RSA-RCT: Attune S+ TKA Versus Sigma TKA
Osteoarthritis ArthritisJoint Disease2 moreThe PFC Sigma Knee by DePuy Synthes is an excellent knee replacement with an excellent clinical track record, good survival rates (98% 10 years survival in patients aged < 55 years) and minimal early migration as measured with RSA (0.5mm MTPM at two years follow-up). The Attune Knee by DePuy Synthes is an advancement in knee replacement options. It is designed to provide better range of motion and address the unstable feeling some patients experience during everyday activities, such as stair descent and bending. To date, more than 470,000 patients have received an Attune Knee and positive feedback was received regarding patient recovery, stability and motion. The objective of this study is to accurately assess and compare migration, clinical and radiological outcome and patient reported outcomes of two knee prostheses: the Cemented Attune Fixed Bearing Cruciate Retaining Knee System and the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System, both by DePuy Synthes, Warsaw, Indiana, USA. The primary objective of this study is to compare the magnitude and pattern of migration of the prostheses (Femoral and Tibial component). The secondary objective of this study is to compare clinical and radiological outcome of the prostheses and PROMS. This study is designed as a single-blind, randomized trial between the Attune Knee System and PFC Sigma Knee System. 32 patients with the Attune Knee System and 32 patients with PFC Sigma Knee System will be included in this study. The study population will consist of patients with symptomatic osteoarthritis of the knee scheduled for knee replacement surgery at the Department of Orthopaedics, Haags Medisch Centrum The Hague (HMC), The Netherlands. Annually 350 TKA procedures are performed in this department, of which about 90% is Osteo Arthritis (OA) and 10% Rheumatoid Arthritis (RA) and other indications. We anticipate that inclusion can be accomplished within a 1 year period and that the total study duration is 3 years. Main study parameters/endpoints are: Migration, measured by means of RSA. Patient Reported Outcome Measures by means of questionnaires.
Research Study on the Immunosuppressive Effects of a Cell Therapy Product on PBMC Isolated From...
Rheumatoid ArthritisPsoriatic Arthritis1 moreRheumatic diseases regroup a variety of disorders affecting the locomotor system including joints, muscles, connective tissues and soft tissues around the joints and bones. Inflammation and/or autoimmune reactions contribute to the aetiology of many rheumatic diseases. Such autoimmune conditions, commonly referred to as inflammatory rheumatic diseases (IRD), include arthritis of various origins such as rheumatoid arthritis (RA), psoriatic arthritis (PsA) or spondylarthritis (SpA). Patients with autoimmune diseases such as RA or SpA are in higher risk of fractures compared to the general population. Initial pharmacotherapies for IRD remain NSAID treatment for pain relief, and anti-resorptive agents (e.g., TNF-alpha blockers) which aim at reducing bone loss and preventing occurrence of new bone erosions. Yet current treatments may have strong side effects and are not always effective (e.g., 35-40% of the patients treated with TNF-alpha inhibitors will initially or progressively loose response). Therefore there is a need for further treatment modalities in IRD, which would focus on both suppressing inflammation and treating bone disorders. Current research studies indicate that Bone Therapeutics' allogeneic osteoblastic cells exhibit in vitro potent immunosuppressive and anti-inflammatory properties (in addition to osteo-regenerative and immune-privileged properties). The present research study aims at investigating in vitro the properties of these osteoblastic cells in the context of inflammatory rheumatic diseases. In this purpose, in vitro assays will be used to test these immunosuppressive effects on peripheral blood mononuclear cells (PBMCs) of subjects diagnosed with RA, PsA and SpA.
Assessment of the Effect of Spa Treatment on Rheumatological Conditions
OsteoarthritisKnee4 morePrimary outcome measure: measuring the effect of spa treatment in patients suffering from lower limb osteoarthritis or any other lower limb rheumatological condition. Percentage of patients with minimum 19,9 mm decrease in pain Visual Analogue Scale (VAS) or WOMAC score (Western Ontario and McMaster Universities Arthritis Index) improvement of at least 9 points (minimal clinically important difference), 6 months after enrollment. Secondary outcome measures: Measuring the effect of spa treatment in patients with concomitant chronic lower back pain. Percentage of patients presenting clinical benefits according to the EIFEL score, with a decrease of at least 5 points, 6 months after enrollment. Quantitative evaluation of pain. Mean pain VAS comparison between enrollment and 6 months after spa treatment. Quantitative evaluation of WOMAC score. Mean WOMAC score comparison between enrollment and 6 months after spa treatment. Quantitative evaluation of EIFEL score. Mean EIFEL score comparison between enrollment and 6 months after spa treatment. Impact of spa treatment on the patient's metabolism. Height and weight (BMI calculation), blood pressure and heart rate measured at enrollment and throughout the follow-up. 8. Quality of life. 36-Item Short Form (SF 36) and EuroQol 5 Dimensions (EQ5D) questionnaires at enrollment, 3 months and 6 months. 9. Doctor and patient opinion. Semi-quantitative scale collected at enrollment, 3 months and 6 months. 10. Medicine consumption Daily medicine consumption evaluated upon the 72 hours preceding the medical visit at enrollment, 3 months and 6 months. 11. Auto-evaluation of pain VAS pain evaluation by the patient every 6 weeks for a more precise time frame of the treatment's effect.
Post-market Follow up Study of the 'BPK-S Integration' UC as Primary Implant in the Variants CoCr...
OsteoarthritisOsteoarthritis6 moreProspective Post-Market Clinical Follow up study according to MEDDEV 2.12/2 rev2 of the European Union. Patients receiving the primary knee implant BPK-S UC as primary implant in either variant ceramic or CoCr (metal) are eligible for the study and will be followed up for 5 years after implantation or until revision of the prosthesis, whichever occurs first. Demographic data will be collected together with data regarding safety and benefit at defined timepoints (preoperative, intraoperative and at 3 months, 1 year, 2 years and 5 years after implantation). Patients will be divided in 2 cohorts (ceramic and metal) and stratified by age.
Effects of Core Stabilization Exercise Plus Kinesio Taping in Woman With Fibromyalgia
FibromyalgiaExercise1 moreThis study aimed to compare the effectiveness of a 6-week core stabilization exercise (CSE) program with and without kinesio taping on pain, fatigue, health status, quality of life, sleep quality and depression in woman with fibromyalgia. Participants were allocated into two groups as CSE and CSE plus kinesio taping group. Pain, fatigue, health status, quality of life, sleep quality and depression were assessed at the baseline and after 6-weeks treatment.
Local Analgesia in Knee- and Hipatroplastic Surgery in Patients With Rheumatic Disease: Extra- vs....
Rheumatoid ArthritisOrthopedic Surgery1 morePostoperative pain is part of surgery trauma. In orthopedic surgery artroplastic replacement of knee- and hipjoints are common. Postoperative pain relieve can be complicated. A new concept for pain relieve postoperative is local infiltration analgesia (LIA). This technique implicates that a catheter is left in the surgical area and that local anestesia can be administered post surgery. The goal is no or only little pain with minimal side effects. The catheter could be placed intra- or extracapsulare. The best position is not known. Primary aim is to study if position of the catheter effects the need of other postoperative analgesia. Secondary aim is to study if the position effects patient mobility within the first two days.
Puerarin Versus Atorvastatin in Treating Metabolism Syndrome in Patients With Chronic Rheumatic...
Rheumatoid ArthritisTo evaluate the Effect of Puerarin tablets versus statins in treating metabolism syndrome in patients with chronic rheumatic diseases
High-Field MRI Characterization of Wrist and Hand Cartilage Abnormalities in Inflammatory and Chronic...
AbnormalityInflammation1 moreThe present project aims at evaluating the diagnostic potential of high-field MRI (3 Teslas) for joint disease. At this field, given that isotropic image resolution of 400 microns can be obtained, one could expect an early detection of joint abnormalities. The additional aim of this project will be to develop a quantitative analyse of the corresponding high-resolution images.
Speckle Tracking for Timing of Surgical Operation in Severe Mitral Regurge
Rheumatic Heart DiseaseRhumatic heart disease patients with mitral regurge untile know had adibat for timming of surgical interferance our study aim to solve this problme using a new technic in echocardiography called speckle tracking which is more accurate in estimating a changes occure to myocyte of the heart and so chosing the proper time for surgery
The Complex Regional Pain Syndrome (CRPS) is a Chronic Pain Condition. This is a Preliminary Study...
Complex Regional Pain SyndromesMusculoskeletal Pain Disorder1 moreMedical functional imagery seems to demonstrate that patients suffering from complex regional pain syndrome (CRPS) have cortical modifications that alter their motor (or mental) imagery capacities. Nowadays, the use of motor imagery exercises are used in conventional rehabilitation treatments. But, in clinical practice, no study has verified if patients with CRPS desmonstrate problems in their motor imagery capacities. The MIQ-RS (Motor Imagery Questionnaire - Revised Second) is a valid, reliable and translated into French questionnaire to measure patients' capacities to do mental imagery. In this study, we compare 3 groups of 50 patients : healthy patients, patients with CRPS and patients with musculoskeletal disorder without CRPS. Every patient will take the MIQ-RS for the right and left body side. We hypothesis that patients with CRPS have more deficit than the 2 others to realise motor imagery.