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PURPOSE: This study employs both the fragility index (FI) and fragility quotient (FQ) to assess the level of robustness in the cervical disc arthroplasty (CDA) literature. We hypothesize that dichotomous outcomes involving CDA would exhibit statistical vulnerability. METHODS: A PubMed search was conducted to evaluate dichotomous data for randomized controlled trials (RCTs) in CDA literature from 2000 to 2023. The FI of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The FQ was calculated by dividing each fragility index by the study sample size. The interquartile range (IQR) was also calculated for the FI and FQ. RESULTS: Of the 1561 articles screened, 111 met the search criteria, with 35 RCTs evaluating CDA included for analysis. Six hundred and ninety-three outcome events with 130 significant (P < 0.05) outcomes and 563 nonsignificant (P ≥ 0.05) outcomes were identified. The overall FI and FQ for all 693 outcomes were 5 (IQR 3-7) and 0.019 (IQR 0.011-0.043). Fragility analysis of statistically significant outcomes and nonsignificant outcomes both revealed an FI of 5. All of the studies reported loss to follow-up (LTF) data where 65.7% (23) did not report or reported an LTF greater or equal to 5. CONCLUSIONS: The literature regarding CDA RCTs lacks statistical robustness and may misrepresent the conclusions with the sole use of the P value. By implementing the FI and FQ along with the P value, we believe the interpretation and contextualization of the clinical data surrounding CDA will be better understood.

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INTRODUCTION: The nature of wrestling may lead athletes to mask injuries with the delayed presentations of youth wrestling-related injuries not being well characterized. METHODS: This descriptive epidemiological study queried the National Electronic Injury Surveillance System database to characterize delayed presentations of wrestling-related injuries in middle and high-school athletes. Data collection consisted of national estimates, demographics, and injury characteristics of patients with delayed (D) presentations (≥1 day) and same-day (S) presentations to US emergency departments after sustaining a wrestling-related injury during the scholastic wrestling season (December to February, 2000 to 2019). RESULTS: Of middle and high-school wrestlers presenting to US emergency departments, 5.6% (95% confidence interval [CI] 4.3% to 7.1%) reported delayed presentations for a total of 1,110 patients (CI, 591 to 1,630) annually. Most commonly (P < 0.001), injuries were sustained on Saturdays in both cohorts (D, 28.2%; CI, 22.4% to 34.8%; S, 29.6%; CI, 24.3% to 35.5%). Patients reporting delayed presentations were less likely to sustain fractures (D, 11.5%; CI, 8.3% to 15.6%; S, 18.9%; CI, 15.0% to 23.5%; P = 0.019) and injuries of the head/neck (D, 20.0%; CI, 16.5 to 24.1%; S, 26.2%; CI, 21.4% to 31.7%; P = 0.011). DISCUSSION: A substantial proportion of adolescent wrestlers report delayed presentations of injuries. This emphasizes the need for vigilance in detecting subtle signs of injury.

Assuntos

Traumatismos em Atletas, Diagnóstico Tardio, Luta Romana, Humanos, Luta Romana/lesões, Adolescente, Masculino, Feminino, Estados Unidos/epidemiologia, Traumatismos em Atletas/epidemiologia, Serviço Hospitalar de Emergência, Criança, Fatores de Tempo

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BACKGROUND: Reverse total shoulder arthroplasty (RTSA) is a common procedure utilized to address degenerative pathologies of the glenohumeral joint and rotator cuff. Increased reliance on patient-reported outcome measures (PROMs) has placed emphasis on the utilization of the minimum clinically important difference (MCID), substantial clinical benefit (SCB), patient acceptable symptom state (PASS), and maximal outcome improvement (MOI) thresholds to assess the clinical efficacy of RTSA. In this study, we systematically reviewed the MCID, SCB, PASS, and MOI thresholds reported for PROMs following RTSA. METHODS: PubMed, Embase, MEDLINE, Cochrane Library, and Google Scholar were queried for articles from Jan. 1, 2000-Aug. 31, 2023 reporting MCID, SCB, PASS, or MOI values for PROMs following RTSA. Patient demographic data, study characteristics, MCID/SCB/PASS/MOI thresholds, and threshold calculation methods were extracted. RESULTS: 141 articles were screened with 39 ultimately included, comprising 11,984 total patients that underwent RTSA. 34 (87%) studies reported MCID thresholds, 20 (51%) reported SCB, 5 (13%) reported PASS, and 2 (5%) reported MOI. 25/39 (64%) studies referenced a previous study when reporting MCID, SCB, PASS, or MOI values, 11 (28%) used an anchor-based method to calculate threshold values, 1 (3%) used a distribution-based method, and 2 (5%) used both anchor and distribution methods. There were 19 newly calculated MCID (11), SCB (5), PASS (1), and MOI (2) thresholds. For five of the six most utilized PROMs (ASES, SST, Constant, UCLA, SPADI), the range of reported MCID values exceeded 50% of the most common threshold. For three of the six, the range of SCB values exceeded 25% of the most common threshold. CONCLUSION: There is substantial variability in the MCID and SCB threshold values reported in the RTSA literature. Standardizing the methodologic calculation and utilization of MCID, SCB, PASS, and MOI thresholds for RTSA may allow for improved assessment of PROMs.

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Background: Surfing is an increasingly popular sport with a high propensity for both traumatic and atraumatic injuries. Purpose: To analyze the trends, etiologies, and diagnoses of lower extremity orthopaedic-related surfing injuries presenting to United States (US) emergency departments (EDs) within a 21-year study period. Study Design: Descriptive epidemiology study. Methods: The National Electronic Injury Surveillance System database was queried for data on lower extremity surfing injuries presenting to US EDs from January 1 to December 31, 2022. Data collected included year, injury mechanism, injury location, diagnosis, and disposition. The raw data were used to calculate national estimates (NEs) based on each hospital's assigned statistical sample weight. Linear regressions were performed to analyze annual trends. Results: A total of 776 lower extremity surfing injuries were included (NE = 49,218 injuries). The mean age of the patients was 29.4 ± 13.6 years. The most common injured areas were the foot (NE = 17,411; 35.4%), lower leg (NE = 8673, 17.6%), and knee (NE = 8139; 16.5%). The most common mechanism of injury was impact with board (NE = 17,144; 34.8%), and the most common fracture locations were the lower leg (NE = 1195; 29.5%), ankle (NE = 1594; 24.5%), and foot (NE = 1495; 23.0%). There were statistically significant decreases in weighted estimates for lower extremity surfing injuries by 108 per year (P < .001), for lacerations by 76 per year (P < .001), and for sprains by 18 per year (P = .01). Impact-with-board injuries decreased by 59 injuries per year (P < .001) and constituted 63.5% of lacerations and 12.1% of fractures. Only 3.9% of patients were admitted for hospitalization. Conclusion: There was a decreasing trend in lower extremity surfing injuries presenting to US EDs during the 21-year study period.

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INTRODUCTION: Randomized controlled trials (RCTs) represent the highest level of evidence in orthopaedic surgery literature, although the robustness of statistical findings in these trials may be unreliable. We used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to evaluate the statistical stability of outcomes reported in RCTs that assess the use of tranexamic acid (TXA) across orthopaedic subspecialties. METHODS: PubMed, EMBASE, and MEDLINE were queried for RCTs (2010-present) reporting dichotomous outcomes with study groups stratified by TXA administration. The FI and rFI were defined as the number of outcome event reversals needed to alter the significance level of significant and nonsignificant outcomes, respectively. FQ was determined by dividing the FI or rFI by sample size. Subgroup analyses were conducted based on orthopaedic subspecialty. RESULTS: Six hundred five RCTs were screened with 108 studies included for analysis comprising 192 total outcomes. The median FI of the 192 outcomes was 4 (IQR 2 to 5) with an associated FQ of 0.03 (IQR 0.019 to 0.050). 45 outcomes were reported as statistically significant with a median FI of 1 (IQR 1 to 5) and associated FQ of 0.02 (IQR 0.011 to 0.034). 147 outcomes were reported as nonsignificant with a median rFI of 4 (IQR 3 to 5) and associated FQ of 0.04 (IQR 0.023 to 0.051). The adult reconstruction, trauma, and spine subspecialties had a median FI of 4. Sports had a median FI of 3. Shoulder and elbow and foot and ankle had median FIs of 6. DISCUSSION: Statistical outcomes reported in RCTs on the use of TXA in orthopaedic surgery are fragile. Reversal of a few outcomes is sufficient to alter statistical significance. We recommend reporting FI, rFI, and FQ metrics to aid in interpreting the outcomes reported in comparative trials.

Assuntos

Antifibrinolíticos, Procedimentos Ortopédicos, Ensaios Clínicos Controlados Aleatórios como Assunto, Ácido Tranexâmico, Humanos, Antifibrinolíticos/uso terapêutico, Antifibrinolíticos/administração & dosagem, Perda Sanguínea Cirúrgica, Ácido Tranexâmico/uso terapêutico

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OBJECTIVES: Randomized controlled trials (RCTs) in the femoral neck fracture literature frequently report P -values for outcomes, which have substantial implications in guiding surgical management. This study used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to assess the statistical stability of outcomes reported in RCTs evaluating the management and treatment of femoral neck fractures. DESIGN: PubMed, Embase, and MEDLINE were queried for RCTs (January 1, 2010 to February 28, 2023). SETTING: RCTs that evaluated surgical management or treatment of femoral neck fractures were included. STUDY SELECTION CRITERIA: RCTs with 2 treatment arms reporting categorical dichotomous outcomes were included. Non-RCT studies, RCTs with greater than 2 treatment arms, and RCTs without a femoral neck fracture cohort were excluded. OUTCOME MEASURES AND COMPARISONS: The FI and rFI were calculated as the number of outcome event reversals required to alter statistical significance for significant ( P < 0.05) and nonsignificant ( P ≥ 0.05) outcomes, respectively. The FQ was calculated by dividing the FI by the sample size for the study. RESULTS: Nine hundred eighty-five articles were screened, with 71 studies included for analysis. The median FI across a total of 197 outcomes was 4 [interquartile range (IQR) 2-5] with an associated FQ of 0.033 (IQR 0.017-0.060). Forty-seven outcomes were statistically significant with a median FI of 2 (IQR 1-4) and associated FQ of 0.02 (IQR 0.014-0.043). One hundred fifty outcomes were statistically nonsignificant with a median rFI of 4 (IQR 3-5) and associated FQ of 0.037 (IQR 0.019-0.065). CONCLUSIONS: Statistical findings in femoral neck fracture RCTs are fragile, with reversal of a median 4 outcomes altering significance of study findings. The authors thus recommend standardized reporting of P -values with FI and FQ metrics to aid in interpreting the robustness of outcomes in femoral neck fracture RCTs. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Assuntos

Fraturas do Colo Femoral, Ensaios Clínicos Controlados Aleatórios como Assunto, Humanos, Fraturas do Colo Femoral/cirurgia, Interpretação Estatística de Dados

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Purpose: To analyze epidemiology, mechanisms, and diagnoses of upper extremity volleyball injuries in youth who present to United States emergency departments. Methods: Data from the National Electronic Injury Surveillance System were analyzed for upper extremity volleyball injuries in patients ≤18 years old from January 1, 2012, to December 31, 2022. Data were collected for body part, diagnosis, mechanism of injury, and disposition. Weighted national estimates were calculated using the hospitals' corresponding statistical sample weights. Linear regressions were used to analyze annual trends. χ2 tests were used to analyze categorical variables. Results: A weighted national estimate of 131,624 upper extremity volleyball-related injuries occurred in the study period. Average age was 13.9 ± 2.3 years. Female patients constituted 77.6% of patients; 99.3% of patients did not require admission. The most common body parts injured were fingers (43.0%), wrists (22.8%), and shoulders (12.2%). The most common identifiable mechanisms of injury were impacts with the floor (19.4%), impacts with the ball (14.7%), and spikes/serves (5.7%). Most common diagnoses were strains/sprains (42.6%) and fractures (19.5%). Most common locations of fracture were fingers (57.4% of all fractures), wrists (16.6%), and lower arms (12.4%). There was a decrease of 544 overall injuries per year (P = .03, 95% confidence interval [CI] -1031 to -58). Female players experienced more contusions/abrasions (16.0% vs 9.9%, P < .001) and strains/sprains (46.1% vs 30.4%, P < .001) compared with male players. Female patients had decreases of 513 overall injuries (P = .01, 95% CI -881 to -144), 349 strains/sprains (P = .002, 95% CI -530 to -168), 102 contusions/abrasions (P = .008, 95% CI 170 to -34), and 92 fractures per year (P = .03, 95% CI -175 to -10). Conclusions: Youth volleyball players are at risk of upper extremity injury, particularly involving the fingers, wrist, and shoulder. Despite increasing national participation in youth volleyball, there is a decreasing incidence of upper extremity injuries. Level of Evidence: Level IV, prognostic case series.

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BACKGROUND: Dichotomous outcomes are frequently reported in orthopaedic research and have substantial clinical implications. This study utilizes the fragility index (FI) and fragility quotient (FQ) metrics to determine the statistical stability of outcomes reported in total joint arthroplasty randomized controlled trials (RCTs) relating to periprosthetic joint infection (PJI). METHODS: The RCTs that reported dichotomous data related to PJI published between January 1, 2010, and December 31, 2022, were evaluated. The FI and reverse FI (RFI) were defined as the number of outcome event reversals required to reverse the significance of significant and nonsignificant outcomes, respectively. The FQ was determined by dividing the FI or RFI by the respective sample size. There were 108 RCTs screened, and 17 studies included for analysis. RESULTS: A total of 58 outcome events were identified, with a median FI of 4 (interquartile range [IQR] 2 to 5) and associated FQ of 0.0417 (IQR 0.0145 to 0.0602). The 13 statistically significant outcomes had a median FI of 1 (IQR 1 to 2) and FQ of 0.00935 (IQR 0.00629 to 0.01410). The 45 nonsignificant outcomes had a median RFI of 4 (IQR 3 to 5) and FQ of 0.05 (IQR 0.0361 to 0.0723). The number of patients lost to follow-up was greater than or equal to the FI in 46.6% of outcomes. CONCLUSIONS: Statistical outcomes in RCTs analyzing PJI are fragile and may lack statistical integrity. We recommend a comprehensive fragility analysis, with the reporting of FI and FQ metrics, to aid in the interpretation of outcomes in the total joint arthroplasty literature.

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BACKGROUND: An increasing reliance on patient-reported outcomes has led to greater emphasis on minimal clinically important difference (MCID), substantial clinical benefit (SCB), and Patient Acceptable Symptom State (PASS) thresholds in assessing rotator cuff repairs. PURPOSE: To review the MCID, SCB, and PASS thresholds reported for patient-reported outcome measures (PROMs) after rotator cuff repair. STUDY DESIGN: Systematic review; Level of evidence, 4. METHODS: The PubMed, Embase, Ovid, Cochrane, and Google Scholar databases were queried for full-text journal articles in English published between January 1, 2000, and May 31, 2022. Studies with MCID, SCB, and PASS thresholds reported for patients with rotator cuff repair and a minimum of 12 months of follow-up were included. Reported MCID, SCB, and PASS thresholds and associated calculation methods were extracted. RESULTS: There were 41 unique studies (6331 shoulders) that met the inclusion criteria. Of these, 37 (90%) reported MCID; 16 (39%), PASS; and 11 (27%), SCB values. The most common PROMs were the American Shoulder and Elbow Surgeons score and the Constant-Murley score. In total, 71% (29/41) of these studies referenced values in the literature, usually studies of patients undergoing rotator cuff repair (21/29). Twelve studies calculated MCID, SCB, or PASS thresholds using anchor-based approaches, whereas 6 studies also calculated thresholds using distribution-based methods. The use of MCID, SCB, and PASS in the rotator cuff repair literature is increasing, with half of the included studies published within the final 17 months of the studied period. CONCLUSION: Significant variability was seen in the reporting of MCID, SCB, and PASS threshold values after rotator cuff repair. Researchers should prioritize studies that report clinical outcome thresholds calculated using anchor-based methods and should critically review both the anchor question and its response choices. Standardization of MCID, SCB, and PASS values and calculation methods will allow for a more reliable assessment of PROMs in rotator cuff repair moving forward.

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OBJECTIVE: Marrow stimulation is used to address knee cartilage defects. In this study, we used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to evaluate statistical fragility of outcomes reported in randomized controlled trials (RCTs) evaluating marrow stimulation. DESIGN: PubMed, Embase, and MEDLINE were queried for recent RCTs (January 1, 2010-September 5, 2023) assessing marrow stimulation for cartilage defects of the knee. The FI and rFI were calculated as the number of outcome event reversals required to alter statistical significance for significant and nonsignificant outcomes, respectively. The FQ was determined by dividing the FI by the study sample size. RESULTS: Across 155 total outcomes from 21 RCTs, the median FI was 3 (interquartile range [IQR], 2-5), with an associated median FQ of 0.067 (IQR, 0.033-0.010). Thirty-two outcomes were statistically significant, with a median FI of 2 (IQR, 1-3.25) and FQ of 0.050 (IQR, 0.025-0.069). Ten of the 32 (31.3%) outcomes reported as statistically significant had an FI of 1. In total, 123 outcomes were nonsignificant, with a median rFI of 3 (IQR, 2-5). Studies assessing stem cell augments were the most fragile, with a median FI of 2. In 55.5% of outcomes, the number of patients lost to follow-up was greater than or equal to the FI. CONCLUSION: Statistical findings in RCTs evaluating marrow stimulation for cartilage defects of the knee are statistically fragile. We recommend combined reporting of P-values with FI and FQ metrics to aid in the interpretation of clinical findings in comparative trials assessing cartilage restoration.

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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.

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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.

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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.

Assuntos

Lesões do Ligamento Cruzado Anterior, Reconstrução do Ligamento Cruzado Anterior, Tendões dos Músculos Isquiotibiais, Ligamento Patelar, Humanos, Ligamento Patelar/transplante, Autoenxertos, Tendões dos Músculos Isquiotibiais/transplante, Enxerto Osso-Tendão Patelar-Osso, Lesões do Ligamento Cruzado Anterior/cirurgia, Lesões do Ligamento Cruzado Anterior/etiologia, Ensaios Clínicos Controlados Aleatórios como Assunto, Reconstrução do Ligamento Cruzado Anterior/efeitos adversos, Transplante Autólogo

RESUMO

PURPOSE: To analyze the statistical stability of randomized controlled trials (RCTs) evaluating the surgical management of autografts versus allografts in the anterior cruciate ligament reconstruction (ACLR) literature and calculate the fragility index (FI) and fragility quotient and explore a subgroup analysis by calculating the proportion of outcome events where the FI was less than the number of patients lost to follow-up. METHODS: Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, we conducted a systematic search in the PubMed and Cochrane databases to identify RCTs published between 2000 and 2022 that investigated the use of autografts versus allografts in ACLR literature and reported dichotomous data. The fragility index of each dichotomous variable was calculated through the reversal of a single outcome event until significance was reversed. The fragility quotient was calculated by dividing each fragility index by the study sample size. The interquartile range also was calculated. RESULTS: Of the 4407 articles screened, 23 met the search criteria, with 11 RCTs evaluating ALCR using autografts and allografts included for analysis. Two hundred and 18 outcome events with 32 significant (P < .05) outcomes and 186 nonsignificant (P ≥ .05) outcomes were identified. The overall fragility index and fragility quotient for all 218 outcomes were 6 subjects (interquartile range 5-8) and 0.058 (interquartile range 0.039-0.077). Fragility analysis of statistically significant outcomes and nonsignificant outcomes had a fragility index of 3.5 (interquartile range 1-5.5) and 6 (interquartile range 5-8), respectively. All of the studies reported a loss to follow-up where 45.5% (5) reported a loss to follow-up greater or equal to 6. CONCLUSIONS: The RCTs in the ACLR peer-reviewed literature evaluating autograft versus allograft use are vulnerable to a small number of outcome event reversals and exemplify significant statistical fragility in statistically significant findings. LEVEL OF EVIDENCE: Level I, systematic review of Level I studies.

Assuntos

Lesões do Ligamento Cruzado Anterior, Reconstrução do Ligamento Cruzado Anterior, Humanos, Autoenxertos, Ligamento Cruzado Anterior/cirurgia, Articulação do Joelho/cirurgia, Aloenxertos, Ensaios Clínicos Controlados Aleatórios como Assunto, Lesões do Ligamento Cruzado Anterior/cirurgia

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Surfing is a globally popular recreational sport with limited epidemiologic data. Currently, there is a paucity of literature regarding injury profiles and mechanisms of orthopaedic-related injuries. This study analyzed trends, etiologies, and diagnoses of upper extremity orthopaedic-related surfing injuries presenting to United States (US) emergency departments. The National Electronic Injury Surveillance System database was accessed to query upper extremity surfing-related injuries presenting to US emergency departments from January 1, 2002 to December 31, 2021. Data were analyzed for year, body part, mechanism of injury, diagnosis, and disposition. National estimates were calculated based on the assigned statistical sample weight of each hospital. A total of 33 323 surfing-related injuries were included. The most common upper extremity body parts involved 15 169 shoulders (45.5%), 4220 fingers (12.7%), and 3753 hands (11.3%). The most common identifiable mechanisms of injuries were 7474 board-to-body (22.4%), 4188 impact with sand (12.6%), and 2639 impact with water (7.9%). Overuse constituted 7.2% of overall upper extremity injuries but 40% of strains. Only 2.2% of injuries required hospital admission. Between 2002 and 2021, there was a decreasing annual trend in upper extremity surfing-related injuries (P=.01). The decreasing trend in emergency department visits may be due to urgent care utilization and training for surfers and lifeguards to manage these injuries on-site, as the majority were minor given the small proportion requiring hospital admission. Chronic stress on rotator cuff and peri-scapular musculature while paddling in the prone position likely contributed to the large proportion of overuse injury.

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Traumatismos do Braço, Traumatismos em Atletas, Humanos, Estados Unidos/epidemiologia, Traumatismos em Atletas/epidemiologia, Traumatismos do Braço/complicações, Serviço Hospitalar de Emergência, Extremidade Superior/lesões, Hospitalização

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PURPOSE: To compare the clinical and patient-reported outcomes of adolescent patients who underwent anterior cruciate ligament reconstruction (ACLR) with quadriceps tendon (QT) versus hamstring tendon (HT) autograft. METHODS: This was a retrospective cohort study of adolescent patients aged 18 years or younger treated at a single tertiary care children's hospital who underwent primary transphyseal ACLR using QT or HT between January 2018 and December 2019. All patients had minimum 6-month follow-up. Outcomes included isokinetic strength testing, postoperative Patient-Reported Outcomes Measurement Information System and International Knee Documentation Committee scores, and complications; these were compared between the QT and HT cohorts. RESULTS: A total of 84 patients (44 HT and 40 QT patients) were included. The QT cohort had a higher proportion of male patients (62.5% vs 34.1%, P = .01). At 3 months, HT patients had a lower hamstring-quadriceps (H/Q) strength ratio (60.7 ± 11.0 vs 79.5 ± 18.6, P < .01) and lower Limb Symmetry Index in flexion (85.6 ± 16.1 vs 95.5 ± 15.7, P = .01) whereas QT patients had a lower Limb Symmetry Index in extension (67.3 ± 9.5 vs 77.4 ± 10.7, P < .01). The H/Q ratio at 6 months was lower in HT patients (59.4 ± 11.5 vs 66.2 ± 7.5, P < .01). Patient-Reported Outcomes Measurement Information System and International Knee Documentation Committee scores were not different at 3 months or latest follow-up. QT patients had more wound issues (20.0% vs 2.3%, P = .01). Patients receiving HT autograft had more ipsilateral knee injuries (18.2% vs 2.5%, P = .03), but there was no difference in graft failure for ACLR using HT versus QT (9.1% vs 2.5%, P = .36). CONCLUSIONS: There were no differences in patient-reported outcome measures between patients receiving QT autografts and those receiving HT autografts. Patients with QT grafts had more postoperative wound issues but a lower rate of ipsilateral knee complications (graft failure or meniscal tear). Differences in quadriceps and hamstring strength postoperatively compared with the contralateral limb were observed for adolescent ACLR patients receiving QT and HT autografts, respectively. This contributed to higher H/Q ratios seen at 3 and 6 months postoperatively for patients receiving QT autografts. LEVEL OF EVIDENCE: Level III, retrospective comparative therapeutic study.

RESUMO

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.

RESUMO

INTRODUCTION: The purpose of this study was to utilize the fragility index to assess the robustness of randomized controlled trials (RCTs) evaluating the management of calcaneus fractures. We hypothesize that the dichotomous outcomes in calcaneus fracture literature will be statistically fragile and comparable to other orthopedic specialties. METHODS: We performed a PubMed search for calcaneus fracture RCTs from 2000 to 2022 using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The fragility index (FI) of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The fragility quotient (FQ) was calculated by dividing each fragility index by study sample size. The interquartile range (IQR) was also calculated for the FI and FQ. RESULTS: Of the 3003 studies screened, 97 met the search criteria, with 19 RCTs evaluating calcaneus fractures included in the analysis. Seventy-nine dichotomous outcomes with 30 significant (P < 0.05) outcomes and 49 with nonsignificant (P> 0.05) outcomes were identified. The overall FI and FQ of all outcomes were 6 (IQR 3-8) and 0.067 (IQR 0.032-0.100), respectively. CONCLUSIONS: The literature surrounding calcaneus fractures may not be as statistically stable as previously thought. The sole reliance on the P value may depict misleading results. We, therefore, recommend reporting the P value in conjunction with the FI and FQ to give a robust contextualization of clinical findings in the calcaneus fracture literature.

Assuntos

Calcâneo, Fraturas Ósseas, Humanos, Ensaios Clínicos Controlados Aleatórios como Assunto, Tamanho da Amostra, Fraturas Ósseas/terapia

RESUMO

Background: Numerous studies have been published on the use of platelet-rich plasma (PRP) for knee osteoarthritis (OA), with conflicting results. Purpose: To determine the fragility index (FI) and fragility quotient (FQ) of randomized controlled trials (RCTs) that evaluated the use of PRP to treat knee OA. Study Design: Systematic review. Methods: RCTs evaluating the efficacy of PRP injections for knee OA from 2000 to 2020 were included for analysis according to PRISMA guidelines. The FI was determined by calculating the number of outcome event reversals required to change the statistical significance. The associated FQ was determined by dividing the FI by the sample size. Results: Our initial search resulted in 41,149 studies, of which 8 RCTs (678 patients, 72 outcome events) were included in the analysis. One study failed to report PRP formulation details, whereas 87.5% of studies reported using either leukocyte-rich or leukocyte-poor PRP. The platelet concentration was reported in 25% of the included trials. The overall FI of the 72 outcome events was 8.5. Accounting for sample size, the associated FQ was determined to be 0.14, suggesting that the reversal of 14% of outcome events was required to change outcome significance. There were 51 statistically significant outcomes, of which the FI and FQ were 12 and 0.164, respectively. Conclusion: Comprehensive fragility analysis suggested that the published literature evaluating the efficacy of PRP use for knee OA may lack statistical stability. We recommend the reporting of both an FI and FQ in addition to P value analysis to provide a clear and thorough understanding of the statistical integrity of studies reporting on PRP use for knee OA.

RESUMO

BACKGROUND: The purpose of this present study was to perform a fragility analysis to assess the robustness of randomized controlled trials (RCTs) evaluating the distal biceps tendon repairs. We hypothesize that the dichotomous outcomes will be statistically fragile, and higher fragility will exist among statistically significant outcomes comparable to other orthopedic specialties. METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), randomized controlled trials from 4 orthopedic journals indexed on PubMed from 2000 to 2022 reporting dichotomous measures relating to distal biceps tendon repairs were included. The fragility index (FI) of each outcome was calculated through the reversal of a single outcome event until significance was reversed. The fragility quotient (FQ) was calculated by dividing each fragility index by study sample size. The interquartile range (IQR) was also calculated for the FI and FQ. RESULTS: Of the 1038 articles screened, 7 RCTs containing 24 dichotomous outcomes were included for analysis. The fragility index and fragility quotient of all outcomes was 6.5 (IQR 4-9) and 0.077 (IQR 0.031-0.123), respectively. However, statistically significant outcomes had a fragility index and fragility quotient of 2 (IQR 2-7) and 0.036 (IQR 0.025-0.091), respectively. The average number of patients lost to follow-up was 2.7 patients, with 28.6% of the included studies reporting loss to follow-up (LTF) greater than or equal to 6.5. CONCLUSIONS: The literature surrounding distal biceps tendon repair may not be as stable as previously thought and presents a similar fragility index to other orthopedic subspecialties. We therefore recommend triple reporting the P value, fragility index, and fragility quotient to aid in the interpretation of clinical findings reported in biceps tendon repair literature.

Assuntos

Ortopedia, Projetos de Pesquisa, Humanos, Ensaios Clínicos Controlados Aleatórios como Assunto, Tamanho da Amostra, Tendões/cirurgia