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Research Methods

Elbow research methods: biomechanics, machine learning, clinical metrics, and challenges of low-volume surgery/RCTs.

Overview

Elbow arthroplasty research utilizes a wide array of outcomes and measurement instruments, highlighting an urgent need to define a core set of outcomes and instruments for future investigations [1]. To ensure validity, quantitative pooling of nonrandomized studies is improper when included studies lack homogeneity or are of lower quality [2]. Exploring clinical and methodologic differences (heterogeneity) allows for more accurate patient care and future research [2].

Methodologic rigor requires careful selection of study design and control arms. The most rigorous scientific methodology utilizes a control arm that represents a clinically relevant baseline for comparison [9]. Future research should investigate perioperative management using treatment groups frequently performed in clinical practice as a baseline control arm [9]. For the majority of treatments, conventional randomized controlled trials (RCTs) will answer the question more easily and precisely than expertise-based RCTs [3]. Researchers should consider using expertise-based RCTs only after carefully considering their arguments and limitations [3].

Transparency and data integrity are critical for evaluating emerging technologies and high-risk devices. Understanding the current evidence and appropriate indications of emerging technologies is of critical importance for their utilization in orthopaedic trauma [11]. Prospective public registration of clinical trials and timely publication or posting of results are desirable goals [16]. However, surveys show substantial reluctance among researchers and editors regarding clinical trial registration and result publication [16]. Existing legislation regarding clinical trial registration is incompletely enforced [16]. Editorial boards of the American Journal of Sports Medicine (AJSM) and Orthopaedic Journal of Sports Medicine (OJSM) have taken steps to require registration and accept trial design articles to accelerate progress [16].

Initiatives such as the CORE–MD project aim to review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources to improve the evaluation of high-risk medical devices in Europe [8]. When using claims data or registries, researchers must utilize additional datapoints and thoughtful methodology to mitigate limitations [21]. Future prospective studies should better classify patients who genuinely require early surgery [6]. In surgical education, accurate metrics and precisely defined outcome measures are key to valid and reliable assessment [35]. The authors advocate for precise definition of assessment tools (checklists and Global Rating Scales) in any study investigating surgical skills in simulation-based training [35].

Anatomy & Pathophysiology

Osseous and Articular Entrapment

Elbow dislocations associated with fractures of the medial epicondyle involving intra-articular entrapment present diagnostic challenges in the acute phase [34].

Ligamentous and Soft Tissue Reconstruction

At time zero, ulnar collateral ligament reconstruction (UCLR) demonstrates inferior biomechanical properties compared with the native intact ligament [49]. For annular ligament defects, a distally based tendon graft reconstruction using the tendon of the superficial head of the brachialis muscle is feasible in most patients based on anatomic study [64].

Kinematics and Dynamic Stability

Pitching 100 balls induces a significant reduction in dynamic stabilizing ability against elbow valgus laxity in high school baseball players [45]. The posterior and posterior superior labral (PPS) injury produces alterations in glenohumeral kinematics with implications for glenohumeral joint instability, increased glenohumeral joint loading, and potential joint damage [63].

Classification

Outcome Measurement Standardization: Numerous outcomes and instruments have been utilized in elbow arthroplasty research, indicating a need to define a core set of outcomes and instruments for future studies [1]. The CORE–MD project aims to review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources to improve the evaluation of high-risk medical devices in Europe [8].

Study Design and Evidence Hierarchy: Quantitative pooling of nonrandomized studies is improper when included studies are not homogeneous or are of lower quality [2]. Exploring clinical and methodologic differences (heterogeneity) allows for more accurate patient care and future research [2]. For the majority of treatments, conventional randomized controlled trials (RCTs) will answer the question more easily and precisely than expertise-based RCTs [3]. Researchers should consider using expertise-based RCTs only after carefully considering their arguments and limitations [3]. Epidemiology and non-epidemiology-trained reviewers can apply the levels-of-evidence guide to published studies with acceptable interobserver agreement [7]. The validity of the levels-of-evidence system remains a question for future research [7].

Data Sources and Methodologic Rigor: Researchers must utilize additional datapoints and thoughtful methodology to mitigate limitations when using claims data or registries [21]. Database linkages can produce richer data sets and more comprehensive and reliable analyses [23], although practical, legal, and financial challenges exist with database linkages [23]. AI-driven prognostication models remain in their infancy and require further work to guide treatment pathways and preventative medicine [14].

Statistical and Interpretive Considerations: Conclusions regarding interobserver reliability based on kappa values can be misleading due to methodological limitations of the kappa statistic [24]. The kappa statistic is dependent on prevalence and the number of categories [24]. Observed differences in knee scores between different study groups that have not been matched for various clinically relevant factors are at least as likely to represent differences in the patient populations as they are to represent differences in the operative technique or the design of the implant [28].

Other Considerations: Evidence-based medicine is a necessary component of urology and the German healthcare system [44]. Evidence-based medicine requires knowledge of its procedures to ensure decisions are based on scientific findings, transparent, and traceable [44]. Translational research aims to bridge the gap between basic and clinical research [46]. New academic posts translationally orientated are urgently needed, particularly in the field of trauma medicine [46].

Clinical Presentation

The evaluation of elbow pathology requires rigorous methodological standards to ensure clinical relevance. Many outcomes have been used with many different instruments for their measurement in elbow arthroplasty research, indicating a need to define a core set of outcomes and instruments for future research [1]. Quantitative pooling of nonrandomized studies is improper when included studies are not homogeneous or are of lower quality; instead, exploring clinical and methodologic differences (heterogeneity) allows for more accurate patient care and future research [2]. The most rigorous scientific methodology utilizes a control arm that represents a clinically relevant baseline for comparison, and future research should investigate perioperative management using treatment groups frequently performed in clinical practice as a baseline control arm [9].

Assessment of patient selection and diagnostic accuracy relies on prospective classification. Future prospective studies are recommended to better classify patients who genuinely require early surgery [6]. For the iBP elbow prosthesis, many patients have radiolucencies, and the discrepancy between clinical signs and radiological results warrants structural follow-up [17]. In lateral epicondylitis, findings point to a lack in robustness for conclusions drawn from RCTs relating to nonoperative treatment, where a reversal of only 3 patient outcomes could considerably influence reported statistically significant findings [22].

Diagnostic reliability and data integrity present specific challenges. Conclusions regarding interobserver reliability based on kappa values can be misleading due to methodological limitations of the kappa statistic, specifically its dependence on prevalence and the number of categories [24]. Epidemiology and non-epidemiology-trained reviewers can apply the levels-of-evidence guide to published studies with acceptable interobserver agreement, though the validity of this system remains a question for future research [7]. Database linkages can produce richer data sets and more comprehensive and reliable analyses, though practical, legal, and financial challenges exist [23].

Research design and publication ethics dictate the quality of available evidence. Researchers should consider using expertise-based randomized controlled trials (RCTs) only after carefully considering their arguments and limitations, as conventional RCTs will answer the question more easily and precisely for the majority of treatments [3]. Review articles and database mining studies are important for rare clinical syndromes where original trials are unfeasible, but the increasing trend raises concerns about the future availability of original articles needed to conduct such reviews [13]. Prospective public registration of clinical trials and timely publication or posting of results are desirable goals, yet surveys show substantial reluctance among researchers and editors; existing legislation is incompletely enforced, though editorial boards of AJSM and OJSM have recently taken steps to require registration and accept trial design articles to accelerate progress [16].

Emerging technologies and broader methodological initiatives are shaping future practice. AI-driven prognostication models remain in their infancy and require further work to guide treatment pathways and preventative medicine [14]. The CORE–MD project aims to review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources to improve the evaluation of high-risk medical devices in Europe [8]. The current state of the orthopaedic literature reflects these methodological realities; more than two-thirds of clinical management questions on the Orthopaedic In-Training Examination were supported by studies whose level of evidence was IV or lower, reflecting the state of the art of the orthopaedic literature rather than a deficiency in the examination itself [25].

Investigations

Plain radiography: Many outcomes in elbow arthroplasty research utilize various instruments, highlighting the need to define a core set of outcomes and instruments for future studies [1]. In the context of the iBP elbow prosthesis, many patients exhibit radiolucencies; however, the discrepancy between clinical signs and radiological results warrants structural follow-up [17]. For displaced fractures of the medial humeral condyle in children, early diagnosis via plain radiography is important to avoid growth disturbance, articular incongruence, and functional disability [56].

MRI: Magnetic resonance imaging indicates that the donor site after autologous osteochondral mosaicplasty for cartilaginous lesions of the elbow joint is resurfaced with fibrous tissue [43]. However, radiographic methods including MRI cannot be considered an accurate and reliable basis for the diagnosis and treatment of subspine impingement in femoroacetabular impingement (FAI) patients [47].

CT: Radiographic methods including 3-D CT cannot be considered an accurate and reliable basis for the diagnosis and treatment of subspine impingement in FAI patients [47].

Bone scan: A negative F-18-FDG PET/CT excludes septic shoulder arthritis with high probability [55]. Overall bone metabolism of the operated intervertebral disc space at six weeks had the highest diagnostic accuracy for predicting fusion status at one year after posterior lumbar interbody fusion [52].

Other Considerations: Quantitative pooling of nonrandomized studies is improper when included studies are not homogeneous or are of lower quality [2]. Exploring clinical and methodologic differences (heterogeneity) allows for more accurate patient care and future research instead of improper quantitative pooling [2]. Researchers should consider using expertise-based RCTs only after carefully considering their arguments and limitations [3]. For the majority of treatments, conventional RCTs will answer the question more easily and precisely than expertise-based RCTs [3]. Understanding the current evidence and appropriate indications of emerging technologies is of critical importance for their utilization [11]. More than two-thirds of clinical management questions on the Orthopaedic In-Training Examination were supported by studies whose level of evidence was IV or lower [25]. Trial reduction is the last chance to get it right and must be performed carefully to detect and correct malalignments that would otherwise lead to poor results [26]. The outcomes of a randomized controlled trial comparing surgical and nonsurgical treatment for cervical radiculopathy will contribute to better decision making in the treatment of this condition [30]. Intraoperative findings of the labrum cannot be considered an accurate and reliable basis for the diagnosis and treatment of subspine impingement in FAI patients [47]. 3D-printed percutaneous guides in drilled decompression of femoral head necrosis reduce operative time, fluoroscopy, and guide needle adjustments [53]. 3D-printed percutaneous guides in drilled decompression of femoral head necrosis are more effective in preventing the progression of femoral head necrosis to advanced stages compared to traditional surgery under fluoroscopy [53]. An interpretable LightGBM machine learning model integrating clinicoradiological and radiomic features was developed and validated to predict the failure of conservative treatment in lateral epicondylitis [54].

Treatment

Non-Operative

Randomized controlled trial outcomes for the nonoperative management of lateral epicondylitis of the elbow are statistically fragile, where a reversal of only 3 patient outcomes could considerably influence reported statistically significant findings [22]. For chronic, nonradicular, discogenic low back pain, intradiskal electrothermal therapy shows reported therapeutic success rates of 60% to 80%, though a more precise quantification of clinical benefits remains to be proved in randomized prospective trials [38].

Operative

Indications: Future prospective studies are recommended to better classify patients who genuinely require early surgery [6]. Custom hemiarthroplasty appears to be a reasonable method to salvage proximal humeral dysplasia epiphysealis hemimelica when nonsurgical management has failed to provide relief [41].

Surgical Approach / Technique: The PREFERE study represents a novel, prospective-randomized comparison of all four S3 guideline-recommended treatment options for localized prostate cancer in Germany, addressing the need for robust evidence-based data amidst concerns of overdiagnosis and overtreatment [18]. The outcomes of a randomized controlled trial comparing the effectiveness of surgical and nonsurgical treatment for cervical radiculopathy will contribute to better decision making in the treatment of cervical radiculopathy [30].

Implant Selection: Patients and clinicians can expect an average procedure survival of 12.5 years and a maximum of 21 years for symptomatic relief in medial opening wedge high tibial osteotomies for the treatment of knee osteoarthritis, with effective pain relief influenced by cartilage treatment and preoperative pain score [27].

Setting of Care: A protocol for a randomized controlled trial describes the first trial to use blinding to evaluate outpatient total hip arthroplasty compared to standard overnight stay and the first to prospectively perform a full economic evaluation [19].

Other Considerations: Many outcomes have been used with many different instruments for their measurement in elbow arthroplasty, indicating a need to define a core set of outcomes and instruments for future research [1]. Quantitative pooling of nonrandomized studies is improper when included studies are not homogeneous or are of lower quality; instead, exploring clinical and methodologic differences (heterogeneity) allows for more accurate patient care and future research [2]. Researchers should consider using expertise-based randomized controlled trials (RCTs) only after carefully considering their arguments and limitations, as conventional RCTs will answer the question more easily and precisely for the majority of treatments [3]. The most rigorous scientific methodology utilizes a control arm that represents a clinically relevant baseline for comparison, and future research should investigate perioperative management using treatment groups frequently performed in clinical practice as a baseline control arm [9]. Randomized clinical trials are iconic but not sacrosanct; while sometimes unethical, they remain a powerful and feasible research methodology that surgeons must be willing to employ to suspend disbelief regarding existing treatment options [51]. Authors agree with recommendations to upload copies of consents and board approvals for prospective studies to eliminate sample size falsification, but note that assessment of such copies will be difficult and time-consuming in international studies [36]. Machine learning 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, but if the algorithms have not been externally validated, then the models are not likely to generalize and their predictions will suffer from inaccuracy [29]. Epidemiology and non-epidemiology-trained reviewers can apply the levels-of-evidence guide to published studies with acceptable interobserver agreement, though the validity of this system remains a question for future research [7].

Complications

Infection (PJI): Medical comorbidities and perioperative allogeneic red blood cell transfusion are risk factors for surgical site infection after shoulder arthroplasty [50]. Gender, rheumatoid arthritis, and long-term (>1 year) corticosteroid use also affect surgical site infection risk after shoulder arthroplasty [50].

Other Considerations: Many outcomes have been used with many different instruments for their measurement in elbow arthroplasty research, indicating a need to define a core set of outcomes and instruments for future research [1]. Quantitative pooling of nonrandomized studies is improper when included studies are not homogeneous or are of lower quality; instead, exploring clinical and methodologic differences (heterogeneity) allows for more accurate patient care and future research [2]. Researchers should consider using expertise-based RCTs only after carefully considering their arguments and limitations; for the majority of treatments, conventional RCTs will answer the question more easily and precisely [3]. Future prospective studies are recommended to better classify patients who genuinely require early surgery [6]. Epidemiology and non-epidemiology-trained reviewers can apply the levels-of-evidence guide to published studies with acceptable interobserver agreement, though the validity of this system remains a question for future research [7]. The CORE–MD project aims to review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources to improve the evaluation of high-risk medical devices in Europe [8]. While review articles and database mining studies are important for rare clinical syndromes where original trials are unfeasible, the increasing trend raises concerns about the future availability of original articles needed to conduct such reviews [13]. Machine learning 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, but if the algorithms have not been externally validated, then the models are not likely to generalize, and their predictions will suffer from inaccuracy [29]. Observed differences in knee scores between different study groups that have not been matched for various clinically relevant factors are at least as likely to represent differences in the patient populations as they are to represent differences in the operative technique or the design of the implant [28]. Despite major primary complications and high incidence of radiographic signs of degenerative changes after 8.8 years, mainly good clinical results were achieved with Judet's bipolar prosthesis [59].

Recovery

Light activity (weeks): Evidence does not provide specific week ranges for light activity, desk work, or driving.

Full activity (months): Evidence does not provide specific month ranges for manual work, sport, or full range of motion/strength return.

Complete recovery / outcome plateau (months): Work-related impairments and associated anxiety diminish substantially within five years in patients with osteonecrosis of the femoral head undergoing femoral osteotomy, suggesting middle-aged patients are often able to resume and sustain employment long-term [31].

Rehabilitation protocol: Evidence does not specify physical therapy phasing, immobilisation duration, weight-bearing/ROM progression, or sling/brace removal timing.

Functional milestones: The Musculoskeletal Function Assessment Questionnaire is more responsive than the SF-36 and more efficient in measuring changes in function between baseline and follow-up values [40]. The Discovery Elbow System resulted in improved function, reduced pain, and high patient satisfaction at a 4-year mean follow-up [12]. Patients and clinicians can expect an average procedure survival of 12.5 years and a maximum of 21 years for symptomatic relief in medial opening wedge high tibial osteotomies for the treatment of knee osteoarthritis [27]. Effective pain relief in medial opening wedge high tibial osteotomies is influenced by cartilage treatment and preoperative pain score [27]. Patients with a preoperative duration of symptomatic medial knee overload/arthritis of two years or greater do not experience inferior PRO or clinical outcomes than patients with a symptom duration of less than 2 years at mid-term follow-up after high tibial osteotomy [32].

Other Considerations: Many outcomes have been used with many different instruments for their measurement in elbow arthroplasty research, indicating a need to define a core set of outcomes and instruments for future research [1]. Future prospective studies are recommended to better classify patients who genuinely require early surgery [6]. Review articles and database mining studies are important for rare clinical syndromes where original trials are unfeasible, but their increasing trend raises concerns about the future availability of original articles needed to conduct such reviews [13]. AI-driven prognostication models remain in their infancy and require further work to guide treatment pathways and preventative medicine [14]. Mobile and fixed-bearing (all-polyethylene tibial component) total knee arthroplasty designs functioned equivalently at the time of early follow-up in a low-to-moderate-demand patient group [15]. Further studies with long-term follow-up are needed to determine whether the grafted area will maintain structural and functional integrity over time after Autologous Matrix-Induced Chondrogenesis for treatment of focal cartilage defects in the knee [20]. Early reimplantation (abbreviated two-stage) provides similar outcomes to traditional two-stage exchange, though optimal timing and selection criteria remain undefined [33]. Elbow dislocations associated with fractures of the medial epicondyle with intra-articular entrapment can be difficult to diagnose in the acute phase, requiring a high level of suspicion [34]. Researchers using patient data coded with different AIS versions should be mindful of changes when combining or comparing data from different time periods [65].

Key Evidence

  • [L4] Many outcomes have been used with many different instruments for their measurement, indicating a need to define a core set of outcomes and instruments for future research in this area. (10.1302/0301-620x.104b10.bjj-2022-0570.r1)
  • [L5] Quantitative pooling of nonrandomized studies is improper when included studies are not homogeneous or are of lower quality; instead, exploring clinical and methodologic differences (heterogeneity) allows for more accurate patient care and future research. (10.1016/j.arthro.2024.09.038)
  • [Letter] Researchers should consider using expertise-based RCTs only after carefully considering their arguments and limitations; for the majority of treatments, conventional RCTs will answer the question more easily and precisely. (10.1007/s11999-008-0575-y)
  • [Letter] They recommend future prospective studies to better classify patients who genuinely require early surgery. (10.5435/jaaos-d-21-00236)
  • [L4] Epidemiology and non-epidemiology-trained reviewers can apply the levels-of-evidence guide to published studies with acceptable interobserver agreement, though the validity of this system remains a question for future research. (10.2106/00004623-200408000-00016)
  • [L5] The CORE–MD project aims to review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources to improve the evaluation of high-risk medical devices in Europe. (10.1302/2058-5241.6.210081)
  • [L5] The most rigorous scientific methodology utilizes a control arm that represents a clinically relevant baseline for comparison, and future research should investigate perioperative management using treatment groups frequently performed in clinical practice as a baseline control arm. (10.1016/j.arth.2025.10.003)
  • [L4] The Discovery Elbow System resulted in improved function, reduced pain, and high patient satisfaction. (10.1016/j.jse.2014.08.013)
  • [L5] While review articles and database mining studies are important for rare clinical syndromes where original trials are unfeasible, the increasing trend raises concerns about the future availability of original articles needed to conduct such reviews. (10.1016/j.jse.2023.01.012)
  • [L4] AI-driven prognostication models remain in their infancy and require further work to guide treatment pathways and preventative medicine. (10.1016/j.jisako.2023.10.015)
  • [L1] The two designs functioned equivalently at the time of early follow-up in this low-to-moderate-demand patient group. (10.2106/jbjs.j.00157)
  • [L5] Prospective public registration of clinical trials and timely publication or posting of results are desirable goals, yet surveys show substantial reluctance among researchers and editors; existing legislation is incompletely enforced, though editorial boards of AJSM and OJSM have recently taken steps to require registration and accept trial design articles to accelerate progress. (10.1177/0363546515614340)
  • [L4] However, many patients have radiolucencies, and the discrepancy between clinical signs and radiological results warrants structural follow-up. (10.1186/s12891-019-2781-z)
  • [L5] The PREFERE study represents a novel, prospective-randomized comparison of all four S3 guideline-recommended treatment options for localized prostate cancer in Germany, addressing the need for robust evidence-based data amidst concerns of overdiagnosis and overtreatment. (10.1007/s00120-011-2641-4)
  • [L2] This protocol describes the first randomized trial to use blinding to evaluate outpatient THA compared to standard overnight stay and the first to prospectively perform a full economic evaluation. (10.1186/s12891-020-03699-z)
  • [L4] However, further studies with long-term follow-up are needed to determine whether the grafted area will maintain structural and functional integrity over time. (10.1007/s00167-010-1042-3)
  • [L5] Researchers must utilize additional datapoints and thoughtful methodology to mitigate these limitations when using claims data or registries. (10.2106/jbjs.22.00565)
  • [L2] Findings point to a lack in robustness for conclusions drawn from RCTs relating to nonoperative treatment for lateral epicondylitis, where a reversal of only 3 patient outcomes could considerably influence reported statistically significant findings. (10.1016/j.xrrt.2025.03.008)
  • [L4] Database linkages can produce richer data sets and more comprehensive and reliable analyses, though practical, legal, and financial challenges exist. (10.2106/jbjs.22.00563)
  • [L5] The authors argue that conclusions regarding interobserver reliability based on kappa values can be misleading due to methodological limitations of the kappa statistic, specifically its dependence on prevalence and the number of categories. (10.1177/1758573218791165)
  • [L4] More than two-thirds of clinical management questions on the Orthopaedic In-Training Examination were supported by studies whose level of evidence was IV or lower, reflecting the state of the art of the orthopaedic literature rather than a deficiency in the examination itself. (10.2106/jbjs.i.00530)
  • [L5] Trial reduction is the last chance to get it right and must be performed carefully to detect and correct malalignments that would otherwise lead to poor results. (10.1016/j.arth.2007.01.013)
  • [L4] Patients and clinicians can expect an average procedure survival of 12.5 years and a maximum of 21 years, with effective pain relief influenced by cartilage treatment and preoperative pain score. (10.1136/jisakos-2017-000169)
  • [L4] Observed differences in knee scores between different study groups that have not been matched for various clinically relevant factors are at least as likely to represent differences in the patient populations as they are to represent differences in the operative technique or the design of the implant. (10.2106/00004623-199706000-00009)
  • [L5] Machine learning 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, but if the algorithms have not been externally validated, then the models are not likely to generalize, and their predictions will suffer from inaccuracy. (10.1016/j.arthro.2022.07.008)
  • [L1] The outcomes of this study will contribute to better decision making in the treatment of cervical radiculopathy. (10.1186/s12891-020-3188-6)
  • [L3] Work-related impairments and associated anxiety diminished substantially within five years, suggesting middle-aged patients are often able to resume and sustain employment long-term. (10.1016/j.arth.2025.06.066)
  • [L4] Patients with a preoperative duration of symptomatic medial knee overload/arthritis of two years or greater do not experience inferior PRO or clinical outcomes than patients with a symptom duration of less than 2 years at mid-term follow-up. (10.1016/j.jisako.2022.03.003)
  • [L1] Early reimplation (abbreviated two-stage) provides similar outcomes to traditional two-stage exchange, though optimal timing and selection criteria remain undefined. (10.1016/j.arth.2025.10.075)
  • [L4] Elbow dislocations associated with fractures of the medial epicondyle with intra-articular entrapment can be difficult to diagnose in the acute phase, and thus a high level of suspicion is required. (10.1016/j.jse.2012.11.009)
  • [L5] The authors advocate for precise definition of assessment tools (checklists and GRS) in any study and emphasize that accurate metrics and precisely defined outcome measures are key to valid and reliable assessment in surgical education. (10.5435/jaaos-d-17-00875)
  • [L5] The authors agree with recommendations to upload copies of consents and board approvals for prospective studies to eliminate sample size falsification, but note that assessment of such copies will be difficult and time-consuming in international studies. (10.1016/j.injury.2020.04.009)
  • [L5] The treatment of chronic, nonradicular, discogenic low back pain remains controversial, and while intradiskal electrothermal therapy shows reported therapeutic success rates of 60% to 80%, a more precise quantification of clinical benefits remains to be proved in randomized prospective trials. (10.5435/00124635-200301000-00003)
  • [L3] It was more responsive than the SF-36 and more efficient in measuring changes in function between baseline and follow-up values. (10.2106/00004623-199709000-00006)
  • [Case_report] This appears to be a reasonable method to salvage this difficult and challenging problem when nonsurgical management has failed to provide relief. (10.1016/j.jse.2011.08.043)
  • [L4] However, magnetic resonance imaging indicates that the donor site is resurfaced with fibrous tissue. (10.1177/0363546507306465)
  • [L5] Evidence-based medicine is a necessary component of urology and the German healthcare system, requiring knowledge of its procedures to ensure decisions are based on scientific findings, transparent, and traceable. (10.1007/s00120-021-01488-7)
  • [L5] Pitching 100 balls induces a significant reduction in dynamic stabilizing ability against elbow valgus laxity. (10.1016/j.jse.2023.11.001)
  • [Paper] Translational research is crucial in the evolution of contemporary biomedical science and aims to bridge the gap between basic and clinical research; new academic posts translationally orientated are urgently needed, particularly in the field of trauma medicine. (10.1016/j.injury.2008.01.051)
  • [L4] Radiographic methods including 3-D CT and MRI as well as the intraoperative findings of the labrum cannot be considered an accurate and reliable basis for the diagnosis and treatment of SSI in FAI patients. (10.1186/s12891-022-06045-7)
  • [L1] At time zero, UCLR has inferior biomechanical properties compared with the native intact ligament. (10.1177/23259671251407657)
  • [L3] Gender, rheumatoid arthritis, and long-term (>1 year) corticosteroid use affect SSI risk after shoulder arthroplasty. (10.1016/j.jse.2017.04.006)
  • [L5] Randomized clinical trials are iconic but not sacrosanct; while sometimes unethical, they remain a powerful and feasible research methodology that surgeons must be willing to employ to suspend disbelief regarding existing treatment options. (10.1177/0363546506294849)
  • [L2] Overall bone metabolism of the operated intervertebral disc space at six weeks had the highest diagnostic accuracy for predicting the fusion status at one year. (10.1186/s13018-025-05814-z)
  • [L3] It reduces operative time, fluoroscopy, and guide needle adjustments, and is more effective in preventing the progression of femoral head necrosis to advanced stages compared to traditional surgery under fluoroscopy. (10.1186/s12891-025-08561-8)
  • [L3] We developed and validated an interpretable LightGBM machine learning model that integrates clinicoradiological and radiomic features to predict the failure of conservative treatment in LE. (10.1186/s13018-025-05901-1)
  • [L3] A negative F-18-FDG PET/CT excludes septic shoulder arthritis with high probability. (10.1016/j.jse.2025.01.047)
  • [L4] Early diagnosis, accurate reduction, and internal fixation are important to avoid growth disturbance, articular incongruence, and functional disability. (10.2106/00004623-198062070-00016)
  • [L4] Despite major primary complications and high incidence of radiographic signs of degenerative changes after 8.8 years, mainly good clinical results were achieved with Judet's bipolar prosthesis. (10.1016/j.jse.2010.05.022)
  • [L5] The PPS injury produces alterations in GH kinematics with implications for GH joint instability, increased GH joint loading, and potential joint damage. (10.1016/j.jse.2024.12.023)
  • [L5] A distally based tendon graft reconstruction of the annular ligament of the elbow using the tendon of the superficial head of the brachialis muscle would be feasible in most patients, based on this anatomic study. (10.1016/j.jhsa.2013.04.008)
  • [L4] Researchers using patient data coded with different AIS versions should be mindful of these changes when combining or comparing data from different time periods. (10.1016/j.injury.2010.05.033)

See Also

References

[1] Elbow arthroplasty research methods, outcome domains, and instruments used in clinical outcome studies. The Bone & Joint Journal. 2022. DOI: 10.1302/0301-620x.104b10.bjj-2022-0570.r1

[2] Systematic Reviews and Meta‐analyses in Arthroscopy : The Difficult Balance Between Accuracy and Clinical Usefulness. Arthroscopy. 2024. DOI: 10.1016/j.arthro.2024.09.038

[3] Letter to the Editor Re: Orthopaedic Surgeons Prefer to Participate in Expertise-based Randomized Trials. Clinical Orthopaedics & Related Research. 2009. DOI: 10.1007/s11999-008-0575-y

[6] Letter to the Editor: Reading Between the Lines: Evidence-Based Medicine Shows What You Want to See. Journal of the American Academy of Orthopaedic Surgeons. 2021. DOI: 10.5435/jaaos-d-21-00236

[7] Interobserver Agreement in the Application of Levels of Evidence to Scientific Papers in the American Volume of The Journal of Bone and Joint Surgery. The Journal of Bone and Joint Surgery-American Volume. 2004. DOI: 10.2106/00004623-200408000-00016

[8] Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE–MD (Coordinating Research and Evidence for Medical Devices). EFORT Open Reviews. 2021. DOI: 10.1302/2058-5241.6.210081

[9] A Call for Clinically Relevant Study Control Arms: A Commentary. The Journal of Arthroplasty. 2025. DOI: 10.1016/j.arth.2025.10.003

[11] Chapter 3 Emerging Technologies in Orthopaedic Trauma. 2021.

[12] Total elbow arthroplasty: a prospective clinical outcome study of Discovery Elbow System with a 4-year mean follow-up. Journal of Shoulder and Elbow Surgery. 2015. DOI: 10.1016/j.jse.2014.08.013

[13] Review articles and database studies. Journal of Shoulder and Elbow Surgery. 2023. DOI: 10.1016/j.jse.2023.01.012

[14] Artificial intelligence and the orthopaedic surgeon: A review of the literature and potential applications for future practice: Current concepts. Journal of ISAKOS. 2024. DOI: 10.1016/j.jisako.2023.10.015

[15] Mobile and Fixed-Bearing (All-Polyethylene Tibial Component) Total Knee Arthroplasty Designs. Journal of Bone and Joint Surgery. 2010. DOI: 10.2106/jbjs.j.00157

[16] Clinical Trial Registration. The American Journal of Sports Medicine. 2015. DOI: 10.1177/0363546515614340

[17] Long-term results of the iBP elbow prosthesis: beware of destructive metallosis!. BMC Musculoskeletal Disorders. 2019. DOI: 10.1186/s12891-019-2781-z

[18] An einem Strang ziehen. Der Urologe. 2011. DOI: 10.1007/s00120-011-2641-4

[19] A protocol for a randomized controlled trial investigating the safety and cost-effectiveness of outpatient total hip arthroplasty. BMC Musculoskeletal Disorders. 2020. DOI: 10.1186/s12891-020-03699-z

[20] Mid‐term results of Autologous Matrix‐Induced Chondrogenesis for treatment of focal cartilage defects in the knee. Knee Surgery, Sports Traumatology, Arthroscopy. 2010. DOI: 10.1007/s00167-010-1042-3

[21] Administrative Data Use in National Registry Efforts: Blessing or Curse?. Journal of Bone and Joint Surgery. 2022. DOI: 10.2106/jbjs.22.00565

[22] Randomized controlled trial outcomes for nonoperative management of lateral epicondylitis of the elbow are statistically fragile: a systematic review. JSES Reviews, Reports, and Techniques. 2025. DOI: 10.1016/j.xrrt.2025.03.008

[23] Linkage Between Databases in Joint Arthroplasty and Orthopaedics. Journal of Bone and Joint Surgery. 2022. DOI: 10.2106/jbjs.22.00563

[24] Methodological issues on interobserver reliability of radiographic assessment after radial head arthroplasty. Shoulder & Elbow. 2018. DOI: 10.1177/1758573218791165

[25] Levels of Evidence Are Low for Clinical Management Questions on the Orthopaedic In-Training Examination. The Journal of Bone & Joint Surgery. 2010. DOI: 10.2106/jbjs.i.00530

[26] Trial Reduction. The Journal of Arthroplasty. 2007. DOI: 10.1016/j.arth.2007.01.013

[27] Symptomatic relief in medial opening wedge high tibial osteotomies for the treatment of knee osteoarthritis is influenced by concurrent procedures and preoperative pain level. Journal of ISAKOS. 2018. DOI: 10.1136/jisakos-2017-000169

[28] Demographic Biases of Scoring Instruments for the Results of Total Knee Arthroplasty. The Journal of Bone & Joint Surgery*. 1997. DOI: 10.2106/00004623-199706000-00009

[29] Editorial Commentary : Knowledge is Power: A Primer for Machine Learning. Arthroscopy. 2023. DOI: 10.1016/j.arthro.2022.07.008

[30] A randomised controlled trial comparing the effectiveness of surgical and nonsurgical treatment for cervical radiculopathy. BMC Musculoskeletal Disorders. 2020. DOI: 10.1186/s12891-020-3188-6

[31] A Five-Year Longitudinal Assessment of Quality of Life and Employment Status in Patients Who Have Osteonecrosis of the Femoral Head Undergoing Femoral Osteotomy: A Multicenter Study. The Journal of Arthroplasty. 2025. DOI: 10.1016/j.arth.2025.06.066

[32] Preoperative symptom duration does not affect clinical outcomes after high tibial osteotomy at a minimum of 2-year follow-up. Journal of ISAKOS. 2022. DOI: 10.1016/j.jisako.2022.03.003

[33] 2025 ICM: Abbreviated Two- and 1.5-Stage. The Journal of Arthroplasty. 2025. DOI: 10.1016/j.arth.2025.10.075

[34] A rare case of elbow dislocation associated with unrecognized fracture of medial epicondyle and delayed ulnar neuropathy in pediatric age. Journal of Shoulder and Elbow Surgery. 2013. DOI: 10.1016/j.jse.2012.11.009

[35] Measuring Surgical Skills in Simulation-based Training. Journal of the American Academy of Orthopaedic Surgeons. 2018. DOI: 10.5435/jaaos-d-17-00875

[36] Medical publication: An insight into the future. Injury. 2020. DOI: 10.1016/j.injury.2020.04.009

[38] Treatment of Chronic Discogenic Low Back Pain With Intradiskal Electrothermal Therapy. Journal of the American Academy of Orthopaedic Surgeons. 2003. DOI: 10.5435/00124635-200301000-00003

[40] Comparison of the Musculoskeletal Function Assessment Questionnaire with the Short Form-36, the Western Ontario and McMaster Universities Osteoarthritis Index, and the Sickness Impact Profile Health-Status Measures. The Journal of Bone and Joint Surgery (American Volume)*. 1997. DOI: 10.2106/00004623-199709000-00006

[41] Treatment of proximal humeral dysplasia epiphysealis hemimelica with custom hemiarthroplasty: a case report. Journal of Shoulder and Elbow Surgery. 2011. DOI: 10.1016/j.jse.2011.08.043

[43] Donor Site Evaluation after Autologous Osteochondral Mosaicplasty for Cartilaginous Lesions of the Elbow Joint. The American Journal of Sports Medicine. 2007. DOI: 10.1177/0363546507306465

[44] Evidenzbasierte Medizin in der Urologie. Der Urologe. 2021. DOI: 10.1007/s00120-021-01488-7

[45] Weakening and factors of medial elbow dynamic stabilizers against elbow valgus laxity after repetitive pitching in high school baseball players. Journal of Shoulder and Elbow Surgery. 2024. DOI: 10.1016/j.jse.2023.11.001

[46] Translational research: From benchside to bedside. Injury. 2008. DOI: 10.1016/j.injury.2008.01.051

[47] A comparison between ultrasound-guided AIIS injection and radiography in the diagnosis of subspine impingement in patients with FAI. BMC Musculoskeletal Disorders. 2022. DOI: 10.1186/s12891-022-06045-7

[49] Elbow Ulnar Collateral Ligament Reconstruction and Repair: A Systematic Review and Meta-analysis of Biomechanical Studies. Orthopaedic Journal of Sports Medicine. 2026. DOI: 10.1177/23259671251407657

[50] Medical comorbidities and perioperative allogeneic red blood cell transfusion are risk factors for surgical site infection after shoulder arthroplasty. Journal of Shoulder and Elbow Surgery. 2017. DOI: 10.1016/j.jse.2017.04.006

[51] Random Thoughts. The American Journal of Sports Medicine. 2006. DOI: 10.1177/0363546506294849

[52] 18F-fluoride PET/CT as an early predictor of bony fusion after posterior lumbar interbody fusion– a prospective study. Journal of Orthopaedic Surgery and Research. 2025. DOI: 10.1186/s13018-025-05814-z

[53] 10-year follow-up results of the initial application of 3D-printed percutaneous guides in drilled decompression of femoral head necrosis. BMC Musculoskeletal Disorders. 2025. DOI: 10.1186/s12891-025-08561-8

[54] Noninvasive prediction of failure of the conservative treatment in lateral epicondylitis by clinicoradiological features and elbow MRI radiomics based on interpretable machine learning: a multicenter cohort study. Journal of Orthopaedic Surgery and Research. 2025. DOI: 10.1186/s13018-025-05901-1

[55] 18F-FDG PET/CT for the diagnosis of septic shoulder arthritis: metabolic uptake pattern and diagnostic performance. Journal of Shoulder and Elbow Surgery. 2025. DOI: 10.1016/j.jse.2025.01.047

[56] Displaced fractures of the medial humeral condyle in children.. The Journal of Bone & Joint Surgery. 1980. DOI: 10.2106/00004623-198062070-00016

[59] Mid- to long-term results after bipolar radial head arthroplasty. Journal of Shoulder and Elbow Surgery. 2010. DOI: 10.1016/j.jse.2010.05.022

[63] 2025 Basic Science Neer Award Winner: The impact of posterior and posterior superior labral injuries and the effect of their treatment on glenohumeral kinematics in the deceleration and follow-through phase of throwing: a biomechanical study. Journal of Shoulder and Elbow Surgery. 2025. DOI: 10.1016/j.jse.2024.12.023

[64] Annular Ligament Reconstruction Using the Distal Tendon of the Superficial Head of the Brachialis Muscle: An Anatomical Feasibility Study. The Journal of Hand Surgery. 2013. DOI: 10.1016/j.jhsa.2013.04.008

[65] Changing to AIS 2005 and agreement of injury severity scores in a trauma registry with scores based on manual chart review. Injury. 2011. DOI: 10.1016/j.injury.2010.05.033

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