Study Design & Demographics

Foot/ankle research methodology: addressing statistical pitfalls, clinically meaningful effect sizes, and injury surveillance standardization.

Overview

Heterogeneity in study, subject, and surgical demographics precludes the assimilation of protocols and outcomes to generate evidence-based guidelines for rehabilitation following hip arthroscopy [1]. Similarly, patient characteristics and indications for surgery are not described in a majority of clinical outcome studies of rotator cuff repair [2]. Studies on secondary patella resurfacing for dissatisfaction following primary knee arthroplasty lacked standardized objective selection criteria and predominantly featured retrospective data with high heterogeneity and variation in outcome reporting [31].

Factors leading to impactful conclusions and clinical change include the role of outcome selection, study design, presentation of results, and stakeholder involvement [5]. The selection of instruments to measure health outcomes in a study protocol should be guided by careful consideration of the rationale and objectives, ensuring instruments capture a comprehensive representation of health and are reliable, valid, and responsive to change [37]. Providers and registries should consider the relative prevalence of published outcome measures when selecting patient-reported outcome measures (PROMs) to better facilitate future cross-study comparison [28].

Large database studies and registries are robust approaches for answering questions regarding rare adverse events, resource utilization, and real-world endpoints that randomized controlled trials (RCTs) cannot address, provided they are methodologically robust and present counterintuitive findings or specific suggestions to improve care [57]. Clinical results and survivorship for short stems were very good despite widened indications, with an overall retrospective evaluation similar to primary hip implants [48]. Clinical outcomes of patients aged 50 and younger who underwent reverse total shoulder arthroplasty (RTSA) are comparable to those of patients aged at least 65 presenting matched indications [26].

Indications and contraindications for three-dimensional metallic implants for reconstruction of critical bone defects after trauma will continue to be refined as more outcomes data become available [6]. Further studies with structured study protocols are needed to better understand risk factors and improve treatment outcomes for infection following fractures of the proximal tibia [10]. Advancements in prosthesis design, expanding indications, a trend toward younger patient populations, and the management of postoperative complications are anticipated to emerge as research hotspots for reverse total shoulder arthroplasty [51].

Anatomy & Pathophysiology

General Biomechanics and Evaluation

Accurate evaluation and appropriate treatment of adult flatfoot require careful clinical and radiographic evaluation, coupled with a thorough understanding of the anatomy and biomechanics of the foot [23]. The textbook chapter provides a descriptive overview of foot and ankle biomechanics, gait analysis, and treatment principles for common nail disorders [84]. The anatomy of the lower extremity relates directly to the ability to run, the running gait cycle, and abnormal anatomy and biomechanics related to running injuries [95].

Osseous and Soft Tissue Anatomy

The paper describes the normal anatomy and biomechanics of the lesser toes [96]. It also describes the pathology of commonly adult lesser toe deformities [96]. The existence of the Achilles tendon and ankle position have a great influence on the kinematic coupling relationship between tarsal bones [86]. Increased stiffness of the Achilles tendon has no influence on the kinematic coupling relationship between tarsal bones [86].

Kinematics and Gait Analysis

Foot bone motion can be described using a biomechanically near-physiological gait simulator with 6 degrees of freedom of the tibia [38]. Dynamic fluoroscopy combined with a plantar pressure plate can obtain in vivo viscoelastic properties and other data of the heel pad during actual gait [64]. Subject-specific, dynamic, multisegment ankle and foot models can be generated to develop linked inverse dynamic and forward dynamic biomechanical foot models for predicting the effect of and improving the efficacy of orthotic devices [70].

The study clarified rearfoot, midfoot, and forefoot kinematics when running in participants with normal foot and flatfoot [87]. The term 'adaptation of running biomechanics' reflects the outcome of an intervention rather than a final adaptation to barefoot running [88]. Changing toe direction significantly affects knee kinetics and kinematics during landing [25]. Gait biomechanics after total knee arthroplasty are not restored to normal [76]. The kinematics of cruciate stabilising (CS) and cruciate retaining (CR) total knee joint replacements are comparable [90].

Significant differences between soccer players with and without chronic ankle instability were seen in the support leg kinematics at flat-foot contact with the ground during the kicking cycle [99]. There is a statistically significant correlation between morphological variables of the foot and postural stability in children aged 10–15 years [93]. Altered sagittal plane biomechanics were observed in female adolescents during a jump-landing task [104]. Altered sagittal plane biomechanics were not observed in male adolescents during a jump-landing task [104].

Ligamentous and Tendon Integrity

All four side-to-side suture configurations for tenorrhaphy sustained loads well above physiologic loads expected in tendons in the foot and ankle [89]. None of the four side-to-side suture configurations for tenorrhaphy distended appreciably during cyclic loading [89]. Accurate diagnosis of anatomy, biomechanics, and soft tissue structures is fundamental to correctly identify patients requiring conservative or surgical treatment to prevent chronic ankle instability [101].

Neurological and Pain Syndromes

Cognitive functional therapy achieved better improvements in gait kinetics compared to movement system impairment treatment in chronic low back pain patients [103].

Classification

Classification systems and the identification of differences among products are necessary to understand the implications of variability in Platelet-rich Plasma orthopaedic applications [20]. For iatrogenic bone and soft tissue trauma in robotic-arm assisted total knee arthroplasty, the MASTI classification system was commended, though specific data mismatches in tables, patient count discrepancies, and typographical errors require clarification and re-evaluation [33]. A simple 4-part classification system based on local and systemic factors demonstrates significant differences between complex groups and standard patients in terms of complication rates and length of stay for primary knee arthroplasty [41].

ROCK: The ROCK Osteochondritis Dissecans knee arthroscopy classification system facilitates multi-center studies for OCD [52]. A simpler classification system for osteochondritis dissecus could be widely applicable because the results could more accurately drive clinical treatment decision making for clinicians [63].

Tibial Plateau: Employing individualized classification systems remains the most logical approach for tibial plateau fractures [55].

OMT: The Oberg, Manske, and Tonkin (OMT) classification system was straightforward to use and allowed for the classification of all individuals in a study of congenital upper limb anomalies [61].

Kinematic Alignment TKA: A proposed classification system describes six specific issues to consider for implanting TKA with the Kinematic Alignment technique, with specific recommendations for each situation type to improve the reliability of prosthetic implantation [66].

Femoral Bone Defects (Revision THA): A consensus on a comprehensive and reliable classification system and management algorithm for femoral bone defects in revision total hip arthroplasty is still lacking [68].

Condylar-Stabilized TKA: A classification system for condylar-stabilized designs in total knee arthroplasty allows for appropriate grouping and comparison of distinct CS implants [69].

Lateral Discoid Meniscus: A novel classification system that more comprehensively and descriptively characterizes the spectrum of lateral discoid meniscus pathology demonstrated moderate or substantial agreement in most diagnostic categories analyzed [72].

Cemented Femoral Stem: A new four-part classification system is proposed to aid in the comparison of results and better understanding of implant biomechanics for cemented femoral stem design and cementation techniques [77].

Classification systems must be both reliable and valid to be useful; however, because confirming validity is difficult, a minimum criterion for acceptance is a high degree of both interobserver and intraobserver reliability [71]. General ICU scoring systems are useful for risk adjustment for research, administrative, and quality improvement purposes in critically injured adults [45]. 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 [46].

Clinical Presentation

Diagnostic Limitations: Clinical findings in isolation demonstrate inadequate diagnostic performance for acute compartment syndrome, with sensitivity ranging from 13% to 54% [21]. Similarly, patients presenting with signs and symptoms of subacromial pain syndrome exhibit a high prevalence of conflicting and concomitant diagnoses [34]. In pediatric populations, a meta-analysis based on cohort studies found no differences in patient characteristics and clinical symptoms between groups of children with culture-negative osteoarticular infections [36].

Symptomatology and Demographics: Heterogeneity in study, subject, and surgical demographics precluded the assimilation of protocols and/or outcomes to generate evidence-based guidelines for rehabilitation following hip arthroscopy [1]. The most influential studies in sports-related concussion focus most heavily on symptomatology and epidemiology/demographics [39]. Understanding sex-based differences in the incidence, clinical presentation, and functional outcomes of common sports injuries is important to optimize musculoskeletal care and improve treatment outcomes [47].

Return-to-Play Protocols: A range of symptom severity endorsement was observed at the initiation of a graduated return-to-play protocol, with higher endorsement among those with higher baseline symptom endorsement and select demographic and medical history factors [19].

Investigations

Plain radiography: Repeat radiographic assessment 2-3 weeks post-injury is supported prior to making definitive treatment decisions for completely displaced adolescent clavicle fractures, as shortening can change in the first 2 weeks [107]. Radiological evaluation protocols for calcaneal fractures require evaluation of more aspects than currently used, according to a Delphi consensus [91]. Functional scores and radiological outcomes were improved in the surgical treatment of patellar instability in children with Down syndrome [106].

MRI: MRI serves as a noninvasive tool that overcomes the shortcomings of radiography by detecting preclinical disease and subtle early abnormalities, evolving as a complete answer for cartilage-imaging requirements for lesion description, treatment planning, and outcome measurement [102]. MRI during the initial management of lower limb fractures associated with multiligament knee injury can lead to better outcomes [92]. Magnetic resonance imaging is emerging as a valuable tool to confirm the diagnosis and guide treatment for fatigue fractures of the femoral neck in athletes [109]. Optimal MRI sequences for characterizing and diagnosing individual syndesmotic structures in asymptomatic and injured cohorts should be clinically implemented to aid in future pre-operative planning and post-operative assessment [111]. MRI at 12 months can predict longer-term clinical outcomes up to 17 years after autologous chondrocyte implantation [113]. Clinical results for the treatment of osteochondral talar lesions with mesenchymal cells on a collagen scaffold were supported by MR images study [116]. The first report of osteochondral allograft transplant of the patella using femoral condylar allografts showed encouraging short-term clinical and MRI results, while improved matching is noted as desirable [112]. MRI-based imaging results for osteochondral lesion repair using MaioRegen® allograft require clarification by mid-term studies [59].

CT: CT parameters were independent of clinical or patient variables within the study population for evaluation of osseous incorporation after osteochondral allograft transplantation, with osseous incorporation identified as the most reliable CT parameter [105].

Other Considerations: Clinical and radiological outcomes for arthroscopic distal tibial allograft with endobutton fixation for anterior shoulder instability were excellent at 2 years, though this is interpreted in the context of a high lost to follow-up rate [15]. Abnormal preoperative MRI findings do not influence the outcome of unicompartmental knee arthroplasty (UKA) when modern radiographic and clinical criteria are met [30]. There is a limited correlation between structural and clinical outcomes in autologous osteochondral transfer, as clinical outcomes improved despite stable MRI findings at a mean 4-year follow-up [85]. No definite relevance was observed between image findings and functional outcome in the assessment of the anterolateral ligament of the knee after primary versus revision anterior cruciate ligament reconstruction [110]. Magnetic Resonance Imaging-based 3-dimensional models of the pelvis and hip using machine learning for automatic bone segmentation in dynamic hip impingement simulation are feasible with routine MRI and short image acquisition time [97]. Prospective studies are needed to critically evaluate the diagnostic utility of imaging to avoid unnecessary CT/MRI for economic and radiation protection reasons, while ensuring imaging is not omitted in indicated cases [98].

Treatment

General Principles & Study Design

Heterogeneity in study, subject, and surgical demographics precluded assimilation of protocols and/or outcomes to generate evidence-based guidelines for rehabilitation following hip arthroscopy [1]. Patients' characteristics and indications for surgery were not described in a majority of clinical outcome studies of rotator cuff repair [2]. Indications and contraindications for three-dimensional metallic implants for reconstruction of critical bone defects after trauma will continue to be refined as more outcomes data become available [6]. Clinical results for total knee arthroplasty using hinge joints generally depend on implant design, appropriate technical use, and adequate indications [29]. Confounding by indication and patient selection bias make it difficult to compare dual-mobility cups with conventional total hip arthroplasty (THA) designs based on registry data alone [60].

Essential methodological criteria for clinical trials evaluating new therapeutic approaches in bone and joint surgery include prospective design with concurrent controls, random allocation, and blind assessment [56]. Understanding the difference between efficacy and effectiveness in clinical trials is important for interpreting results and deciding if conclusions can inform clinical practice [62]. Reclassification using standardized definitions demonstrated changes in reported treatment efficacy for periprosthetic joint infections in oncologic endoprostheses [65]. Heterogeneity limits the generalizability of findings regarding antibiotic treatment length for periprosthetic joint infection, requiring further high-quality, standardized research to determine optimal treatment lengths [67]. Well-designed, controlled, randomized, blinded, and adequately powered clinical trials are needed to answer basic questions regarding treatment effectiveness [73].

The hierarchy of evidence, quality indicators, and the balance between efficacy and effectiveness should guide clinicians in appraising intervention studies and applying evidence to individual patients [80]. Well-conducted non-randomised studies, including case-series and observational cohort studies, can provide reasonably valid answers to clinically important questions regarding safety and effectiveness when RCTs are not feasible, provided methodological strengths and weaknesses are carefully considered [81]. A 2-year minimum follow-up period is generally preferred to ensure methodologic rigor and meaningful assessment of treatment durability, but shorter durations may be justified when clinical outcomes plateau earlier depending on the research question, diagnosis, treatment, and primary outcome measure [82]. High proportions of retrospectively registered or unregistered trials and a very high proportion of inconsistencies in reporting of primary outcomes compared to trial registries were found in the Journal of Arthroplasty [83].

Non-Operative Management

Both operative and nonoperative management of medial collateral ligament (MCL) tears demonstrated clinical improvements between study enrollment and 2-year follow-up [100]. Non-operative treatment for completely displaced clavicle fractures in teenagers is supported by nearly perfect outcomes, questioning the role of acute operative management given its associated risks and costs [108]. No significant difference was seen between outcomes of patients with stable juvenile osteochondritis dissecans lesions of the knee treated with non-operative methods including unloader bracing versus non-unloader bracing or other modalities [115]. Nonoperative treatment should be performed early for optimal outcomes in the nonoperative treatment of rotator cuff tears [130].

Non-operative treatment is preferable for Ehlers-Danlos syndromes, but specific joint stabilization and nerve decompression procedures can provide symptomatic relief for carefully selected patients when conservative measures fail [124]. Nonoperative management is recommended initially for Morton’s interdigital neuroma, while operative treatment is indicated after nonoperative management has failed [126]. Nonoperative treatment is almost always initiated for primary and posttraumatic arthritis of the elbow, although surgical treatment may be indicated in cases refractory to conservative management [128].

Nonoperative management or delayed surgery for distal semimembranosus tendon avulsions may result in poor outcomes [117]. Conservative treatment or non-anatomical repair of the distal tendon of the biceps brachii results in significant loss of supination strength and variable loss of flexion strength [118]. Elbows that did not undergo surgery for osteochondritis dissecans of the capitellum had slightly increased symptoms and decreased functional outcomes compared to those treated surgically, though an initial trial of non-operative treatment did not adversely impact the success of future surgery at long-term follow-up [121]. The study was unable to identify any difference in patient-reported outcome measures (LEFS) between surgically and non-surgically treated patients with proximal hamstring avulsions in middle-aged patients [127]. Both nonsurgical management (immobilization and nonweight bearing) and surgical management (open reduction and internal fixation) have demonstrated good results for navicular stress fractures [129].

Operative Management

Specific joint stabilization and nerve decompression procedures can provide symptomatic relief for carefully selected patients with Ehlers-Danlos syndromes when conservative measures fail [124]. Operative treatment is indicated for Morton’s interdigital neuroma after nonoperative management has failed [126]. Surgical treatment may be indicated for primary and posttraumatic arthritis of the elbow in cases refractory to conservative management [128]. Surgical management (open reduction and internal fixation) has demonstrated good results for navicular stress fractures [129].

Complications

Other Considerations: Long-term longitudinal studies are warranted to determine if head impacts in youth football influence long-term health [3]. Long-term follow-up is necessary to evaluate differences in long-term durability between gap balancing and measured resection techniques in simultaneous bilateral total knee arthroplasty [4]. There is a paucity of studies showing long-term differences in functional outcomes or implant survivorship for robotic unicompartmental knee arthroplasty, requiring further clinical studies to establish how statistical differences in accuracy translate to long-term outcomes [7]. Longer-term follow-up is required to determine whether the excellent results of isolated polyethylene insert exchange for flexion instability after primary total knee arthroplasty are durable over time [8]. Longer term follow-up data are needed to more adequately assess the outcomes and durability of ulnar collateral ligament repair with collagen-coated suture tape augmentation [9]. Further studies with structured study protocols are needed to better understand risk factors for infection following fractures of the proximal tibia to improve treatment outcomes [10]. Further follow-up studies are needed to determine the long-term outcomes of open repair of quadriceps tendon with suture anchors and semitendinosus tendon allograft augmentation [11]. Studies of natural history and retrospective studies of treatment for scoliosis and kyphosis should adopt a 10-degree difference as an indication of a true change in radiographic measurements [12]. Lower rates of ceramic femoral head use in non-white patients in the United States did not translate into worse clinical outcomes on short-term follow-up [13]. A higher powered and long-term study with validated patient-reported outcomes is needed to confirm observations regarding patient-reported outcomes following fixation of Jones fractures in elite athletes with BMAC [14]. The natural history of osteoarthritic patients undergoing primary TKA or THA includes data on the fate of remaining knee(s) or hip(s), providing data to accurately advise patients about the natural history of their disease in other joints [16]. The natural history of neonatal brachial palsy with absent biceps function at three months of age provides a benchmark for comparing outcomes with microsurgical repair [17]. Melorheostosis progresses in both childhood and adult life, often causing contractures, deformities, and pain that may require surgical treatment but frequently progress despite intervention [18]. Further prospective comparative studies reporting long-term outcomes are needed for medial unicompartmental knee replacement after failed high tibial osteotomy, as high-level studies on this topic are lacking [50]. Further clinical studies are needed to clarify the long-term outcomes of titanium versus carbon fiber peek intramedullary nailing for impending or pathologic fracture of the long bone [79]. Despite recent advances in understanding the epidemiology, biomechanics, pathophysiology, long-term effects, associated risks, and natural history of concussive brain injury, no proven effective therapies or preventative measures exist [94]. The morbidity and mortality after radical cystectomy in the studied series are comparable to large published series [114]. Registry studies use inconsistent methods to account for patients lost to follow-up, and rates of patients lost to follow-up are unacceptably high [119]. The natural history of Achilles tendinopathy is typically a long protracted course where management focuses on physiotherapy; while exercises improve function in the majority, 40% of patients report ongoing pain even after five years of therapy [123]. In a study of spine-fusion operation for tuberculosis of the spine, 100 out of 192 patients were followed for five years or more, with the remaining patients followed for less time or having died [125].

Recovery

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

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

Complete recovery / outcome plateau (months): Long-term follow-up is necessary to evaluate differences in long-term durability between gap balancing and measured resection techniques in simultaneous bilateral total knee arthroplasty [4]. Further clinical studies are required to establish how statistical differences in accuracy translate to long-term outcomes for robotic unicompartmental knee arthroplasty [7]. Longer-term follow-up is required to determine whether the excellent results of isolated polyethylene insert exchange for flexion instability after primary total knee arthroplasty are durable over time [8]. Longer term follow-up data are needed to more adequately assess the outcomes and durability of ulnar collateral ligament repair with collagen-coated suture tape augmentation [9]. Further follow-up studies are needed to determine the long-term outcomes of open repair of quadriceps tendon with suture anchors and semitendinosus tendon allograft augmentation [11]. A higher powered and long-term study with validated patient-reported outcomes is needed to confirm observations regarding Jones fracture fixation with BMAC in elite athletes [14]. Long-term clinical and radiographic follow-up is necessary to determine the natural history of asymptomatic talar bone marrow edema in professional ballet dancers [137].

Rehabilitation protocol: Evidence does not provide specific details on physical therapy phasing, immobilisation duration, weight-bearing/ROM progression, or sling/brace removal timing across the cited studies.

Functional milestones: Midterm follow-up of primary meniscal allograft transplantation in the adolescent population resulted in predictable improvements in functional outcomes maintained at an average follow-up of 9.5 years [74]. Functional outcomes for very long-term post-traumatic bone defect reconstruction by the induced membrane technique can be expected to be satisfactory despite the retrospective design and loss to follow-up [58]. Clinical and radiological outcomes for arthroscopic distal tibial allograft with endobutton fixation for anterior shoulder instability were excellent at 2 years, but this should be interpreted in the context of a high lost to follow-up rate in the cohort [15].

Other Considerations: Long-term studies are warranted to determine if head impacts in youth football influence long-term health [3]. There is a paucity of studies showing long-term differences in functional outcomes or implant survivorship for robotic unicompartmental knee arthroplasty, and further clinical studies are required to establish how statistical differences in accuracy translate to long-term outcomes [7]. Studies of natural history and retrospective studies of treatment should adopt a 10-degree difference as an indication of a true change in scoliosis and kyphosis radiographs [12]. Differences in ceramic femoral head use rates among non-white patients did not translate into worse clinical outcomes on short-term follow-up [13]. The study on the fate of remaining knee(s) or hip(s) in osteoarthritic patients includes the largest cohort and longest follow-up time ever reported, providing data to accurately advise patients about the natural history of their disease in other joints [16]. The natural history of neonatal brachial palsy with absent biceps function at three months of age provides a benchmark for comparing outcomes with microsurgical repair [17]. Melorheostosis progresses in both childhood and adult life, often causing contractures, deformities, and pain that may require surgical treatment but frequently progress despite intervention [18]. In analysis of time-to-event outcomes, defining comparison groups based on an exposure that occurs after the beginning of the study follow-up results in a period of immortal time [131]. From a cohort of consecutive patients from a tertiary referral centre, no prognostic demographic or lesion factors for procedure survival could be identified for arthroscopic bone marrow stimulation for osteochondral lesions of the talus at 15 years [132]. Long-term survival of femoral stems in total hip prostheses was associated with a tumor-free interval of more than two years and one to four thoracotomies at which few foci were present [133]. Prognosis for neonatal septic arthritis is significantly influenced by follow-up duration, anatomic site of involvement (particularly the hip), and the timeliness of intervention [134]. Unicompartmental knee arthroplasty caseload and usage can achieve results similar to long-term series with an average 10-year survival of 94% [135]. Prognosis for malignant hemangioendothelioma of bone is poor, with a five-year survival for only two of the six patients in the series [136].

Key Evidence

• [L2] Heterogeneity in study, subject, and surgical demographics precluded assimilation of protocols and/or outcomes to generate evidence-based guidelines. (10.3389/fsurg.2015.00021)
• [L3] The patients' characteristics and indications for surgery were not described in a majority of clinical outcome studies of rotator cuff repair. (10.1007/s11999-008-0585-9)
• [L2] Longitudinal studies are warranted to determine if these impacts influence long-term health. (10.1177/2325967119s00001)
• [L1] Long-term follow-up will be necessary to evaluate any differences in long-term durability. (10.1016/j.arth.2019.10.002)
• [Paper] The purpose of this review is to discuss which factors lead to impactful conclusions and clinical change, including the role of outcome selection, study design, presentation of results, and stakeholder involvement. (10.1016/j.injury.2019.10.082)
• [L5] With increased use and as more outcomes data become available, indications and contraindications will continue to be refined and best practices established. (10.5435/jaaos-d-22-00676)
• [L4] However, there is a paucity of studies showing long-term differences in functional outcomes or implant survivorship, and further clinical studies are required to establish how statistical differences in accuracy translate to long-term outcomes. (10.1302/2058-5241.5.190089)
• [L4] Longer-term follow-up is required to determine whether these results are durable over time. (10.1016/j.arth.2020.01.006)
• [L4] Longer term follow-up data are needed to more adequately assess the outcomes and durability of this procedure. (10.1177/23259671211038320)
• [L1] Further studies with structured study protocols should be performed for a better understanding of risk factors to improve treatment outcomes. (10.1186/s12891-017-1847-z)
• [Paper] However, further follow-up studies are needed to determine the long-term outcomes of these patients. (10.1016/j.eats.2017.08.005)
• [L4] Studies of natural history and retrospective studies of treatment should adopt a 10-degree difference as an indication of a true change. (10.2106/00004623-199072030-00003)
• [L3] These differences did not translate into worse clinical outcomes on a short-term follow-up. (10.1016/j.arth.2022.03.050)
• [L3] A higher powered and long-term study with validated patient-reported outcomes is needed to confirm our observations. (10.1177/2325967118s00160)
• [L3] Clinical and radiological outcomes were excellent at 2 years, but this should be interpreted in the context of a high lost to follow-up rate in this cohort. (10.1016/j.arthro.2024.11.028)
• [L3] This study includes the largest cohort and longest follow-up time ever reported, providing data to accurately advise patients about the natural history of their disease in other joints. (10.1016/j.arth.2012.10.008)
• [L2] A range of symptom severity endorsement was observed at GRTP protocol initiation, with higher endorsement among those with higher baseline symptom endorsement and select demographic and medical history factors. (10.1177/0363546520913252)
• [L4] Classification systems and identification of differences among products are needed to understand the implications of variability. (10.5435/jaaos-21-12-739)
• [L4] Clinical findings in isolation have inadequate diagnostic performance characteristics with sensitivity ranging from 13% to 54%. (10.2106/jbjs.rvw.17.00016)
• [L5] Careful clinical and radiographic evaluation, coupled with a thorough understanding of the anatomy and biomechanics of the foot, will allow accurate evaluation and appropriate treatment. (10.5435/00124635-199509000-00005)
• [L1] The efficacy of future RCTs can be enhanced by randomizing patients in specific patient cohorts stratified to age and gender in multicenter RCTs. (10.1007/s11999-010-1459-5)
• [L4] Changing toe direction significantly affects knee kinetics and kinematics during landing. (10.1007/s00167-013-2815-2)
• [L3] The study shows that clinical outcomes of patients aged 50 and younger who underwent RTSA are comparable to those of aged at least 65 and presenting matched indications. (10.1016/j.jisako.2025.100759)
• [L4] Providers and registries should consider the relative prevalence of published outcome measures when selecting which PROMs to use, to better facilitate future cross-study comparison. (10.1016/j.arth.2018.06.034)
• [L4] Clinical results generally depend on implant design, appropriate technical use, and adequate indications. (10.1302/2058-5241.4.180056)
• [L3] The results of this study suggest abnormal preoperative MRI findings do not have an influence on the outcome of UKA when modern radiographic and clinical criteria are met. (10.1016/j.arth.2013.05.011)
• [L1] However, studies lacked standardized objective selection criteria for the procedure and the available data was predominantly retrospective, with high heterogeneity and variation in outcome reporting. (10.1016/j.arth.2023.10.027)
• [L5] The authors commend the MASTI classification system and the original study's findings but highlight specific data mismatches in tables, patient count discrepancies, and typographical errors that require clarification and re-evaluation. (10.1016/j.arth.2024.02.061)
• [L3] Patients presenting with signs and symptoms of subacromial pain syndrome have a high prevalence of conflicting and concomitant diagnoses. (10.1177/23259671251332942)
• [L3] However, no differences in patient characteristics and clinical symptoms were found between the two groups. (10.1530/eor-24-0048)
• [Paper] In designing a study protocol, the selection of instruments to measure health outcomes should be guided by careful consideration of the rationale and objectives of the study, ensuring instruments capture a comprehensive representation of health and are reliable, valid, and responsive to change. (10.1016/j.injury.2010.11.049)
• [L5] This study described foot bone motion using a biomechanically near-physiological gait simulator with 6 DOF of the tibia. (10.1186/s13018-020-01830-3)
• [L4] The most influential studies in sports-related concussion are predominantly cohort studies (Level IV evidence) and descriptive articles (Level V evidence) published in the United States after 2006, with current research focusing most heavily on symptomatology and epidemiology/demographics. (10.1016/j.asmr.2021.06.016)
• [L3] A simple 4-part classification system based on local and systemic factors demonstrates significant differences between complex groups and standard patients in terms of complication rates and length of stay. (10.1016/j.arth.2008.02.010)
• [L3] In this subset a more general ICU scoring system is useful for risk adjustment for research, administrative and quality improvement purposes. (10.1016/j.injury.2009.03.004)
• [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] Understanding sex-based differences in the incidence, clinical presentation, and functional outcomes of common sports injuries is important to optimize musculoskeletal care and improve treatment outcomes. (10.5435/jaaos-d-16-00607)
• [L4] Clinical results and survivorship were very good despite widened indications, giving an overall retrospective evaluation similar to primary hip implants. (10.1530/eor-2025-0056)
• [L4] Further prospective comparative studies reporting long-term outcomes are needed, as high-level studies on this topic are lacking. (10.1530/eor-21-0133)
• [L5] Advancements in prosthesis design, expanding indications, a trend toward younger patient populations, and the management of postoperative complications are anticipated to emerge as research hotspots. (10.1530/eor-23-0106)
• [L4] This classification system will facilitate multi-center studies for OCD. (10.1177/2325967113s00074)
• [L2] Therefore, employing individualized classification systems remains the most logical approach at present. (10.1530/eor-2024-0184)
• [L5] The article outlines essential methodological criteria for clinical trials, including prospective design with concurrent controls, random allocation, and blind assessment, to ensure new therapeutic approaches are adequately evaluated before widespread clinical introduction. (10.2106/00004623-198567080-00027)
• [Commentary] Large database studies and registries are robust approaches for answering questions regarding rare adverse events, resource utilization, and real-world endpoints that RCTs cannot address, provided they are methodologically robust and present counterintuitive findings or specific suggestions to improve care. (10.1007/s11999-015-4223-z)
• [Paper] Functional outcomes can be expected to be satisfactory despite the retrospective design and loss to follow-up. (10.1016/j.otsr.2018.11.012)
• [L4] MRI based imaging results need further clarification by mid term studies. (10.1177/2325967116s00046)
• [L1] The authors note that confounding by indication and patient selection bias make it difficult to compare the two groups based on registry data alone. (10.1097/corr.0000000000002275)
• [L3] The OMT classification system was straightforward to use and allowed for the classification of all individuals. (10.1016/j.jhsa.2014.10.038)
• [L5] Understanding the difference between efficacy and effectiveness in clinical trials is very important in interpreting the results, and deciding if you can use the conclusions to inform your clinical practice. (10.1302/0301-620x.99b4.bjj-2016-1247)
• [L4] This simpler classification system could be widely applicable because the results could more accurately drive clinical treatment decision making for clinicians. (10.1177/2325967120s00262)
• [L4] By using dynamic fluoroscopy combined with the plantar pressure plate, the in vivo viscoelastic properties and other data of the heel pad in the actual gait can be obtained. (10.1186/s12891-022-05197-w)
• [L2] Reclassification using standardized definitions demonstrated changes in reported treatment efficacy. (10.5435/jaaos-d-25-00523)
• [L5] The proposed classification system describes six specific issues to consider, with specific recommendations for each situation type to improve the reliability of prosthetic implantation. (10.1302/2058-5241.6.210042)
• [L5] Despite promising findings, heterogeneity limits generalizability, and further high-quality, standardized research is required to determine optimal treatment lengths. (10.1302/0301-620x.107b11.bjj-2025-0374.r2)
• [L4] A consensus on a comprehensive and reliable classification system and management algorithm is still lacking. (10.1530/eor-21-0088)
• [L4] The classification developed allows for appropriate grouping and comparison of distinct CS implants. (10.1016/j.arth.2025.05.039)
• [L4] This protocol will lead to the generation of unique datasets which will be used to develop linked inverse dynamic and forward dynamic biomechanical foot models that may be beneficial in predicting the effect of and thus improving the efficacy of orthotic devices for the foot and ankle. (10.1186/1471-2474-12-256)
• [L5] Classification systems must be both reliable and valid to be useful; however, because confirming validity is difficult, a minimum criterion for acceptance is a high degree of both interobserver and intraobserver reliability. (10.5435/00124635-200207000-00007)
• [L4] A novel classification system that more comprehensively and descriptively characterizes the spectrum of LDM pathology demonstrated moderate or substantial agreement in most diagnostic categories analyzed. (10.1177/2325967120s00244)
• [L4] At midterm follow-up, primary MAT in the adolescent population resulted in predictable improvements in functional outcomes maintained at an average follow-up of 9.5 years. (10.1177/2325967123s00060)
• [L5] Future studies should prospectively evaluate the effectiveness of individual or combined identified aspects for their influence on patient adherence in longitudinal study designs. (10.1186/s12891-023-06724-z)
• [L3] Gait biomechanics after TKA are not restored to normal. (10.1016/j.arth.2017.09.061)
• [L4] The authors propose a new four-part classification system to aid in the comparison of results and better understanding of implant biomechanics. (10.1302/2058-5241.5.190034)
• [L5] The conclusions drawn by the authors of the original study must be interpreted with caution due to limitations in study design, patient representativeness, and lack of data on efficacy, safety, and quality of life. (10.1016/j.arth.2017.10.003)
• [L3] Further clinical studies are needed to clarify the long-term outcomes of these implants. (10.1530/eor-22-0001)
• [Paper] The article reviews the hierarchy of evidence, quality indicators, and the balance between efficacy and effectiveness to guide clinicians in appraising intervention studies and applying evidence to individual patients. (10.1016/j.csm.2018.03.008)
• [L5] Well-conducted non-randomised studies, including case-series and observational cohort studies, can provide reasonably valid answers to clinically important questions regarding safety and effectiveness when RCTs are not feasible, provided methodological strengths and weaknesses are carefully considered. (10.1016/j.injury.2006.01.026)
• [L5] While a 2-year minimum follow-up period is generally preferred to ensure methodologic rigor and meaningful assessment of treatment durability, the authors encourage authors to justify shorter durations when clinical outcomes plateau earlier, depending on the research question, diagnosis, treatment, and primary outcome measure. (10.1016/j.arthro.2025.08.019)
• [L4] High proportions of retrospectively registered or unregistered trials and a very high proportion of inconsistencies in reporting of primary outcomes compared to the trial registries were found. (10.1016/j.arth.2022.02.105)
• [L4] The further improvement in clinical outcomes, despite stable MRI findings, suggests a limited correlation between structural and clinical outcomes. (10.1177/23259671251356267)
• [L5] The existence of the Achilles tendon and ankle position have a great influence on the kinematic coupling relationship between tarsal bones, while increased stiffness of the Achilles tendon has no influence. (10.1186/s13018-020-01728-0)
• [L3] The study aimed to clarify rearfoot, midfoot, and forefoot kinematics when running in participants with normal foot and flatfoot. (10.1002/jor.24877)
• [L5] The authors conclude that the terminology used in their study does not interfere with the interpretation of their results, as the term 'adaptation of running biomechanics' reflects the outcome of their intervention rather than a final adaptation to barefoot running. (10.1177/0363546519878154)
• [L5] All four side-to-side configurations sustained loads well above physiologic loads expected in tendons in the foot and ankle, and none distended appreciably during cyclic loading. (10.2106/jbjs.l.01552)
• [L1] The kinematics of CS and CR TKJR are comparable. (10.1177/2325967116s00091)
• [Paper] This Delphi consensus shows that more aspects require evaluation than currently used in radiological evaluation protocols. (10.1007/s00402-013-1823-5)
• [L4] We consider an MRI during the initial management can lead to better outcomes. (10.1177/2325967117s00029)
• [L4] There is a statistically significant correlation between morphological variables of the foot and postural stability. (10.1186/s12891-019-2923-3)
• [L5] Despite recent advances in understanding the epidemiology, biomechanics, pathophysiology, long-term effects, associated risks, and natural history of concussive brain injury, no proven effective therapies or preventative measures exist. (10.1016/j.csm.2010.09.008)
• [Paper] This article discusses the anatomy of the lower extremity as it relates to the ability to run, the running gait cycle, and abnormal anatomy and biomechanics related to running injuries. (10.1016/j.csm.2011.10.001)
• [L5] The paper describes the normal anatomy and biomechanics of the lesser toes, the pathology of commonly adult deformities, and discusses the rationale behind various treatment strategies, proposing management algorithms based on current literature. (10.1302/2058-5241.1.160017)
• [L3] The method was feasible with routine MRI and a short image acquisition time. (10.1177/23259671251334138)
• [L4] The study highlights the need for prospective studies to critically evaluate the diagnostic utility of imaging, as economic and radiation protection reasons suggest avoiding unnecessary CT/MRT, while their omission in indicated cases is also unjustified. (10.1007/s00120-009-2207-x)
• [L4] Significant differences between players with and without CAI were seen in the support leg kinematics at flat-foot contact with the ground during the kicking cycle. (10.1177/23259671221112966)
• [L3] Both operative and nonoperative management of MCL tears demonstrated clinical improvements between study enrollment and 2-year follow-up. (10.1177/2325967117s00126)
• [L5] Accurate diagnosis of anatomy, biomechanics, and soft tissue structures is fundamental to correctly identify patients requiring conservative or surgical treatment to prevent chronic ankle instability. (10.1177/23259671211021352)
• [L5] MRI is evolving as a complete answer to cartilage-imaging requirements for lesion description, treatment planning, and outcome measurement, serving as a noninvasive tool that overcomes the shortcomings of radiography by detecting preclinical disease and subtle early abnormalities. (10.2106/jbjs.rvw.15.00093)
• [L1] CFT also achieved better improvements in gait kinetics. (10.1186/s12891-023-06815-x)
• [L3] Altered sagittal plane biomechanics were observed in female adolescents, but not in male adolescents during a jump-landing task. (10.1177/2325967120s00281)
• [L4] CT parameters were independent of clinical or patient variables within the study population, and osseous incorporation was the most reliable CT parameter. (10.1177/23259671211022682)
• [L4] Functional scores and radiological outcomes were improved. (10.1186/s13018-024-04730-y)
• [L3] The findings of this study support repeat radiographic assessment 2-3 weeks post-injury prior to making definitive treatment decisions. (10.1177/2325967121s00455)
• [L2] This study further supports the role of non-operative treatment for teenagers, with nearly perfect outcomes reported bringing into question the role of acute operative management of these fractures given its associated risks and costs. (10.1177/2325967123s00041)
• [L4] Magnetic resonance imaging is emerging as a valuable tool to both confirm the diagnosis and guide treatment. (10.5435/00124635-199711000-00001)
• [L3] Regardless of observational differences between the 2 groups, no definite relevance was observed between the image and the functional outcome. (10.1177/23259671211026237)
• [L4] The authors propose that the optimal MRI sequences defined in this study be clinically implemented to aid in future pre-operative planning and post-operative assessment. (10.1177/2325967114s00075)
• [L5] The authors conclude that while improved matching is desirable, the first report of this technique showed encouraging short-term clinical and MRI results. (10.1177/23259671211000096)
• [L3] MRI at 12 months can predict longer-term clinical outcomes after ACI. (10.1177/2325967118788280)
• [L4] The morbidity and mortality in the studied series are comparable to large published series. (10.1007/s00120-013-3401-4)
• [L4] No significant difference was seen between outcomes of patients treated with non-operative methods that included unloader bracing versus non-unloader bracing or other modalities. (10.1177/2325967116s00198)
• [L4] The clinical results has been supported by MR images study. (10.1016/j.arthro.2020.12.069)
• [L4] Nonoperative management or delayed surgery may result in poor outcomes. (10.1177/2325967117731102)
• [L4] Conservative treatment or non-anatomical repair results in significant loss of supination strength and variable loss of flexion strength. (10.2106/00004623-198567030-00011)
• [L2] Registry studies use inconsistent methods to account for patient lost to follow-up, and rates of patients lost to follow-up are unacceptably high. (10.1016/j.asmr.2021.07.016)
• [L3] Elbows that did not undergo surgery had slightly increased symptoms and decreased functional outcomes compared to those treated surgically, though an initial trial of non-operative treatment did not adversely impact the success of future surgery at long term follow-up. (10.1177/2325967123s00024)
• [L5] Non-operative treatment is preferable, but for carefully selected patients, specific joint stabilization and nerve decompression procedures can provide symptomatic relief when conservative measures fail. (10.1002/ajmg.c.31551)
• [L5] Nonoperative management is recommended initially, while operative treatment is indicated after nonoperative management has failed. (10.1302/2058-5241.4.180025)
• [L3] The study was unable to identify any difference in patient-reported outcome measures (LEFS) between surgically and non-surgically treated patients. (10.1136/bmjsem-2019-000511)
• [L5] Nonoperative treatment is almost always initiated although surgical treatment may be indicated in cases refractory to conservative management. (10.1155/2013/473259)
• [L5] Both nonsurgical management (immobilization and nonweight bearing) and surgical management (open reduction and internal fixation) have demonstrated good results. (10.5435/jaaos-d-20-00869)
• [L2] The results suggest that nonoperative treatment should be performed early for optimal outcomes. (10.1177/2325967118788531)
• [L5] In analysis of time-to-event outcomes, defining comparison groups based on an exposure that occurs after the beginning of the study follow-up results in a period of immortal time. (10.1016/j.arth.2021.06.012)
• [L3] From this cohort of consecutive patients from a tertiary referral centre no prognostic demographic or lesion factors for procedure survival could be identified. (10.1016/j.jisako.2023.03.007)
• [L4] Long-term survival was associated with a tumor-free interval of more than two years and one to four thoracotomies at which few foci were present. (10.2106/00004623-197658050-00006)
• [L1] Prognosis is significantly influenced by follow-up duration, anatomic site of involvement (particularly the hip), and the timeliness of intervention. (10.1186/s13018-026-06662-1)
• [L2] If they do this, they can expect to achieve results similar to long-term series with an average 10-year survival of 94%. (10.1016/j.arth.2017.04.063)
• [L4] Prognosis is poor, with a five-year survival for only two of the six patients in this series. (10.2106/00004623-197557010-00015)
• [L4] Long-term clinical and radiographic follow-up is necessary to determine the natural history of these lesions. (10.1177/23259671231159910)

See Also

• Surgical Management

References

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[131] Immortal Time Bias in the Analysis of Time-to-Event Data in Orthopedics. The Journal of Arthroplasty. 2021. DOI: 10.1016/j.arth.2021.06.012

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[137] Prevalence of Asymptomatic Talar Bone Marrow Edema in Professional Ballet Dancers: Preliminary Data From a 2-Year Prospective Study. Orthopaedic Journal of Sports Medicine. 2023. DOI: 10.1177/23259671231159910