The statistical fragility of intramedullary reaming in tibial nail fixation: a systematic review.

PURPOSE: To report the statistical stability of prospective clinical trials evaluating the effect of intramedullary reaming on rates of non-union in tibial fractures through calculation of the fragility metrics for non-union rates and all other dichotomous outcomes. METHODS: Literature search was conducted for prospective clinical trials evaluating the effect of intramedullary reaming on non-union rates in tibial nailing. All dichotomous outcomes were extracted from the manuscripts. The fragility index (FI) and reverse fragility index (RFI) were calculated by determining the number of event reversals required for a statistically significant outcome to lose significance and vice-versa. The fragility quotient (FQ) and reverse fragility quotient (RFQ) were calculated by dividing the FI or RFI by the sample size, respectively. Outcomes were defined as "fragile" if the FI or RFI was found to be less than or equal to the number of patients lost to follow-up. RESULTS: Literature search identified 579 results which produced ten studies meeting the criteria for review. There were 111 outcomes identified for analysis, of which 89 (80%) exhibited statistical fragility. For reported outcomes across the studies the median and mean FI was 2, the median FQ was 0.019, the mean FQ was 0.030, the median RFI was 4, the mean RFI was 3.95, the median RFQ was 0.045, and the mean RFQ was 0.030. Four studies reported outcomes which were found to have an FI of 0. CONCLUSIONS: The studies evaluating the effect of intramedullary reaming on tibial nail fixation demonstrate considerable fragility. On average, two event reversals for significant findings, and four event reversals for insignificant findings are sufficient to alter statistical significance. LEVEL OF EVIDENCE: Level II, systematic review of Level I and Level II studies.

The Statistical Fragility of Operative vs Nonoperative Management for Achilles Tendon Rupture: A Systematic Review of Comparative Studies.

BACKGROUND: The statistical significance of randomized controlled trials (RCTs) and comparative studies is often conveyed utilizing the P value. However, P values are an imperfect measure and may be vulnerable to a small number of outcome reversals to alter statistical significance. The interpretation of the statistical strength of these studies may be aided by the inclusion of a Fragility Index (FI) and Fragility Quotient (FQ). This study examines the statistical stability of studies comparing operative vs nonoperative management for Achilles tendon rupture. METHODS: A systematic search was performed of 10 orthopaedic journals between 2000 and 2021 for comparative studies focusing on management of Achilles tendon rupture reporting dichotomous outcome measures. FI for each outcome was determined by the number of event reversals necessary to alter significance (P < .05). FQ was calculated by dividing the FI by the respective sample size. Additional subgroup analyses were performed. RESULTS: Of 8020 studies screened, 1062 met initial search criteria with 17 comparative studies ultimately included for analysis, 10 of which were RCTs. A total of 40 outcomes were examined. Overall, the median FI was 2.5 (interquartile range [IQR] 2-4), the mean FI was 2.90 (±1.58), the median FQ was 0.032 (IQR 0.012-0.069), and the mean FQ was 0.049 (±0.062). The FI was less than the number of patients lost to follow-up for 78% of outcomes. CONCLUSION: Studies examining the efficacy of operative vs nonoperative management of Achilles tendon rupture may not be as statistically stable as previously thought. The average number of outcome reversals needed to alter the significance of a given study was 2.90. Future analyses may benefit from the inclusion of a fragility index and a fragility quotient in their statistical analyses.

Statistical Fragility of Single-Row Versus Double-Row Anchoring for Rotator Cuff Repair: A Systematic Review of Comparative Studies.

Background: Comparative studies and randomized controlled trials (RCTs) often use the P (probability) value to convey the statistical significance of their findings. P values are an imperfect measure, however, and are vulnerable to a small number of outcome reversals to alter statistical significance. The inclusion of a fragility index (FI) and fragility quotient (FQ) may aid in the interpretation of a study's statistical strength. Purpose/Hypothesis: The purpose of this study was to examine the statistical stability of studies comparing single-row to double-row rotator cuff repair. It was hypothesized that the findings of these studies would be vulnerable to a small number of outcome event reversals, often fewer than the number of patients lost to follow-up. Study Design: Systematic review; Level of evidence, 3. Methods: We analyzed comparative studies and RCTs on primary single-row versus double-row rotator cuff repair that were published between 2000 and 2021 in 10 leading orthopaedic journals. Statistical significance was defined as a P < .05. The FI for each outcome was determined by the number of event reversals necessary to alter significance. The FQ was calculated by dividing the FI by the respective sample size. Results: Of 4896 studies screened, 22 comparative studies, 10 of which were RCTs, were ultimately included for analysis. A total of 74 outcomes were examined. Overall, the median FI was 2 (interquartile range [IQR], 1-3), and the median FQ was 0.035 (IQR, 0.020-0.057). The mean FI was 2.55 ± 1.29, and the mean FQ was 0.043 ± 0.027. In 64% of outcomes, the FI was less than the number of patients lost to follow-up.) Additionally, 81% of significant outcomes needed just a single outcome reversal to lose their significance. Conclusion: Over half of the studies currently used to guide clinical practice have a number of patients lost to follow-up greater than their FI. The results of these studies should be interpreted within the context of these limitations. Future analyses may benefit from the inclusion of the FI and the FQ in their statistical analyses.

Early Versus Delayed Active Range of Motion After Open Subpectoral Biceps Tenodesis.

BACKGROUND: Little is known regarding the effect of early active elbow range of motion (ROM) protocols on failure rates and outcomes after open subpectoral biceps tenodesis. HYPOTHESIS: We hypothesized that patients managed using an early active ROM protocol after open subpectoral biceps tenodesis would demonstrate similar failure rates and functional outcomes compared to patients managed using a traditional delayed active ROM protocol. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: We evaluated 63 patients who underwent open subpectoral biceps tenodesis with unicortical suture button fixation. Based on surgeon preference, 22 patients were managed using an early active motion protocol consisting of no restrictions on elbow flexion or forearm supination, while 41 patients were managed using a delayed motion protocol postoperatively. Primary outcome measures included failure of biceps tenodesis and American Shoulder and Elbow Surgeons (ASES) and Single Assessment Numeric Evaluation (SANE) scores. Secondary outcomes included shoulder and elbow ROM at 6 months postoperatively. RESULTS: The mean follow-up for the 63 patients was 24.2 months postoperatively. One patient (2.4%) in the delayed active motion cohort and no patients in the early active motion cohort experienced failure. Final outcome scores as well as 6-month shoulder and elbow ROM indicated excellent functional outcomes, with no significant difference between motion cohorts. The median postoperative ASES scores were 97.99 in the early active motion cohort (mean ± standard deviation [SD], 95.49 ± 7.68) and 95.42 in the delayed motion cohort (mean ± SD, 90.93 ± 16.08), while median postoperative SANE scores were 96 in the early motion cohort (mean ± SD, 94.23 ± 6.68) and 95 in the delayed motion cohort (mean ± SD, 88.39 ± 17.98). Subgroup analysis demonstrated no significant difference in outcome scores based on the performance of concomitant rotator cuff repair or hand dominance. CONCLUSION: Early active ROM after open subpectoral biceps tenodesis with unicortical suture button fixation resulted in low failure rates and excellent clinical outcomes, comparable to the results of patients managed using delayed active ROM protocols. This suggests that patients undergoing open subpectoral biceps tenodesis may be managed using either early or delayed active motion protocols without compromising functional outcome.

Labral Index-Controlling Femoral Size to Evaluate the Relationship Between Relative Labral Size and Acetabular Version.

PURPOSE: To assess the relationship of acetabular version with the length of the anterior and posterior labrum and to introduce a developed metric, the labral index, as a means of controlling for femoral head size when measuring labral length. METHODS: One hundred forty-eight patients who underwent hip arthroscopies for femoroacetabular impingement from October 2017 to October 2019 by a single hip surgeon were retrospectively reviewed. Magnetic resonance imaging arthrogram was used to measure central acetabular version (at the center of the femoral head) and cranial acetabular version (at the midpoint between the acetabular roof and center of the femoral head), as well as labral length at the anterior, posterior, and superolateral locations (3, 9, and 12 o'clock, respectively). Labral index was calculated by dividing anterior, posterior, and superolateral labral lengths by the radius of the femoral head. Pearson correlation analysis was used to assess the association between the 2 continuous variables. A priori alpha of 0.05 was established as the cutoff for significance. RESULTS: Forty-three patients (26 female, 17 male) with an average age of 34.2 ± 11.6 years were included in analysis. Increased central anteversion was significantly associated with a larger anterior labral length and index (P = .023, r = 0.343 and .005, r = 0.415, respectively). Cranial anteversion weakly correlated with a significantly increased anterior labral index (P = .047, r = 0.304) but not with larger anterior labral length (P = .089, r = 0.262). No statistically significant association was present for central or cranial version with posterior or superolateral labral measurements. Lateral center edge angle did not correlate with labral size at any location. CONCLUSIONS: In patients undergoing hip arthroscopy for symptomatic femoroacetabular impingement, greater acetabular anteversion was significantly associated but weakly correlated with increased anterior labral length, whereas no association was found between posterior labral length and acetabular version. The labral index may be a useful metric to normalize labral length relative to the radius of the femoral head that warrants further investigation for its clinical utility in guiding labral reconstruction versus labral repair. LEVEL OF EVIDENCE: Level IV, diagnostic case series.

Rare presentation of bilateral thumb psoriatic arthritis treated with arthrodesis: a case report.

Psoriatic arthritis (PsA) is a seronegative inflammatory arthritis that occurs concomitantly with cutaneous manifestations and tendinous pathology that affects up to 1% of the general population. While the majority of cases are mild, nearly 20% of PsA patients will progress to severe disease manifesting as debilitating polyarticular inflammation and joint destruction. PsA is most commonly asymmetric and bilateral severe disease involving the same joints in each hand has rarely been reported in the literature. It is estimated that PsA only presents bilaterally in a quarter of patients. The recent increase in popularity and efficacy of disease-modifying anti-rheumatic drugs (DMARDs) has led to increasing rarity of such severe disease progression. We present a case of a 47-year-old male with PsA who had a unique pattern of bilateral first metacarpophalangeal (MP) and interphalangeal (IP) involvement with minimal erosion leading to significant joint pain, instability, dislocation, and loss of function. After failure of conservative treatment that included both DMARDs and non-steroidal anti-inflammatory drugs (NSAIDs), the patient opted for surgical management. The purpose of this report is to identify a rare presentation of PsA and consider the significance of MP joint arthrodesis as a viable treatment to restore functional status and improve quality of life.

The Statistical Fragility of Single-Bundle vs Double-Bundle Autografts for ACL Reconstruction: A Systematic Review of Comparative Studies.

BACKGROUND: The statistical significance of a given study outcome can be liable to small changes in findings. P values are common, but imperfect statistical methods to convey significance, and inclusion of the fragility index (FI) and fragility quotient (FQ) may provide a clearer perception of statistical strength. PURPOSE/HYPOTHESIS: The purpose was to examine the statistical stability of studies comparing primary single-bundle to double-bundle anterior cruciate ligament reconstruction (ACLR) utilizing autograft and independent tunnel drilling. It was hypothesized that the study findings would be vulnerable to a small number of outcome event reversals, often less than the number of patients lost to follow-up. STUDY DESIGN: Systematic review; Level of evidence, 2. METHODS: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, the authors searched PubMed for comparative studies and randomized controlled trials (RCTs) published in select journals, based on impact factor, between 2005 and 2020. Risk-of-bias assessment and methodology scoring were conducted for the included studies. A total of 48 dichotomous outcome measures were examined for possible event reversals. The FI for each outcome was determined by the number of event reversals necessary to alter significance. The FQ was calculated by dividing the FI by the respective sample size. RESULTS: Of the 1794 studies screened, 15 comparative studies were included for analysis; 13 studies were RCTs. Overall, the mean FI and FQ were 3.14 (IQR, 2-4) and 0.050 (IQR, 0.032-0.062), respectively. For 72.9% of outcomes, the FI was less than the number of patients lost to follow-up. CONCLUSION: Studies comparing single-bundle versus double-bundle ACLR may not be as statistically stable as previously thought. Comparative studies and RCTs are at substantial risk for statistical fragility, with few event reversals required to alter significance. The reversal of fewer than 4 outcome events in a treatment group can alter the statistical significance of a given result; this is commonly less than the number of patients lost to follow-up. Future comparative study analyses might consider including FI and FQ with P values in their statistical analysis.

The Statistical Fragility of Hamstring Versus Patellar Tendon Autografts for Anterior Cruciate Ligament Reconstruction: A Systematic Review of Comparative Studies.

BACKGROUND: Evidence-based medicine utilizes data to inform clinical decision making, despite the ability of a small number of outcome reversals to change statistical significance. P values are common measurements of statistical significance that possess inherent flaws. The inclusion of the fragility index (FI) and fragility quotient (FQ) may provide a clearer conveyance of statistical strength. PURPOSE/HYPOTHESIS: The purpose was to examine the statistical stability of studies comparing hamstring tendon and bone-patellar tendon-bone autografts in primary single-bundle anterior cruciate ligament reconstruction with independent tunnel drilling. We hypothesized that the findings of these studies are vulnerable to a small number of outcome event reversals, often fewer than the number of patients lost to follow-up. STUDY DESIGN: Systematic review. METHODS: Comparative studies and randomized controlled trials (RCTs) published in 10 leading orthopaedic journals between 2000 and 2020 were analyzed. Statistical significance was defined as a P value ≤.05. FI for each outcome was determined by the number of event reversals necessary to alter significance. FQ was calculated by dividing the FI by the respective sample size. RESULTS: Of the 1803 studies screened, 643 met initial search criteria, with 18 comparative studies ultimately included for analysis, 8 of which were RCTs. A total of 114 outcomes were examined. Overall, the mean (interquartile range) FI and FQ were 3.77 (2-4) and 0.040 (0.016-0.055), respectively. The FI was less than the number of patients lost to follow-up for 76.3% of outcomes. CONCLUSION: Studies examining graft choice for anterior cruciate ligament reconstruction may not be as statistically stable as previously thought. Comparative studies and RCTs are at substantial risk for statistical fragility, with few event reversals required to alter significance. The reversal of <4 outcome events in a treatment group can alter the statistical significance of a given result; this is commonly fewer than the number of patients lost to follow-up. Future comparative study analyses might consider including FI and FQ with P values in their statistical analysis.

Standardized Platelet Rich Plasma Injections for Osteoarthritis of the Knee.

Objective Platelet-rich plasma (PRP) and adipose-derived stem cells (ADSC) injections are non-surgical treatments for knee osteoarthritis (OA). The purpose of this study is to assess the effectiveness of serial PRP with or without ADSC injections in the treatment of refractory OA of the knee.  Design Patients who failed to achieve pain relief with conventional non-surgical treatments, with Kellgren-Lawrence grade 3 or 4 knee OA, were recruited from a private outpatient clinic. Over 67 patients were elected to receive serial PRP injections and 22 patients were elected to receive an ADSC+PRP injection. These patients completed Western Ontario and McMaster Universities Arthritis Index (WOMAC) surveys prior to each treatment and at follow-up appointments. These surveys were retrospectively reviewed to assess changes in functional status and pain over time. Results Twenty-nine patients from the PRP group and eight patients in the ADSC+PRP group had adequate follow-up for inclusion in the analysis. The PRP group had an improvement in WOMAC scores by 34.30%, 60.2%, and 58.5% for patients reporting at 1-3, 4-6, and >6 months of follow-up. The ADSC+PRP group experienced an improvement of 51% at an average of 4.66 months of follow-up. Conclusions Serial PRP injections and a single ADSC+PRP injection yield improved and sustained functional outcome scores for patients with severe, refractory OA of the knee. Future studies should consider consistent orthobiologic preparation protocols to ensure reproducibility.