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Osteoarthritis clinical trials

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NCT ID: NCT03106584 Not yet recruiting - Knee Osteoarthritis Clinical Trials

The Marigot Osteoarthritis Nutritional Intervention (MOANi) Trial

MOANi
Start date: May 1, 2017
Phase: N/A
Study type: Interventional

The purpose of the study is to test 30 individuals with mild-moderate knee joint osteoarthritis to investigate whether the combination of Aquamin (a calcium-rich marine multi-mineral) and a polyphenol-rich pine bark extract (Enzogenol), when taken as a food supplement for 3 months has comparable or superior benefits to glucosamine sulphate in patients with painful knee osteoarthritis (KOA). From here on in we refer to Aquamin's combination product as Aquamin-plus. The main outcome measure is a reduction in pain. Provision of data that demonstrate preliminary equivalency or superiority to current, non-pharmaceutical options such as glucosamine will broaden consumer choice, and provide them with an option that is supported by science, rather than marketing alone. The hypothesis of the study is that the consumption of Aquamin-plus will have comparable effects on reducing pain in individuals with Knee Joint OA to glucosamine.

NCT ID: NCT02993016 Not yet recruiting - Clinical trials for Osteoarthritis, Patient-specific Instruments

Conventional Versus Patient-specific Instruments in Total Knee Arthroplasty

Start date: December 2016
Phase: N/A
Study type: Interventional

Total knee arthroplasty (TKA) has a high success rate for addressing pain and improving function. However, in instances where incorrect positioning and malignment of the TKA components are observed, patients can experience a range of negative postoperative outcomes such as loss of thickness of polyethylene tibial bearings, eccentric loading, implant loosening, and eventual early revision. To avoid these complications, achieving a postoperative alignment within the range of 0°±3° of the mechanical axis is recommended. Manual intramedullary/extramedullary guides are not thought to be capable of consistently achieving axes in this range, and though computer-assisted navigation has shown superior results in comparison with conventional instrumentation, it is also limited by increased surgical times and no clear superiority in improving short-term clinical outcomes. Thus, there has been in a push in the orthopaedic community to create more precise technologies to aid in the reconstruction of the knee's mechanical axis. Patient-specific instrumentation (PSI), which uses anatomical data obtained primarily from pre-operative axial computed tomography (CT) or magnetic resonance imaging (MRI) to create disposable cutting jigs individualized to the patient's unique anatomy, was created with this goal. This study aims to compare the clinical results of conventional and patient-specific instruments in total knee arthroplasty.

NCT ID: NCT02992613 Not yet recruiting - Clinical trials for Osteoarthritis, Ultra-Congruent(UC) Insert

Ultra-Congruent(UC) Versus Posterior-stabilized(PS) Insert in Bilateral Total Knee Arthroplasty

Start date: December 2016
Phase: N/A
Study type: Interventional

Numerous studies have echoed the superior clinical outcomes of posterior-stabilized (PS) total knee arthroplasty compared to posterior cruciate-retaining (CR) total knee arthroplasty. The post-cam mechanism of posterior-stabilized (PS) total knee arthroplasty has been postulated to provide reproducible femoral rollback and increased flexion. However, posterior-stabilized (PS) total knee arthroplasty systems are purportedly limited due to several post-cam related problems, including post-cam dislocation, wear and breakage of post, and patellar clunk syndrome. Moreover, the post-cam mechanism requires additional bone resection and poses a risk for intercondylar fracture of the distal femur during box preparation. To overcome these issues, a fixed-bearing highly conforming ultra-congruent (UC) total knee arthroplasty was introduced. This study aims to compare the clinical results of Ultra-Congruent(UC) and posterior-stabilized(PS) insert in bilateral total knee arthroplasty.

NCT ID: NCT02964143 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Clinical Investigation to Compare the Safety and Efficacy of Cellular Matrix to Those of Ostenil® Plus and to Those of PRP Only

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

Platelet-rich plasma (PRP) is an autologous product prepared from the patient's own blood, representing a powerful source of platelet-derived growth factors, particularly useful in the field of regenerative medicine. The active and sequential secretion of these growth factors induces different cell signaling cascades that activate angiogenesis, cell proliferation, cell differentiation, eventually leading to new matrix synthesis and tissue regeneration. The potential benefits from the use of PRP for the treatment of cartilage defects rely on a number of studies conducted in validated animal models or in vitro, demonstrating the ability of PRP to stimulate collagen production and proteoglycans synthesis, as well as the proliferation and differentiation of mesenchymal stem cells into chondrocytes. Additionally, an increasing number of clinical studies shows an improvement of symptoms, most especially pain, without any occurrence of serious adverse events. Hyaluronic acid (HA), as one of the major components of the synovial fluid surrounding the cartilage, assumes an important role in the viscoelastic properties of the articular cartilage, conferring its shock absorbing and lubricating functions. It was demonstrated that rheological properties of synovial fluid decrease with aging and in patients suffering from osteoarthritis. Nowadays, intra-articular injections of hyaluronic acid represent a well recommended therapeutic option to relieve osteoarthritic symptoms, conferring a mechanical action on joints structures, thus leading to reduced pain and improved joint function Based on these data, it seems reasonable to hypothesize that a combination of both PRP and hyaluronic acid could provide greater benefits compared to the administration of each product alone, as their effects on osteoarthritis improvement are based on different mechanisms of action. In fact, on one side PRP promotes cartilage regeneration, while on the other side the HA acts as 3-dimensional support mesh for PRP, providing optimal release of platelets growth factors, strengthening and extending in time the activity of PRP. Cellular MatrixTM is a CE-marked class III medical device manufactured by the Swiss company RegenLab SA. Cellular MatrixTM allows to prepare autologous PRP combined with a non-crosslinked hyaluronic acid in a safe, rapid manner and in a single step. The PRP/HA combination is intended to be injected intra-articularly, in order to relieve osteoarthritic symptoms and to improve joint mobility and function. Therefore, the PRP/HA combination might represent a novel therapeutic option for patient suffering from knee osteoarthritis. This study will evaluate whether the effects of a PRP/HA combination prepared with Cellular Matrix™, when injected intra-articularly for the treatment of mild to moderate knee osteoarthritis, are superior to those of a well-recognized hyaluronic acid treatment (Ostenil® Plus), on one hand, and to those of PRP alone, on the other hand.

NCT ID: NCT02949466 Not yet recruiting - Physical Activity Clinical Trials

Additional Effects of Triamcinolone to Hyaluronic Acid on Knee Osteoarthritis

Start date: October 2016
Phase: Phase 4
Study type: Interventional

Using a double-blind, randomized controlled design to investigate the additional therapeutic effects of 3 times of combined triamcinolone and hyaluronic acid injections to 3 times of hyaluronic acid injections to patients with knee osteoarthritis.

NCT ID: NCT02948218 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis

Start date: January 2017
Phase: Phase 3
Study type: Interventional

Knee osteoarthritis (KOA) is a major public health problem among the elderly and is associated with considerable disability. A recent analysis of data indicated that about 35% of women and men aged 60 years and above had radiographic knee OA.Despite the high prevalence rate of OA, the treatment of OA is far from satisfactory. Acupuncture may be a promising treatment option for knee OA due to the effectiveness of the pain relief and the rarity of adverse effects. In order to get some more reliable data to confirm acupuncture effectiveness on KOA, a long-term follow up interventional study will be started to confirm the effects of long term for acupuncture treatment.

NCT ID: NCT02928666 Not yet recruiting - Hypertension Clinical Trials

Integration of Guidelines for Comorbidities

Start date: October 2018
Phase: N/A
Study type: Interventional

Introduction: in the course of the research, the investigators will develop a decision-support system (comorbidity-DSS) consisting (1) a knowledge base (KB) consisting of (a) computer-interpretable clinical guidelines for type 2 diabetes and 2 other diseases from: obstructive pulmonary disease, osteoporosis, hypertension, and osteoarthritis; and (b) an ontology of relevant general medical knowledge that could complement (a) in order to propose non conflicting treatment options not mentioned in the clinical practice guidelines; and (2) an algorithm that matches the KB with a patient's data set to identify the guidelines-based recommendations applicable for the patient and their interactions and which proposes ways to mitigate conflicting interactions (e.g., suggesting to select intervention A.2 (instead of A.1) from guideline A and intervention B.3 (instead of B.1) from guideline B together with an action B' mentioned in the general medical knowledge, because these interventions are not conflicting yet A.3 fulfills the same goals as intervention A.1 and intervention B.3 + B' together fulfill the same goal as B.1). Research purpose: Assessing the correctness and completeness of detection of recommendation-interaction and generation of conflict-free recommendations by a comorbidity-DSS Research question: How will the usage of the comorbidity-DSS affect the completeness and correctness of clinicians regarding (a) detection of interactions between recommendations originating from different clinical guidelines applicable for patients with comorbidities and (b) identification of interventions that fulfill the guidelines' goals and are not conflicting.

NCT ID: NCT02924662 Not yet recruiting - Depression Clinical Trials

The Investigation of the Depression in Osteoarthritis

Start date: October 2016
Phase: N/A
Study type: Observational

Studies have reported that the patient's psychological state such as anxiety, depression and other emotion affect the therapeutic effect of osteoarthritis, also may be the important reason for the poor knee joint osteoarthritis efficacy. The aim of this study are firstly to investigate the depression status of patients with osteoarthritis. Secondly, the study will aim to assess whether osteoarthritis progression will affect depression status, ultimately, provide reference for clinical.

NCT ID: NCT02885402 Not yet recruiting - Osteoarthritis Clinical Trials

Functional Exploration of Cartilage in Patients With Osteoarthritis of the Knee Through MRI Sodium ( 23Na )

Start date: October 2016
Phase: N/A
Study type: Interventional

Osteoarthritis is a degenerative disease of hyaline cartilage not associated with an infection or an inflammatory process that affects millions of people. The first symptoms usually appear from 40-50 years and at this point, conventional radiological tests provide diagnostic elements relatively late, poorly correlated with pain relief and providing no functional information. In this context, there is a real need for imaging techniques for early detection of osteoarthritic changes in a still reversible stage for faster support and MRI appears to be the tool of choice. Conventional proton MRI sequences already allow improved detection possibilities compared to conventional radiology and CT arthrography supplanted. They nevertheless remain insufficient to identify incipient lesions or paradoxically to the point of too advanced lesions. Due to recent technological advances, exploration MRI other nuclei such as sodium is now possible. Quantitation of sodium in the cartilage by sodium MRI allow quantifying proteoglycan loss and ultimately a gradation osteoarthritic reached. This project's main objective is to quantify the biochemical changes (sodium content) occurring at different stages of osteoarthritis defined by clinical algofunctional scores (Lequesne) and conventional radiographic scores (Kellgren and Lawrence).

NCT ID: NCT02873611 Not yet recruiting - Knee Osteoarthritis Clinical Trials

Estimation of the Localization Accuracy of the Genicular Ablation Procedure Applied for Chronic Pain Suppression

Start date: August 2016
Phase: N/A
Study type: Interventional

Estimation of the localization accuracy of the genicular ablation procedure applied for chronic pain suppression