Statistical Fragility of Surgical Clinical Trials in Orthopaedic Trauma.

INTRODUCTION: The Fragility Index (FI) and the Fragility Quotient (FQ) are powerful statistical tools that can aid clinicians in assessing clinical trial results. The purpose of this study was to use the FI and FQ to evaluate the statistical robustness of widely cited surgical clinical trials in orthopaedic trauma. METHODS: We performed a PubMed search for orthopaedic trauma clinical trials in high-impact orthopaedics-focused journals and calculated the FI and FQ for all identified dichotomous, categorical outcomes. RESULTS: We identified 128 studies with 545 outcomes. The median FI was 5, and the median FQ was 0.0482. For statistically significant and not statistically significant outcomes, the median FIs were 3 and 5, and the mean FQs were 0.0323 and 0.0526, respectively. The FI was greater than the number of patients lost to follow-up in most outcomes. CONCLUSIONS: The orthopaedic trauma literature is of equal or higher quality than research in other orthopaedic subspecialties, suggesting that other orthopaedic subspecialties may benefit from modeling their clinical trials after those in orthopaedic trauma.

Anatomic total shoulder arthroplasty using a stem-free ellipsoid humeral implant in patients of all ages.

BACKGROUND: Stem-free shoulder arthroplasty has recently been shown to have comparable results to stemmed arthroplasty, though stemless designs are typically used in a younger patient population. Additionally, although the native humeral head is elliptical in shape, clinical results with ellipsoid implants in shoulder arthroplasty have not been reported on previously. This case series reports on the outcomes of a recently introduced anatomic total shoulder arthroplasty with an ellipsoid-shaped articular surface and unique multiplanar platform type of stemless fixation. METHODS: This retrospective case series examines the initial cohort of patients who received an anatomic total shoulder arthroplasty using an ellipsoid stem-free humeral prosthesis and an all-polyethylene glenoid component from the Catalyst CSR Total Shoulder System (Catalyst OrthoScience) over a 1-year period. Inclusion criteria were patients with a diagnosis of advanced glenohumeral joint arthritis with an intact rotator cuff, regardless of patient age. Clinical outcomes including shoulder range of motion and patient-reported outcome measures, as well as radiographs, were evaluated at multiple time points postoperatively, with minimum 2-year follow-up. RESULTS: Sixty-three shoulders in 57 patients with a mean age of 73.0 years (range 60-85 years) were included in the study with a mean follow-up period of 30.5 months (range 24-41 months). Forward elevation improved from 121° to 150° (P < .0001), external rotation improved from 28° to 48° (P < .0001), and internal rotation improved from L3 to L1 (P < .001). There were statistically significant improvements exceeding the minimal clinically important difference (MCID) in the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score (37 to 94, P < .001), Single Assessment Numeric Evaluation (SANE) (40 to 93, P < .001), visual analog scale (6.3 to 0.4, P < .001), and Patient-Reported Outcomes Measurement Information System physical domain T score (44 to 57, P < .001). The improvement in the ASES score also exceeded the threshold for the substantial clinical benefit. Age, sex, and preoperative glenoid morphology did not appear to have an effect on the clinical outcome scores. There were no implant failures or evidence of radiographic loosening of the humerus component in any patients. CONCLUSION: At 2-year minimum follow-up, this stem-free ellipsoid humerus total shoulder arthroplasty provides very good results with high patient satisfaction, clinical improvement in all outcome measures studied, and no signs of loosening.

Lessons Learned for Orthopaedic Care Within the NYC COVID Epicenter Using the United States Naval Ship Comfort.

Although elective surgeries and in-person office visits were greatly reduced during the COVID-19 crisis, orthopaedic surgeons continue to play a critical role in caring for both orthopaedic and nonorthopaedic problems during this pandemic. Orthopaedic departments provide the ability to off-load emergency departments of orthopaedic issues, redeploy staff to areas of need across the hospital system, and provide direct care to COVID-19 patients. The following will discuss the experience of a large academic orthopaedic surgery department within the epicenter of the COVID-19 pandemic with respect to redeployment of human capital and unique resources such as the United States Naval Ship Comfort as well as our recommended strategy for handling future disaster situations.

Gross Motor Function Classification System Specific Growth Charts-Utility as a Risk Stratification Tool for Surgical Site Infection Following Spine Surgery.

BACKGROUND: There is currently minimal evidence that preoperative malnutrition increases surgical site infection (SSI) risk in children with cerebral palsy (CP) undergoing spinal deformity surgery. Growth charts specifically for patients with CP have been created to aid in the clinical interpretation of body mass index (BMI) as a marker of nutritional status, but to our knowledge these charts have never been used to risk stratify patients before orthopaedic surgery. We hypothesize that patients with CP who have BMI-for-age below the 10th percentile (BMI≤10) on CP-specific growth charts are at increased risk of surgical site infection following spinal deformity surgery compared with patients with BMI-for-age above the 10th percentile (BMI>10). METHODS: Single-center, retrospective review comparing the rate of SSI in patients with CP stratified by BMI-for-age percentiles on CP-specific growth charts who underwent spinal deformity surgery. Odds ratios with 95% confidence intervals and Pearson χ tests were used to analyze the association of the measured nutritional indicators with SSI. RESULTS: In total, 65 patients, who underwent 74 procedures, had complete follow-up data and were included in this analysis. Ten patients (15.4%) were GMFCS I-III and 55 (84.6%) were GMFCS IV-V; 39 (60%) were orally fed and 26 (40%) were tube-fed. The rate of SSI in this patient population was 13.5% with 10 SSIs reported within 90 days of surgery. There was a significant association between patients with a BMI below the 10th percentile on GMFCS-stratified growth charts and the development of SSI (OR, 13.6; 95% CI, 2.4-75.4; P=0.005). All SSIs occurred in patients that were GMFCS IV-V. There was no association between height, weight, feeding method, or pelvic instrumentation and development of SSI. CONCLUSIONS: CP-specific growth charts are useful tools for identifying patients at increased risk for SSI following spinal instrumentation procedures, whereas standard CDC growth charts are much less sensitive. There is a strong association between preoperative BMI percentile on GMFCS-stratified growth charts and SSI following spinal deformity surgery. LEVEL OF EVIDENCE: Level III-Retrospective Study.

Time to Diagnosis and Treatment of Surgical Site Infections in Foot and Ankle Surgery.

BACKGROUND: The time at which patients typically present with surgical site infections (SSI) following foot and ankle surgery has not been characterized. The primary aim of this study was to quantify the time to definitive treatment of SSIs. METHODS: We performed a retrospective review of 1933 foot and ankle procedures in 1632 patients from 2011 through 2015. Demographic and surgical data were collected. Time to presentation in cases diagnosed with postoperative wound complications or SSIs was analyzed. Wound complications were defined as any case with concerning wound appearance that subsequently resolved with antibiotic therapy alone. SSIs were defined as cases requiring operative irrigation and debridement (I&D) for successful definitive management. RESULTS: A total of 1569 procedures met inclusion criteria, with 17 SSIs (1.1%) and 63 wound complications (4.0%). Time between surgery and definitive treatment in the SSI group was significantly greater than in the wound complication group (28.2 ± 9.1 vs 13.4 ± 4.7 days, P < .00001). Eleven (64.7%) cases in the SSI group failed a trial of antibiotics prior to I&D, and 6 (35.3%) cases did not receive antibiotics prior to I&D. Antibiotic treatment prior to I&D did not significantly decrease the yield of intraoperative wound cultures (70% vs 100%, P = .51). CONCLUSION: In our cohort of patients, the time to diagnosis and treatment of SSIs was longer than that of wound complications. SSIs requiring operative intervention did not present until an average of 4 weeks after surgery. These data are of some benefit in trying to define and understand SSI. LEVEL OF EVIDENCE: Level III, retrospective cohort study.