View clinical trials related to Osteoarthritis, Knee.
Filter by:Study objectives: - Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety, tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945. - Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and tolerability of a single intra-articular dose of SAR113945.
This study evaluates the effects of specialized footwear on pain and knee loading in knee osteoarthritis. The hypothesis is that this footwear will lead to decreased knee loading and knee pain.
Primary Objective: - To evaluate the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore (walking pain) at 26 weeks compared to the Baseline score - To evaluate the safety using the incidence, severity, seriousness, relatedness, and frequency of all treatment emergent Adverse Events (AEs) Secondary Objectives: - To evaluate the change in WOMAC A1 subscore (walking pain) between baseline and weeks 8, and 12 - To evaluate the change in WOMAC A, B and C score between baseline and weeks 8, 12 and 26 - To evaluate the change in Patient Global Assessment (PTGA) score between baseline and weeks 8, 12 and 26 - To evaluate the change in Clinical Observer Global Assessment (COGA) score between baseline and weeks 8, 12 and 26 - To evaluate the change in concomitant Osteoarthritis (OA) therapy over 26 weeks and between baseline and weeks 1, 2, 8, 12 and 26
In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis. The trial is based in our own previous results with autologous MSC (ongoing NCT01183728 trial). We propose here a multicenter, phase I-II clinical trial, prospective, randomized, blinded, and controlled for the treatment of osteoarthritis (degrees II and III and IV). The assay consists of two arms with 15 patients each one. Patients in the experimental arm will be given an intra-articular transplantation of allogenic MSC, expanded "Ex Vivo" with our GMP-compliant procedure (MSV, PEI No. 10-134, authorized by the Competent Authority; same as in NCT01183728). In the control arm a standard treatment with intra-articular injection of hyaluronic acid shall be given. We shall follow the evolution of pain, disability, quality of life and quantitative changes in structure and composition of cartilage determined by T2-weighted MRI relaxation (Cartigram) for one year.
Knee osteoarthritis (O.A. from now on) is associated to muscular weakness of inferior limbs, especially the quadriceps; leading to disease progression. Advantages of muscular strength training for the treatment of this kind of O.A. is now well established. In this therapeutic field, isokinetic exercises seem to have a better efficiency than other, more frequently used, kinds of exercises such as isometric or isotonic exercises. Functional impairment caused by knee O.A. is mainly affecting walking. Walking induces muscles to work in eccentric mode. The hypothesis of this study is that muscular strengthening using isokinetic exercises in eccentric mode would have a more important benefit than isokinetic exercises in concentric mode. Such an hypothesis, if verified, could lead to a better management of rehabilitative knee exercises in the treatment of knee O.A.
The objective of this study was to to evaluate the efficacy and safety of PG201 in osteoarthritis patients. This clinical study was designated to be non-inferiority test with level of significance: 95%, α=0.05. Type 2 error (β) was set as 0.2, and the power of the test was set as 80%. Assuming 20% drop-out rate, the number of subjects required for each treatment group was estimated to be 154, while the total number of subjects required for the study 308. non-inferiority margin: 8mm
Osteoarthritis (OA) has a major impact on mobility, disability and loss of productivity of patients. Patients can become disabled early in life by OA. The Osteoarthritis Research Society International (OARSI) is concerned to publish guidelines with the respective levels of evidence on the various forms of treatment of osteoarthritis of the knee and hip.It is believed that an education program has a positive impact on quality of life of patients with OA. Changing the habits of those patients is imperative for clinical improvement. The investigators propose the creation of an educational program consisting of various health professionals so that we can educate the patients about OA disease, and their role in treatment. This program will be administered in a single day and reviewed/reinforced after an interval of time. Half the patients will be monitored monthly by phone when questions specific to each health area will be made to participants. This way we will evaluate the strength of the telephone follow-up. The investigators are going to create educational printed an audiovisual materials for patients, so the patients can access the information given in the theoretical course at home. Calculation of cost-effectiveness and presentation of data to the authorities.
Osteoarthritis (OA) is the most prevalent form of arthritis in the elderly. It is estimated that 7% of men and 11% of women over the age of 65 have KOA. The most significant symptoms of the disease are pain and functional disability. This study has two aims: 1. To characterise the gait patterns and clinical parameters of patients with knee osteoarthritis (KOA) in Singapore at baseline, prior to treatment. 2. To investigate the changes in gait patterns and the clinical benefits of treatment with a new biomechanical device, AposTherapy, for patients with KOA.
The purpose of this study is to evaluate whether the investigators can develop a computer algorithm to predict which individual patients will respond to injections of hyaluronic acid (HA) products for knee osteoarthritis.
The purpose of this study is to assess the efficacy of a single dose level of gefapixant (AF-219/MK-7264) in subjects with moderate to severe pain associated with osteoarthritis (OA) of the knee compared with placebo after 4 weeks of treatment. The study will also assess the safety and tolerability, changes in physical function, stiffness, treatment response and health outcomes.