The fragility of statistical findings in the reverse total shoulder arthroplasty literature: a systematic review of randomized controlled trials.

BACKGROUND: Reverse total shoulder arthroplasty (RTSA) has seen increasing utilization as an effective intervention for a wide variety of shoulder pathologies. The scope and indications for growth are often driven by findings from randomized controlled trials (RCTs) guiding surgical decision-making for RTSA. In this study, we utilized the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to assess the robustness of outcomes reported in RCTs in the RTSA literature. METHODS: PubMed, Embase, and MEDLINE were queried for RCTs (Jan. 1, 2010-Mar. 31, 2023) in the RTSA literature reporting dichotomous outcomes. The FI and rFI were defined as the number of outcome reversals required to alter statistical significance for significant and nonsignificant outcomes, respectively. The FQ was determined by dividing the FI by the sample size of each study. Subgroup analysis was performed based on outcome category. RESULTS: One hundred seventy-six RCTs were screened with 18 studies included. The median FI across 59 total outcomes was 4 (interquartile range [IQR]: 3-5) with an associated FQ of 0.051 (IQR: 0.029-0.065). Thirteen outcomes were statistically significant with a median FI of 3 (IQR: 1-4) and FQ of 0.033 (IQR: 0.012-0.066). Forty-six outcomes were nonsignificant with a median rFI of 4 (IQR: 3-5) and FQ of 0.055 (IQR: 0.032-0.065). The most fragile outcome category was revision/reoperations with a median FI of 2.50 (IQR: 1.00-3.25), followed by clinical score/outcome (median FI: 3.00), complications (median FI: 4.00), "other" (median FI: 4.00), and radiographic findings (median FI: 5.00). Notably, the number of patients lost to follow-up was greater than or equal to the FI for 59% of outcomes. CONCLUSION: The statistical findings in RTSA RCTs are fragile and should be interpreted with caution. Reversal of only a few outcomes, or maintaining postoperative follow-up, may be sufficient to alter significance of study findings. We recommend standardized reporting of P values with FI and FQ metrics to allow clinicians to effectively assess the robustness of study findings.

Epidemiology and Sex-Specific Analysis of Basketball-Related Lower Extremity Fractures: A 10-Year Analysis of National Injury Data.

BACKGROUND: Basketball-related fractures involving the lower extremities frequently present to emergency departments (ED) in the United States (US). This study aimed to identify the primary mechanisms, distribution, and trends of these injuries. HYPOTHESIS: We hypothesize that (1) lower extremity fracture frequency will decrease from 2013 to 2022, (2) the ankle will be the most common fracture site, and (3) noncontact twisting will be the most common injury mechanism. STUDY DESIGN: Descriptive epidemiological. LEVEL OF EVIDENCE: Level 3. METHODS: The National Electronic Injury Surveillance System (NEISS) was queried for lower extremity fractures from basketball presenting to US EDs from January 1, 2013 to December 31, 2022. Patient demographics, injury location, and disposition were recorded. The injury mechanism was characterized using the provided narrative. National estimates (NEs) were calculated using the NEISS statistical sample weight. Injury trends were evaluated by linear regression. RESULTS: There were 6259 cases (NE: 185,836) of basketball-related lower extremity fractures. Linear regression analysis of annual trends demonstrated a significant decrease in lower extremity fractures over the study period (2013-2022: P = 0.01; R2 = 0.64). The most common injury mechanism was a noncontact twisting motion (NE: 49,897, 26.9%) followed by jumping (NE: 39,613, 21.3%). The ankle was the most common fracture site (NE: 69,936, 37.6%) followed by the foot (NE: 49,229, 26.49%). While ankle and foot fractures decreased significantly (P < 0.05), fractures of the lower leg, knee, toe, and upper leg showed no significant trends (P = 0.09, 0.75, 0.07, and 0.85, respectively). CONCLUSION: Basketball-related lower extremity fractures decreased from 2013 to 2022, with the ankle being the most common fracture site and most fractures arising from a noncontact twist. Increasing utilization of outpatient clinics may have contributed to the decline, particularly for ankle and foot fractures. The prevalence of ankle fractures and twisting-related injuries reinforces the importance of protective footwear and targeted strengthening protocols.