Randomized Controlled Trials Comparing Bone-Patellar Tendon-Bone Versus Hamstring Tendon Autografts in Anterior Cruciate Ligament Reconstruction Surgery Are Statistically Fragile: A Systematic Review.

PURPOSE: To assess the statistical fragility of recently published randomized controlled trials (RCTs) comparing the use of hamstring tendon autograft with bone-patellar tendon-bone autograft for anterior cruciate ligament (ACL) reconstruction. METHODS: The PubMed, Embase, and MEDLINE databases were queried for RCTs published since 2010 comparing autograft type (bone-patellar tendon-bone vs hamstring tendon) in ACL reconstruction surgery. The fragility index (FI) and reverse FI (rFI) were determined for significant and nonsignificant outcomes, respectively, as the number of outcome reversals required to change statistical significance. The fragility quotient (FQ) and reverse FQ, representing fragility as a proportion of the study population, were calculated by dividing the FI and rFI, respectively, by the sample size. RESULTS: We identified 19 RCTs reporting 55 total dichotomous outcomes. The median FI of the 55 total outcomes was 5 (interquartile range [IQR], 4-7), meaning a median of 5 outcome event reversals would alter the outcomes' significance. Five outcomes were reported as statistically significant with a median FI of 4 (IQR, 2-6), meaning a median of 4 outcome event reversals would change outcomes to be nonsignificant. Fifty outcomes were reported as nonsignificant with a median rFI of 5 (IQR, 4-7), meaning a median of 5 outcome event reversals would change outcomes to be significant. The FQ and reverse FQ for significant and nonsignificant outcomes were 0.025 (IQR, 0.018-0.045) and 0.082 (IQR, 0.041-0.106), respectively. For 61.8% of outcomes, patients lost to follow-up exceeded the corresponding FI or rFI. CONCLUSIONS: There is substantial statistical fragility in recent RCTs on autograft choice in ACL reconstruction surgery given that altering a few outcome events is sufficient to reverse study findings. For over half of outcomes, maintaining patients lost to follow-up may have been sufficient to reverse study conclusions. CLINICAL RELEVANCE: We recommend co-reporting FIs and P values to provide a more comprehensive representation of a study's conclusions when conducting an RCT.

Prior COVID-19 and Venous Thromboembolism Risk in Total Joint Arthroplasty in Patients Over 65 Years of Age.

BACKGROUND: The COVID-19 pandemic has been associated with increased risks of venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE). However, there is limited literature investigating prothrombotic states and complications after total hip arthroplasty (THA) and total knee arthroplasty (TKA). We investigated (1) trends in VTE, PE, and DVT rates post-THA and TKA from 2016 to 2019 compared to 2020 to 2021 and (2) associations between prior COVID-19 diagnosis and VTE, PE, and DVT. METHODS: A national dataset was queried for elective THA and TKA cases from 2016 to 2021. We first assessed trends in 90-day VTE prevalence between 2016 to 2019 and 2020 to 2021. Second, we investigated associations between previous COVID-19 and 90-day VTE with regression models. RESULTS: From 2016 to 2021, a total of 2,422,051 cases had an annual decreasing VTE prevalence from 2.2 to 1.9% (THA) and 2.5 to 2.2% (TKA). This was evident for both PE and DVT (all trend tests P < .001). After adjusting for covariates (including vaccination status), prior COVID-19 was associated with significantly increased odds of developing VTE in TKA patients (odds ratio 1.2, 95% confidence interval 1.1 to 1.4, P = .007), but not DVT or PE (P > .05). There were no significant associations between prior COVID-19 and VTE, DVT, or PE after THA (P > .05). CONCLUSIONS: Our study suggests that a previous diagnosis of COVID-19 is associated with increased odds of VTE, but not DVT or PE, in TKA patients. Ongoing data monitoring is needed given our effect estimates, emerging COVID-19 variants, and evolving vaccination rates.

Did the COVID-19 Pandemic Coincide With an Increase in Osteonecrosis as Indication for Total Hip Arthroplasty in Older Patients?

BACKGROUND: Osteonecrosis of the femoral head is a common indication for total hip arthroplasty (THA). It is unclear to what extent the COVID-19 pandemic has impacted its incidence. Theoretically, the combination of microvascular thromboses and corticosteroid use in patients who have COVID-19 may increase the risk of osteonecrosis. We aimed to (1) assess recent osteonecrosis trends and (2) investigate if a history of COVID-19 diagnosis is associated with osteonecrosis. METHODS: This retrospective cohort study utilized a large national database between 2016 and 2021. Osteonecrosis incidence in 2016 to 2019 was compared to 2020 to 2021. Secondly, utilizing a cohort from April 2020 through December 2021, we investigated whether a prior COVID-19 diagnosis was associated with osteonecrosis. For both comparisons, Chi-square tests were applied. RESULTS: Among 1,127,796 THAs performed between 2016 and 2021, we found an osteonecrosis incidence of 1.6% (n = 5,812) in 2020 to 2021 compared to 1.4% (n = 10,974) in 2016 to 2019; P < .0001. Furthermore, using April 2020 to December 2021 data from 248,183 THAs, we found that osteonecrosis was more common among those who had a history of COVID-19 (3.9%; 130 of 3,313) compared to patients who had no COVID-19 history (3.0%; 7,266 of 244,870); P = .001). CONCLUSION: Osteonecrosis incidence was higher in 2020 to 2021 compared to previous years and a previous COVID-19 diagnosis was associated with a greater likelihood of osteonecrosis. These findings suggest a role of the COVID-19 pandemic on an increased osteonecrosis incidence. Continued monitoring is necessary to fully understand the impact of the COVID-19 pandemic on THA care and outcomes.