The Reverse Fragility Index: Interpreting the Evidence for Arthroscopic Rotator Cuff Repair Healing Associated With Early Versus Delayed Mobilization.

Background: The American Academy of Orthopaedic Surgeons (AAOS) clinical practice guidelines (CPGs) note "strong" evidence that early and delayed mobilization protocols after small to medium arthroscopic rotator cuff repairs achieve similar rotator cuff healing rates. Purpose: We utilized the reverse fragility index (RFI) to assess the fragility of randomized controlled trials (RCTs) reporting no statistically significant difference in tendon re-tear rates after rotator cuff repair in those undergoing early versus delayed rehabilitation. Methods: Randomized controlled trials used in the most recent AAOS CPGs on the timing of postoperative mobilization after arthroscopic rotator cuff repairs were analyzed. Only RCTs with a reported P value ≥ .05 were included. The RFI at a threshold of P < .05 was calculated for each study. The reverse fragility quotient (RFQ) was calculated by dividing the RFI by the study sample size. Results: In 6 clinical trials with a total of 542 patients, the number of tendon re-tear events was 48. The median RFI at the P < .05 threshold was 4 (range: 3.25-4.75), and the median RFQ was .05 (range: 0.03-0.08). The median loss to follow-up was 6 patients. Of the 6 studies investigated, 3 reported a loss to follow-up greater than their respective RFI. Conclusion: The equivalence in rotator cuff repair healing rates associated with early and delayed mobilization protocols rests on fragile studies, as their statistical non-significance can be reversed by changing the outcome status of only a handful of patients. Consideration should be given to the routine reporting of RFI in clinical practice guidelines including RCTs with statistically non-significant results.

Concomitant Procedures, Black Race, Male Sex, and General Anesthesia Show Fair Predictive Value for Prolonged Rotator Cuff Repair Operative Time: Analysis of the National Quality Improvement Program Database Using Machine Learning.

PURPOSE: To develop machine learning models using the American College of Surgeons National Quality Improvement Program (ACS-NSQIP) database to predict prolonged operative time (POT) for rotator cuff repair (RCR), as well as use the trained machine learning models, cross-referenced with traditional multivariate logistic regression (MLR), to determine the key perioperative variables that may predict POT for RCR. METHODS: Data were obtained from a large national database (ACS-NSQIP) from 2021. Patients with unilateral RCR procedures were included. Demographic, preoperative, and operative variables were analyzed. An MLR model and various other machine learning techniques, including random forest (RF) and artificial neural network, were compared using area under the curve, calibration, Brier score, and decision curve analysis. Feature importance was identified from the overall best-performing model. RESULTS: A total of 6,690 patients met inclusion criteria. The RF machine learning model had the highest area under the curve upon internal validation (0.706) and the lowest Brier score (0.15), outperforming the other models. The RF model also demonstrated strong performance upon assessment of the calibration curves (slope = 0.86, intercept = 0.08) and decision curve analysis. The model identified concomitant procedure, specifically labral repair and biceps tenodesis, as the most important variable for determining POT, followed by age <30 years, Black or African American race, male sex, and general anesthesia. CONCLUSIONS: Despite the advanced machine learning models used in this study, the ACS-NSQIP data set was only able to fairly predict POT following RCR. The RF model identified concomitant procedures, specifically labral repair and biceps tenodesis, as the most important variables for determining POT. Additionally, demographic factors such as age <30 years, Black race, and general anesthesia were significant predictors. While male sex was identified as important in the RF model, the MLR model indicated that its predictive value is primarily in conjunction with specific procedures like biceps tenodesis and subacromial decompression. LEVEL OF EVIDENCE: Level IV, retrospective comparative prognostic trial.

Functional somatic syndromes are associated with inferior outcomes and increased complications after hip and knee arthroplasty: a systematic review.

BACKGROUND: Functional somatic syndromes (FSSs), defined as chronic physical symptoms with no identifiable organic cause, may impact results after hip and knee arthroplasty. The purpose of this study was to perform a systematic review assessing the relationship between FSSs and clinical outcomes after primary total hip arthroplasty (THA), total knee arthroplasty (TKA), and unicompartmental knee arthroplasty (UKA). METHODS: The PubMed and Web of Science databases were queried from January 1955 through December 2021 for studies investigating the impact of at least one FSS (fibromyalgia, irritable bowel syndrome (IBS), chronic headaches, and chronic low back pain) on outcomes after primary THA/TKA/UKA. Outcomes of interest included patient-reported outcome measures (PROMs), postoperative opioid use, complications, revisions, and costs of care. RESULTS: There were twenty-eight studies, including 768,909 patients, of which 378,384 had an FSS. Five studies reported preoperative PROMs prior to THA/TKA, all of which showed worse PROMs among patients with at least 1 FSS diagnosis. Thirteen studies reported postoperative PROMs after THA/TKA, all of which demonstrated worse PROMs among patients with at least 1 FSS diagnosis. Patients with FSS diagnoses were more likely to continue using opioids at 3, 6, and 12 months following TKA, THA, and UKA. Medical and surgical complications, as well as revision rates, were higher among patients with FSSs. CONCLUSION: Patients with FSSs have inferior PROMs and are at increased risk for prolonged postoperative opioid use, medical and surgical complications, and revision after hip and knee arthroplasty. Improved understanding of the factors influencing the success of hip and knee arthroplasty is critical. Future studies should address the biopsychosocial determinants of health that can impact outcomes after total joint arthroplasty.

Effect of Antibiotic Administration Before Joint Aspiration on Synovial Fluid White Blood Cell Count in Native Joint Septic Arthritis.

Background: This study was performed to assess the impact of preaspiration antibiotics on synovial fluid analysis and timing of operative treatment in native-joint septic arthritis. Methods: We performed a retrospective record review of adult patients from an urban level 1 trauma center with native joint septic arthritis in 2015-2019, identified by means of codes from the International Classification of Diseases (Ninth Revision and Tenth Revision). Univariate and multivariate analyses were performed to determine whether antibiotics were associated with lower synovial fluid white blood cell counts (WBCs), the percentage of polymorphonuclear neutrophil (PMNs), and rate of culture positivity. Secondary analysis included time elapsed from aspiration to surgery. Results: Of the 126 patients with septic joints included, nearly two-thirds (n = 80 [63.5%]) received antibiotics before joint aspiration. The synovial fluid WBC count, percentage of PMNs, and rate of culture positivity were significantly lower in patients who received preaspiration antibiotics than in those who did not (mean WBC count, 51 379.1/µL [standard deviation, 52 576.3/µL] vs 92 162.7/µL [59 330.6/µL], respectively [P < .001]; PMN percentage, 83.6% [20.5%] vs 91.9% [6.0%; P = .01]; and culture positivity, 32.5% vs 59.1% [P = .008]). Multivariable analyses revealed that these associations remained after controlling for potential confounders (change in PMNs, -42 784.60/µL [95% confidence interval, -65 355/µL to -20 213.90/µL [P < .001]; change in PMNs, -7.8% [-13.7% to -1.8%] [P = .01]; odds ratio, 0.39 [.18-.87; P = .02). Patients with a synovial fluid WBC count ≤50 000/µL experienced significant delay in time from joint aspiration to operative intervention (mean [standard deviation], 10.5 [11.3] vs 17.9 [17.2] hours; P = .02). Conclusions: The administration of antibiotics before joint aspiration for suspected septic arthritis appears to decrease the synovial fluid WBC count, the percentage of PMNs, and the rate of culture positivity. Efforts to limit antibiotic administration before joint aspiration are important to minimize diagnostic dilemmas and circumvent treatment delays.

Clinically significant outcome thresholds and rates of achievement by shoulder arthroplasty type and preoperative diagnosis.

BACKGROUND: Clinically significant outcome (CSO) benchmarks have been previously established for shoulder arthroplasty by assimilating preoperative diagnoses and arthroplasty types. The purpose of this study was to establish unique CSO thresholds and compare the time-to-achievement of these for reverse shoulder arthroplasty (RSA) for osteoarthritis (GHOA), RSA for rotator cuff arthropathy (RCA), and total shoulder arthroplasty (TSA) for GHOA. MATERIALS AND METHODS: Consecutive patients who underwent elective RSA for GHOA, TSA for GHOA, or RSA for RCA between February 2015 and May 2020, with 2-year minimum follow-up, were retrospectively identified from a prospectively maintained single surgeon registry. The American Shoulder and Elbow Surgeons (ASES) score was administered preoperatively and postoperatively at 2-week, 6-week, 3-month, 6-month, 1-year, and 2-year timepoints. Satisfaction and subjective overall improvement anchor questionnaires were administered at the time of final follow-up. Distribution-based methods were used to calculate the Minimal Clinically Important Difference (MCID), and anchor-based methods were used to calculate the Substantial Clinical Benefit (SCB) and the Patient Acceptable Symptom State (PASS) for each patient group. Median time to achievement, individual incidence of achievement at each time point, and cumulative incidence of achievement calculated using Kaplan-Meier survival curve analysis with interval censoring were compared between groups for each CSO. Cox-regression analyses were also performed to determine which patient factors were significantly associated with early or delayed achievement of CSOs. RESULTS: There were 471 patients eligible for study analysis: 276 RSA for GHOA, 107 TSA for GHOA, and 88 RSA for RCA. The calculated MCID, SCB, and PASS scores differed for each group. There were no significant differences in median time to achievement of any CSO between groups. Log-rank testing revealed that cumulative achievements significantly differed between groups for MCID (P = .014) but not for SCB (P = .053) or PASS (P = .620). On cox regression analysis, TSA patients had earlier achievement of SCB, whereas TSA and RSA for GHOA patients had earlier achievement of MCID. At 2-years, a significantly higher percentage of RSA for GHOA patients achieved MCID and SCB compared to RSA for RCA (MCID:100%, 95.5%, P = .003, SCB:94.6%, 86.4%, P = .036). CONCLUSION: Calculated CSO thresholds differ according to preoperative diagnosis and shoulder arthroplasty type. Patients undergoing TSA and RSA for GHOA achieve CSOs earlier than RSA for RCA patients, and a significantly higher percentage of RSA for GHOA patients achieve CSOs by 2 years compared to RSA for RCA patients.

Reverse Fragility Index Comparing Rates of Rerupture After Open Achilles Tendon Repair Versus Early Functional Rehabilitation: A Systematic Review of Randomized Controlled Trials.

BACKGROUND: Despite similar published rates of rerupture among patients treated with early functional rehabilitation and open repair for acute Achilles tendon rupture, uncertainty still exists regarding the optimal treatment modality. The reverse fragility index (RFI) is a statistical tool that provides an objective measure of the study's neutrality by determining the number of events that need to change for a nonsignificant result to be significant. PURPOSE: The purpose was to utilize the RFI to appraise the strength of neutrality of randomized controlled trials (RCTs) comparing the rerupture rates of acute Achilles tendon ruptures treated with open repair versus early functional rehabilitation. STUDY DESIGN: Systematic review; Level of evidence, 1. METHODS: A systematic review was performed including all RCTs comparing the rerupture rates after operative repair and early functional rehabilitation for acute Achilles tendon ruptures. Studies were included that explicitly used early functional rehabilitation, defined as weightbearing and exercise-based interventions initiated within 2 weeks, as compared with open repair and reported a nonsignificant difference in rerupture rates. The RFI, with rerupture as the primary outcome, was calculated for each study (significance threshold, P < .05). The RFI quantifies a study's strength of neutrality and is defined as the minimum number of event reversals necessary to change a nonsignificant result to statistically significant. RESULTS: Nine RCTs were included, with 713 patients and 46 reruptures. The median (interquartile range) rerupture rate was 7.69% (6.38%-9.64%) overall, 4.00% (2.33%-7.14%) in the operative group, and 10.00% (5.26%-12.20%) in the nonoperative group. The median RFI was 3, indicating that an outcome reversal of 3 patients was necessary to change the results from nonsignificant to statistically significant. The median number of patients lost to follow-up was 6 (3-7). Of 9 studies, 7 (77.8%) had a loss to follow-up greater than or equal to its RFI. CONCLUSION: The statistical nonsignificance of studies reporting equivalent rerupture rates in the management of acute Achilles tendon ruptures with open repair versus nonoperative management with early functional rehabilitation can be reversed by changing the outcome status of only a few patients.

Arthroscopic Treatment Is a Safe and Effective Alternative to Open Treatment for Acute Septic Arthritis of the Native Knee: A Systematic Review.

PURPOSE: To compare complication rates, reoperation rates, and subjective outcomes after arthroscopic and open irrigation and debridement for treatment of native knee septic arthritis. METHODS: Following The Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, a systematic review of the Embase, Cochrane, and PubMed databases was performed. Comparative studies reporting clinical outcomes after arthroscopic versus open treatment for septic arthritis of the native knee in human adults were included. Excluded were case series with <10 patients, inclusion of patients <18 years old, studies on non-native joints, abstract-only publications, and studies without stratification of the involved joint. Two reviewers in duplicate independently performed search and data extraction. The quality of the included studies was assessed with the Methodological Index for Non-Randomized Studies instrument. The mean score among the included studies was 18.2 (range 16-23). RESULTS: Eleven studies were included, comprising 2,343 knees treated arthroscopically, and 1,595 treated with arthrotomy. Studies reported no differences in erythrocyte sedimentation rate, C-reactive protein, peripheral white blood cells, or symptom chronicity between groups. Nine studies (81.8%) attempted to control for potentially confounding variables in their analyses, and 4 studies (36.4%) reported significant differences in patient characteristics. Reoperation rates ranged from 0% to 50% for arthroscopy and 6% to 71% for arthrotomy. Complication rates ranged from 0% to 39.4% arthroscopically and 0% to 49% for arthrotomy. Superior patient-reported outcomes were achieved after arthroscopy in 2 studies that analyzed subjective outcomes. CONCLUSIONS: Arthroscopic management of native knee septic arthritis is a safe and effective alternative to open treatment and is associated with comparable complication rates, reoperation rates, hospitalization lengths, readmission rates, and superior patient-reported outcomes compared with open irrigation and debridement. LEVEL OF EVIDENCE: Level IV, systematic review of Level I, III, and IV studies.

Incidence of Complications and Revision Surgery After High Tibial Osteotomy: A Systematic Review.

BACKGROUND: High tibial osteotomy (HTO) is a well-recognized procedure for its effectiveness in treating symptomatic early knee arthritis and malalignment. Although there are numerous systematic reviews evaluating the management and outcomes after HTO, there are few investigations on complications of this procedure. PURPOSE: To systematically review the literature to determine the incidence of intraoperative and postoperative complications associated with medial opening wedge and lateral closing wedge HTOs. STUDY DESIGN: Systematic review; Level of evidence, 4. METHODS: The Cochrane Database of Systematic Reviews, PubMed, Embase, and MEDLINE databases were queried for studies reporting complications associated with HTO with or without concomitant procedures. Data including patient characteristics, procedure type, concomitant procedures, follow-up time, and postoperative imaging were extracted. Rates of intra- and postoperative complications, reoperations, and conversion to arthroplasty were recorded. RESULTS: A total of 71 studies were included for analysis, comprising 7836 patients. The overall intraoperative complication rate during HTO was 5.5% (range, 0%-29.3%), and the overall postoperative complication rate was 6.9% (range, 0%-26.6%). The most common intraoperative complication was lateral hinge fracture (incidence, 9.1%; range, 0%-30.4%) in medially based HTOs and peroneal nerve injury in laterally based HTOs (incidence, 3.2%; range, 0%-8.7%). The overall incidence of neurovascular injury after medially or laterally based HTOs was 1.1% (range, 0%-18.9%). The most common postoperative complication was superficial infection (incidence, 2.2%; range, 0%-13%). Of the included studies, 62 included postoperative radiographic analysis, and among those, the incidence of nonunion was 1.9% (range, 0%-15.5%), loss of correction was 1.2% (range, 0%-34.3%), and implant failure was 1.0% (range, 0%-10.2%). Among studies reporting revision surgeries, the overall reoperation rate was 15.5% (range, 0%-70.7%), with the most common type of reoperation being hardware removal (incidence, 10.0%; range, 0%-60%). CONCLUSION: Intraoperatively, medially based HTOs are associated with a 1 in 11 risk of lateral hinge fracture and laterally based HTOs with a 1 in 30 risk of peroneal nerve injury. Postoperative complication rates in the range of 10% to 15% can be expected, including infection (2.9%), loss of correction (1.2%), and nonunion (1.9%). Patients should also be counseled that the reoperation rate is approximately 15%, with hardware removal being the most common procedure.

Google Search Analytics for Lateral Epicondylitis.

BACKGROUND: The use of online search engines for health information is becoming common practice. We analyzed Google search queries to identify the most frequently asked topics and questions related to lateral epicondylitis ("tennis elbow") and the Web sites provided to address these questions. METHODS: Four search terms for lateral epicondylitis were entered into Google Web Search. A list of the most frequently asked questions along with their associated Web sites was extracted and categorized by 2 independent reviewers. RESULTS: A total of 400 questions were extracted with 168 associated Web sites. The most popular question topics were related to indications/management (39.0%), risks/complications (19.5%), and the ability to perform specific activities (18.8%). Frequently asked questions had to do with the duration of symptoms, self-management strategies (eg, brace use and self-massage), and the indications for surgery. The most common Web sites provided to address these questions were social media (27.5%), commercial (24.5%), academic (16.5%), and medical practice (16.3%). CONCLUSION: The most frequently asked questions about lateral epicondylitis on Google centered around symptom duration and management, with most information originating from social media and commercial Web sites. Our data can be used to anticipate patient concerns and set expectations regarding the prognosis and management of lateral epicondylitis.

Comparing Orthopaedic Randomized Control Trials Published in High-Impact Medical and Orthopaedic Journals.

INTRODUCTION: Orthopaedic studies published in high-impact medical journals are often believed to have a high prevalence of negative or neutral results and possess methodological characteristics that may bias toward nonsurgical treatments. The purpose of this study was to compare study characteristics, methodologic quality, exposure, and outcome direction among orthopaedic randomized control trials (RCTs) published in high-impact medical and orthopaedic journals and to identify study attributes associated with greater impact. METHODS: RCTs published between January 2010 and December 2020 in the five medical journals and 10 orthopaedic journals with the highest 5-year impact factors were analyzed. Inclusion criteria were RCTs reporting on orthopaedic surgical intervention compared with nonsurgical or less-invasive surgical procedures. Study characteristics, methodologic quality (Jadad scale), outcomes, and altmetric data were collected. Primary outcomes were categorized as positive (favoring surgical/more-extensive surgery), negative (favoring nonsurgical/less-extensive surgery), or neutral. RESULTS: One hundred twenty-eight RCTs were analyzed; 26 from medical and 102 from orthopaedic journals. Studies published in medical journals included more authors ( P < 0.001), larger sample sizes ( P < 0.001), more institutions ( P < 0.001), and more often received funding ( P < 0.001). The average Jadad scale did not significantly differ between journals ( P = 0.14). The direction of the primary study outcome did not differ between journals ( P = 0.22). Average AAS and annual citation rates were higher in RCTs published in medical journals ( P < 0.001). Publication in a medical journal was the only covariate associated with higher annual citation rates ( P < 0.001) and AAS ( P < 0.001) on multivariable analyses. DISCUSSION: High-impact medical journals do not publish orthopaedic RCTs with negative or neutral findings at a rate that significantly differs from orthopaedic journals. However, the higher impact and digital coverage of the studies published in medical journals may disproportionally influence the practices of nonorthopaedic providers. Raising awareness of critical findings published in orthopaedic journals may be particularly important for improving healthcare policies and orthopaedic referral patterns for musculoskeletal problems.

The role of the anterior shoulder joint capsule in primary glenohumeral osteoarthritis.

The pathogenesis of primary glenohumeral arthritis (GHOA) is mediated by a complex interaction between osseous anatomy and the surrounding soft tissues. Recently, there has been growing interest in characterizing the association between the anterior shoulder joint capsule and primary GHOA because of the potential for targeted treatment interventions. Emerging evidence has shown substantial synovitis, fibrosis, and mixed inflammatory cell infiltrate in the anterior capsule of osteoarthritic shoulders. In addition, increased thickening of the anterior shoulder joint capsule has been associated with greater posterior glenoid wear and humeral head subluxation. While these findings suggest that anterior capsular disease may play a causative role in the etiology and progression of eccentric GHOA, further studies are needed to support this association. The purpose of this article is to review the pathogenesis of primary GHOA, contextualize current hypotheses regarding the role of the anterior capsule in the disease process, and provide directions for future research.

How to place a cephalomedullary screw when visualization is obscured by the jig in peritrochanteric hip fractures using "peek radiographs."

Lag screw positioning can be difficult to discern intraoperatively on lateral fluoroscopic imaging during intramedullary fixation of proximal femur fractures in some nailing systems due to the drill guide handle obstructing the view. We have described a method of obtaining non-obstructed lateral-oblique "peek" views that reliably assist in obtaining adequate tip-apex distance (TAD) measurements when using intramedullary fixation for these fractures. The purpose of this study was (1) to describe an intraoperative radiographic technique to obtain non-obscured views for appropriate center-center placement of the lag screw(s) within the femoral head during jig-aided cephalomedullary nailing of peritrochanteric hip fractures and (2) to present a case series detailing the radiographic results using this technique. This clinical series of sixty-five patients with intertrochanteric or subtrochanteric proximal femur fractures stabilized with a cephalomedullary nail had an average TAD of 15.1 ± 3.3mm (range: 9.4mm-26.2mm). This suggests that our technical trick of obtaining "peek" radiographs intraoperatively may aid in a precise lag-screw placement.

Subjective Outcomes After Allograft Reconstruction and Nonoperative Treatment of Anterior Cruciate Ligament Ruptures Are Similar in Patients Aged 40 Years and Older: A 2:1 Propensity Score-Matched Analysis.

Purpose: To compare subjective outcomes and rates of subsequent operations for patients aged 40 years and older with anterior cruciate ligament (ACL) ruptures who elected nonoperative management or allograft ACL reconstruction (ACLR). Methods: This was a retrospective study comparing 2-year minimum results of nonoperative treatment and primary allograft ACLR among patients aged 40 years and older presenting to a single institution between the years 2005 and 2016. Patients who elected nonoperative management were 2:1 propensity score (PS)-matched to patients who elected ACLR based on age, sex, body mass index, sports-related mechanism of injury, Outerbridge grade III or IV chondral lesions, and medial or lateral meniscus tears. Univariate analysis was performed to compare subjective outcome measures of International Knee Documentation Committee and Marx activity level scores, subsequent operations, and satisfaction rates. Results: After 2:1 PS matching, 40 ACLR and 20 nonoperative patients with mean ages of 52.2 years and 54.5 years, respectively, were included with a mean follow-up of 5.7 years (SD 2.1 years, range 2.3-10.6 years). There were no significant differences between the groups in any of the matching variables. There were no significant differences in International Knee Documentation Committee scores (81.9 ± 14.1, CI 77.4-86.5 vs 84.3 ± 12.8, CI 78.3-90.3, P = .53), Marx activity level scores (5.8 ± 4.8, CI 4.2-7.3 vs 5.7 ± 5.1, CI 3.3-8.1, P = .96), or satisfaction rates (100% vs 90%, P = .11) between the ACLR and nonoperative groups. Four (10%) patients who underwent ACLR sustained a graft treated with revision ACLR. 7 (17.5%) ACLR and 0 nonoperative patients subsequently received further ipsilateral knee surgeries (P = .08), including 2 total knee arthroplasties. Conclusions: In this PS-matched analysis of patients aged 40 years and older with ACL ruptures, patients who elected nonoperative management had similar subjective outcomes compared with those who elected allograft ACLR. Patients who elected allograft ACLR did not have fewer subsequent operations than those who elected nonoperative treatment. Level of Evidence: Level III, retrospective cohort study.

The reverse fragility index: RCTs reporting non-significant differences in failure rates between hamstring and bone-patellar tendon-bone autografts have fragile results.

PURPOSE: The reverse fragility index (RFI) is a novel metric to appraise the results of studies reporting statistically non-significant results. The purpose of this study was to determine the statistical robustness of randomized controlled trials (RCTs) reporting non-significant differences in anterior cruciate ligament reconstruction (ACLR) graft failure rates, defined as re-rupture/revision ACLR rate, between hamstring tendon (HT) and bone-patellar tendon-bone (BTB) autografts by calculating RFIs. METHODS: A systematic review was performed to identify RCTs that compared HT to BTB grafts for ACLR through January 2022. Studies reporting non-significant differences in graft re-rupture and revision ACLR rate (n.s.) were included. The RFI, defined as the fewest number of event reversals needed to change the non-significant graft re-rupture/revision outcome to statistically significant (P < 0.05), was recorded for each study. In addition, the number of studies in which the loss to follow-up exceeded the RFI was recorded. RESULTS: Among the 16 included RCTs, the median (interquartile range [IQR]) sample size was 71 (64-114), and the median (IQR) total number of graft re-rupture/revision ACLR events was 4 (4-6). The median (IQR) graft re-rupture/revision ACLR rate was 4.3% (3.0-6.4) overall, 4.1% (2.6-6.7) in the BTB group, and 5.4% (3.0-6.3) in the HT group. The median (IQR) RFI was 3 (3-4), signifying that a reversal of the outcome in 3 patients in one arm was needed to flip the studies' result from non-significant to statistically significant (P < 0.05). The median (IQR) number of participants lost to follow-up was 11 (3-13), and 13 (81.3%) of the included studies had a loss to follow-up greater than the studies' RFI. CONCLUSION: The results of RCTs reporting statistically non-significant re-rupture/revision ACLR rates between HT and BTB autografts would become significant if the outcome were reversed in a small number of patients-a number that was less than the loss to follow-up in the majority of studies. Thus, the neutrality of these studies is fragile, and a true statistically significant difference in re-rupture/revision rates may have been undetected. LEVEL OF EVIDENCE: Level I.

The Majority of Sports Medicine and Arthroscopy-Related Randomized Controlled Trials Reporting Nonsignificant Results Are Statistically Fragile.

PURPOSE: To evaluate the robustness of sports medicine and arthroscopy related randomized controlled trials (RCTs) reporting nonsignificant results by calculating the reverse fragility index (RFI) and reverse fragility quotient (RFQ). METHODS: All sports medicine and arthroscopic-related RCTs from January 1, 2010, through August 3, 2021, were identified. Randomized-controlled trials comparing dichotomous variables with a reported P value ≥ .05 were included. Study characteristics, such as publication year and sample size, as well as loss to follow-up and number of outcome events were recorded. The RFI at a threshold of P < .05 and respective RFQ were calculated for each study. Coefficients of determination were calculated to determine the relationships between RFI and the number of outcome events, sample size, and number of patients lost to follow-up. The number of RCTs in which the loss to follow-up was greater than the RFI was determined. RESULTS: Fifty-four studies and 4,638 patients were included in this analysis. The mean sample size and loss to follow-up were 85.9 patients and 12.5 patients, respectively. The mean RFI was 3.7, signifying that a change of 3.7 events in one arm was needed to flip the results of the study from non-significant to significant (P < .05). Of the 54 studies investigated, 33 (61%) had a loss to follow-up greater than their calculated RFI. The mean RFQ was 0.05. A significant correlation between RFI with sample size (R2 = 0.10, P = .02) and the total number of observed events (R2 = 0.13, P < .01) was found. No significant correlation existed between RFI and loss to follow-up in the lesser arm (R2 = 0.01, P = .41). CONCLUSIONS: The RFI and RFQ are statistical tools that allow the fragility of studies reporting nonsignificant results to be appraised. Using this methodology, we found that the majority of sports medicine and arthroscopy-related RCTs reporting nonsignificant results are fragile. CLINICAL RELEVANCE: RFI and RFQ serve as tools that can be used to assess the validity of RCT results and provide additional context for appropriate conclusions.

Preoperative factors associated with failure to reach the patient acceptable symptom state after anterior cruciate ligament reconstruction in patients aged 40 and older.

PURPOSE: To perform a predictive analysis to identify preoperative patient factors associated with failure to achieve a newly defined patient acceptable symptom state (PASS) for the International Knee Documentation Committee (IKDC) Score after anterior cruciate ligament reconstruction (ACLR) in patients aged ≥ 40 years with a minimum of 2-year follow-up. METHODS: This was a secondary analysis of a retrospective review of all patients aged 40 years or older receiving a primary allograft ACLR at a single institution between the years of 2005 and 2016, with 2-year minimum follow-up. Using an updated PASS threshold of 66.7 for the International Knee Documentation Committee (IKDC) score previously established for this patient cohort, a univariate and multivariate analysis was performed to identify preoperative patient characteristics predictive of failure to achieve PASS. RESULTS: A total of 197 patients with a mean follow-up of 6.2 ± 2.1 years (range 2.7 - 11.2) were included in the analysis (48.5 ± 5.6 years, 51.8% female, Body Mass Index (BMI) 25.9 ± 4.4). PASS was achieved by 162 patients (82.2%). Patients who failed to achieve PASS more often had lateral compartment cartilage defects (P = 0.001) and lateral meniscus tears (P = 0.004), higher BMIs (P = 0.004), and Workers' Compensation status (P = 0.043) on univariable analysis. Factors predictive of failure to achieve PASS on multivariable analysis included BMI and lateral compartment cartilage defect (OR 1.12 [1.03-1.23], P = 0.013; OR 5.1 [1.87-13.9], P = 0.001). CONCLUSION: Among patients ≥ 40 years who receive a primary allograft ACLR, patients who fail to achieve PASS more often had lateral compartment cartilage defects and higher BMIs. LEVEL OF EVIDENCE: Level IV.

Patients With Functional Somatic Syndromes-Fibromyalgia, Irritable Bowel Syndrome, Chronic Headaches, and Chronic Low Back Pain-Have Lower Outcomes and Higher Opioid Usage and Cost After Shoulder and Elbow Surgery.

PURPOSE: To perform a systematic review assessing the relationship between functional somatic syndromes (FSSs) and patient-reported outcome measures (PROMs), postoperative opioid consumption, and hospitalization costs after shoulder and elbow surgery. METHODS: A systematic review of the PubMed and Web of Science databases was conducted according to Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines to identify all studies evaluating the effect of having at least 1 FSS (fibromyalgia, irritable bowel syndrome, chronic headaches, chronic low back pain) on outcomes after shoulder and elbow surgeries. Outcomes of interest included postoperative analgesic use, PROMs, and hospitalization costs. RESULTS: The review identified a total of 320 studies, of which 8 studies met the inclusion criteria. The total number of participants in our 8 included studies was 57,389. Three studies (n = 620) reported PROMs. These studies demonstrated that the presence of at least 1 FSS is predictive of significantly greater pain scores and lower quality of recovery, Disability Arm Shoulder and Hand, American Shoulder and Elbow Surgeons Shoulder Score, and Single Assessment Numeric Evaluation scores postoperatively. Although scores were inferior in among patients with FSS, 2 of the 3 studies showed improvement in PROMs in this group of patients. Seven studies (n = 56,909) reported postoperative opioid use. Of these, 5 reported that a diagnosis of at least 1 FSS was a strong risk factor for long-term opioid use after surgery. One study (n = 480) found that time-driven activity-based costs were significantly greater in patients with FSSs. CONCLUSIONS: Patients with functional somatic syndromes have less-favorable PROMs postoperatively, consume more opioids postoperatively, and have greater health care costs after elective shoulder and elbow procedures. Although PROMs among patients with FSSs are inferior compared with those without FSSs, PROMs still improved compared with baseline. LEVEL OF EVIDENCE: Level III, systematic review of Level II-III studies.

The Reverse Fragility Index: Interpreting the Current Literature on Long-Term Survivorship of Computer-Navigated Versus Conventional TKA: A Systematic Review and Cross-Sectional Study of Randomized Controlled Trials.

BACKGROUND: Despite the most recent American Academy of Orthopaedic Surgeons clinical practice guideline making a "strong" recommendation against the use of intraoperative navigation in total knee arthroplasty (TKA), its use is increasing. We utilized the concept of the reverse fragility index (RFI) to assess the strength of neutrality of the randomized controlled trials (RCTs) comparing the long-term survivorship of computer-navigated and conventional TKA. METHODS: A systematic review was performed including all RCTs through August 3, 2021, comparing the long-term outcomes of computer-navigated and conventional TKA. Randomized trials with mean follow-up of >8 years and survivorship with revision as the end point were included. The RFI quantifies the strength of a study's neutrality by calculating the minimum number of events necessary to flip the result from nonsignificant to significant. The RFI at a threshold of p < 0.05 was calculated for each study reporting nonsignificant results. The reverse fragility quotient (RFQ) was calculated by dividing the RFI by the study sample size. RESULTS: Ten clinical trials with 2,518 patients and 38 all-cause revisions were analyzed. All 10 studies reported nonsignificant results. The median RFI at the p < 0.05 threshold was 4, meaning that a median of 4 events would be needed to change the results from nonsignificant to significant. The median RFQ was 0.029, indicating that the nonsignificance of the results was contingent on only 2.9 events per 100 participants. The median loss to follow-up was 27 patients. In all studies, the number of patients lost to follow-up was greater than the RFI. CONCLUSIONS: The equipoise in long-term survivorship between computer-navigated and conventional TKA rests on fragile studies, as their statistical nonsignificance could be reversed by changing the outcome status of only a handful of patients--a number that was always smaller than the number lost to follow-up. Routine reporting of the RFI in trials with nonsignificant findings may provide readers with a measure of confidence in the neutrality of the results. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Intraosseous Regional Administration of Antibiotic Prophylaxis for Total Knee Arthroplasty: A Systematic Review.

BACKGROUND: Intraosseous regional administration (IORA) of antibiotics after tourniquet inflation has recently been introduced as a technique to deliver antibiotics directly to the surgical site among patients undergoing total knee arthroplasty (TKA). METHODS: PubMed and Embase were queried for studies reporting on IORA for perioperative prophylaxis during TKA. Primary outcome measures were local tissue antibiotic concentrations and rates of prosthetic joint infection (PJI). Eight studies were included for analysis. Four studies (all randomized controlled trials) compared local tissue concentrations between patients receiving IORA and intravenous (IV) antibiotics. Six studies assessed the rate of PJI among patients receiving IORA versus IV antibiotics. RESULTS: All studies found a statistically significant increase in antibiotic concentration in femoral bone and fat samples in patients who were treated with IORA (44.04 µg/g [fat] and 49.3 µg/g [bone] following 500 mg of intraosseous vancomycin) versus IV (3.5 µg/g [fat] and 5.2 µg/g [bone] following 1 g IV of vancomycin). The two studies powered to determine differences in PJI rates found a statistically significant decrease in the rate of PJI among patients receiving IORA versus IV antibiotics. The incidence of PJI in patients treated with IORA and IV antibiotics across all studies was 0.3 and 1.1%, respectively. CONCLUSION: Perioperative IORA of antibiotics in TKA provides local tissue concentrations of antibiotics that are on average 10 times higher than IV administration alone. Although more adequately powered investigations are necessary to determine the effectiveness of IORA in reducing PJI rates, adoption of IORA should be considered in high-risk patients where elevated tissue antibiotic concentrations would be of a maximum benefit.

Preoperative allergy testing for patients reporting penicillin and cephalosporin allergies is economically justified in preventing infection after total shoulder arthroplasty.

BACKGROUND: The use of alternative antibiotics to cefazolin has been associated with increased risk of infection after shoulder arthroplasty. Routine preoperative allergy testing in patients reporting penicillin and cephalosporin allergies increases the number able to receive cefazolin and may reduce the occurrence of infection after shoulder arthroplasty, but the financial viability of this practice is unclear. We used break-even modeling to determine the economic viability of routine preoperative allergy testing for infection prevention in total shoulder arthroplasty patients reporting penicillin and cephalosporin allergies. METHODS: Allergy testing cost ($248.24), infection rates after shoulder arthroplasty following use of noncefazolin antibiotics (3.09%), and infection-related care costs ($55,243) were derived from the literature. A break-even equation using these variables was developed to determine the absolute risk reduction (ARR) in the infection rate that would economically justify the routine implementation of preoperative allergy testing. The number needed to treat was calculated from the ARR. RESULTS: Preoperative allergy testing is considered economically justified if it prevents at least 1 infection out of 223 shoulder arthroplasties (ARR = 0.45%). These protocols remained economically viable at varying allergy testing costs, initial infection rates, and infection-related care costs. CONCLUSIONS: Routine preoperative penicillin allergy testing is an economically justified infection prevention strategy among patients reporting penicillin and cephalosporin allergies in the setting of elective shoulder arthroplasty. Widespread implementation of this practice may considerably reduce the economic and societal burden associated with prosthetic infections.