The Fragility of Statistical Significance in Sham Orthopaedic Surgery: A Systematic Review of Randomized Controlled Trials.

OBJECTIVES: The purpose of this study was to determine the stability of statistical findings among sham surgery randomized controlled trials (RCTs) in orthopaedic surgery using fragility analysis. METHODS: PubMed systematic review was conducted to include studies reporting dichotomous outcomes pertaining to sham surgery. The final review included eight RCTs involving only partial meniscectomies and vertebroplasties from 2009 to 2020. With a fixed sample size with dichotomous outcome measures (events versus non-events), the Total Fragility Index (TFI), which is composed of the fragility index (FI) and reverse fragility index (RFI), was calculated by altering the ratio of events to non-events in an iterative fashion until results were reversed from significant to nonsignificant findings (FI) or vice versa (RFI). The TFI, FI, and RFI were divided by their sample sizes to obtain the respective total fragility quotient, fragility quotient (FQ), and reverse fragility quotient. Median fragility indices and quotients were reported for all studies. RESULTS: The eight RCTs included 50 dichotomous outcomes involving either partial meniscectomies or vertebroplasties, with a median TFI and total fragility quotient of 5 [interquartile range (IQR) 4 to 6] and 0.035 (IQR 0.028 to 0.048), respectively, indicating that a median of five total patients or 3.5 per 100 patients would need to experience a different outcome to reverse significant or insignificant findings for each of the eight trials. Among the 8 statistically significant ( P < 0.05) outcome events (16%), the respective FI and FQ were 2 (IQR 1 to 5) and 0.018 (IQR 0.010 to 0.044). Among the 42 statistically insignificant outcome events (84%), the respective RFI and reverse fragility quotient were 5 (IQR 4 to 6) and 0.04 (IQR 0.034 to 0.048). The median number of patients lost to follow-up was 1.5 (IQR 0.5 to 2). CONCLUSION: The unstable findings in partial meniscectomy and vertebroplasty sham surgical RCTs undermine their study conclusions and recommendations. We recommend using fragility analysis in future sham surgical RCTs to contextualize statistical findings. LEVEL OF EVIDENCE: Level IV; Systematic Review.

The Fragility of Statistical Significance in Patellofemoral Instability Research: A Systematic Review.

BACKGROUND: Fragility analysis is increasingly utilized to evaluate the robustness of results within the orthopaedic literature and has frequently revealed instability of reported outcomes. PURPOSE/HYPOTHESIS: The purpose of this investigation was to utilize a fragility analysis to evaluate the stability of reported results in the patellofemoral instability (PFI) literature. We hypothesized the demonstration of significant fragility in patellofemoral research to be similar to that identified throughout other areas of the orthopaedic literature. STUDY DESIGN: Systematic review; Level of evidence, 4. METHODS: The PubMed database was queried from January 1, 2000, to October 10, 2020 for comparative trials in 10 prominent orthopaedic journals that reported dichotomous outcomes related to the management of PFI. The fragility index (FI) and the fragility quotient (FQ) were calculated for each individual outcome event, and the overall FI and FQ were determined for all included studies. RESULTS: A total of 22 comparative studies comprising 11 randomized controlled trials and 11 nonrandomized trials were included for the analysis. A total of 75 outcome events underwent a fragility analysis and revealed a median FI and FQ of 3 (interquartile range [IQR], 1-5) and 0.043 (IQR, 0.018-0.081), respectively. Also 27% of included studies reported loss to follow-up greater than the overall FI, therefore suggesting the maintenance of the follow-up may have resulted in the reversal of significance. CONCLUSION: The result of the comprehensive fragility analysis demonstrated a lack of robustness in PFI research with the alteration of only a few outcome events required to reverse statistical significance. We therefore recommend the triple reporting of the P value, the FI, and the FQ to aid in the interpretation of the statistical integrity of future comparative trials in the PFI literature.

Return-to-Sport Outcomes After Primary Ulnar Collateral Ligament Reconstruction With Palmaris Versus Hamstring Tendon Grafts: A Systematic Review.

BACKGROUND: Ulnar collateral ligament (UCL) reconstruction is the current gold standard of treatment for overhead athletes with a symptomatic, deficient UCL of the elbow who have failed nonoperative treatment and wish to return to sport (RTS) at a high level. The palmaris longus and hamstring tendons are common graft choices, but no study has analyzed the existing literature to assess whether one graft is superior to the other. PURPOSE: To systematically report on the outcomes of UCL reconstruction using palmaris and hamstring autografts. STUDY DESIGN: Systematic review; Level of evidence, 4. METHODS: A combination of the terms "ulnar collateral ligament," "valgus instability," "Tommy John surgery," "hamstring," and "palmaris longus" were searched in PubMed, Embase, and the Cochrane Library. RTS and return-to-same-level (RSL) rates, patient-reported outcomes, and complications were included for analysis. We used the modified Coleman Methodology Score and risk-of-bias tool for nonrandomized studies to assess the quality of the included studies. RESULTS: This review included 6 studies (combined total of 2154 elbows) that directly compared palmaris and hamstring graft use in UCL reconstruction. Follow-up ranged from 24 to 80.4 months, and the mean patient age across all studies was 21.8 years. The mean RSL across all studies and grafts was 79.0%, and the mean RTS was 84.1%, consistent with results previously reported in the literature. The mean RTS and RSL rates for the palmaris graft group were 84.6% and 82%, respectively; the hamstring graft group showed mean RTS and RSL rates of 80.8% and 80.8%. Meta-analysis revealed no significant difference in RSL between the 2 graft groups (odds ratio, 1.06; 95% CI, 0.77-1.46). The combined complication rate of the included studies was 18.2%, with failure rates ranging from 0% to 7.1%. CONCLUSION: Results of this review indicated that both palmaris and hamstring tendon grafts are viable options for primary UCL reconstruction. Graft choice should be determined by a combination of patient and surgeon preference.

Using machine learning methods to predict nonhome discharge after elective total shoulder arthroplasty.

BACKGROUND: Machine learning has shown potential in accurately predicting outcomes after orthopedic surgery, thereby allowing for improved patient selection, risk stratification, and preoperative planning. This study sought to develop machine learning models to predict nonhome discharge after total shoulder arthroplasty (TSA). METHODS: The American College of Surgeons National Surgical Quality Improvement Program database was queried for patients who underwent elective TSA from 2012 to 2018. Boosted decision tree and artificial neural networks (ANN) machine learning models were developed to predict non-home discharge and 30-day postoperative complications. Model performance was measured using the area under the receiver operating characteristic curve (AUC) and overall accuracy (%). Multivariate binary logistic regression analyses were used to identify variables that were significantly associated with the predicted outcomes. RESULTS: There were 21,544 elective TSA cases identified in the National Surgical Quality Improvement Program registry from 2012 to 2018 that met inclusion criteria. Multivariate logistic regression identified several variables associated with increased risk of nonhome discharge including female sex (odds ratio [OR] = 2.83; 95% confidence interval [CI] = 2.53-3.17; P < .001), age older than 70 years (OR = 3.19; 95% CI = 2.86-3.57; P < .001), American Society of Anesthesiologists classification 3 or greater (OR = 2.70; 95% CI = 2.41-2.03; P < .001), prolonged operative time (OR = 1.38; 95% CI = 1.20-1.58; P < .001), as well as history of diabetes (OR = 1.56; 95% CI = 1.38-1.75; P < .001), chronic obstructive pulmonary disease (OR = 1.71; 95% CI = 1.46-2.01; P < .001), congestive heart failure (OR = 2.65; 95% CI = 1.72-4.01; P < .001), hypertension (OR = 1.35; 95% CI = 1.20-1.52; P = .004), dialysis (OR = 3.58; 95% CI = 2.01-6.39; P = .002), wound infection (OR = 5.67; 95% CI = 3.46-9.29; P < .001), steroid use (OR = 1.43; 95% CI = 1.18-1.74; P = .010), and bleeding disorder (OR = 1.84; 95% CI = 1.45-2.34; P < .001). The boosted decision tree model for predicting nonhome discharge had an AUC of 0.788 and an overall accuracy of 90.3%. The ANN model for predicting nonhome discharge had an AUC of 0.851 and an overall accuracy of 89.9%. For predicting the occurrence of 1 or more postoperative complications, the boosted decision tree model had an AUC of 0.795 and an overall accuracy of 95.5%. The ANN model yielded an AUC of 0.788 and an overall accuracy of 92.5%. CONCLUSIONS: Both the boosted decision tree and ANN models performed well in predicting nonhome discharge with similar overall accuracy, but the ANN had higher discriminative ability. Based on the findings of this study, machine learning has the potential to accurately predict nonhome discharge after elective TSA. Surgeons can use such tools to guide patient expectations and to improve preoperative discharge planning, with the ultimate goal of decreasing hospital length of stay and improving cost-efficiency.

Telehealth Utilization in Response to the Novel Coronavirus (COVID-19) Pandemic in Orthopaedic Surgery.

INTRODUCTION: The purpose of this investigation is to assess the current utilization of telehealth capabilities at academic orthopaedic departments in the United States and to determine how practice patterns have been directly influenced by the coronavirus disease 19 (COVID-19) pandemic. METHODS: Orthopaedic surgery programs participating in the Electronic Residency Application Service were identified. One hundred seventy-five (175) programs were presented with a seven-item questionnaire addressing whether each program is using telehealth services in response to the COVID-19 pandemic. RESULTS: Of the 175 Electronic Residency Application Service participant orthopaedic programs, 168 responded for a total response rate of 96%. Of the 106 institutions using telehealth services, 88 (83%) cited the COVID-19 pandemic as the impetus for implementation of telehealth services. Institutions located in the Northeast and South regions were markedly more likely to offer telehealth services. Heat map analysis demonstrates an associative overlap of regional "hot spots" with direct comparison of COVID-19 cases in the United States and orthopaedic departments providing telehealth services. DISCUSSION: This study demonstrates the impressive measures academic orthopaedic institutions are taking to meet the needs of our patients by identifying a notable increase in new telehealth offerings throughout the United States with a positive correlation with COVID-19 disease burden.

Preparation, characterization, and evaluation of radiopaque hydrogel filaments for endovascular embolization.

Radiopaque hydrogel filaments were prepared, characterized, and evaluated for potential use as implants for endovascular embolization of vascular defects. Three hydrogel formulations were prepared by free radical polymerization: (i) poly(ethylene glycol) diacrylate with 2,4,6-triiodophenyl penta-4-enoate (PEG-I), (ii) poly(ethylene glycol) diacrylamide with barium sulfate (PEG-B), and (iii) poly(propylene glycol) diacrylate with barium sulfate (PPG-B). The PEG-B and PPG-B hydrogels exhibited radiopacity comparable with clinically used platinum coils, whereas the PEG-I hydrogel did not. In the dry state, the average ultimate tensile strength and strain of the hydrogels ranged from 37 to 128 gf and 21% to 72%, respectively. The PEG-B hydrogel had significantly higher tensile strength compared with the PEG-I hydrogel. In the hydrated state, the average ultimate tensile strength and strain ranged from 5 to 15 gf and 7% to 30%, respectively. Statistically significant differences in tensile strength were not present when hydrated. Compared with poly(ethylene) after 4-week implantation into the subcutaneous space of rabbits, the PEG-I hydrogel elicited slightly more inflammation, whereas the PEG-B and PPG-B hydrogels elicited less inflammation. All three hydrogel formulations elicited less fibrous encapsulation than poly(ethylene). With further development, these materials have potential as embolization devices.