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NCT07416656
The purpose of this study is to examine whether the blood test Hemoglobin A1c (HbA1c) gives an accurate picture of blood glucose levels in patients with inflammatory arthritis who are treated with sulfasalazine. HbA1c is widely used to diagnose and monitor diabetes, but sulfasalazine can shorten red blood cell lifespan and thereby lower HbA1c values independently of actual glucose levels. This may lead to underdiagnosis of diabetes in patients who develop diabetes during sulfasalazine treatment, and to undertreatment in patients with known diabetes due to falsely reassuring HbA1c values. The study aims to answer two main questions: 1. How many patients treated with sulfasalazine have undiagnosed diabetes despite having HbA1c values below the diagnostic threshold? 2. Does HbA1c underestimate actual glucose levels when compared with continuous glucose monitoring (CGM) in patients with sulfasalazine-treated inflammatory arthritis, both in those with known diabetes and those that are not diagnosed with diabetes but have borderline HbA1c values (≥ 38 mmol/mol)?
NCT06533423
Background: In patients newly diagnosed with inflammatory arthritis, a self-management intervention is anticipated to enhance self-management skills, thereby improving patient function, well-being, and survival. The primary objective of the trial is to investigate the short-term efficacy of the NISMA intervention and usual care, compared to usual care alone (control group), on self-management skills and techniques in patients newly diagnosed with inflammatory arthritis. Method: This study aims to test the efficacy of the "Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention" (NISMA) through a multicenter pragmatic randomized controlled trial (RCT). The trial will involve 130 patients newly diagnosed with IA from three Danish hospitals. Participants will be randomly assigned to either the NISMA intervention group or a control group receiving usual care. The NISMA intervention includes three mandatory individual sessions with a nurse, supplemented by two optional group sessions over 12 months. Primary outcomes will be measured using the Health Education Impact Questionnaire (heiQ), focusing on the "skill and technique acquisition" domain. Secondary outcomes include other heiQ domains, quality of life, loneliness, physical function, pain intensity, pain, self-efficacy, anxiety and depression, fatigue, patient global assessment, disease activity, and medication adherence. Data will be collected at baseline, 12 months, and 18 months post-baseline. Discussion: This RCT will provide essential insights into the effectiveness of a targeted self-management intervention for patients newly diagnosed with IA. The NISMA intervention, developed following the Medical Research Council Framework for complex interventions, aims to improve self-management skills and overall QoL. By addressing the unique challenges faced by newly diagnosed patients, this study seeks to enhance the initial management of IA, aligning with the European Alliance of Associations for Rheumatology (EULAR) recommendations for self-management support. If successful, the NISMA intervention could represent a significant advancement in the non-pharmacological management of IA, offering a comprehensive, patient-centered approach that addresses both physical and psychological needs.
NCT03827759
The purpose is to found new biomarker that differentiate septic arthritis and Juvenile Idiopathic Arthritis in children. Synovial liquid and blood samples with proteomic, MiRNA searching, multiplex cytokine analysis and cellular phenotyping, will be analysed. The results for each data will be compared in function of the disease to search discriminant markers. On behalf with this result specific pathways could be identified .
NCT06993935
Purpose: This study aimed to evaluate rational drug use (RDU), health literacy (HL), and cyberchondria levels among individuals diagnosed with inflammatory rheumatic diseases, and to investigate the factors associated with these three key health-related variables. Methods: This research was designed as a cross-sectional study and conducted between December 2024 and May 2025. The study enrolled three cohorts: a case cohort comprising patients diagnosed with rheumatic disease as patient group (group 1); a disease control cohort of knee osteoarthritis (group 2), and a reference control cohort of age- and sex-matched healthy participants (group 3). Disease Activity Score 28 (DAS28) was administered to patients with rheumatoid arthritis; Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was administered to patients with ankylosing spondylitis; Psoriatic Arthritis Disease Activity Index (DAPSA) was administered to patients with psoriatic arthritis; Western Ontario and McMaster University Osteoarthritis Index (WOMAC) was administered to patients with knee osteoarthritis; and Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Turkey Health Literacy Scale-32 (THLS-32), Rational Drug Use Scale (RDUS), and Cyberchondria Severity Scale (CSS) were administered to all participants. Results: The study sample consisted of 228 participants, with 76 individuals assigned to each of the three groups. Mean age, and gender distribution were similar in all three groups. Statistically significant variations were observed across the three groups regarding THLS-32, RDUS, and CSS scores (p \< 0.001). Group 1 had the highest HL and RDUS scores, and moderate CSS scores. In contrast, Group 2 showed the lowest HL and RDUS scores, while Group 3 demonstrated the highest CSS scores. HL was positively correlated with RDU (r = 0.552, p \< 0.001), and moderately negatively correlated with cyberchondria (r = -0.448, p \< 0.001). These results indicate that higher HL is associated with more rational medication behavior and reduced susceptibility to online health-related anxiety. (p\< 0.001). Conclusions: To our knowledge, this is the first study to simultaneously investigate RDU and CSS in individuals diagnosed with RA, AS, and knee osteoarthritis. Our findings demonstrate that higher levels of HL are significantly associated with more appropriate medication behaviors and lower levels of internet-related health anxiety. These results emphasize the multidimensional role of HL, not only in promoting RDU but also in mitigating maladaptive digital health information-seeking patterns.
NCT03372278
This study is a multicenter, prospective, non-controlled post market clinical follow-up study. The objectives of this study are to confirm the safety and performance of the commercially available Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty.
NCT06402396
Prospective cohort study using drug survival rates to assess the predictive value of the PDQ when used to classify patients into a non-neuropathic pain phenotype group (score \<13) or a neuropathic pain phenotype group (score ≥13)
NCT00512239
Inflammatory joint diseases are major causes of invalidity and morbidity. Rheumatoid arthritis (RA), the most frequent of chronic arthritides, affects close to 1% of the Canadian population. Direct and indirect costs of RA represent close to 1% of the gross national product. Recent evidence suggest that initiation of early (e.g., during the first 3-12 months of disease) aggressive treatment decreases both mortality and long term invalidity in RA and other chronic arthritides. However, a significant proportion of patients with early polyarthritis (EPA) have a benign evolution, even if they fulfill criteria for RA. On the contrary, most patients whose arthritis persist for more than 12 months have a progressive and destructive disease. Currently available clinical, serological and genetic markers of severity in arthritic patients perform poorly in EPA patients to identify those patients whose arthritis is likely to persist and thus who deserve an aggressive treatment. The Investigators propose a prospective and longitudinal study to define the contribution of detection of rheumatoid arthritis-specific autoantibodies (RASA), either alone or in combination with other markers of severity, in the prognostic evaluation of patients presenting with EPA. Availability of such an effective serological tool to establish prognosis in individual patients would improve therapeutic decisions in clinical practice. The same prognostic tools would represent very powerful instruments to subset patients into more homogeneous groups in clinical trials, increasing their power.
NCT03672916
This is a multi-center, prospective, non-controlled post market surveillance study. The objectives of this study are to obtain survival and outcome data on the Allofit IT Shell in combination with the BIOLOX® delta Taper Liner when used in primary total hip arthroplasty.
NCT00826098
Clinical study to evaluate the effect of platelet rich plasma (PRP), a derivative of a patient's whole blood, on short-term patient outcomes following total knee replacement (TKR).
NCT05138445
Many individuals with Inflammatory Arthritis (IA) experience symptoms of pain and fatigue which interfere with work. Over 50% of people with IA report workplace difficulties resulting in sick leave, absenteeism and reduced productivity. Loss of ability to continue paid employment results in physical, emotional and financial hardship for individuals with IA and has societal and economic implications. Previous research has identified pain and fatigue as dominant symptoms that interfere with work capacity and therefore interventions are required to reduce the impact of these symptoms on work activities. The purpose of this study therefore is to test the effectiveness of a 4-week Fatigue and Activity Management Education for Work intervention. The study will use a mixed methods design. A randomized control trial will test the effectiveness of the intervention and a qualitative process evaluation with explore acceptability and participants' experiences of the intervention. Individuals with IA, of working age, will be recruited in Rheumatology outpatient departments of three hospitals. Study participants will be randomly assigned to a four-week online self-management intervention or a self-guided symptom management workbook. Study measures consist of self-report questionnaires related to work and symptom management. All participants will also be invited to an interview to discuss their experience of participating in the study.
NCT04806867
The project proposes to evaluate a strategy for prioritizing teleconsultation for patients with chronic inflammatory rheumatic diseases during the COVID-19 pandemia. This selection will be done through telephone contact by medical students, supervised by residents and rheumatologists on a patient database. The other objectives are to assess the impact of the pandemia on the physical and mental health of patients classified as being at risk