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The mathematical formulas underpinning biostatistical modeling in medical research can be complicated. Nomograms are pictoral tools showing a graphical solution of a formula in which all variables in the formula can be read off the diagram. Nomograms can be used to simplify the calculation of risk of recurrence of injuries or disease. Although nomograms can be valuable, external validation is required (of all models) to ensure accuracy outside of the original population, because variation in patient populations, activities, and risk behaviors outside of the patient data used in the original analysis may deteriorate model performance (external validity). A model also needs to be maintained over time to ensure continued accuracy as populations and activities change. A model that fails to keep up will eventually have its accuracy and clinical utility fade. An externally validated, well-maintained model can be a valuable tool for patient counseling and decision-making.
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Pesquisa Biomédica , Nomogramas , Humanos , Tomada de Decisões , Modelos Estatísticos , Reprodutibilidade dos TestesRESUMO
The minimal clinically important difference (MCID) is a frequently reported metric for describing within-patient improvement in patient-reported outcome measures (PROMs). It was originally defined by Jaeschke et al. as "the smallest difference in score in the domain of interest which patients perceive as beneficial and which would mandate, in the absence of troublesome side effects and excessive cost, a change in the patient's management." The latter part of this statement is often omitted, and this results in a loss of the originally intended value through lack of sufficient clinical importance to change management. Other pitfalls in the use of the MCID include that they are population- and condition-specific. As such, MCIDs lack external validity and cannot easily be extrapolated from one study to another. Furthermore, broadly different values can be obtained depending on the calculation method used. This makes the MCID an unhelpful metric when seeking to understand the true efficacy of a given intervention. The Food and Drug Administration recommends anchor-based methodologies (which take into account patient perception), over distribution-based methods (which are purely statistical and do not account for clinical meaningfulness to patients). Regardless, it should be noted that even anchor-based methodologies are susceptible to statistical bias, and measures are apt to be influenced by the regression to mean phenomena, where the value of the preintervention scores and their relationship to postintervention scores can bias estimates of the MCID. Finally, when using MCIDs, one must consider that they are a low bar. This means that patients do not undergo treatment to achieve minimally perceptible clinical improvements; instead, they undergo treatment with the hope of achieving substantial clinical benefit or a patient acceptable symptom state, and so these are more appropriate individual-level metrics to consider when evaluating clinically meaningful outcomes of treatment.
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Artroscopia , Diferença Mínima Clinicamente Importante , Humanos , Resultado do Tratamento , Medidas de Resultados Relatados pelo Paciente , Medição da DorRESUMO
Essential elements required for proper use of artificial intelligence machine learning tools in biomedical research and scientific publications include (1) explanation justifying why a machine learning approach contributes to the purpose of the study; (2) description of the adequacy of the data (input) to produce the desired results (output); (3) details of the algorithmic (i.e., computational) approach including methods for organizing the data (preprocessing); the machine learning computational algorithm(s) assessed; on what data the models were trained; the presence of bias and efforts to mitigate these effects; and the methods for quantifying the variables (features) most influential in determining the results (e.g., Shapley values); (4) description of methods, and reporting of results, quantitating performance in terms of both model accuracy and model calibration (level of confidence in the model's predictions); (5) availability of the programming code (including a link to the code when available-ideally, the code should be available); (6) discussion of model internal validation (results applicable and sensitive to the population investigated and data on which the model was trained) and external validation (were the results investigated as to whether they are generalizable to different populations? If not, consideration of this limitation and discussion of plans for external validation, i.e., next steps). As biomedical research submissions using artificial intelligence technology increase, these requirements could facilitate purposeful use and comprehensive methodological reporting.
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Inteligência Artificial , Pesquisa Biomédica , Humanos , Aprendizado de Máquina , Algoritmos , PublicaçõesRESUMO
Ceiling effects (CEs) are a major limitation of frequently used patient-reported outcomes measures (PROMs) in the assessment of shoulder function. It is generally considered that a CE may be present when the best possible score for a given PROM is achieved by at least 15% of the study population. When a CE occurs, it typically indicates that the scoring criteria are relatively easy and therefore may not reliably capture greater levels of patient function. This is a particular problem with the use of activities of daily living-oriented PROMs in the evaluation of athletic patients because they can still score highly, despite limitations in athletic shoulder function. When a CE is present, it can result in failure to determine the true efficacy of a procedure, limited responsiveness to change, and furthermore if a subsequent comparison of 2 groups of patients is undertaken, it may produce similar results despite meaningful differences between them. It is important to recognize that CEs are common and have important consequences but that careful selection of PROMs adapted to the characteristics of the study population and the specific research question can help to mitigate these issues.
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Atividades Cotidianas , Ombro , Humanos , Extremidade Superior , Atletas , Medidas de Resultados Relatados pelo PacienteRESUMO
Despite a push for a focus on clinical rather than "statistical" significance and an emphasis on reporting of outcome thresholds such as the patient acceptable symptomatic state (PASS) and substantial clinical benefit (SCB), the PASS and SCB are rarely reported and, when reported, are often reported incorrectly. Yet, patients require satisfaction (PASS) as a result of our treatments, and patients desire to improve substantially (SCB). Determining whether patients are satisfied and/or substantially improved is simple . . . just ask them. The questions are known as anchor questions. Obviously, different patients have different PASS and SCB thresholds, and reliance on previously published literature for values of these thresholds can result in error-thus, the anchor questions. And, each patient must be assessed individually. Outcome thresholds are not group-level metrics, and they must be reported as the percentage of individuals who achieve the clinically significant outcome. Certain patients, such as athletes, have high baseline function and may demand maximum outcome improvement. In contrast, the minimal clinically important difference is a less-than-ideal measure; patients do not desire "minimal" improvement. Journals must do a better job of publishing patient-reported outcome measures that matter most to patients: satisfaction and substantial benefit.
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Ulnar collateral ligament (UCL) tears have moved from a career-ending injury to one in which success is almost expected from reconstruction. In reality, however, success from a UCL reconstruction is not guaranteed. As we have attempted to assess the true success rate of UCL reconstructions, we have also learned the difficulties of this assessment. Rates of return to sport after UCL reconstruction vary by level of play, the primary or revision status of the repair, along with the specific surgical techniques performed, the chronicity of the tear, the rehabilitation protocols associated with the surgery, and more. Return to sport is difficult to assess, as high school, collegiate, and even professional careers can be variable and there are no standard definitions of "returning to play." These variables also affect our assessments of performance after UCL reconstruction. Decisions for UCL reconstructions and appropriate counseling of patients regarding the likelihood of success currently remain an individual process.
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Ligamento Colateral Ulnar , Volta ao Esporte , Reconstrução do Ligamento Colateral Ulnar , Humanos , Ligamento Colateral Ulnar/cirurgia , Ligamento Colateral Ulnar/lesõesRESUMO
The Fragility Index (FI) is defined as the number of patients whose outcome would need to change to reverse a statistically significant finding to a nonsignificant finding. The FI is nothing more than a repackaging of statistical significance based on the P value, perpetuating the (1) ignoring of results that are "not" statistically significant, (2) treating results that are statistically significant as certain, and (3) distracting from evaluation of clinical significance. A well-designed trial includes a sample size calculation to determine the minimum number of patients required to observe a difference between study groups (if a difference exists). By including this minimum number, clinical trials are designed to be fragile, yet subsequently criticized as such, leading readers to the incorrect conclusion that the studies are flawed. It's time to move past systematic reviews focused on the FI.
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PURPOSE: To quantify progression of chondral and meniscal injuries between primary and revision anterior cruciate ligament (ACL) surgery. METHODS: Patients who underwent both index and revision ACL reconstruction between 2000 and 2020 at our institution were identified, and dates of injury and surgery, demographics, and clinical data were obtained from operative reports. Outerbridge grade was recorded in each compartment, along with presence and location of meniscal injury. The frequency of each injury between first and second cases was calculated. Differences in injury and progression were compared over time as well as between patient sex and age. RESULTS: The study included 189 patients (96 female, 93 male). Age at first surgery was 31.7 ± 13.2 years. Mean time to second injury was 3.3 ± 3.0 years. In total, 116 patients had a new or previous chondral injury (odds ratio, 1.6; 95% CI, 1.2-2.1). The medial femoral condyle (31%) and the patella (21%) accounted for the highest proportion of new injury to articular surfaces, whereas new injury to menisci was comparable between the medial (25%) and lateral (23%) meniscus. At the time of revision ACL reconstruction, females had a high prevalence of chondral injuries to the lateral compartment, whereas males had a high prevalence of chondral injury to the medial femoral condyle. The prevalence of new chondral injuries was comparable between sexes, with males having a slightly higher proportion. While time between surgeries, sex, and age had graphical evidence of moderating risk, the effects were small and imprecise. CONCLUSIONS: Revision ACL reconstruction carried a 1.6 increase in the odds for new or progressive chondral lesions in our cohort. At the time of revision, females had a relatively higher proportion of lateral-sided chondral injuries, whereas males had a relatively higher proportion of medial femoral condyle injuries. The greatest increase in the prevalence of new and progressive lesions was observed in the medial femoral condyle and trochlea. This progression appeared to be moderated by time between surgeries, patient sex, and age; however, the differences were small and imprecise. LEVEL OF EVIDENCE: Level IV, therapeutic case series.
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Lesões do Ligamento Cruzado Anterior , Reconstrução do Ligamento Cruzado Anterior , Cartilagem Articular , Progressão da Doença , Reoperação , Humanos , Masculino , Feminino , Adulto , Reoperação/estatística & dados numéricos , Lesões do Ligamento Cruzado Anterior/cirurgia , Fatores Sexuais , Cartilagem Articular/lesões , Cartilagem Articular/cirurgia , Adulto Jovem , Lesões do Menisco Tibial/cirurgia , Estudos Retrospectivos , Adolescente , Pessoa de Meia-IdadeRESUMO
Disaggregation, in the medical literature, means separation into demographic groups. This results in an opportunity to discover differences in outcomes by group, which could improve future treatments and provide outcome data, by group, that could be included in future systematic reviews. In research, the term disaggregation is most often used in reference to addressing inequities. We support the Sex and Gender Equity Research (SAGER) guidelines and encourage authors to examine how sex and gender are taken into account in their study and ensure adequate representation by sex and gender. (We respect that not all studies can or are designed to capture data by sex and gender, and that gender is "complex" and "fluid.") Disaggregation is encouraged, when possible, for other demographic variables allowing evaluation of all marginalized (as well as nonmarginalized) populations, so that we can better care for patients.
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Pesquisa Biomédica , Humanos , Masculino , Feminino , Fatores Sexuais , Assistência ao Paciente , Melhoria de Qualidade , Equidade de GêneroRESUMO
The Fragility Index (FI) provides the number of patients whose outcome would need to have changed for the results of a clinical trial to no longer be statistically significant. Although it's a well-intended and easily interpreted metric, its calculation is based on reversing a significant finding and therefore its interpretation is only relevant in the domain of statistical significance. Its interpretation is only relevant in the domain of statistical significance. A well-designed clinical trial includes an a priori sample size calculation that aims to find the bare minimum of patients needed to obtain statistical significance. Such trials are fragile by design! Examining the robustness of clinical trials requires an estimation of uncertainty, rather than a misconstrued, dichotomous focus on statistical significance. Confidence intervals (CIs) provide a range of values that are compatible with a study's data and help determine the precision of results and the compatibility of the data with different hypotheses. The width of the CI speaks to the precision of the results, and the extent to which the values contained within have potential to be clinically important. Finally, one should not assume that a large FI indicates robust findings. Poorly executed trials are prone to bias, leading to large effects, and therefore, small P values, and a large FI. Let's move our future focus from the FI toward the CI.
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Ensaios Clínicos como Assunto , Intervalos de Confiança , Humanos , Viés , Tamanho da AmostraRESUMO
The reporting and analysis of patient-reported outcome measures have come a long way. Since the concept of the minimally clinically important difference was first introduced in 1989, threshold scores have grown to include substantial clinical benefit and patient acceptable symptomatic state (PASS). The initial motivation for developing these thresholds was rooted in separating clinical significance from statistical. These thresholds provide insight into the relationship between scores on patient-reported outcome measures (PROM) and patient-reported improvement and satisfaction. It follows that in order to evaluate PROM scores, the best method for deriving the threshold typically uses an anchor-based methodology, i.e., "ask the patient." Specifically, patients are asked how much change they've experienced and whether they consider their current state to be satisfactory. The responses to these questions are compared with the scores on PROMs to find outcome thresholds that best separate patients who reported no improvement from those who reported minimal improvement, substantial improvement, and satisfaction with their current state of health (PASS). The PASS is of particular importance as it speaks to what arguably matters most to patients-a satisfactory state of health. Finally, viewing the PASS from the perspective of variation from study to study rather than as a uniform classifier is needed to make use of the growing number of papers reporting these thresholds. Examining differences in PASS values across papers can provide insight into how well PROM scores reflect patient satisfaction in different settings.
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Artroplastia do Joelho , Satisfação do Paciente , Humanos , Medidas de Resultados Relatados pelo Paciente , Diferença Mínima Clinicamente Importante , Resultado do TratamentoRESUMO
PURPOSE: To examine the effect of various biologic adjuvants on the polarization of macrophages in an in vitro model for rotator cuff tears. METHODS: Tissue was harvested from 6 patients undergoing arthroscopic rotator cuff repair. An in vitro model of the supraspinatus and subacromial bursa was created and treated with control, platelet-rich plasma (PRP), autologous activated serum (AAS), or a combination of PRP+AAS. The effect of treatment on macrophage polarization between M1 proinflammatory macrophages or M2 anti-inflammatory macrophages was measured using gene expression, protein expression, flow cytometry, and nitric oxide production. RESULTS: Tendon and bursa treated with PRP, AAS, and PRP+AAS significantly decreased the gene expression of M1 markers interleukin (IL)-12 and tumor necrosis factor-alpha while significantly increasing the expression of M2 markers arginase, IL-10, and transforming growth factor-ß (P < .05) compared with treatment with control. Enzyme-linked immunosorbent assay analysis of protein production demonstrated that, compared with control, coculture treated with PRP, AAS, and PRP+AAS significantly decreased markers of M1-macrophages (IL-6, IL-12, and tumor necrosis factor-alpha) while significantly increasing the expression of markers of M2-macrophages (arginase, IL-10, and transforming growth factor-beta) (P < .05). Flow cytometry analysis of surface markers demonstrated that compared with control, tendon and bursa treated with PRP, AAS, and PRP+AAS significantly decreased markers of M1-macrophages (CD80, CD86, CD64, CD16) while significantly increasing the expression of markers of M2-macrophages (CD163 and CD206) (P < .05). Treatment of the coculture with PRP, AAS, and PRP+AAS consistently demonstrated a decrease in nitric oxide production (P < .05) compared with control. AAS and PRP+AAS demonstrated an increased macrophage shift to M2 compared with PRP alone, whereas there was not as uniform of a shift when comparing PRP+AAS with AAS alone. CONCLUSIONS: In an in vitro model of rotator cuff tears, the treatment of supraspinatus tendon and subacromial bursa with PRP, AAS, and PRP+AAS demonstrated an increase in markers of anti-inflammatory M2-macrophages and a concomitant decrease in markers of proinflammatory M1-macrophages. AAS and PRP+AAS contributed to a large shift to macrophage polarization to the anti-inflammatory M2 compared with PRP. CLINICAL RELEVANCE: The mechanism of biologic adjuvant effects on the rotator cuff remains poorly understood. This study suggests that they may contribute to polarization of macrophages for their proinflammatory (M1) state to the anti-inflammatory (M2) state.
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PURPOSE: To analyze radiographic outcomes by conventional radiography, computed tomography (CT), or both and complication rates of open coracoid transfer at a minimum of 12-months follow-up. METHODS: A literature search was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, using PubMed, Medline (Ovid), and EMBASE library databases. Inclusion criteria were clinical studies reporting on open Latarjet as the primary surgical procedure(revision coracoid transfer after failed prior stabilization excluded) with postoperative radiographic outcomes at a minimum mean 1-year follow-up. Patient demographics, type of postoperative imaging modality, and radiographic outcomes and complications including graft union, osteoarthritis, and osteolysis were systematically reviewed. Data were summarized as ranges of reported values for each outcome metric. Each radiographic outcome was graphically represented in a Forest plot with point estimates of the incidence of radiographic outcomes with corresponding 95% confidence intervals and I2. RESULTS: Thirty-three studies met inclusion criteria, with a total of 1,456 shoulders. The most common postoperative imaging modality was plain radiography only (n = 848 [58.2%]), both CT and radiography (n = 287 [19.7%]), and CT only (n = 321 [22.1%]). Overall, the reported graft union rate ranged from 75% to 100%, of which 79.8% (n = 395) were detected on plain radiography. The most common reported postoperative radiographic complications after the open coracoid transfer were osteoarthritis (range, 0%-100%, pooled mean 28%), graft osteolysis (range, 0%-100%, pooled mean 30%), nonunion (range, 0%-32%, pooled mean 5.1%), malpositioned graft (range, 0%-75%, pooled mean 14.75%), hardware issues (range, 0%-9.1%, pooled mean 5%), and bone block fracture (range, 0%-8%, pooled mean 2.1%). Graft healing was achieved in a majority of cases (range, 75%-100%). CONCLUSION: Postoperative radiographic outcomes after open coracoid transfer vary greatly in definition, classification, and imaging modality of choice. Greater consistency in postoperative radiographic outcomes is essential to evaluate graft healing, osteolysis, and nonunion. LEVEL OF EVIDENCE: Level IV, systematic review of Level III-IV studies.
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Fraturas Ósseas , Instabilidade Articular , Osteoartrite , Osteólise , Luxação do Ombro , Articulação do Ombro , Humanos , Articulação do Ombro/cirurgia , Instabilidade Articular/cirurgia , Ombro/cirurgia , Luxação do Ombro/cirurgia , Osteoartrite/diagnóstico por imagem , Osteoartrite/cirurgia , Osteoartrite/complicações , Fraturas Ósseas/complicações , Processo Coracoide/cirurgia , Processo Coracoide/transplanteRESUMO
PURPOSE: To quantify cellular senescence in supraspinatus tendon and subacromial bursa of humans with rotator cuff tears and to investigate the in vitro efficacy of the senolytic dasatinib + quercetin (D+Q) to eliminate senescent cells and alter tenogenic differentiation. METHODS: Tissue was harvested from 41 patients (mean age, 62 years) undergoing arthroscopic rotator cuff repairs. In part 1 (n = 35), senescence was quantified using immunohistochemistry and gene expression for senescent cell markers (p16 and p21) and the senescence-associated secretory phenotype (SASP) (interleukin [IL] 6, IL-8, matrix metalloproteinase [MMP] 3, monocyte chemoattractant protein [MCP] 1). Senescence was compared between patients <60 and ≥60 years old. In part 2 (n = 6) , an in vitro model of rotator cuff tears was treated with D+Q or control. D+Q, a chemotherapeutic and plant flavanol, respectively, kill senescent cells. Gene expression analysis assessed the ability of D+Q to kill senescent cells and alter markers of tenogenic differentiation. RESULTS: Part 1 revealed an age-dependent significant increase in the relative expression of p21, IL-6, and IL-8 in tendon and p21, p16, IL-6, IL-8, and MMP-3 in bursa (P < .05). A significant increase was seen in immunohistochemical staining of bursa p21 (P = .028). In part 2, D+Q significantly decreased expression of p21, IL-6, and IL-8 in tendon and p21 and IL-8 in bursa (P < .05). Enzyme-linked immunosorbent assay analysis showed decreased release of the SASP (IL-6, MMP-3, MCP-1; P = .002, P = .024, P < .001, respectively). Tendon (P = .022) and bursa (P = .027) treated with D+Q increased the expression of COL1A1. CONCLUSIONS: While there was an age-dependent increase in markers of cellular senescence, this relationship was not consistently seen across all markers and tissues. Dasatinib + quercetin had moderate efficacy in decreasing senescence in these tissues and increasing COL1A1 expression. CLINICAL RELEVANCE: This study reveals that cellular senescence may be a therapeutic target to alter the biological aging of rotator cuffs and identifies D+Q as a potential therapy.
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Lesões do Manguito Rotador , Humanos , Pessoa de Meia-Idade , Lesões do Manguito Rotador/tratamento farmacológico , Lesões do Manguito Rotador/cirurgia , Dasatinibe/farmacologia , Dasatinibe/uso terapêutico , Quercetina/farmacologia , Quercetina/uso terapêutico , Metaloproteinase 3 da Matriz/genética , Interleucina-6/metabolismo , Interleucina-8 , Senescência CelularRESUMO
BACKGROUND: The Goutallier classification (GC) is used to assess fatty atrophy in rotator cuff (RC) tears, yet limitations exist. A battery of 3-dimensional (3D) magnetic resonance imaging (MRI) volumetric scores (VSs) was developed to provide comprehensive characterization of RC pathology. The purposes of this study were to (1) describe the correlation between GC and VSs for supraspinatus changes in RC tears, (2) characterize the chronicity of RC tears using a battery of 12 VS measurements, and (3) compare GC and VSs to determine which method most closely corresponds with preoperative patient-reported outcome measures (PROMs). METHODS: Preoperative shoulder MRIs were reviewed after arthroscopic RC repair. Preoperative GC stage and Patient-Reported Outcomes Measurement Information System (PROMIS) physical function (PF) and pain interference (PI) scores were collected. The battery of VSs included fat infiltration (FIS), muscle size (MSS), and relative volume contribution (RCS) for each RC muscle. Backward linear regression was performed to compare GC stage with preoperative PROMIS PF and PI to determine which VS measurement most closely correlated with preoperative PROMs. RESULTS: Eighty-two patients underwent RC repair (mean age 55 ± 8.2 years, 63% male, 68% GC stage ≤1). In evaluation of the supraspinatus, there was a moderate positive correlation between GC and FIS (r = 0.459, P < .001); strong negative correlations were observed between MSS (r = -0.800, P < .001) and RCS (r = -0.745, P < .001) when compared to GC. A negligible linear correlation was observed between GC and preoperative PROMIS PF (r = -0.106, P = .343) and PI (r = -0.071, P = .528). On multivariate analysis, subscapularis MSS (ß >0, P = .064) was a positive predictor and subscapularis FIS (ß <0, P = .137), teres minor MSS (ß <0, P = .141), and FIS (ß <0, P = .070) were negative predictors of preoperative PF (r = 0.343, P = .044); in contrast, supraspinatus MSS (ß >0, P = .009) and FIS (ß >0, P = .073), teres minor FIS (ß >0, P = .072), and subscapularis FIS (ß >0, P = .065) were positive predictors of preoperative PI (r = 0.410, P = .006). CONCLUSION: Although the criterion standard in evaluation of RC pathology, GC demonstrated negligible correlation with preoperative functional disability. Alternatively, a battery of 3D VSs showed strong correlation with GC through a quantitative, comprehensive evaluation of the RC unit including several moderate predictors of preoperative functional disability.
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BACKGROUND: A patient's decision-making process to undergo surgery is crucial for surgeons to understand for patient counseling purposes. Total knee and hip arthroplasty, like any other major surgery, is associated with serious, sometimes life-threatening, complications. Using the results of discrete choice experiments (DCE), we aimed to understand the relationship between a patient's risk tolerance and choosing to undergo surgery in real life. METHODS: This is a retrospective study of prospectively collected DCE results for 142 potential knee or hip arthroplasty clinic patients from October 2021 to March 2022. The DCE presented the patient with two scenarios, each of which was made up of different combinations of attributes and levels. A hierarchal Bayesian model was utilized to obtain a risk score that reflected the risk attributes chosen by each patient. Logistic regressions were then utilized to evaluate the association between a patient's willingness to incur risk and their decision to undergo a total joint arthroplasty (TJA). RESULTS: Out of the 142 patients enrolled in the DCE, 89 (62.3%) underwent a TJA. Risk score (OR [odds ratio] = 2.6, 95% CI [confidence interval] 1.1 to 6.6, P = 0.0400), men (OR = 2.5, 95% CI 1.1 to 5.9, P = 0.0280), and patients who have hip osteoarthritis (OR = 2.4, 95% CI 1.1 to 5.5, P = 0.0360) increased the odds of undergoing arthroplasty, whereas physical function of at least 75% at the initial visit (OR = 0.3, 95% CI 0.1 to 0.7, P = 0.0040) decreased these odds. CONCLUSIONS: We found that a patient's willingness to incur risk, lower baseline physical function, and men were all independently associated with undergoing total knee arthroplasty. We believe that these findings prompt much-needed future studies that focus solely on the relationship between patients inherent risk behavior and surgical and patient-reported outcomes.
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BACKGROUND: Elliptical shape humeral head prostheses have been recently proposed to reflect a more anatomic shoulder replacement. However, its effect on obligate glenohumeral translation during axial rotation compared to a standard spherical head is still not well understood. The purpose of the study was to compare obligate humeral translation during axial rotation using spherical and elliptical shaped humeral head prostheses. It was hypothesized that the spherical head design would show significantly more obligate translation when compared to the elliptical design. METHODS: Six fresh-frozen cadaveric shoulders were utilized for biomechanical testing of internal (IR) and external (ER) rotation at various levels of abduction (0°, 30°, 45°, 60°) with lines of pull along each of the rotator cuff muscles. Each specimen underwent the following three conditions: (1) native; total shoulder arthroplasty (TSA) using (2) an elliptical and (3) spherical humeral head implant. Obligate translation during IR and ER was quantified using a 3-dimensional digitizer. The radius of curvature of the superoinferior and anteroposterior dimensions of the implants was calculated across each condition. RESULTS: Posterior and inferior translation as well as compound motion of spherical and elliptical heads during ER was similar at all abduction angles (P > 0.05, respectively). Compared to the native humeral head, both implants demonstrated significantly decreased posterior translation at 45° (elliptical: P = 0.003; spherical: P = 0.004) and 60° of abduction (elliptical: P < 0.001; spherical: P < 0.001). During internal rotation at 0° abduction, the spherical head showed significantly more compound motion (P = 0.042) compared to the elliptical head. The spherical implant also demonstrated increased anterior translation and compound motion during internal rotation at 60° abduction (P < 0.001) compared to the resting state. This difference was not significant for the native or elliptical head design at this angle (P > 0.05). CONCLUSION: In the setting of TSA, elliptical and spherical head implants showed similar obligate translation and overall compound motion during axial rotation. A gained understanding of the consequences of implant head shape in TSA may guide future surgical implant choice for better recreation of native shoulder kinematics and potentially improved patient outcomes. LEVEL OF EVIDENCE: Controlled Laboratory Study.
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Artroplastia do Ombro , Artroplastia de Substituição , Bursite , Humanos , Rotação , Extremidade Superior , Cabeça do Úmero/cirurgiaRESUMO
Patient-reported outcome measures (PROM) need to be responsive, reliable, and validated for the specific condition or treatment. PROMs also need to exhibit a dose-dependent response across a diverse patient population, unlimited by floor and ceiling effects. Statistically significant differences between compared groups might not always represent clinically important differences. Measures of clinical significance reflect a spectrum of patient satisfaction after an intervention. A noticeable difference to the patient is assessed with minimal clinically important difference (MCID), patient satisfaction by patient acceptable symptomatic state (PASS), and a "considerable" improvement by substantial clinical benefit (SCB). Clinical relevance measured by these clinically significant outcomes (CSO) are limited by ceiling effects. Maximal outcome improvement (MOI) might more accurately account for patients with higher baseline or preoperative PROMs, thereby limiting ceiling effects. The acts of measuring (and reporting) patient-centered endpoints may actually be of greater importance than collecting objective clinician-measured data. As the old surgeon's aphorism goes, "nothing ruins good results like good follow-up."
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Relevância Clínica , Diferença Mínima Clinicamente Importante , Humanos , Resultado do Tratamento , Artroscopia/métodos , Satisfação do Paciente , Medidas de Resultados Relatados pelo PacienteRESUMO
Machine learning (ML) has become an increasingly common statistical methodology in medical research. In recent years, ML techniques have been used with greater frequency to evaluate orthopaedic data. ML allows for the creation of adaptive predictive models that can be applied to clinical patient outcomes. However, ML models for predicting clinical or safety outcomes may be made available online so that physicians may apply these models to their patients to make predictions. If the algorithms have not been externally validated, then the models are not likely to generalize, and their predictions will suffer from inaccuracy. This is especially important to bear in mind because the recent increase in ML papers in the medical literature includes publications with fundamental flaws.
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Algoritmos , Aprendizado de Máquina , HumanosRESUMO
A recent research study showed that blood flow restriction (BFR) therapy was safe and well tolerated but failed to demonstrate efficacy as a modality that provides greater gains in quadriceps strength when added to a standard home program in patients awaiting anterior cruciate ligament (ACL) reconstruction. Despite employing a validated method of measurement, the results were highly variable, indicating the need for measurements with sufficient accuracy to detect the small, but potentially meaningful, gains in quadriceps strength that's been attributed to BFR. The results inform future investigations of BFR prior to ACL surgery by demonstrating the need for accurate methods of measurements when the anticipated effects are small.