for planning and an intraoperative O-arm for screw evaluation were preformed. Outcomes included screw accuracy, robot time/screw, robot abandonment, and radiation. Screw accuracy was measured using Vitrea Core software by 2 orthopedic surgeons. Screw breach was measured according to the Gertzbein/Robbins classification. Results: After PSA, a total of 65 patients (Renaissance: 22 vs. X: 43) were included. Patient/operative factors were similar between robot systems ( P > .05). The pedicle screw accuracy was similar between robots (Renaissance: 1.1%% vs. X: 1.3%, P = .786); however, the S2AI screw breach rate was significantly lower for the X (Renaissance: 9.5% vs. X: 1.2%, P = .025). Robot time per screw was not statistically different (Renaissance: 4.6 minutes vs. X: 3.9 minutes, P = .246). The X was more reliable with an abandonment rate of 2.3% vs. Renaissance:22.7%, P = .007. Radiation exposure were not different between robot systems. Non-robot related complications including dural tear, loss of motor/sensory function, and blood transfusion were similar between robot systems. Conclusion: This is the first comparative analyses of screw accuracy, robot time/screw, robot abandonment, and radiation exposure between the Mazor X and Renaissance systems. There are substantial improvements in the X robot, particularly in the perioperative planning processes, which likely contribute to the X’s superiority in S2AI screw accuracy by nearly 8-fold and robot reliability by nearly 10-fold.
Study Design. Retrospective cohort study. Objective. Assess whether modifying spinal alignment goals to accommodate frailty considerations will decrease mechanical complications and maximize clinical outcomes. Summary of Background Data. The Global Alignment and Proportion (GAP) score was developed to assist in reducing mechanical complications, but has had less success predicting such events in external validation. Higher frailty and many of its components have been linked to the development of implant failure. Therefore, modifying the GAP score with frailty may strengthen its ability to predict mechanical complications. Materials and Methods. We included 412 surgical ASD patients with two-year follow-up. Frailty was quantified using the modified Adult Spinal Deformity Frailty Index (mASD-FI). Outcomes: proximal junctional kyphosis and proximal junctional failure (PJF), major mechanical complications, and “Best Clinical Outcome” (BCO), defined as Oswestry Disability Index<15 and Scoliosis Research Society 22-item Questionnaire Total>4.5. Logistic regression analysis established a six-week score based on GAP score, frailty, and Oswestry Disability Index US Norms. Logistic regression followed by conditional inference tree analysis generated categorical thresholds. Multivariable logistic regression analysis controlling for confounders was used to assess the performance of the frailty-modified GAP score. Results. Baseline frailty categories: 57% not frail, 30% frail, 14% severely frail. Overall, 39 of patients developed proximal junctional kyphosis, 8% PJF, 21% mechanical complications, 22% underwent reoperation, and 15% met BCO. The mASD-FI demonstrated a correlation with developing PJF, mechanical complications, undergoing reoperation, and meeting BCO at two years (all P<0.05). Regression analysis generated the following equation: Frailty-Adjusted Realignment Score (FAR Score)=0.49×mASD-FI+0.38×GAP Score. Thresholds for the FAR score (0–13): proportioned: <3.5, moderately disproportioned: 3.5–7.5, severely disproportioned: >7.5. Multivariable logistic regression assessing FAR score demonstrated associations with mechanical complications, reoperation, and meeting BCO by two years (all P<0.05), whereas the original GAP score was only significant for reoperation. Conclusion. This study demonstrated adjusting alignment goals in adult spinal deformity surgery for a patient’s baseline frailty status and disability may be useful in minimizing the risk of complications and adverse events, outperforming the original GAP score in terms of prognostic capacity. Level of Evidence. III.
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