Effectiveness of implementation strategies for increasing clinicians' use of five validated imaging decision rules for musculoskeletal injuries: a systematic review.

BACKGROUND: Strategies to enhance clinicians' adherence to validated imaging decision rules and increase the appropriateness of imaging remain unclear. OBJECTIVE: To evaluate the effectiveness of various implementation strategies for increasing clinicians' use of five validated imaging decision rules (Ottawa Ankle Rules, Ottawa Knee Rule, Canadian C-Spine Rule, National Emergency X-Radiography Utilization Study and Canadian Computed Tomography Head Rule). DESIGN: Systematic review. METHODS: The inclusion criteria were experimental, quasi-experimental study designs comprising randomised controlled trials (RCTs), non-randomised controlled trials, and single-arm trials (i.e. prospective observational studies) of implementation interventions in any care setting. The search encompassed electronic databases up to March 11, 2024, including MEDLINE (via Ovid), CINAHL (via EBSCO), EMBASE (via Ovid), Cochrane CENTRAL, Web of Science, and Scopus. Two reviewers assessed the risk of bias of studies independently using the Cochrane Effective Practice and Organization of Care Group (EPOC) risk of bias tool. The primary outcome was clinicians' use of decision rules. Secondary outcomes included imaging use (indicated, non-indicated and overall) and knowledge of the rules. RESULTS: We included 22 studies (5-RCTs, 1-non-RCT and 16-single-arm trials), conducted in emergency care settings in six countries (USA, Canada, UK, Australia, Ireland and France). One RCT suggested that reminders may be effective at increasing clinicians' use of Ottawa Ankle Rules but may also increase the use of ankle radiography. Two RCTs that combined multiple intervention strategies showed mixed results for ankle imaging and head CT use. One combining educational meetings and materials on Ottawa Ankle Rules reduced ankle injury imaging among ED physicians, while another, with similar efforts plus clinical practice guidelines and reminders for the Canadian CT Head Rule, increased CT imaging for head injuries. For knowledge, one RCT suggested that distributing guidelines had a limited short-term impact but improved clinicians' long-term knowledge of the Ottawa Ankle Rules. CONCLUSION: Interventions such as pop-up reminders, educational meetings, and posters may improve adherence to the Ottawa Ankle Rules, Ottawa Knee Rule, and Canadian CT Head Rule. Reminders may reduce non-indicated imaging for knee and ankle injuries. The uncertain quality of evidence indicates the need for well-conducted RCTs to establish effectiveness of implementation strategies.

Comparison of ultrasound guidance with landmark guidance for symptomatic benefits in knee, hip and hand osteoarthritis: Systematic review and meta-analysis of randomised controlled trials.

Introduction: More than half of the patients with moderate and severe osteoarthritis (OA) report unsatisfactory pain relief, requiring consideration of intra-articular (IA) injections as the second-line management. Ultrasound-guided IA injection has proven evidence of higher accuracy in administering IA injectates into the joints than landmark-guided or blind IA injections. However, questions remain about translating higher accuracy rates of ultrasound-guided injection into better clinical improvements. Therefore, we examined the symptomatic benefits (pain, function and patient satisfaction) of ultrasound-guided injection in knee, hip and hand OA compared with blind injections by synthesising a systematic review and meta-analysis of randomised controlled trials (RCT). Methods: PubMed, Medline and Embase databases were searched for eligible studies from their inception to August 28, 2023. Results: Out of 295 records, our meta-analysis included four RCTs (338 patients with knee OA), demonstrating significant improvement in procedural pain [-0.89 (95% CI -1.25, -0.53)], pain at follow-up [-0.51 (95% CI -0.98, -0.04)] and function [1.30 (95% CI 0.86, 1.73)], favouring ultrasound guidance. One single study showed higher patient satisfaction with ultrasound guidance. Conclusion: Ultrasound-guided IA injection provided superior clinical outcomes compared with landmark-guided IA injection.

Efficacy and safety of pentosan polysulfate sodium in people with symptomatic knee osteoarthritis and dyslipidaemia: protocol of the MaRVeL trial.

INTRODUCTION: Knee osteoarthritis (OA) is the most prevalent arthritis type and a leading cause of chronic mobility disability. While pain medications provide only symptomatic pain relief; growing evidence suggests pentosan polysulfate sodium (PPS) is chondroprotective and could have anti-inflammatory effects in knee OA. This study aims to explore the efficacy and safety of oral PPS in symptomatic knee OA with dyslipidaemia. METHODS AND ANALYSIS: MaRVeL is a phase II, single-centre, parallel, superiority trial which will be conducted at Royal North Shore Hospital, Sydney, Australia. 92 participants (46 per arm) aged 40 and over with painful knee OA and mild to moderate structural change on X-ray (Kellgren and Lawrence grade 2 or 3) will be recruited from the community and randomly allocated to receive two cycles of either oral PPS or placebo for 5 weeks starting at baseline and week 11. Primary outcome will be the 16-week change in overall average knee pain severity measured using an 11-point Numeric Rating Scale. Main secondary outcomes include change in knee pain, patient global assessment, physical function, quality of life and other structural changes. A biostatistician blinded to allocation groups will perform the statistical analysis according to the intention-to-treat principle. ETHICS AND DISSEMINATION: The protocol has been approved by the NSLHD Human Research Ethics Committee (HREC) (2021/ETH00315). All participants will provide written informed consent online. Study results will be disseminated through conferences, social media and academic publications. TRIAL REGISTRATION NUMBERS: Australian New Zealand Clinical Trial Registry (ACTRN12621000654853); U1111-1265-3750.

Awareness and use of five imaging decision rules for musculoskeletal injuries: a systematic review.

BACKGROUND: Several validated decision rules are available for clinicians to guide the appropriate use of imaging for patients with musculoskeletal injuries, including the Canadian CT Head Rule, Canadian C-Spine Rule, National Emergency X-Radiography Utilization Study (NEXUS) guideline, Ottawa Ankle Rules and Ottawa Knee Rules. However, it is unclear to what extent clinicians are aware of the rules and are using these five rules in practice. OBJECTIVE: To determine the proportion of clinicians that are aware of five imaging decision rules and the proportion that use them in practice. DESIGN: Systematic review. METHODS: This was a systematic review conducted in accordance with the 'Preferred reporting items for systematic reviews and meta-analyses' (PRISMA) statement. We performed searches in MEDLINE (via Ovid), CINAHL (via EBSCO), EMBASE (via Ovid), Cochrane Central Register of Controlled Trials (CENTRAL), Web of Science and Scopus databases to identify observational and experimental studies with data on the following outcomes among clinicians related to five validated imaging decision rules: awareness, use, attitudes, knowledge, and barriers and facilitators to implementation. Where possible, we pooled data using medians to summarise these outcomes. RESULTS: We included 39 studies. Studies were conducted in 15 countries (e.g. the USA, Canada, the UK, Australasia, New Zealand) and included various clinician types (e.g. emergency physicians, emergency nurses and nurse practitioners). Among the five decision rules, clinicians' awareness was highest for the Canadian C-Spine Rule (84%, n = 3 studies) and lowest for the Ottawa Knee Rules (18%, n = 2). Clinicians' use was highest for NEXUS (median percentage ranging from 7 to 77%, n = 4) followed by Canadian C-Spine Rule (56-71%, n = 7 studies) and lowest for the Ottawa Knee Rules which ranged from 18 to 58% (n = 4). CONCLUSION: Our results suggest that awareness of the five imaging decision rules is low. Changing clinicians' attitudes and knowledge towards these decision rules and addressing barriers to their implementation could increase use.

Lesser Metatarsophalangeal Joint Plantar Plate Degeneration and Tear and Acute First Metatarsophalangeal Joint Capsuloligamentous Injury: What the Surgeon Wants to Know.

Injuries to the plantar plate complex of the first toe and the lesser toes, although closely related anatomically, differ significantly in their pathogenesis. Lesser metatarsophalangeal joint plantar plate degeneration and tear typically presents as an attritional pattern of capsuloligamentous deficiency in middle-aged patients, whereas first metatarsophalangeal joint capsuloligamentous injury is typically acute and occurs in younger adult athletes engaged in sports involving repetitive running and jumping. Consequently, considerations regarding surgical decision-making also differ. Knowledge of the anatomy, pathophysiological basis, common patterns, grading and classification of these injuries, and indications for surgery, will aid imaging interpretation in the preoperative setting. The acuity and extent of injury, tissue quality and functional requirements of the patient (such as timely return to sport) influence clinical decision-making with respect to conservative versus surgical management and are informed by the use of optimized multimodal imaging. This section will provide an overview of these injuries in 2 parts, separated into those affecting the first toe and the lesser toes, and will highlight imaging findings relevant to surgical decision-making.

Inflammatory ultrasound features as prognostic factors of pain and functional outcomes following intra-articular platelet-rich plasma in knee osteoarthritis.

AIM: To explore inflammatory ultrasound predictors of improvements in pain and function over 2, 6, and 12 months following administration of intra-articular platelet-rich plasma (PRP) in knee osteoarthritis (OA). METHOD: Patients with painful mild-moderate radiographic knee OA from a subset of the RESTORE RCT underwent ultrasound assessment according to the standardized OMERACT scanning protocol to detect inflammatory features such as synovitis, synovial hypertrophy, and effusion with power Doppler. The study knee was treated with 3 once-weekly PRP injections obtained after centrifugation at 1500 g for 5 min. Numerical Rating Score (NRS), Intermittent and Constant Osteoarthritis Pain (ICOAP) questionnaire, and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) function sub-score were used to measure pain and functional severity. Separate linear regression models were performed to determine whether baseline ultrasound-detected features of inflammation predicted the improvement in pain and function following PRP injection in both unadjusted and adjusted models for confounders. RESULTS: Forty-four participants were included, with 25 (56.8%) being female. In an unadjusted model, higher OMERACT scores for inflammatory features such as global synovitis and/or effusion were significantly associated with greater improvement in all outcomes measured at 2 months but not at 6 and 12 months for pain measures. Only global synovitis showed significant association with functional improvement at 2 and 12 months. Similar findings were observed in the adjusted model. CONCLUSION: Ultrasound indices of knee inflammation predicted short-term improvements in pain severity and both short- and longer-term improvements in function following intra-articular PRP injection.

Combined femoral and acetabular version and synovitis are associated with dGEMRIC scores in people with femoroacetabular impingement (FAI) syndrome.

This study sought to explore, in people with symptoms, signs and imaging findings of femoroacetabular impingement (FAI syndrome): (1) whether more severe labral damage, synovitis, bone marrow lesions, or subchondral cysts assessed on magnetic resonance imaging (MRI) were associated with poorer cartilage health, and (2) whether abnormal femoral, acetabular, and/or combined femoral and acetabular versions were associated with poorer cartilage health. This cross-sectional study used baseline data from the 50 participants with FAI syndrome in the Australian FASHIoN trial (ACTRN12615001177549) with available dGEMRIC scans. Cartilage health was measured using delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) score sampled at the chondrolabral junction on three midsagittal slices, at one acetabular and one femoral head region of interest on each slice, and MRI features were assessed using the Hip Osteoarthritis MRI Score. Analyses were adjusted for alpha angle and body mass index, which are known to affect dGEMRIC score. Linear regression assessed the relationship with the dGEMRIC score of (i) selected MRI features, and (ii) femoral, acetabular, and combined femoral and acetabular versions. Hips with more severe synovitis had worse dGEMRIC scores (partial η2 = 0.167, p = 0.020), whereas other MRI features were not associated. A lower combined femoral and acetabular version was associated with a better dGEMRIC score (partial η2 = 0.164, p = 0.021), whereas isolated measures of femoral and acetabular version were not associated. In conclusion, worse synovitis was associated with poorer cartilage health, suggesting synovium and cartilage may be linked to the pathogenesis of FAI syndrome. A lower combined femoral and acetabular version appears to be protective of cartilage health at the chondrolabral junction.

Which hip morphology measures and patient factors are associated with age of onset and symptom severity in femoroacetabular impingement syndrome?

BACKGROUND: Bony morphology is central to the pathomechanism of femoroacetabular impingement syndrome (FAIS), however isolated radiographic measures poorly predict symptom onset and severity. More comprehensive morphology measurement considered together with patient factors may better predict symptom presentation. This study aimed to determine the morphological parameter(s) and patient factor(s) associated with symptom age of onset and severity in FAIS. METHODS: 99 participants (age 32.9 ± 10.5 years; body mass index (BMI 24.3 ± 3.1 kg/m2; 42% females) diagnosed with FAIS received standardised plain radiographs and magnetic resonance scans. Alpha angle in four radial planes (superior to anterior), acetabular version (AV), femoral torsion, lateral centre-edge, anterior centre-edge (ACEA) and femoral neck-shaft angles were measured. Age of symptom onset (age at presentation minus duration of symptoms), international Hip Outcome Tool-33 (iHOT-33) and modified UCLA activity scores were recorded. Backward stepwise regression assessed morphological parameters and patient factors (age, sex, BMI, symptom duration, annual income, private/public healthcare system accessed) to determine variables independently associated with onset age and iHOT-33 score. RESULTS: Earlier symptom onset was associated with larger superoanterior alpha angle (p = 0.007), smaller AV (p = 0.023), lower BMI (p = 0.010) and public healthcare system access (p = 0.041) (r2 = 0.320). Worse iHOT-33 score was associated with smaller ACEA (p = 0.034), female sex (p = 0.040), worse modified UCLA activity score (p = 0.010) and public healthcare system access (p < 0.001) (r2 = 0.340). CONCLUSIONS: Age of symptom onset was chiefly predicted by femoral and acetabular bony morphology measures, whereas symptom severity predominantly by patient factors. Factors measured explained a small amount of variance in the data; additional unmeasured factors may be more influential.

Pain, function, and radiographic disease in trapeziometacarpal osteoarthritis.

INTRODUCTION: Trapeziometacarpal joint osteoarthritis (OA) produces significant functional impairment due to pain and loss of strength in both power and precision grips, but few studies have related radiographic scores to functional and pain-based measures. PURPOSE: To investigate the association between markers of radiographic disease and outcomes for symptomatic and functional disease. STUDY DESIGN: This study in an exploratory analysis of baseline data from the first 100 participants in a clinical trial evaluating the efficacy of combined conservative therapies for base of thumb OA (COMBO). METHODS: Functional Index for Hand Osteoarthritis (FIHOA) scores and Visual Analogue Scale (VAS) scores for pain were recorded for the index hand. Bilateral isometric grip and tip-pinch strength measurements were taken, as well as posteroanterior and Eaton stress-view hand radiographs. Generalized estimating equations (GEEs), univariate, and multivariate analyses were used according to whether the data were bilateral or unilateral. RESULTS: A total of 79 females and 21 males were included, with a median Kellgren-Lawrence (KL) grade of 3 in the index hand. Higher KL and Eaton grades were associated with lower grip strength in the GEE analysis (B-coefficients of -1.25 and -1.16, and P-values of .002 and .010, respectively). Higher KL grade was also associated with poorer function and higher pain levels in the multivariable analysis (B-coefficients of 1.029 and 3.681, and P-values of .021 and .047, respectively). Lower radial subluxation ratios were associated with lower grip strength in the GEE analysis, and higher pain scores in the multivariable analysis (B-coefficients of 2.06 and -42.1, and P-values of .006 and .031, respectively). Greater pain scores were also associated with poorer function (B-coefficient 0.082, P-value .001). CONCLUSION: More advanced radiographic trapeziometacarpal OA severity is associated with lower grip strength and poorer self-reported functional outcomes. Lower subluxation ratios were associated with higher pain scores and lower grip strength.

Do patients with femoroacetabular impingement syndrome who undergo hip arthroscopy display improved alpha angle (magnetic resonance imaging) and radiographic hip morphology?

AIMS: To compare (a) the change in radiological bony morphology between participants with femoroacetabular impingement (FAI) syndrome who underwent arthroscopic hip surgery compared to physiotherapist-led non-surgical care and (b) the change in radiological bony morphology between participants with FAI syndrome who underwent arthroscopic hip surgery involving cam resection or acetabular rim trimming or combined cam resection and acetabular rim trimming. METHODS: Maximum alpha angle measurements on magnetic resonance imaging and Hip2 Norm standardized hip measurements on radiographs were recorded at baseline and at 12 months postoperatively. One-way analysis of covariance and independent T tests were conducted between participants who underwent arthroscopic hip surgery and physiotherapist-led non-surgical care. Independent T tests and analysis of variance were conducted between participants who underwent the 3 different arthroscopic hip procedures. RESULTS: Arthroscopic hip surgery resulted in significant improvements to mean alpha angle measurements (decreased from 70.8° to 62.1°) (P value < .001, 95% CI -11.776, -4.772), lateral center edge angle (LCEA) (P value = .030, 95% CI -3.403, -0.180) and extrusion index (P value = 0.002, 95% CI 0.882, 3.968) compared to physiotherapist-led management. Mean maximum 1-year postoperative alpha angle was 59.0° (P value = .003, 95% CI 4.845, 18.768) for participants who underwent isolated cam resection. Measurements comparing the 3 different arthroscopic hip procedures only differed in total femoral head coverage (F[2,37] = 3.470, P = .042). CONCLUSION: Arthroscopic hip surgery resulted in statistically significant improvements to LCEA, extrusion index and alpha angle as compared to physiotherapist-led management. Measured outcomes between participants who underwent cam resection and/or acetabular rim trimming only differed in total femoral head coverage.

Moderators, Mediators, and Prognostic Indicators of Treatment With Hip Arthroscopy or Physical Therapy for Femoroacetabular Impingement Syndrome: Secondary Analyses From the Australian FASHIoN Trial.

BACKGROUND: Although randomized controlled trials comparing hip arthroscopy with physical therapy for the treatment of femoroacetabular impingement (FAI) syndrome have emerged, no studies have investigated potential moderators or mediators of change in hip-related quality of life. PURPOSE: To explore potential moderators, mediators, and prognostic indicators of the effect of hip arthroscopy and physical therapy on change in 33-item international Hip Outcome Tool (iHOT-33) score for FAI syndrome. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: Overall, 99 participants were recruited from the clinics of orthopaedic surgeons and randomly allocated to treatment with hip arthroscopy or physical therapy. Change in iHOT-33 score from baseline to 12 months was the dependent outcome for analyses of moderators, mediators, and prognostic indicators. Variables investigated as potential moderators/prognostic indicators were demographic variables, symptom duration, alpha angle, lateral center-edge angle (LCEA), Hip Osteoarthritis MRI Scoring System (HOAMS) for selected magnetic resonance imaging (MRI) features, and delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) score. Potential mediators investigated were change in chosen bony morphology measures, HOAMS, and dGEMRIC score from baseline to 12 months. For hip arthroscopy, intraoperative procedures performed (femoral ostectomy ± acetabular ostectomy ± labral repair ± ligamentum teres debridement) and quality of surgery graded by a blinded surgical review panel were investigated for potential association with iHOT-33 change. For physical therapy, fidelity to the physical therapy program was investigated for potential association with iHOT-33 change. RESULTS: A total of 81 participants were included in the final moderator/prognostic indicator analysis and 85 participants in the final mediator analysis after exclusion of those with missing data. No significant moderators or mediators of change in iHOT-33 score from baseline to 12 months were identified. Patients with smaller baseline LCEA (ß = -0.82; P = .034), access to private health care (ß = 12.91; P = .013), and worse baseline iHOT-33 score (ß = -0.48; P < .001) had greater iHOT-33 improvement from baseline to 12 months, irrespective of treatment allocation, and thus were prognostic indicators of treatment response. Unsatisfactory treatment fidelity was associated with worse treatment response (ß = -24.27; P = .013) for physical therapy. The quality of surgery and procedures performed were not associated with iHOT-33 change for hip arthroscopy (P = .460-.665 and P = .096-.824, respectively). CONCLUSION: No moderators or mediators of change in hip-related quality of life were identified for treatment of FAI syndrome with hip arthroscopy or physical therapy in these exploratory analyses. Patients who accessed the Australian private health care system, had smaller LCEAs, and had worse baseline iHOT-33 scores, experienced greater iHOT-33 improvement, irrespective of treatment allocation.

Postoperative MRI of the Ankle and Foot.

Many surgical procedures and operations are used to treat ankle and foot disorders. Radiography is the first-line imaging for postoperative surveillance and evaluation of pain and dysfunction. Computed tomography scans and MR imaging are used for further evaluation. MR imaging is the most accurate test for soft tissues assessments. MR imaging protocol adjustments include basic and advanced metal artifact reduction. We chose a surgical approach to select the common types of procedures and discuss the normal and abnormal postoperative MR imaging appearances, highlighting potential complications. This article reviews commonly used surgical techniques and their normal and abnormal MR imaging appearances.

Traumatic irreducible anterior dislocation of the radio-capitellar joint due to entrapment of the brachialis tendon lateral to the radial head: A case report.

Elbow dislocation is the second most common type of joint dislocation in adults and the most common joint dislocation in children. These dislocations are commonly associated with significant soft tissue injury and/or fractures. Anterior dislocation of the radio-capitellar articulation is uncommon. Failure of relocation of the radial head due to soft tissue imposition requiring open reduction is rare, however, is extremely important to recognise clinically and radiologically. This case report describes a case of anterior dislocation of the radio-capitellar joint due to entrapment of the brachialis tendon lateral to the radial head and discusses the radiological assessment and the spectrum of causes of a clinically irreducible radio-capitellar joint. Misdiagnosis of a dislocation or failed reduction may result in long-term functional sequelae for the patient.

Acute calcific periarthritis-a commonly misdiagnosed pathology.

Acute calcific periarthritis (ACP) is a self-limiting, monoarticular, peri-articular process of dystrophic mineral deposition and adjacent inflammation. Patients present with a sudden onset of pain, localised swelling, erythema, tenderness and restricted range of motion. Symptoms reduce in severity within 4-7 days and self resolve in 3-4 weeks. ACP is commonly misdiagnosed, in particular, as infective or inflammatory pathologies such as septic arthritis and gout. This condition has specific imaging findings which allows differentiation from other disorders when combined with the clinical presentation. Prompt diagnosis results in appropriate management and reduces the likelihood of unnecessary diagnostic and therapeutic procedures.

Presurgical Perspective and Postsurgical Evaluation of Plantar Plate and Turf Toe.

Capsuloligamentous injury of the first metatarsophalangeal (MTP) joint (eponymously called "turf toe") mostly occurs in athletes and involves acute trauma, whereas tears of the lesser MTP joint plantar plate typically are an attritional-degenerative condition. This article reviews the anatomy, pathophysiology, mechanism and patterns of injury, grading and classification of injury, imaging appearances (pre- and postoperative), and management of first MTP joint capsuloligamentous injuries and lesser MTP joint plantar plate tears. These two distinct pathologies are discussed in separate sections.

Reliability and Convergent Construct Validity of Quantitative Ultrasound for Synovitis, Meniscal Extrusion, and Osteophyte in Knee Osteoarthritis With MRI.

AIMS: To determine: 1) inter-rater reliability of quantitative measurements of ultrasound-detected synovitis, meniscal extrusion, and osteophytes; and 2) construct (convergent) validity via correlations and absolute agreements between ultrasound- and gold-standard magnetic resonance imaging (MRI)-outcomes in knee osteoarthritis. METHODS: Dynamic ultrasound images for supra-patellar synovitis, meniscal extrusion, and osteophytes were acquired and quantified by a physician operator, musculoskeletal ultrasonographer, and medical student independently. On the same day, 3T MRI images were acquired. Effusion-synovitis, meniscal extrusion, and osteophytes were quantified on sagittal or coronal proton-density-weighted fat-suppressed noncontrast TSE sequences, respectively. Intra-class correlation coefficients (ICCs), Pearson's correlations (r), and Bland-Altman plots were used to analyze inter-rater reliability, and correlations, and agreements between the two imaging modalities. RESULTS: Eighty-nine participants [48 females (53.9%)] with mean (standard deviation) age of 61.5 ± 6.9 years were included. The inter-rater reliability was excellent for osteophytes (ICC range = 0.90-0.96), meniscal extrusion (ICC range = 0.90-0.93), and synovitis (ICC range = 0.86-0.88). The correlations between ultrasound pathologies and their MRI counterparts were very strong (ICC range = 0.85-0.98) except for lateral meniscal extrusion [0.66 (95% CI, 0.52-0.76)]. Bland-Altman plots showed 0.01, 0.05, 0.10, 0.53, and 0.60 mm larger size in ultrasound medial tibial and medial femoral osteophytes, medial meniscal extrusions, synovitis, and lateral meniscal extrusions with 95% limits of agreements [±0.39, ±0.44, ±0.85, ±0.70, and ±0.90 (SDs)] than MRI measures, respectively. The lines of equality were within 95% CI of the mean differences (bias) only for medial osteophytes and medial meniscal extrusion. CONCLUSION: The quantitative assessment of synovitis, meniscal extrusion, and osteophytes generally showed excellent inter-rater reliability and strong correlations with MRI-based measurements. Absolute agreement was strong for medial tibiofemoral pathologies.

Efficacy and cost-effectiveness of Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis: protocol for a randomised placebo-controlled trial (the SCUlpTOR trial).

INTRODUCTION: Knee osteoarthritis (KOA) is a highly prevalent disabling joint disease. Intra-articular stem cell therapy is increasingly being used for treating KOA with little high-quality evidence to support its use. The aim of this study is to investigate the efficacy, safety and cost-effectiveness of allogeneic mesenchymal stem cells (Cymerus MSCs) for treating symptomatic tibiofemoral KOA and improving knee structure over 24 months. METHODS AND ANALYSIS: The Stem Cell injections for symptomatic relief and strUctural improvement in people with Tibiofemoral knee OsteoaRthritis study is a phase III, multi-centre, parallel, superiority, randomised, double-blind, placebo-controlled trial, which will be conducted in Sydney and Hobart, Australia. 440 participants (220 per arm) aged over 40 years with painful KOA and mild to moderate structural change on X-ray (Kellgren and Lawrence grade 2 or 3) with medial minimum joint space width between 1 and 4 mm in the study knee will be recruited from the community and randomly allocated to receive either intra-articular MSCs or saline at baseline, week 3 and week 52. The coprimary outcomes will be the proportion of participants achieving patient-acceptable symptom state for knee pain at 24 months and quantitative central medial femorotibial compartment cartilage thickness change from baseline to 24 months. Main secondary outcomes include change in knee pain, Patient Global Assessment, physical function, quality of life and other structural changes. Additional data for cost-effectiveness analysis will also be recorded. Adverse events will be monitored throughout the study. The primary analysis will be conducted using modified intention-to-treat. ETHICS AND DISSEMINATION: This protocol has been approved by The University of Sydney (USYD) Human Research Ethics Committee (HREC) #: 2020/119 and The University of Tasmania (UTAS) HREC #: H0021868. All participants will be required to provide informed consent. Dissemination will occur through conferences, social media, and scientific publications. TRIAL REGISTRATION NUMBERS: Australian New Zealand Clinical Trials Registry (ACTRN12620000870954); U1111-1234-4897.

Effect of Intra-articular Platelet-Rich Plasma vs Placebo Injection on Pain and Medial Tibial Cartilage Volume in Patients With Knee Osteoarthritis: The RESTORE Randomized Clinical Trial.

Importance: Most clinical guidelines do not recommend platelet-rich plasma (PRP) for knee osteoarthritis (OA) because of lack of high-quality evidence on efficacy for symptoms and joint structure, but the guidelines emphasize the need for rigorous studies. Despite this, use of PRP in knee OA is increasing. Objective: To evaluate the effects of intra-articular PRP injections on symptoms and joint structure in patients with symptomatic mild to moderate radiographic medial knee OA. Design, Setting, and Participants: This randomized, 2-group, placebo-controlled, participant-, injector-, and assessor-blinded clinical trial enrolled community-based participants (n = 288) aged 50 years or older with symptomatic medial knee OA (Kellgren and Lawrence grade 2 or 3) in Sydney and Melbourne, Australia, from August 24, 2017, to July 5, 2019. The 12-month follow-up was completed on July 22, 2020. Interventions: Interventions involved 3 intra-articular injections at weekly intervals of either leukocyte-poor PRP using a commercially available product (n = 144 participants) or saline placebo (n = 144 participants). Main Outcomes and Measures: The 2 primary outcomes were 12-month change in overall average knee pain scores (11-point scale; range, 0-10, with higher scores indicating worse pain; minimum clinically important difference of 1.8) and percentage change in medial tibial cartilage volume as assessed by magnetic resonance imaging (MRI). Thirty-one secondary outcomes (25 symptom related and 6 MRI assessed; minimum clinically important difference not known) evaluated pain, function, quality of life, global change, and joint structures at 2-month and/or 12-month follow-up. Results: Among 288 patients who were randomized (mean age, 61.9 [SD, 6.5] years; 169 [59%] women), 269 (93%) completed the trial. In both groups, 140 participants (97%) received all 3 injections. After 12 months, treatment with PRP vs placebo injection resulted in a mean change in knee pain scores of -2.1 vs -1.8 points, respectively (difference, -0.4 [95% CI, -0.9 to 0.2] points; P = .17). The mean change in medial tibial cartilage volume was -1.4% vs -1.2%, respectively (difference, -0.2% [95% CI, -1.9% to 1.5%]; P = .81). Of 31 prespecified secondary outcomes, 29 showed no significant between-group differences. Conclusions and Relevance: Among patients with symptomatic mild to moderate radiographic knee OA, intra-articular injection of PRP, compared with injection of saline placebo, did not result in a significant difference in symptoms or joint structure at 12 months. These findings do not support use of PRP for the management of knee OA. Trial Registration: Australian New Zealand Clinical Trials Registry Identifier: ACTRN12617000853347.

Multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapist-led care for femoroacetabular impingement (FAI) syndrome on hip cartilage metabolism: the Australian FASHIoN trial.

BACKGROUND: Arthroscopic surgery for femoroacetabular impingement syndrome (FAI) is known to lead to self-reported symptom improvement. In the context of surgical interventions with known contextual effects and no true sham comparator trials, it is important to ascertain outcomes that are less susceptible to placebo effects. The primary aim of this trial was to determine if study participants with FAI who have hip arthroscopy demonstrate greater improvements in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to participants who undergo physiotherapist-led management. METHODS: Multi-centre, pragmatic, two-arm superiority randomised controlled trial comparing physiotherapist-led management to hip arthroscopy for FAI. FAI participants were recruited from participating orthopaedic surgeons clinics, and randomly allocated to receive either physiotherapist-led conservative care or surgery. The surgical intervention was arthroscopic FAI surgery. The physiotherapist-led conservative management was an individualised physiotherapy program, named Personalised Hip Therapy (PHT). The primary outcome measure was change in dGEMRIC score between baseline and 12 months. Secondary outcomes included a range of patient-reported outcomes and structural measures relevant to FAI pathoanatomy and hip osteoarthritis development. Interventions were compared by intention-to-treat analysis. RESULTS: Ninety-nine participants were recruited, of mean age 33 years and 58% male. Primary outcome data were available for 53 participants (27 in surgical group, 26 in PHT). The adjusted group difference in change at 12 months in dGEMRIC was -59 ms (95%CI - 137.9 to - 19.6) (p = 0.14) favouring PHT. Hip-related quality of life (iHOT-33) showed improvements in both groups with the adjusted between-group difference at 12 months showing a statistically and clinically important improvement in arthroscopy of 14 units (95% CI 5.6 to 23.9) (p = 0.003). CONCLUSION: The primary outcome of dGEMRIC showed no statistically significant difference between PHT and arthroscopic hip surgery at 12 months of follow-up. Patients treated with surgery reported greater benefits in symptoms at 12 months compared to PHT, but these benefits are not explained by better hip cartilage metabolism. TRIAL REGISTRATION DETAILS: Australia New Zealand Clinical Trials Registry reference: ACTRN12615001177549 . Trial registered 2/11/2015.

Are OMERACT Knee Osteoarthritis Ultrasound Scores Associated With Pain Severity, Other Symptoms, and Radiographic and Magnetic Resonance Imaging Findings?

OBJECTIVE: To investigate the associations of Outcome Measures in Rheumatology (OMERACT) ultrasound scores for knee osteoarthritis (OA) with pain severity, other symptoms, and OA severity on radiographs and magnetic resonance imaging (MRI). METHODS: Participants with symptomatic and mild to moderate radiographic knee OA underwent baseline dynamic ultrasound (US) assessment according to standardized OMERACT scanning protocol. Using the published US image atlas, a physician operator obtained semiquantitative or binary scores for US pathologies. Clinical severity was measured on numerical rating scale (NRS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) symptoms and pain subscores. OA severity was assessed using the Kellgren-Lawrence (KL) grade on radiographs and MRI Osteoarthritis Knee Score (MOAKS) on noncontrast-enhanced MRI. Separate linear regression models were used to determine associations of US OA pathologies with pain and KOOS subscores, and Spearman correlations were used for US scores with KL grade and MOAKS. RESULTS: Eighty-nine participants were included. Greater synovial hypertrophy, power Doppler (PD), and meniscal extrusion scores were associated with worse NRS pain [ß 0.92 (95% CI 0.25-1.58), ß 0.73 (95% CI 0.11-1.35), and ß 1.01 (95% CI 0.22-1.80), respectively]. All greater US scores, except for cartilage grade, demonstrated significant associations with worse KOOS symptoms, whereas only PD and meniscal extrusion were associated with worse KOOS pain. All US scores, except for PD, were significantly correlated with KL grade. US pathologies, except for cartilage, revealed moderate to good correlation with their MOAKS counterparts, with US synovitis having the greatest correlation (0.69, 95% CI 0.60-0.78). CONCLUSION: OMERACT US scores revealed significant associations with pain severity, KL grade, and MOAKS.