The Number of Patients Lost to Follow-Up May Exceed the Fragility Index of a Randomized Controlled Trial Without Reversing Statistical Significance: A Systematic Review and Statistical Model.

PURPOSE: To (1) analyze trends in the publishing of statistical fragility index (FI)-based systematic reviews in the orthopaedic literature, including the prevalence of misleading or inaccurate statements related to the statistical fragility of randomized controlled trials (RCTs) and patients lost to follow-up (LTF), and (2) determine whether RCTs with relatively "low" FIs are truly as sensitive to patients LTF as previously portrayed in the literature. METHODS: All FI-based studies published in the orthopaedic literature were identified using the Cochrane Database of Systematic Reviews, Web of Science Core Collection, PubMed, and MEDLINE databases. All articles involving application of the FI or reverse FI to study the statistical fragility of studies in orthopaedics were eligible for inclusion in the study. Study characteristics, median FIs and sample sizes, and misleading or inaccurate statements related to the FI and patients LTF were recorded. Misleading or inaccurate statements-defined as those basing conclusions of trial fragility on the false assumption that adding patients LTF back to a trial has the same statistical effect as existing patients in a trial experiencing the opposite outcome-were determined by 2 authors. A theoretical RCT with a sample size of 100, P = .006, and FI of 4 was used to evaluate the difference in effect on statistical significance between flipping outcome events of patients already included in the trial (FI) and adding patients LTF back to the trial to show the true sensitivity of RCTs to patients LTF. RESULTS: Of the 39 FI-based studies, 37 (95%) directly compared the FI with the number of patients LTF. Of these 37 studies, 22 (59%) included a statement regarding the FI and patients LTF that was determined to be inaccurate or misleading. In the theoretical RCT, a reversal of significance was not observed until 7 patients LTF (nearly twice the FI) were added to the trial in the distribution of maximal significance reversal. CONCLUSIONS: The claim that any RCT in which the number of patients LTF exceeds the FI could potentially have its significance reversed simply by maintaining study follow-ups is commonly inaccurate and prevalent in orthopaedic studies applying the FI. Patients LTF and the FI are not equivalent. The minimum number of patients LTF required to flip the significance of a typical RCT was shown to be greater than the FI, suggesting that RCTs with relatively low FIs may not be as sensitive to patients LTF as previously portrayed in the literature; however, only a holistic approach that considers the context in which the trial was conducted, potential biases, and study results can determine the merits of any particular RCT. CLINICAL RELEVANCE: Surgeons may benefit from re-examining their interpretation of prior FI reviews that have made claims of substantial RCT fragility based on comparisons between the FI and patients LTF; it is possible the results are more robust than previously believed.

Root Repair Has Superior Radiological and Clinical Outcomes Than Partial Meniscectomy and Nonoperative Treatment in the Management of Meniscus Root Tears: A Systematic Review.

PURPOSE: To compile and analyze structural and clinical outcomes after meniscus root tear treatment as currently described in the literature. METHODS: A review was conducted to identify studies published since 2011 on efficacy of repair, meniscectomy, and nonoperative management in the treatment of meniscus root tears. Patient cohorts were grouped into treatment categories, with medial and lateral root tears analyzed separately; data were collected on patient demographics, structural outcomes including joint space width, degree of medial meniscal extrusion, progression to total knee arthroplasty, and patient-reported outcome measures. Risk of bias was assessed using the MINORS (methodological index for non-randomized studies) criteria. Heterogeneity was measured using the I-statistic, and outcomes were summarized using forest plots without pooled means. RESULTS: The 56 included studies comprised a total of 3,191 patients. Mean age among the included studies ranged from 24.6 to 65.6 years, whereas mean follow-up ranged from 12 to 125.9 months. Heterogeneity analysis identified significant differences between studies. Change in joint space width ranged from -2.4 to -0.6 mm (i.e., decreased space) after meniscectomy (n = 186) and -0.9 to -0.1 mm after root repair (n = 209); change in medial meniscal extrusion ranged from -0.6 to 6.5 mm after root repair (n = 521) and 0.2 to 4.2 mm after meniscectomy (n = 66); and event rate for total knee arthroplasty ranged from 0.00 to 0.22 after root repair (n = 205), 0.35 to 0.60 after meniscectomy (n = 53), and 0.27 to 0.35 after nonoperative treatment (n = 93). Root repair produced the greatest numerical increase in International Knee Documentation Committee and Lysholm scores of the 3 treatment arms. In addition, root repair improvements in Knee Injury and Osteoarthritis Outcome Score Pain (range: 22-32), Sports and Recreational Activities (range: 23-36), Quality of Life (range: 22-42), and Symptoms subscales (range: 10-19), in studies with low risk of bias. CONCLUSIONS: The literature reporting on the treatment of meniscus root tears is heterogenous and largely limited to Level III and IV studies. Current evidence suggests root repair may be the most effective treatment strategy in lessening joint space narrowing of the knee and producing improvements in patient-reported outcomes. LEVEL OF EVIDENCE: Level IV, systematic review of Level II-IV studies.

A Machine Learning Model Demonstrates Excellent Performance in Predicting Subscapularis Tears Based on Pre-Operative Imaging Parameters Alone.

PURPOSE: To develop a machine learning model capable of identifying subscapularis tears before surgery based on imaging and physical examination findings. METHODS: Between 2010 and 2020, 202 consecutive shoulders underwent arthroscopic rotator cuff repair by a single surgeon. Patient demographics, physical examination findings (including range of motion, weakness with internal rotation, lift/push-off test, belly press test, and bear hug test), and imaging (including direct and indirect signs of tearing, biceps status, fatty atrophy, cystic changes, and other similar findings) were included for model creation. RESULTS: Sixty percent of the shoulders had partial or full thickness tears of the subscapularis verified during surgery (83% of these were upper third). Using only preoperative imaging-related parameters, the XGBoost model demonstrated excellent performance at predicting subscapularis tears (c-statistic, 0.84; accuracy, 0.85; F1 score, 0.87). The top 5 features included direct signs related to the presence of tearing as evidenced on magnetic resonance imaging (MRI) (changes in tendon morphology and signal), as well as the quality of the MRI and biceps pathology. CONCLUSIONS: In this study, machine learning was successful in predicting subscapularis tears by MRI alone in 85% of patients, and this accuracy did not decrease by isolating the model to the top features. The top five features included direct signs related to the presence of tearing as evidenced on MRI (changes in tendon morphology and signal), as well as the quality of the MRI and biceps pathology. Last, in advanced modeling, the addition of physical examination or patient characteristics did not make a significant difference in the predictive ability of this model. LEVEL OF EVIDENCE: Level III, diagnostic case-control study.

Elbow Ulnar Collateral Ligament Tears in 2023: Evaluation and Management.

The ulnar collateral ligament, also called the medial collateral ligament of the elbow, is the primary stabilizer against valgus loads. This ligament can be traumatically torn, such as in an elbow dislocation, or can tear through attritional damage with overhead sports. Although baseball pitching is the most common contributor, these injuries also occur with volleyball, gymnastics, and javelin throwing. Patients most commonly report a history of medial elbow pain with associated loss of command, control, and throw velocity. The ulnar nerve lies directly superficial to the posterior band of the ulnar collateral ligament and ulnar neuritis is commonly associated with ulnar collateral ligament pathology. Nonsurgical treatment, including rest from activity, flexor-pronator strengthening, and possible platelet-rich plasma injections, can be considered for partial-thickness tears. Surgical treatment can be considered for patients in whom nonsurgical treatment fails and full-thickness tears. Historically, surgical treatment involved reconstruction of the ligament with a tendon graft. Ipsilateral palmaris longus autograft has been the most commonly used graft, but contralateral palmaris, autograft hamstring tendons, and allograft tendon have also been used. This procedure has a high rate of return to play and a low complication rate, but most athletes require 12 to 18 months to fully return. More recently, repair of the ligament, with the addition of a biologic ingrowth ligament augmentation suture, has demonstrated similarly high rates of return to play and low complication rates, with a full return to play in 6 months.

High incidence of medial meniscus root/radial tears and extrusion in 253 patients with subchondral insufficiency fractures of the knee.

PURPOSE: The demographic and radiological risk factors of subchondral insufficiency fractures of the knee (SIFK) continue to be a subject of debate. The purpose of this study was to associate patient-specific factors with SIFK in a large cohort of patients. METHODS: Inclusion criteria consisted of patients with SIFK as verified on magnetic resonance imaging (MRI). All radiographs and MRIs were reviewed to assess characteristics such as meniscus tear presence and type, subchondral oedema presence and location, location of SIFK, mechanical limb alignment, osteoarthritis as assessed by Kellgren-Lawrence grade and ligamentous injury. A total of 253 patients (253 knees) were included, with 171 being female. The average body mass index (BMI) was 32.1 ± 7.0 kg/m2. RESULTS: SIFK was more common in patients with medial meniscus tears (77.1%, 195/253) rather than tears of the lateral meniscus (14.6%, 37/253) (p < 0.001). Medial meniscus root and radial tears of the posterior horn were present in 71.1% (180/253) of patients. Ninety-one percent (164/180) of medial meniscus posterior root and radial tears had an extrusion ≥3.0 mm. Eighty-one percent (119/147) of patients with SIFK on the medial femoral condyle and 86.8% (105/121) of patients with SIFK on the medial tibial plateau had a medial meniscus tear. Varus knees had a significantly increased rate of SIFK on the medial femoral condyle in comparison to valgus knees (p = 0.016). CONCLUSION: In this large cohort of patients with SIFK, there was a high association with medial meniscus root and radial tears of the posterior horn, meniscus extrusion ≥3.0 mm as well as higher age, female gender and higher BMI. Additionally, there was a particularly strong association of medial compartment SIFK with medial meniscus tears. As SIFK is frequently undiagnosed, identifying patient-specific demographic and radiological risk factors will help achieve a prompt diagnosis. LEVEL OF EVIDENCE: Level IV.

A practical guide to the development and deployment of deep learning models for the orthopaedic surgeon: Part III, focus on registry creation, diagnosis, and data privacy.

Deep learning is a subset of artificial intelligence (AI) with enormous potential to transform orthopaedic surgery. As has already become evident with the deployment of Large Language Models (LLMs) like ChatGPT (OpenAI Inc.), deep learning can rapidly enter clinical and surgical practices. As such, it is imperative that orthopaedic surgeons acquire a deeper understanding of the technical terminology, capabilities and limitations associated with deep learning models. The focus of this series thus far has been providing surgeons with an overview of the steps needed to implement a deep learning-based pipeline, emphasizing some of the important technical details for surgeons to understand as they encounter, evaluate or lead deep learning projects. However, this series would be remiss without providing practical examples of how deep learning models have begun to be deployed and highlighting the areas where the authors feel deep learning may have the most profound potential. While computer vision applications of deep learning were the focus of Parts I and II, due to the enormous impact that natural language processing (NLP) has had in recent months, NLP-based deep learning models are also discussed in this final part of the series. In this review, three applications that the authors believe can be impacted the most by deep learning but with which many surgeons may not be familiar are discussed: (1) registry construction, (2) diagnostic AI and (3) data privacy. Deep learning-based registry construction will be essential for the development of more impactful clinical applications, with diagnostic AI being one of those applications likely to augment clinical decision-making in the near future. As the applications of deep learning continue to grow, the protection of patient information will become increasingly essential; as such, applications of deep learning to enhance data privacy are likely to become more important than ever before. Level of Evidence: Level IV.

Autologous Osteochondral Transfer of the Knee Demonstrates Continued High Rates of Return to Sport and Low Rates of Conversion to Arthroplasty at Long-Term Follow-Up: A Systematic Review.

PURPOSE: To perform a systematic review of the literature to evaluate (1) activity level and knee function, (2) reoperation and failure rates, and (3) risk factors for reoperation and failure of autologous osteochondral transfer (AOT) at long-term follow-up. METHODS: A comprehensive review of the long-term outcomes of AOT was performed. Studies reported on activity-based outcomes (Tegner Activity Scale) and clinical outcomes (Lysholm score and International Knee Documentation Committee score). Reoperation and failure rates as defined by the publishing authors were recorded for each study. Modified Coleman Methodology Scores were calculated to assess study methodological quality. RESULTS: Twelve studies with a total of 495 patients and an average age of 32.5 years at the time of surgery and a mean follow-up of 15.1 years (range, 10.4-18.0 years) were included. The mean defect size was 3.2 cm2 (range, 1.9-6.9 cm2). The mean duration of symptoms before surgery was 5.1 years. Return to sport rates ranged from 86% to 100%. Conversion to arthroplasty rates ranged from 0% to 16%. The average preoperative International Knee Documentation Committee scores ranged from 32.9 to 36.8, and the average postoperative International Knee Documentation Committee scores at final follow-up ranged from 66.3 to 77.3. The average preoperative Lysholm scores ranged from 44.5 to 56.0 and the average postoperative Lysholm scores ranged from 70.0 to 96.5. The average preoperative Tegner scores ranged from 2.5 to 3.0, and the average postoperative scores ranged from 4.1 to 7.0. CONCLUSIONS: AOT of the knee resulted in high rates of return to sport with correspondingly low rates of conversion to arthroplasty at long-term follow-up. In addition, AOT demonstrated significant improvements in long-term patient-reported outcomes from baseline. LEVEL OF EVIDENCE: Level IV, systematic review of Level I-IV studies.

A Number of Modifiable and Nonmodifiable Factors Increase the Risk for Elbow Medial Ulnar Collateral Ligament Injury in Baseball Players: A Systematic Review.

PURPOSE: To analyze the current literature regarding risk factors associated with medial ulnar collateral ligament (MUCL) injury in baseball players and to serve as a robust source for identifying modifiable risk factors that once optimized, have the potential to reduce injury risk. METHODS: Comprehensive search of the available literature was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. Studies were included if they evaluated risk factors for MUCL injuries in the elbow of baseball players. Risk of bias assessment was performed via Methodological Index for Non-randomized Studies (MINORS) scoring system. The Oxford Centre for Evidence-Based Medicine was used to determine level of evidence. Variables of interest; player age, position, shoulder motion, humeral retrotorsion, joint laxity, strength, balance, geography, velocity, pitch count, pitch types, throwing volumes, and throwing mechanics were recorded. RESULTS: Twenty-one studies were included in this systematic review. MINORS scores ranged from 75 to 87%, and variables demonstrated significant heterogeneity. Performance-based risk factors for MUCL injury included: increased pitch count (both annual and per game), higher percentage of fastballs thrown, smaller pitch repertoire, and/or a loss of pitching velocity. Biomechanical studies demonstrated the relationship between decreased shoulder range of motion (total ROM, ER, IR, and abduction), increased humeral retrotorsion, increased elbow valgus opening in the throwing arm, lower Y-Balance score, and increased lateral release position to increased MUCL injury. CONCLUSIONS: Risk factors for MUCL injury can generally be categorized into 4 primary groups: 1) various player demographics and characteristics, 2) throwing too hard (high velocity), 3) throwing too much (pitch count/volume), and 4) throwing with poor mechanics. In this systematic review, the most significant nonmodifiable risk factors for MUCL injuries included: increased glenohumeral retrotorsion and elbow valgus opening. The most consistent modifiable risk factors included: total shoulder range of motion, pitch count, pitch selection, Y balance score, and lateral release position. Pitch velocity was inconsistent in literature, but most studies found this as a risk for injury. These risk factors may serve as appropriate targets for future evidence-based injury mitigation strategies. LEVEL OF EVIDENCE: Level IV, systematic review of Level II-IV studies.

Improved Yet Varied Clinical Outcomes Observed With Comparison of Arthroscopic Superior Capsular Reconstruction Versus Arthroscopy-Assisted Lower Trapezius Transfer for Patients With Irreparable Rotator Cuff Tears.

PURPOSE: To evaluate the outcomes of arthroscopic superior capsular reconstruction (SCR) and arthroscopy-assisted lower trapezius tendon transfer (LTT) for posterosuperior irreparable rotator cuff tears (IRCTs). METHODS: Over an almost 6-year period (October 2015 to March 2021), all patients who underwent IRCT surgery with a minimum 12-month follow-up period were identified. For patients with a substantial active external rotation (ER) deficit or lag sign, LTT was preferentially selected. Patient-reported outcome scores included the visual analog scale (VAS) pain score, strength score, American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score, Single Assessment Numeric Evaluation (SANE) score, and Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) score. RESULTS: We included 32 SCR patients and 72 LTT patients. Preoperatively, LTT patients had more advanced teres minor fatty infiltration (0.3 vs 1.1, P = .009), a higher global fatty infiltration index (1.5 vs 1.9, P = .035), and a higher presence of the ER lag sign (15.6% vs 48.6%, P < .001). At a mean follow-up of 2.9 ± 1.3 years (range, 1.0-6.3 years), no differences in patient-reported outcome scores were observed. Postoperatively, SCR patients had a lower VAS score (0.3 vs 1.1, P = .017), higher forward elevation (FE) (156° vs 143°, P = .004), and higher FE strength (4.8 vs 4.5, P = .005) and showed greater improvements in the VAS score (6.8 vs 5.1, P = .009), FE (56° vs 31°, P = .004), and FE strength (1.0 vs 0.4, P < .001). LTT patients showed greater improvement in ER (17° vs 29°, P = .026). There was no statistically significant between-cohort difference in complication rate (9.4% vs 12.5%, P = .645) or reoperation rate (3.1% vs 10%, P = .231). CONCLUSIONS: With adequate selection criteria, both SCR and LTT provided improved clinical outcomes for posterosuperior IRCTs. Additionally, SCR led to better pain relief and restoration of FE whereas LTT provided more reliable improvement in ER. LEVEL OF EVIDENCE: Level III, treatment study with retrospective cohort comparison.

Platelet-Rich Plasma and Marrow Venting May Serve as Cost-Effective Augmentation Techniques for Isolated Meniscal Repair: A Decision-Analytical Markov Model-Based Analysis.

PURPOSE: To evaluate the cost-effectiveness of 3 isolated meniscal repair (IMR) treatment strategies: platelet-rich plasma (PRP)-augmented IMR, IMR with a marrow venting procedure (MVP), and IMR without biological augmentation. METHODS: A Markov model was developed to evaluate the baseline case: a young adult patient meeting the indications for IMR. Health utility values, failure rates, and transition probabilities were derived from the published literature. Costs were determined based on the typical patient undergoing IMR at an outpatient surgery center. Outcome measures included costs, quality-adjusted life-years (QALYs), and the incremental cost-effectiveness ratio (ICER). RESULTS: Total costs of IMR with an MVP were $8,250; PRP-augmented IMR, $12,031; and IMR without PRP or an MVP, $13,326. PRP-augmented IMR resulted in an additional 2.16 QALYs, whereas IMR with an MVP produced slightly fewer QALYs, at 2.13. Non-augmented repair produced a modeled gain of 2.02 QALYs. The ICER comparing PRP-augmented IMR versus MVP-augmented IMR was $161,742/QALY, which fell well above the $50,000 willingness-to-pay threshold. CONCLUSIONS: IMR with biological augmentation (MVP or PRP) resulted in a higher number of QALYs and lower costs than non-augmented IMR, suggesting that biological augmentation is cost-effective. Total costs of IMR with an MVP were significantly lower than those of PRP-augmented IMR, whereas the number of additional QALYs produced by PRP-augmented IMR was only slightly higher than that produced by IMR with an MVP. As a result, neither treatment dominated over the other. However, because the ICER of PRP-augmented IMR fell well above the $50,000 willingness-to-pay threshold, IMR with an MVP was determined to be the overall cost-effective treatment strategy in the setting of young adult patients with isolated meniscal tears. LEVEL OF EVIDENCE: Level III, economic and decision analysis.