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Osteoarthritis, Knee clinical trials

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NCT ID: NCT02873403 Recruiting - Clinical trials for Osteoarthritis, Knee

Novel 3D Printed Knee Brace for Medial Knee Osteoarthritis

Start date: March 2017
Phase: N/A
Study type: Interventional

Around 250 millions of people in the world (3.8%) have knee osteoarthritis (KOA). Due to aging and increasing obesity, the prevalence of KOA is expected to increase in the developed country in the next 20 years. KOA decreases quality of life of patients through chronic pain, joint stiffness, and reduced social activity, which influence emotional wellness as well. KOA has also impact on the biomechanics of the lower limbs, leading or amplifying the tibiofemoral misalignment and an increase of the medial knee joint loading. Increase of the medial knee joint loading may lead patients into a vicious circle by increasing knee pain, decreasing activities, increasing weight and disease progression. Knee brace is a non-pharmacological treatment recommended for KOA. It aims to reduce misalignment of the limb. However, the main issue is the poor compliance because of lack of effectiveness, more drawbacks than benefits, discomfort, bad fitting, migration of the brace, bulkiness, aesthetic, skin irritation, blisters and too much pressure on the knee. By its freedom in design, 3D printing may resolve most of these complaints. This study aims to compare clinical and biomechanical effectiveness, comfort and patients complaints of a knee brace made by 3D printing to a conventional knee brace. The institute for Applied Health Research of Glasgow Caledonian University (GCU) will lead the experimental trial. They will recruit men or women (40 to 70 years old) suffering from medial KOA in Glasgow area. Participants will be in study for 10 weeks. During this period, they will wear 2 different knee braces for two weeks each with a 1-week period without knee brace between. Participants will have five visits to GCU: once for leg measurement to make knee braces and four times to fill questionnaires and perform gait analysis. Besides, they will wear activity monitor for 3 non-consecutive weeks.

NCT ID: NCT02845206 Recruiting - Knee Osteoarthritis Clinical Trials

Bespoke vs Standard Instrumentation in TKR

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

Total knee replacement (TKR) is an established treatment for knee osteoarthritis and leads to a satisfactory outcome in over 75% of patients. The pain and function after TKR can be dependent on the accuracy of initial implantation, as deviation of more than 3 degrees from the normal alignment of the limb can lead to abnormal stresses on the implant and accelerated failure. Patient specific cutting blocks may result in a more individualised implant placement, improved pain and function following surgery, and a long-lasting implant. This trial is designed to investigate if there is any benefit to bespoke instrumentation in terms of pain and function to the patient, and an economic benefit to the NHS.

NCT ID: NCT02844751 Recruiting - Osteoarthritis Clinical Trials

Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee

Start date: July 2015
Phase: Phase 2
Study type: Interventional

This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000 patients.

NCT ID: NCT02829281 Recruiting - Knee Osteoarthritis Clinical Trials

Intra-articular Botox Type A Versus Corticosteroids in Knee Osteoarthritis

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

Introduction: Osteoarthritis of the knee is a very common disease. However there are few treatment options for these patients. Botulinum toxin type A is an option for chronic pain. If the investigators prove effectiveness of its use for intra-articular analgesia, Botulinum toxin type A can be useful for treat these patients. Objective: Compare the effectiveness of the use of intra-articular corticosteroid versus Botulinum toxin type A in the treatment of patients with knee osteoarthritis. Methods: A prospective controlled randomized double blind studied with three groups (n = 35 each group) of patients with symptomatic osteoarthritis of the knees receive intra-articular medication in a single moment will be undertaken. The three groups will be: Botulinum toxin type A Group: patients who receive 100 units of botulinum toxin; hexacetonide of triamcinolone Group: patients who receive 40mg of triamcinolone hexacetonide, and saline group: patients who receive 2ml of normal saline. Patients will be assessed by evaluators " blind " in 4 times during 12 weeks of follow-up with clinical assessment instruments (pain, quality of life questionnaire as short form 36 questionnaire) , functional ( WOMAC questionnaire) , and ultrasound (quantitative and semi quantitative measure of synovial hypertrophy and semi quantitative Power Doppler ) .The following statistical tests will be used : Student's t test, Mann - Whitney , chi- square test and ANOVA for repeated measures . Will be considered as statistical significance the difference of 5 %.

NCT ID: NCT02826031 Recruiting - Knee Osteoarthritis Clinical Trials

Clinical Study of Artz in the Treatment of Knee Osteoarthritis

Artz
Start date: April 2016
Phase: Phase 4
Study type: Interventional

This is a multi-center, randomized, open-label, parallel-arm phase IV clinical study, for which a total of 300 patients with mild to moderate knee osteoarthritis will be enrolled. In the first 4 weeks (run-in period), the subjects will receive on-demand treatment with Diclofenac Sodium Sustained Release Tablets (DICL-SR) 75mg, quaque die(QD). After the run-in period, the subjects, if their knee pain has not worsened to a level requiring surgical treatment, will be randomized to two groups in 1:1 ratio: one group receiving Artz® via intra-articular injection (once weekly, for 5 consecutive weeks) in combination with DICL-SR 75mg,quaque die(QD), for 12 consecutive weeks on demand. The other group receiving DICL-SR 75mg alone,quaque die(QD), for 12 consecutive weeks on demand. DICL-SR 75mg quaque die(QD) may be administered to the subjects of both groups on demand as long as they have a knee pain. If the knee pain has disappeared, this drug may be withdrawn. However, if the pain occurs again and requires treatment, oral administration of DICL-SR may be resumed. A subject is allowed to withdraw from this study prematurely if unable to tolerate the adverse effects. A total of 8 visits have been scheduled for this study, including Visit 1/screening period (Week -4), Visit 2/baseline (Week 0), Visit 3 (Week 1), Visit 4 (Week 2), Visit 5 (Week 3), Visit 6 (Week 4), Visit 7 (Week 8) and Visit 8 (Week 12). A total of 300 subjects will participate in this study at 6 to 8 centers in China, and patient enrollment is expected to take up to 12 months.

NCT ID: NCT02821468 Recruiting - Clinical trials for Osteoarthritis, Knee

Evaluation of the Evolution of Imaging Markers of Cartilage Degradation in Patients With Knee Osteoarthritis Receiving DROGLICAN

DRIP
Start date: June 2016
Phase: Phase 4
Study type: Interventional

A previous multicenter trial led by Bioiberica S.A. has confirmed the efficacy and safety of DROGLICAN for the treatment of osteoarthritis (OA) in patients with severe pain. The MOVES study was a phase IV, double blind, randomized and non-inferiority trial to compare the efficacy and safety of a fixed dose combination of glucosamine hydrochloride (GH) + chondroitin sulfate (CS) (DROGLICAN) versus celecoxib in patient with symptomatic knee OA with moderate to severe pain. This study concluded that both drugs reduced the WOMAC Pain subscale by 50% without significant difference between groups. Further, there was no difference in all secondary outcomes assessing patient's pain, functional capacity, stiffness, inflammation, joint swelling, effusion, and overall quality of life. This new exploratory trial is aimed to evaluate the beneficial effect of DROGLICAN on the good health of the cartilage of patients suffering of knee osteoarthritis as revealed by qualitative assessment of cartilage biochemical composition in vivo.

NCT ID: NCT02766231 Recruiting - Knee Osteoarthritis Clinical Trials

Physica CR and Physica PS Clinical Trial

Start date: February 2016
Phase:
Study type: Observational

Type & Design: Post-market, international, multicentre Prospective, parallel groups, open-label, baseline controlled Objectives: 1. Assessment of clinical, radiographic and patient-reported outcomes of Physica CR and PS designs 2. Incidence of adverse events and identification of possible risk factors for unsatisfactory results 3. Mid-term survivorship of the implants

NCT ID: NCT02760459 Recruiting - Clinical trials for Osteoarthritis of the Knee

Effects of Perioperative Intravenous Dexamethasone on the Severity of Persistent Postsurgical Pain After Total Knee Arthroplasty : A Prospective, Randomized, Double-blind, Placebo-controlled Trial

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

To compare the effects of perioperative intravenous Dexamethasone with a placebo on the severity of persistent postsurgical pain after total knee arthroplasty.

NCT ID: NCT02738476 Recruiting - Clinical trials for Osteoarthritis, Knee

Outcomes of MAKOplasty Patellofemoral Arthroplasty in Younger Active Patients

Start date: April 2016
Phase:
Study type: Observational [Patient Registry]

The primary purpose of this investigation is to report the short-term clinical outcomes (2-3 years) of patellofemoral arthroplasty implanted using the MAKOplasty knee resurfacing system.

NCT ID: NCT02734342 Recruiting - Knee Osteoarthritis Clinical Trials

Mixed Methods Assessment of Exercises for Knee OA

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

Osteoarthritis (OA) is a condition that causes cartilage loss, bony remodeling, joint stiffness and generalized muscle weakness. 90% of OA presentation has been reported within the leg; with 44% affecting the knee joint. Knee OA is expected to increase by 50% over the next twenty years due to an ageing population, obesity, and societal trends such as lack of activity. Only 13% of knee OA sufferers reach the recommended levels of exercise therefore an understanding of how psychological and functional relationships effect exercise engagement, which in turn would provide a more comprehensive rehabilitation programme for patients with knee OA. The aim of this study is to investigate exercise in knee OA and it it's correlation with fear of movement, using a mixed methods approach. Quantitative methodology will investigate lower limb exercises for pain and function and fear of movement. The desired outcome of the study will show that a reduction in pain with patient specific exercise will also reduce the fear of movement and allow patients to self-manage their symptoms without fear. Other quantitative factors such as intensity of exercise and postural stabilization using the Y balance test will also be utilized to review the functional relationship of muscle strength and balance to kinesiophobia. A semi-structured interview will be completed at the end of the course of treatment to highlight what patients think about exercise as an intervention. Participants aged forty-five and above with specific clinical symptoms will be invited into the study and will be asked to attend eight exercise sessions within a class environment, which will last for 1 hour within the Physiotherapy Department.