View clinical trials related to Osteoarthritis, Knee.
Filter by:The purpose of this study is to investigate the efficacy and safety of pulsed radiofrequency of the saphenous nerve in the treatment of pain due to knee osteoarthritis (OA). The investigators will conduct real pulsed radiofrequency or sham, over the saphenous nerve during 4 separate sessions. The investigators will evaluate pain intensity, quality of life, function, and disability via clinical validated scales. The research question is whether pulsed radiofrequency can lessen knee pain and improve function and quality of life in patients with chronic knee pain due OA. It is hypothesized, that less knee pain and improved function, and quality of life after the pulsed radiofrequency sessions.
The research questions of this study are; 1. Is platelet rich plasma (PRP) treatment effective in knee osteoarthritis (OA)? 2. What are the indications for PRP treatment? 3. Which patients are the most suitable for the PRP treatment method? 4. How does age, Body Mass Index (BMI), lower extremity mechanical axis angle and OA stages affect the success of the PRP treatment? 5. Is there any advantage of multiple PRP doses? 6. What is the therapeutic effect of placebo? This study was designed to find answers of these questions. The hypotheses of this study are; "PRP treatment is more effective than placebo; PRP treatment effectiveness decreases with age and advanced stages of OA; BMI is a factor that negatively affects the treatment effectiveness of the PRP; as the mechanical axis angle of the lower limb increases, it will adversely affect the effectiveness of PRP therapy; multiple dose of PRP affects the effectiveness and duration of PRP as positively compared to single dose of PRP". The primary purpose of this study; to prove the effectiveness of PRP treatment on knee pain and functions in patients with knee OA by comparing it with the placebo control group. Secondary purposes of this study; to understand the effect of age, BMI, OA grade and lower limb mechanical axis angle on PRP effectiveness. This study, designed as a randomized, double-blind and placebo control group, with a high level of scientific evidence. Thus, it will be scientifically possible to find answers to the investigators research questions and to prove the investigators hypothesis.
To define the clinical effects of intra-articular transplantation of bone-marrow-derived (BM-MMSCs) and placenta-derived multipotent mesenchymal stem / stromal cells (P-MMSCs) for knee osteoarthritis.
This is a phase 2 open-label, 6 arms (1 study group and 1 control group for each joint category), randomized control group clinical study with 300 subjects diagnosed with osteoarthritis of knees (n=100), hips (n=100) and shoulders (n=100). The study subjects will be evaluated for disease-associated severity according to symptoms, such as pain, mobility, daily active life, and functions using arthritis society established specific measurement tools related to the joints (KOOS and KSS for OA-knees: HOOS and HHS for OA-hips and ASES and CSS for OA-shoulders).
PPV-06 immunotherapy targets interleukin-6 (IL-6), a key molecule of the immune system whose overproduction is implicated in many inflammatory and autoimmune diseases such as rheumatoid arthritis and osteoarthritis. The benefit of vaccination with PPV-06 is to induce, in response to immunizations, the production of antibodies directed against IL-6. The antibodies produced will neutralize the biological activity of IL-6 involved in the body's inflammatory process. The primary objective is to evaluate the safety/tolerability of vaccination with PPV-06.
Non-surgical treatment options, like exercise therapy, show excellent short-term effects regarding pain reduction and improvement of knee function. However, mid- and long-term effects are missing so far. This might indicate that long-lasting changes in motor-skill performance (Motor Learning) have not occurred. Motor learning is associated with permanent changes in the capability for skilled movement behavior avoiding unfavorable joint loads and inappropriate muscle activation patterns, leading to compensatory movement strategies. One-sided and high repetitive loads in the knee joint could be one reason for the progression of knee osteoarthritis. Physiotherapeutic strategies should therefore be able to stimulate motor learning processes. In physiotherapy, motor learning can be optimized by using instructions and feedback, targeting an external focus of attention, when learning specific movement patterns. This study investigates the effects of a 12 week exercise therapy program, using an external focus of attention, on functional and biomechanical parameters in patients with knee osteoarthritis. To measure possible changes, functional measurements are taking place at baseline, after 6, 12 and 24 weeks. The biomechanical measurements (3D gait analysis) are taking place at baseline, after 12 and 24 weeks.
All across surgery specialties, wound or implant infections constitute rare, yet potentially severe complications of surgical procedure. It is considered, that glucose metabolism disorders, e.g. diabetes, are one of the main risk factors of such condition. Aim of the study The aim of the study is a prospective evaluation of glucose blood level and its variability during 2 weeks before hospitalization and 2 weeks of postoperative period in patients, that will undergo elective orthopaedic surgeries, and its impact on number of cardiovascular and orthopaedic complications. Materials and methods To this study, patients qualified for elective total knee or hip replacement in the single orthopedic center will be recruited. 100 patients will be included in this study. Every patient will be evaluated on the risk of developing diabetes mellitus in 10 years time and on the risk of death in 10 years due to the cardiovascular events. 14 days before procedure patients will have continuous glucose level measurement sensor implemented in subcutaneous tissue. After 14 days, during standard visit for stitches removal, the sensor will be removed and glycemia data will be collected. Next, patients will have their casual glucose blood level checked and surgery outcome, cardiovascular events or surgery complication risk evaluated in 3-, 6- and 12 month follow-up visits. Expected benefits of the study Results of this study may allow to define impact of orthopaedic treatment on glycemia and possible necessity to modify treatment of hyperglycemia in perioperative period in patients with Diabetes Mellitus type 2 (DM2). Moreover it will allow to specify change of glucose levels and possibly implicating a need to monitor perioperative glycemia in patients without carbohydrate metabolism disorders. Additionally, the study will help to evaluate corelation between perioperative glucose blood level and the risk of cardiovascular events or surgical complications in 1-year after the procedure, which may decrease the risk of such incidents in the future (e.g. by adequate control and effective treatment of hyperglycemia), hence may result in reduction of mortality and lesser lowering of the quality of life in patients with DM2 or high risk of it.
Knee osteoarthritis (OA) is the most common form of arthritis and the most common cause of knee pain in the world. The rate of knee arthritis is as high as that of cardiac disease and is the most common problem in individuals over the age of 65. Central Sensitization (CS) is a marker of widespread pain sensitivity that can occur throughout the central nervous system distribution, leading to changes in the spinal cord as well as in the brain. The presence of CS increases the complexity of the clinical picture and can negatively affect treatment outcomes. CS is present in >20% of patients suffering from knee OA indicating that in the majority of individuals suffering with painful knee OA, knee pain should be related to molecular changes in the joint. CS might be also associated with discrete synovial fluid proteomic signatures due to the generation by the joint of chemical mediators (e.g. nerve growth factor) that drive CS, or CS might moderate the relationship between synovial fluid proteomic signatures and symptoms due to alterations in pain processing. The aim of this study is to explore the potential molecular links between pain and structure on knee pain using synovial fluid proteomics. A secondary purpose is to explore the association of knee pain with biomarkers of stress, metabolism and dietary habits. In a single session, ultrasound-guided synovial fluid, blood urine and saliva extraction, clinical assessment, completion of a questionnaire booklet and knee x-rays will be conducted. The clinical assessment will measure three features of central sensitisation (sensitivity to blunt pressure on the most painful knee, changes in pain felt during repeated light pricking of the knee skin, and reduction in pain that accompanies inflation of a blood pressure cuff on the non-dominant arm), features of leg strength (dynamometer, time up-and-go test) and features of balance (sway). Participant involvement at each session is expected to last less than 3 hours. Individuals over 45 having complaints of knee pain for 3-6 months are eligible to participate. The clinical assessments, questionnaire completion and subsequent statistical analysis are expected to be completed within 18 months of study commencement. The findings can provide more insight into the traits of knee pain, allow the examination of possible correlations to each other, and highlight potential detrimental effects of them on knee joint health.
Although intra-articular knee injection with platelet-rich plasma (PRP) may have better outcomes than using hyaluronic acid (HA) for people with knee osteoarthritis (OA), it is expensive to use PRP. Programs with a combination of PRP and HA (PRP+HA) showed good results in vitro and animal studies. This 2-year study aims to clarify the short- and long-term effectiveness of the PRP+HA program for knee OA. The study will recruit 60 persons aged between 50 and 80 years who have experienced symptomatic knee OA for 6 months or more and have a radiographic picture of knee OA of grades 1-3, based on the Kellegren-Lawrence scale. Those who have diabetes, fever, anemia (Hb <10 g/dl), thrombocytopenia (platelet count <150000/ml), a blood-clotting disease, knee deformity (genu valgum/varum >20 degrees), impaired leg mobility secondary to neuromuscular diseases or a bony fracture, impaired mental function, severe cardiopulmonary impairment, taking anticoagulants long-term, a history of intra-articular steroid injection in the prior 1 year, a history of knee injury involving ligaments and menisci, and a history of malignancy are excluded. All participants will be randomly divided into group A and group B. At the beginning of the study (T0), group A will receive one course of PRP+HA program and group B will receive one HA course (a single HA injection (Hyajoint) weekly for 3 weeks). The PRP+HA program includes 3 HA injections and a single PRP injection (Arthrex double syringe system). In the 6th month, alternately, group B will receive one PRP+HA program and group A will receive one HA course. The study has 3 outcome assessment tools including a self-administered Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index, measurement of quadriceps strength with a digital handheld dynamometer, and measurement of femoral condylar cartilage thickness with musculoskeletal ultrasound. The investigators will conduct those assessments in the beginning (T0) of the study and the following 1st (T1), 3rd (T2), 6th (T3), and 9th (T4) months. In the 18th month following the beginning of the study, both groups will receive a booster course of PRP+HA program. During the first week of the program, group A will receive a HA injection before the PRP injection and group B will receive the HA injection after the PRP injection. The investigators will conduct the long-term assessments in the 12th (T5), 15th (T6), 18th (T7), and 21st (T8) months since the beginning of the study.
This study is a pivotal study to evaluate the efficacy and safety of a single injection of autologous adipose-derived SVF produced using the GID SVF-2 device system for treatment of pain with concomitant improvement in function associated with osteoarthritis of the knee joint.