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Osteoarthritis clinical trials

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NCT ID: NCT04058002 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Project Arthritis Recovering Quality of Life Through Education 70+

PARQVE
Start date: August 15, 2019
Phase: N/A
Study type: Interventional

Introduction: Quadriceps weakness was previously associated with functional impairment of osteoarthritis (OA). Evidence also suggests that muscle strength may prevent the progression of existing OA. It is estimated that the decline in muscle mass between 40 and 80 years is between 30% and 50%, with reported losses in functional capacity reaching 3% each year beyond the age of 60 years. Therefore, procedures capable of increasing the effects of exercise on muscle strength and function may be beneficial for elderly patients with knee OA. The results of our studies have shown that with each year of life the patient loses strength gain capacity. Objective: To evaluate if a multiprofessional educational program associated with BCAA and creatine supplementation improves the quality of life, function, pain and body composition of patients with OA and age greater than or equal to 70 years. METHODS: 34 patients with knee OA and age greater than or equal to 70 years will undergo an educational and physical training program lasting 20 weeks. Half of the patients will receive creatine (control) and the others will receive creatine and BCAA (study). Patients will be evaluated through functional tests (sit-up and 30-second tests and time up and go), standardized questionnaires (WOMAC and Lequesne), quality of life scales (Euroqol-EQ-5D-5L), pain (through VAS), body composition and bone density (through densitometry), and level of physical activity. All of the above parameters will be assessed at the beginning of the study and 6 and 12 months later. All project costs will be reported and a cost-effectiveness and cost-utility analysis will be performed. All project costs will be reported and a cost-effectiveness and cost-utility analysis will be performed.

NCT ID: NCT04052308 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Decrease in Blood Pressure in PARQVE

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

The tripod of OA clinical treatment is education, weight loss and exercise. A sedentary lifestyle has been characterized as an independent risk factor for cardiovascular disease. Studies have shown the inverse association between the level of physical activity and the incidence of cardiovascular disease. High Intensity Interval Training (HIIT), which consists of repeated high-intensity exercise sessions interspersed with passive recovery. Active, has been studied as a new therapeutic approach and has been shown to be effective in controlling blood pressure (BP) and arterial stiffness in treated hypertensive individuals. HIIT training has also been shown to be able to reverse the hemodynamic, metabolic and hormonal changes that are involved in the pathophysiology of essential hypertension, leading to improved arterial stiffness and BP response, endothelin-1 and nitrite / nitrate to exercise, increased cardiorespiratory fitness when compared to moderate-intensity continuous exercise in young women with a family history of essential hypertension. Six weeks of HIIT training (3 times / week) reduced body fat and waist circumference in young women. , while increasing fat-free mass, maximum running speed and aerobic fitness. Two recent studies evaluating body weight change in overweight patients have shown that HIIT training is comparable to moderate-intensity continuous exercise, but HIIT is more efficient compared to time spent training, which may facilitate the inclusion of daily routine training of patients. Previous work performed by the authors patients undergoing an education and physical activity program showed improvement in WOMAC. The investigators believe that the inclusion of an HIIT training protocol may lead to improved BP and hemodynamic variables in patients with knee osteoarthritis. To evaluate the effect of high intensity interval physical training associated with an educational program on BP, hemodynamic variables of individuals undergoing treatment for knee OA. 63 patients with knee OA will be randomized into 3 groups: interval exercise (21), continuous exercise (21) and control (21). Patients will be evaluated for BP using ABPM, arterial stiffness and endothelial reactivity by measuring carotid-femoral pulse wave velocity and quality of life using the Euroqol scale.

NCT ID: NCT04050111 Not yet recruiting - Knee Osteoarthritis Clinical Trials

The Evaluation of Safety and Effectiveness of Intraarticular Administration of Autologous Stromal-Vascular Fraction of Adipose Tissue Cells for Treatment of Knee Joint Arthrosis

Start date: August 21, 2019
Phase: Phase 2
Study type: Interventional

Stromal vascular fraction of cells (SVF) will be extracted from lipoaspirate by enzymatic digestion. SVF will be administered in a single dose intraarticularly. All patients will receive cell therapy.This is a single arm study with no control.

NCT ID: NCT04036266 Not yet recruiting - Clinical trials for Osteo Arthritis Knee

Clinical and Radiographic Outcomes of Medial Open-wedge High Tibial Osteotomy

Start date: October 1, 2019
Phase:
Study type: Observational

Osteoarthritis is a common degenerative disorder of the articular cartilage . Risk factors include genetics, female sex, past trauma, advancing age, and obesity. The diagnosis is based on a history of joint pain worsened by movement, which can lead to disability in activities of daily living . Diagnosis of knee osteoarthritis can be confirmed based on clinical and/or radiological features. The potential of a progressive disease can be prevented or decreased by earlier recognition and correction of associated factors. Obesity and alignment especially varus malalignment are recognized factors of a progressive disease. High tibial osteotomy (HTO) is a widely performed procedure, and good results can be achieved with appropriate patient selection and precise surgical technique. It is reported to be an effective treatment for varus knee osteoarthritis (OA) by redistributing the load line within the knee joint . With an HTO, the surgeon aims to change the coronal alignment of the leg in order to shift the center of force passing axially through the knee from the arthritic region of the knee towards the unaffected side. The amount of alignment correction to be performed is calculated before surgery based on the extent of knee arthrosis and on the alignment of the patient's lower limbs on long-leg weight bearing radiographs . Our study is focused on effectiveness of open wedge High tibial osteotomy on clinical and radiographic outcomes of patients with medial knee osteoarthritis.

NCT ID: NCT04033588 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

Freedom® Total Knee System for Treatment of Osteoarthritis, Rheumatoid Arthritis or Post-traumatic Arthritis

Freedom®450
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

A prospective, multi-centre, non-comparative, post-market clinical follow-up study to evaluate the survivorship, safety and performance of the Freedom® Total Knee System in the treatment of approximately 450 subjects who in the surgeon's opinion require a primary total knee replacement due to severe knee joint pain and loss of mobility due to osteoarthritis, rheumatoid arthritis or post-traumatic arthritis at upto 15 centers in the United Kingdom (UK). The primary objective of this study is to obtain implant survivorship and clinical outcomes data for commercially available Freedom® Total Knee System used in total knee replacement. Subjects must meet all the study inclusion / exclusion criteria before enrolment in the study. Subjects will be requested to attend out-patients clinic for clinical follow-up (CFU) or approached for telephonic follow-up (TFU) post-operatively as mentioned below. Clinical & Telephonic Follow-up details: - 6-8 weeks ± 1week (Clinical follow-up) - 1 year ± 1 month (Clinical follow-up) - 3 years ± 6 months (Clinical follow-up) - 5 years ± 6 month (Clinical follow-up (optional) / Telephonic follow-up) - 10 years± 6 month (Clinical follow-up (optional) / Telephonic follow-up)

NCT ID: NCT04018690 Not yet recruiting - Hip Osteoarthritis Clinical Trials

Project Arthritis Recovering Quality of Life Through Education - Hip

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Introduction: One in four people are at risk of developing symptomatic hip OAH. Perhaps the greatest potential for improvement in OAH treatment is to approach the early stages of pathology, since total hip arthroplasty was considered 20th century surgery, with high cost-effectiveness in patients who are not responding to clinical treatment. Joint lavage with saline shows significant pain relief in patients with knee and hip OA. In addition, when the saline solution is injected under pressure, it can generate a hydraulic distension of the capsule, increasing the joint amplitude and increasing the effect of drugs injected after washing. Injection of corticosteroids (CS) is recognized for improving the effects of joint washing, pain and even viscosupplementation. In the investigators experience, lavage and infiltration of triamcinolone, lidocaine with or without hyaluronic acid led to subjective-functional improvement and range of motion of the majority of patients with OAH grades 2 and 3 of K & L undergoing the procedure. Intra-articular injection of hyaluronic acid (HA) is analgesic and anti-inflammatory in addition to promoting better distribution of forces, lowering pressure by weight and recovering the viscoelastic properties of synovial fluid, i.e., mechanical effects. In previous studies by the investigators, the addition of hilano to the lavage and injection of triamcinolone and local anesthetic led to gains in joint amplitude that were maintained over a year. Objective: To evaluate whether lavage followed by injection of triamcinolone, ropivacaine and 4 mL of hylan in the affected joint (Hilano) improves function, range of motion, pain, quality of life and muscle strength in patients with OAH in the early stages METHODS: 48 patients from the public network attended by the Orthopedics and Traumatology Institute of the General Hospital of the Medical School of the University of São Paulo, already identified with bilateral OA of the hip submitted to THR in one limb and the other limb presenting OA mild or moderate with indication of non-surgical treatment will be submitted to lavage, saline infiltration and CS (control group) or lavage, saline infiltration, CS and Hilano. Patients will be assessed at 1, 3, 6 and 12 months after the procedure using standardized questionnaires (WOMAC and Lequesne), quality of life scales (Euroqol-EQ-5D-5L), pain, range of motion and strength using an isokinetic dynamometer.

NCT ID: NCT04017858 Not yet recruiting - Knee Osteoarthritis Clinical Trials

PARQVE Prior to Total Knee Replacement

Start date: August 1, 2019
Phase: N/A
Study type: Interventional

Introduction: Elderly patients, the majority of the population submitted to total knee arthroplasty (TKA), have a lower capacity for adaptation to hospitalization and surgical stress. Exercise before cardiac and abdominal elective surgery was shown to reduce the number of complications. Studies have shown that preoperative exercise improves functional performance, strength and may decrease hospital stay after an ATJ. Objective: To evaluate if the program exercises before TKA improves quality of life, function, pain and body composition, time of hospitalization and number of complications of patients submitted to TKA. Methods: 44 patients awaiting TKA in IOT-HC-FMUSP will be divided into two groups. Half of the patients will undergo a multiprofessional and physical activity educational program for 20 weeks while the other half will wait for the TCA in the outpatient clinic. Patients will be evaluated through functional tests (sit-up and 30-second tests and time up and go), standardized questionnaires (WOMAC and Lequesne), quality of life scales (Euroqol-EQ-5D-5L), pain (through VAS), body composition and bone density (through densitometry), time of hospitalization and complications resulting from TKA. All of the above parameters will be assessed at baseline and 1 and 6 months after TKA. All project costs will be reported and a cost-effectiveness and cost-utility analysis will be performed.

NCT ID: NCT04001699 Not yet recruiting - Multimorbidity Clinical Trials

Interprofessional Preoperative Geriatric Assessment for Older Arthroplasty Patients With Multimorbidity

IPPGA-RCT
Start date: August 19, 2019
Phase: N/A
Study type: Interventional

The objective of this randomized control trial is to investigate effects and cost effectiveness of interprofessional preoperative assessment among older knee or hip arthroplasty patients. The main hypothesis is that preoperative assessment and optimization have a positive impact on the patents' quality of life and expenditure of social and health care services.

NCT ID: NCT04001361 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Laser Cell Therapy for Knee Cartilage Repair

Start date: July 15, 2019
Phase: N/A
Study type: Interventional

Laser pulsed energy will be delivered over an optical fiber to create channels into damaged cartilage of the knee or knees. The channels have a diameter of approximately 100 microns or less and an approximate depth of 1 millimeter or less. Bone marrow aspirate will then be delivered into the damaged joint.

NCT ID: NCT03985709 Not yet recruiting - Clinical trials for Osteoarthritis of Multiple Joints

Probiotic for Osteoarthritis

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

The gut microbiome appears to be a significant contributor to musculoskeletal health and disease. Microbiome composition and its functional implications have been associated with prevention of bone loss and/or reducing fracture risk. Genetic background, gender, dietary intake, and social factors are also important factors which contribute to the musculoskeletal health, as well as to the normal balance of intestinal microbiota. The link between gut microbiota and joint inflammation in murine models of arthritis has been established, and it is now receiving increasing attention in human studies. Recent papers have demonstrated substantial alterations in the gut microbiota in patients with rheumatoid arthritis (RA) and osteoarthritis (OA). These alterations resemble those established in systemic inflammatory conditions (inflammatory bowel disease, spondyloarthritides, psoriasis), which include decreased microbial diversity and lower abundances of bacteria belonging to the Firmicutes phylum that are known to have immunoregulatory properties.These new findings open important future horizons both for understanding disease pathophysiology and for developing novel biomarkers and treatment strategies. Further investigation into the mechanisms linking changes in the microbiome to alterations in bones and joints is necessary. Next Generation Sequencing, metatranscriptomic analysis, and metabolomic approaches may provide yet-greater insight and help further understand these mechanisms. To investigate gut microbiota change will be associated with the sintoms of knee and / or hip OA in italian patients.