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Osteoarthritis, Knee clinical trials

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NCT ID: NCT04938271 Enrolling by invitation - Clinical trials for Osteoarthritis, Knee

A Telehealth Study of a Wearable Electroceutical & Sports Sleeve for Knee Osteoarthritis Pain Relief & Improved Function

HEAL01WMCOA1
Start date: November 22, 2021
Phase: N/A
Study type: Interventional

The purpose of this telemedicine 24-person open-label study is to evaluate the safety and usability of a proprietary wearable microcurrent electroceutical (a device that delivers micro-ampere electronic pulses) made by Healables, Ltd. to promote healing of chronic mild to moderate knee osteoarthritis as shown by decreased disability and relief of pain. In this study, subjects treat themselves at home once/day for an hour using a smart phone to activate the device worn on an e-textile sports knee sleeve. Microcurrent signals are transmitted from a device thru built in conductive pathways to strategic electrodes placed above and below the knee. A proprietary App both activates therapeutic protocols to transmit microcurrent signals as well as allows user-generated recording of the status of knee pain & function prior to and following each treatment. These records are then transmitted to health professionals using software compliant with human use data transmission regulations including subject anonymity. The rationale that the device would be effective is supported by microcurrent treatment for osteoarthritis at several US clinics including the prestigious Cleveland Clinic as well as by data of published randomized controlled clinical trials. One reason that more persons do not avail themselves of microcurrent therapy is that treatment usually requires several trips to a clinic often requiring considerable travel by a patient who may be in considerable pain. The health provider typically administers therapy in a clinic using electrodes with a desktop sized instrument. Our miniaturization of a microcurrent device and its use with wearable e-textiles such as a knee compression sleeve is a distinct advantage that enables regular use of effective therapy in home-based self-treatment to provide pain relief and improved knee function. Microcurrent electrotherapy represents a significant improvement in pain control and healing since it employs current in the microampere range, 1000 times less than that of Transcutaneous Electrical Nerve Stimulator (TENS) devices that transmit millicurrent electrical signals. This study is designed to demonstrate use of a wearable microcurrent electroceutical at home for subjects to self-treat at their leisure in a comfortable environment that facilitates healing. Moreover, data communication via a smart phone App to health providers enables digital telemedicine for rapid collation and interpretation of relevant data.

NCT ID: NCT04660955 Enrolling by invitation - Clinical trials for Osteoarthritis, Knee

MOON Onsite MRI 10 Years After ACL Reconstruction

MRI
Start date: January 1, 2020
Phase:
Study type: Observational

In this study, a total of 219 subjects from the MOON nested cohort will be studied at CCF, Vanderbilt and OSU, Table 1. Among them, some will have added MRI during their 10-year visit for the MOON study. Some subjects who finished their 10-year visit for the MOON Onsite study already will be called back to have MRI. PROMs and other information of these subjects will be collected through the MOON study.

NCT ID: NCT04653623 Enrolling by invitation - Clinical trials for Osteoarthritis, Knee

Effect of Tranexamic Acid on Blood Loss After High Tibial Osteotomy

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

This study aims to examine whether tranexamic acid has an meaningful clinical effect on blood loss after high tibial osteotomy. This study design is a double-blind randomized controlled trial. The patients were randomly assigned to intervention or usual care groups. Intervention patients receive tranexamic acid 2g for 10 minutes just before surgery. Primary outcome is hemoglobin level preoperatively, postoperative 1 day, 2 days, 3 days, 2 weeks. Secondary outcome included hematocrit level, hemovac drainage, total blood loss, need for transfusion, deep vein thrombosis, Visual Analog Pain Scale, and wound complication.

NCT ID: NCT04641351 Enrolling by invitation - Clinical trials for Osteoarthritis, Knee

Corticosteroid Meniscectomy Randomized Trial

CoMeT
Start date: May 27, 2021
Phase: Phase 4
Study type: Interventional

Synovitis has an important role in the symptoms and progression of Osteoarthritis (OA). Inflamed synovium has been associated with both increased symptoms and increased progression in OA patients. Furthermore, synovitis observed during knee arthroscopy in our patients undergoing arthroscopic partial meniscectomy (APM) was associated with worse symptoms while adjusting for confounding factors.Therefore, a better understanding of synovitis as a predictor of outcome after APM and as a target for treatment is needed to improve outcomes in this patient population. Triamcinolone has been shown to decrease synovitis-associated outcomes in both animal and human studies after anterior cruciate ligament (ACL) injury. In a porcine model of ACL injury, treatment with triamcinolone resulted in decreased formation of synovitis-related collagen breakdown products as well as decreased cellularity of the synovium.And in a trial of triamcinolone injected after ACL injury, similar findings of decreased C-telopeptide of type II collagen (CTX-II), associated with collagen type II breakdown, was found in knees administered triamcinolone compared to placebo controls.

NCT ID: NCT04503941 Enrolling by invitation - Knee Osteoarthritis Clinical Trials

Ultrasound Examination of Inguinal Lymph Node Used to Evaluate the Effect of Acupuncture on Knee Osteoarthritis

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

Knee osteoarthritis (KOA) is a major public health problem among the elderly and is associated with considerable disability. Previous studies on the pathogenesis of this disease mainly focus on cartilage degeneration, but lack of attention to synovitis lesions, and even believe that it is a secondary change in the pathogenesis of osteoarthritis.In recent years, a large number of studies at home and abroad have pointed out that the occurrence and development of knee osteoarthritis are accompanied by synovitis at each stage, and synovial lesions may be the primary manifestation of knee osteoarthritis and affect the evolution of knee osteoarthritis.To this end, some scholars proposed that synovitis lesions as a starting point, may be a new target for the treatment of knee osteoarthritis.

NCT ID: NCT04314102 Enrolling by invitation - Quality of Life Clinical Trials

The Effect of Kinesiophobia on Spatio-temporal and Functionality in Total Knee Replacement Surgery

Start date: February 1, 2020
Phase:
Study type: Observational [Patient Registry]

It is stated that after arthroplasty surgery, besides the physiological factors, the factors related to the individuals may affect the recovery. Among these factors, one of the most defined in the literature is kinesiophobia. Although kinesiophobia is defined as the terms of "fear of movement" and "fear related to pain"; There are also definitions for situations in which fear of movement is most extreme or pain-related fear avoidance beliefs. Kinesiophobia, which usually occurs in the preoperative period and supports the development of chronic pain, may also affect the early recovery findings. It is very important to determine the presence and severity of kinesiophobia as it is associated with functional results after surgery. Individuals' perceptions about themselves, expectations of recovery, and personal beliefs before surgery are thought to affect recovery in the early period. In the studies conducted, it was stated that individuals with high perception about himself and the surgical process recover faster and return to activities. However, it is emphasized that studies should be conducted on the effect of individuals' personal factors such as self-efficacy, self-perception and their perspective on health on the healing process.

NCT ID: NCT03931837 Enrolling by invitation - Clinical trials for Osteoarthritis, Knee

Efficacy Testing of Different Tourniquet Pressure Used for Postoperative Pain Reduction in Total Knee Arthroplasty

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

Tourniquet use during total knee replacement (TKR) improves visibility, significantly decreases intra-operative blood loss and reduce operative time. However, tourniquet use also has a negative effect on postoperative pain, postoperative range of motion(ROM), wound complication, deep vein thrombosis (DVT), pulmonary embolism (PE), thigh muscle strength, and functional recovery after TKR. Therefore, the investigators conducted a three-arm prospective, randomized, controlled trial study to compare the efficacy of different tourniquet pressure used between systolic blood pressure + 75 mmHg, systolic blood pressure + 100 mmHg, and systolic blood pressure + 150 mmHg.

NCT ID: NCT03801564 Enrolling by invitation - Knee Osteoarthritis Clinical Trials

Knee Osteoarthritis: Platelet Rich Plasma or Hyaluronic Acid

OA
Start date: January 7, 2019
Phase: N/A
Study type: Interventional

PURPOSE: To compare the effect of hyaluronic acid (HA) or platelet-rich plasma (PRP) on pain, physical function, quality of life and knee joint morphology in patients with knee osteoarthritis severity II-III. BACKGROUND: Knee osteoarthritis affects quality of life significantly because it is the most common joint disease and causes considerable disability. Pathogenesis is multifactorial, nevertheless reduced cartilage production, increased destruction, and synovial inflammation are important factors in the osteoarthritis process. Today, symptomatic drugs are commonly used in the treatment of osteoarthritis, but these treatments have limited effects on cartilage degeneration. Intraarticularly, hyaluronic acid (HA) and platelet-rich plasma (PRP) treatments have been used for osteoarthritis due to pain and functional effects. HA has been shown to reduce the levels of collagen degradation products and maintain normal cartilage metabolism. PRP is thought to have positive effects on clinical and tissue healing due to the numerous growth factors involved. However there is no research to prove definitively that one of the two applications in knee osteoarthritis is superior to the other. METHOD: 120 patients between the ages of 50-70, OA severity II-III will be included in the study. Patients will be stratified according to the severity and age of OA, and two groups will be randomly assigned as HA and PRP. HA and PRP injections will be performed two times and one month apart. Outcome measures are pain, physical function, quality of life, muscle strength, WORMS, and patient satisfaction. Each patient will be examined at baseline, first, third, sixth, ninth and twelfth months.

NCT ID: NCT03681977 Enrolling by invitation - Clinical trials for Osteoarthritis, Knee

Clinical Outcomes of MP Persona vs. Persona Knee-PS

MP-Persona
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

Knee osteoarthritis (OA) is a highly prevalent condition that results in substantial pain and loss of function. The end stage treatment for knee OA is total knee arthroplasty (TKA), a common and safe procedure typically performed for relief of symptoms. However, an increasing number of patients are complaining about their TKA due to altered sensations between their previous joint and the implant. Although several designs have been proposed to improve these outcomes, the knee kinematics after TKA remains different from physiological kinematics. The Medial Pivot TKA design was introduced to closely mimic normal knee kinematics and create the natural feeling of the knee. This study is intended to evaluate the clinical effectiveness and ability to restore knee motion of two TKA devices: the Medial Pivot Persona TKA Zimmer design with the traditional Zimmer Persona Knee-PS. The investigator's hypothesis is that the Medial Pivot design will results in better patient outcomes and restore knee motion at natural parameters.

NCT ID: NCT03679507 Enrolling by invitation - Clinical trials for Osteoarthritis in the Knee

The Effect of Low Intensity Ultrasound Therapy on Chronic Pain Due to Osteoarthritis of the Knee.

Start date: June 15, 2019
Phase: N/A
Study type: Interventional

To evaluate a new, low intensity ultrasound device in the treatment of chronic pain due to osteoarthritis in the knee. Enhancing CBD oil penetration into joints by sonophoresis.