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Osteoarthritis, Knee clinical trials

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NCT ID: NCT04240873 Recruiting - Clinical trials for Osteoarthritis, Knee

Clinical Study of Intra Articular Injection of Catholic MASTER Cell (Bone Marrow Derived Mesenchymal Stem Cell) in Knee Osteoarthritis

MSC-OA
Start date: November 15, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

1. objective - safety and efficacy evalaution of MASTER cells injected into knee of patients with osteoarthritis 2. background - osteoarthritis - Osteoarthritis is severe and intractable musculoskeletal disease that eventually leads to joint failure and pain due to inflammation and joint injury. - OA is one of the most prevalent diseases. The prevalence increases with age, but overuse and trauma can result in OA in young population as well. - Injured cartilage can not be regenerated spontaneously, untreated injured cartilage eventually leads to osteoarthritis. Surgical treatment may repair the damage but the reparied cartilage may turn out to be fibrocartilage rather than hyaline cartilage. - Curent treatment - medical therapy: medication for symptom relief, together with exercise. Medications include NSAIDS visco-supplement. - surgical therapy: total knee replacement arthroplasty - to overcome such limitations, cell therapy such as stem cell/ chondrocyte injection is being investigated 3. Hypothesis - Intra articular injection of MASTER cells will show safety and efficacy in terms of pain and functional improvement. 4. Protocol 1) deisgn : Injection of MASTER cell 1X 10^8 cells/2cc (experimental arm) or 2cc saline (placebo arm) into knee of patients with osteoarthritis 2) outcomes - primary outcome : safety evaluation(adverse event) - secondary outcomes : check on 1,2,3,6,9,12 months, atient reported outcome (WOMAC, KOOS, IKDC, pain VAS) 3,12 months SF-36, knee MRI score, serum cytokine, bone turnover marker 12 months x-ray 3) Disease - osteoarthritis 4) Subjects 1. inclusion : age 20-80yrs, diagnosed with OA according to ACR criteria for knee OA, baseline pain VAS equal or more than 50mm 2. exclusion: lower extremities surgery within 6months or planned surgery, concommitant systemic rheumatic diseases that can affect the results of the trial, steroid intraarticular inejction into the index knee within 3months, clinicallly meaningful abnormal lab tests (liver function, kidney function) 5) evaluation - primary outome : compare the number and proportion of of adverse event and lab test abnormalities between the two arms - secondary outome 1. change of 100mm pain VAS 2. change of Western Ontario and McMAster Universities Osteoarthritis (WOMAC) pain VAS, IKDC, KOOS total score 3. change WOMAC sub scale, IKDC, KOOS 4. chagne of KHAQ 5. change of MRI indices 6. change of x-ray( joins space narrowing) 7. change of serum ESR/CRP, CTX-II

NCT ID: NCT04238143 Recruiting - Osteoarthritis Clinical Trials

Adipose-Derived Biocellular Regenerative Therapy for Osteoarthritis

GARM-MSK-ALD
Start date: January 10, 2020
Phase: N/A
Study type: Interventional

Use of Biocellular and cellular approaches to treatment of Osteoarthritis (OA), musculoskeletal aging processes, pain, and degenerative changes are to be studied with minimally invasive protocols, and non-pharmaceutical means to relieve OA and its associated issues. Traditional surgical interventions have not yielded convincing long-term outcomes, including total joint replacement surgeries and medical management of the supportive structures. This study is to use a person's own stem/stromal Cells (autologous) plus HD-PRP (important healing growth factors and signal molecules) in such cases of OA for long-term minimally invasive treatments. Baseline (existing) findings are documented, and thence tracked as to progress deemed to be result of the intervention.

NCT ID: NCT04235283 Recruiting - Clinical trials for Osteoarthritis, Knee

Comparison of Pinless Navigation and Conventional Method in Total Knee Arthroplasty

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

The purpose of this study is to conduct a prospective randomized clinical trial to compare the accuracy of prosthesis, radiographic alignment, total blood loss, the risk of venous thromboembolism between pinless-navigated total knee arthroplasty (TKA) and traditional TKA.

NCT ID: NCT04234282 Recruiting - Knee Osteoarthritis Clinical Trials

Rate of Torque Development and Voluntary Quadriceps Activation in Patients With Knee Osteoarthritis: A Quantitative Analysis Before and After a Single Session of Manual Physical Therapy

Start date: January 2020
Phase: N/A
Study type: Interventional

This is a randomized control trial to determine if there is a measurable change in voluntary quadriceps activation, RTD, pain, and function before and after a single session of manual physical therapy. The researchers will utilize a sample of convenience with consecutive sampling at the Brooke Army Medical Center physical therapy clinic for patients referred for knee osteoarthritis. As is standard of care, patients will be provided a medical intake form and a clinical outcome measure commensurate with their primary anatomic region for which they are seeking physical therapy (i.e.: Lower Extremity Functional Scale for hip, knee, or ankle pain). If patients choose to partake in the study, they will complete the consent form and the initial physical therapy evaluation will be conducted. They will then be provided an appointment for data collection at the Army-Baylor Center for Rehabilitation Research biomechanics lab at the Army Medical Department Center and School. The treatment group will receive one 30-minute session of orthopedic manual physical therapy targeting the knee joint and soft tissues with complementary exercises targeted at their impairment. The control group will receive a 30-minute class on knee OA diagnosis, prognosis, various treatment options, and will conclude with a question and answer with the researcher. Both groups will receive their intervention from a board-certified physical therapist in the Army-Baylor Orthopedic Manual Therapy Fellowship program. At the conclusion of formal testing, the patient will be provided standard physical therapy care as deemed appropriate by their evaluating physical therapist. Thus, all subjects, regardless of their assigned group, will receive the same standard of care for their knee pain.

NCT ID: NCT04230902 Recruiting - Knee Osteoarthritis Clinical Trials

Effects of α MAT Versus Steroid Injection in Knee Osteoarthritis (STα MAT-knee Study)

Start date: March 4, 2019
Phase: Phase 3
Study type: Interventional

Knee Osteoarthritis (OA) is a common degenerative knee condition of the knee which is treated symptomatically. Knee cartilage tissue has little regenerative ability With the developments in regenerative medicine, stem cells might also be used in knee OA. Recently, adipose tissue has been identified as means for autologous mesenchymal stem cells (aMAT) using non-enzymatic method. Lipogems® is FDA-approved closed-system and directly producing ready-to-use aMAT. Some observational studies showed its potential in knee chondropathy. With no clinical trial done as yet, the investigators will hereby study the comparative efficacy of corticosteroid (current practice) versus Lipogems® in patients with knee OA. The knee MRI changes, clinical and patient-based outcomes will compared between baseline and throughout till 6 months after treatment. This study aims to show the comparative efficacy of Lipogems® as compared to corticosteroid in knee OA patients and to demonstrate its cartilage regeneration potential, which will ultimately deter surgery.

NCT ID: NCT04230616 Recruiting - Clinical trials for Osteoarthritis, Knee

Efficacy and Safety of NAVIO

Start date: February 1, 2021
Phase: N/A
Study type: Interventional

The goal of the study is to compare the efficacy, safety and costs of the NAVIO™ system with the conventional intramedullary alignment guide for total knee replacement in a clinical setting. The hypothesis is that total knee arthroplasty (TKA) with the use of NAVIO™ is at least as efficient and safe as TKA with the use of conventional intramedullary alignment guiding.

NCT ID: NCT04228731 Recruiting - Clinical trials for Osteoarthritis, Knee

Inpatient vs Outpatient Total Knee Replacement

Start date: October 22, 2020
Phase: N/A
Study type: Interventional

This is a prospective cohort study comparing standard inpatient (overnight hospital stay) total knee arthroplasty with same day discharge. Patients who are medically well and have a good support structure at home will be recruited. This study will compare patient satisfaction and costs from the perspectives of the Ministry of Health, the institution, society and the patient.

NCT ID: NCT04212728 Recruiting - Knee Osteoarthritis Clinical Trials

Treatment of Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem Cells

Start date: December 29, 2019
Phase: N/A
Study type: Interventional

The purpose of this study is to explore the efficacy and safety of autologous adipose-derived mesenchymal stem cells (AMSCs) plus autologous platelet rich plasma (PRP) in the treatment of severe knee osteoarthritis.

NCT ID: NCT04205656 Recruiting - Clinical trials for Osteoarthritis, Knee

Prospective Evaluation of PRP and BMC Treatment to Accelerate Healing After ACL Reconstruction

Start date: January 2, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This is a prospective, randomized, placebo-controlled trial to evaluate potential beneficial effects of leukocyte-poor platelet rich plasma and bone marrow concentrate on the healing and health of critical joint tissues in the knee following anterior cruciate ligament (ACL) reconstruction. Bone marrow contains stem cells which can change into cells of various different tissue types, while platelet rich plasma contains growth factors. This trial will compare the two procedures against placebo.

NCT ID: NCT04197284 Recruiting - Clinical trials for Osteoarthritis, Knee

Determination of the Effectiveness of Certain Physical Methods in the Treatment of Knee Osteoarthritis

BFBOA
Start date: August 28, 2020
Phase: N/A
Study type: Interventional

Osteoarthritis (OA) is a chronic joint disease that involves the entire joint, causing cartilage damage, bone remodeling, osteophyte formation and loss of normal joint function. Knee OA is one of the leading causes of disability in the world and thus represents a major public health problem. Knee OA treatment can be operative and non-operative. Non-operative treatment includes pharmacological treatment, changing life style and physical therapy. The goal of physical therapy in knee OA is to reduce pain and improve knee function through therapeutic exercise, especially by strengthening the quadriceps muscle. In addition to therapeutic exercise, muscle electrical stimulation is often used, and in the literature there is evidence of biofeedback therapy efficacy. Goal of the study is to investigate whether there is a difference in pain reduction, increase in quadriceps muscle strength, and improvement in knee function in patients who had only kinesitherapy, from those who underwent kinesitherapy and biofeedback, and in patients who received electrical stimulation of quadriceps muscle with kinesitherapy. 93 patients with knee OA according to ACR criteria and Kellgren and Lawrence radiological classification grades 1 and 2 will be included in study. Subjects will complete: Visually Analogous Pain Scale (VAS), Western Ontario Universities Osteoarthritis Index (WOMAC), 36 Item Short Form Health Survey (SF 36), International Classification of Functioning, Disability and Health (ICF) osteoarthritis core set, and quadriceps muscle strength will be measured by EMG biofeedback device.