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Osteo Arthritis Knee clinical trials

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NCT ID: NCT05126485 Recruiting - Back Pain Clinical Trials

Biofeedback Retention in Individuals With AKA

Start date: September 15, 2021
Phase: Early Phase 1
Study type: Interventional

More than two million Americans are currently living with a full or partial limb loss, and an additional 185,000 amputations occur each year. The majority of amputations occur in the lower limbs. There are many potential causes for amputation, but the majority can be attributed to vascular diseases, such as diabetes, traumatic injury, and cancer. For these individuals, prosthetic devices play an important role in restoring mobility and enabling them to participate in everyday activities. However, when learning to use these devices, patients often alter their movement patterns to compensate for pain or discomfort, a decreased ability to feel what their prosthetic limb is doing, and/or a fear of falling. By changing their movement patterns, patients will tend to am their intact leg, which has been shown to lead to long-term joint damage and chronic injury. For perspective, 75% of United States veterans living with amputation are diagnosed with a subsequent disease affecting their muscle, bone, and/or joint health. Therefore, therapy sessions, known as gait retraining, are an integral part of teaching prosthesis users to walk in a safe and efficient manner. With recent advances in wearable technology, researchers and therapists have begun exploring the use of biofeedback systems to assist with this retraining. In these systems, wearable sensors are used to measure how the patient is moving in real-time, and can provide information on how much time they spend on each leg and how much each joint moves during walking. Biofeedback refers to the process of communicating the information from these sensors back to the patients instruct them whether they need to change their movements. Previous research has shown that these systems have excellent potential for helping patients with physical disabilities improve their quality of motion. However, relatively little research has explored how well individuals with above-knee leg amputations respond to biofeedback during gait retraining. Importantly, the question of whether the new movement patterns taught using biofeedback will persist after training has finished remains unanswered. Therefore, the primary objective of this research is to determine whether biofeedback is a feasible tool for gait retraining with above-knee prosthesis (including a prosthetic knee, ankle, and foot) users. To answer these questions, forty individuals currently using above-knee prosthetic systems will undergo a single session of biofeedback training. Half of these populations will be from the civilian population, and half will be military veterans. During this training, the biofeedback system will apply short vibrations - similar to those generated by cellphones - to their skin every time that the patient reaches the desired degree of hip rotation during walking. Participants will be instructed to keep increasing their hip motion until they feel a vibration on every step. Before training, they will be instrumented with a wearable motion captures system, pressure sensors embedded in their shoes, and a wearable heart rate monitor. Using these devices, researchers will measure the participants' walking patterns without biofeedback determine their current ability. Once training is complete, their walking patterns will be measured again, first while using the biofeedback system, and then again fifteen minutes and thirty minutes after the biofeedback system has been removed. The data measured during these tests will enable researchers to calculate functional mobility scores that are used to evaluate the quality of a patient's walking, and then compare how these scores change before, during, and after biofeedback training. The knowledge gained through this research constitutes a critical step towards identifying optimal biofeedback strategies for maximizing patient mobility outcomes. The findings will be essential for the development of gait retraining protocols designed to reduce the incidence of chronic injury, and enable patients to achieve their full mobility potential. Building on these results, the next research phase will be to incorporate biofeedback training into a standard six-week gait retraining protocol to evaluate its long-term effectiveness as a rehabilitation tool. Unlike traditional gait retraining, which requires patients to visit clinics in-person for all sessions, the wearable, automated nature of biofeedback training will allow patients to continue gait training from home. This ability will enable patients to continue training activities between sessions, and ultimately may be able to substitute for some in-person visits. This potential for remote therapy has exciting implications for improved access to care for individuals living long distances from their rehabilitation providers, or those suffering from social anxiety, as well as during global health pandemics where in-person visits are difficult.

NCT ID: NCT04971629 Recruiting - Clinical trials for Osteo Arthritis Knee

The Relationship Between Cannabis Use, Biomarkers, Tissue Cannabinoid Levels and Clinical Outcomes in Patients With OA

Start date: July 13, 2021
Phase:
Study type: Observational

Osteoarthritis (OA), the most common form of arthritis, is a leading cause of disability, affecting the quality of life, pain, and physical functioning of 4.6 million Canadians. About half of OA patients have limited response to primary therapy. The number of OA patients continues to rise, affecting the quality of life of those with OA. There is a dire need to develop future effective treatment options. Cannabis is a potential therapy for those with OA and may provide analgesic, anti-inflammatory, and disease modifying effects. The common barriers to use are a lack of knowledge regarding efficacy, access, and commonly used products, doses and routes of administration. No high-quality clinical trials of cannabis for OA have been conducted, leaving physicians struggling to guide and inform patients regarding symptom relief. Findings from clinical trials of cannabis for other painful conditions have been variable, perhaps due to suboptimal cannabis products and failure to consider important patient characteristics. The goal of the current study is to characterize patient- and cannabis-level factors that are associated with OA pain and address other knowledge gaps.

NCT ID: NCT04922268 Recruiting - Clinical trials for Osteo Arthritis Knee

External Focus of Attention Posttraumatic Osteoarthritis

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Knee injuries, especially those to the ACL, are common among physically active people. These injuries are frequently treated with surgical reconstruction (ACL reconstruction; ACLR). While ACLR restores stability it does not protect against future injury, long-term pain, disability, and arthritis associated with these injuries. Our study is going to examine new ways to provide feedback about the way people move to determine if these are better at modifying movement patterns that are known risk factors of posttraumatic osteoarthritis development than current standard treatments. If you participate, you will be asked to undergo a movement analysis in a research laboratory while you perform tasks such as walking and hopping. After this initial assessment, you will be randomly allocated to one of 2 treatment groups. Each treatment group will perform 4 weeks (3x/week) of exercises to change the way people walk. Participants will then report for follow-up movement analysis testing 1- and 4-weeks after completing the intervention.

NCT ID: NCT04886960 Recruiting - Clinical trials for Osteo Arthritis Knee

pAF for the Treatment of Osteoarthritis

Start date: July 8, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II Randomized Double-Blinded Standard of Care (Corticosteroid) vs. Sterile Amniotic Fluid for Osteoarthritis

NCT ID: NCT04795336 Recruiting - Clinical trials for Osteo Arthritis Knee

Melatonin Use After Primary Total Joint Arthroplasty

Start date: July 12, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the effect of melatonin supplementation on patient sleep quality, length of stay, and opioid consumption following primary, unilateral, elective total hip or knee arthroplasty.

NCT ID: NCT04767841 Recruiting - Clinical trials for Osteo Arthritis Knee

The AMPK Modulator Metformin as a Novel Adjunct to Conventional Therapy in Patients With Knee Osteoarthritis

Start date: February 16, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

metformin alleviates drug-induced osteoarthritis (OA)-like change in mice knee joint through activating autophagy and downregulating apoptosis. Metformin exerts its protective effects against OA through the AMPKa2/ SIRT1 pathway. Metformin suppresses IL-1β-induced oxidative and osteoarthritis-like inflammatory changes by enhancing the SIRT3/PINK1/Parkin signaling pathway, thereby indicating metformin's potential in prevention and treatment of osteoarthritic joint disease.

NCT ID: NCT04753424 Recruiting - Clinical trials for Patient Satisfaction

Semitendinosus Graft as Meniscal Transplant

Start date: January 1, 2018
Phase:
Study type: Observational

Removal of meniscal tissue is described to result in poor knee function and a significant risk for future development of osteoarthritis. Different implants have been suggested to substitute a removed meniscus. Meniscal allograft transplantation is not widely available due to costs and availability. The semitendinosus tendon is a known graft with biological properties with potential to remodel and revascularize in an intraarticular environment such as anterior cruciate ligament reconstruction. The objective for this study was to investigate whether the semitendinosus tendon graft could function as a meniscal transplant.

NCT ID: NCT04748510 Recruiting - Osteoarthritis Clinical Trials

Functionally Aligned vs Mechanical Axis Aligned Total Knee Arthroplasty

FATKAvsMATKA
Start date: April 30, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to compare clinical and radiological outcomes in robotic-arm assisted TKA using mechanical alignment (MA TKA) versus robotic-arm assisted TKA with functional alignment (FA TKA). Both FA TKA and MA TKA are performed through similar skin incisions, robotic-guidance, and use identical implants. In MA TKA, bone is prepared and implants positioned to ensure that that the overall alignment of the leg is in neutral. In FA TKA, the bone is prepared and implants positioned to restore the natural alignment of the patient's leg. Both of these surgical techniques provide excellent outcomes in TKA but it is not known which of the two techniques is better for patient recovery. Mako robotic-assisted TKA is an established treatment for arthritis of the knee joint. The positions of the implants and overall alignment of the leg are important as they influence how quickly the implants wear out and need replacing. The aim of this study is to determine if patient recovery is better with functionally aligned Mako robotic-assisted total knee arthroplasty (FA TKA) or mechanically aligned Mako robotic-assisted total knee arthroplasty (MA TKA)

NCT ID: NCT04727060 Recruiting - Clinical trials for Total Knee Arthroplasty

Open Label Study to Collect Clinical Data to Document Clinical Performance and Safety in Total Knee Arthroplasty

Start date: December 15, 2011
Phase:
Study type: Observational

The purpose of this study is to evaluate clinical performance and safety in total knee arthroplasty using HLS implants.

NCT ID: NCT04716803 Recruiting - Clinical trials for Osteo Arthritis Knee

Bone Marrow Aspirate Concentrate (BMAC)Treatment for Knee Osteoarthritis

BMAC
Start date: July 8, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the safety and effectiveness of bone marrow aspirate concentrate (BMAC) in patients with moderate to severe osteoarthritis of the knee. BMAC provides a rich source of mesenchymal stem cells (MSCs) and is a stem cell-based therapy that has been reported to preserve or improve the structure of joints. The Angel System is the device used in this study to concentrate bone marrow from the patient and is intended to separate a mixture of blood and bone marrow and collect plasma rich platelets preoperative to a surgical procedure. The goal of this study is to identify whether BMAC can be an effective and safe treatment for patients with osteoarthritis of the knee.