Knee Replacement / Arthroplasty

Researchers are evaluating the effects of high-intensity pulsed electromagnetic field therapy (HI-PEMF) in older adults with moderate to severe knee osteoarthritis (OA). This randomized, double-blind clinical trial compares two treatment methods: HI-PEMF applied only to the knee joint versus HI-PEMF applied both to the knee and the quadriceps muscles. The study aims to understand pain reduction and improvement in functional performance in this population, addressing common issues such as muscle weakness and frailty associated with knee OA. Participants will be randomly assigned to one of two groups. Group A will receive HI-PEMF therapy focused exclusively on the symptomatic knee for 10 minutes per session, twice weekly for 5 weeks, totaling 9 sessions. Group B will receive HI-PEMF therapy applied to both the knee and the quadriceps muscle, with each site treated for 10 minutes per session under the same schedule. Both groups will also follow a standardized, home-based exercise program involving five specific strengthening and mobility exercises performed three times per week during the 5-week treatment period. The BTL-6000 Super Inductive System device is used for all HI-PEMF treatments. During the study, participants will be assessed at the start, after the 5-week intervention, and at a 2-month follow-up. Researchers will measure changes in pain using the Numeric Analog Scale (NAS), functional mobility through the Timed Up and Go (TUG) test, and lower-limb strength with the 5-times Sit-to-Stand (5STS) test. Additional evaluations include monitoring paracetamol use, frailty, sarcopenia, and radiological OA grade. Adherence to treatment sessions and exercises will be closely followed, and safety monitored throughout the study, which lasts a total of about three months including follow-up.

Researchers are evaluating the effectiveness of Mulligan Mobilization Technique compared to proprioceptive exercises for treating adults aged 40 and above with mild to moderate knee osteoarthritis, classified as Grades 2 and 3 on the Kellgren and Lawrence scale. The study aims to assess these treatments over a 10-week period, focusing on pain levels, movement, functional activities, balance, and quality of life improvements. Participants are selected based on clinical diagnosis and mobility ability without assistive devices. The study involves three groups: one receiving proprioceptive exercises designed to improve balance and joint position sense, another receiving Mulligan Mobilization Technique, a manual therapy to improve joint mobility, and a control group undergoing traditional physical therapy. Each participant receives 30 treatment sessions over 10 weeks, with three sessions per week lasting 40 to 60 minutes each. Treatments are delivered by trained physical therapists, and assessments occur at the start and end of the treatment period. Participants will complete questionnaires and undergo evaluations measuring pain intensity, range of motion, functional status, and balance using tools like the Numeric Pain Rating Scale, Universal Goniometer, Knee Injury and Osteoarthritis Outcome Score, and Berg Balance Scale. Quality of life is also assessed using the SF-36 questionnaire. The study follows a double-blind, randomized design to ensure unbiased results. Confidentiality is maintained, and participants may withdraw at any time without penalty.

Knee osteoarthritis (OA) is a common degenerative and inflammatory joint disease causing pain and limited mobility, affecting millions worldwide. This research evaluates the clinical results of treating patients with knee OA and chronic pain that has not improved after at least three months of conventional conservative therapy. The study focuses on selective arterial embolization as a treatment option for patients who are not candidates for or refuse surgery and suffer from refractory chronic pain. The treatment involves transarterial microembolization, which selectively targets and blocks blood vessels causing inflammation in the knee. This procedure uses micro-catheters to inject embolizing material into pathological genicular arterial branches, followed by diagnostic arteriography to confirm successful embolization. The study includes 43 patients who will undergo this procedure after providing informed consent. Patients will be followed up with clinical evaluations at 1, 3, 6, 12, and 24 months after treatment or until they drop out for other reasons. Participants will be involved in regular clinical assessments to monitor pain levels using the Visual Analog Scale (VAS) and other measures like quality of life (SF-36), joint function (WOMAC score), range of motion, and overall treatment assessment over two years. Researchers will also measure bilateral knee circumferences to evaluate changes. The study aims to understand the treatment's impact on pain reduction and joint function over time, with ongoing safety and progress monitoring throughout the follow-up period.

Researchers are evaluating BBM-A101, an AAV-based gene therapy, to treat people with moderate knee osteoarthritis. The study aims to assess the safety, tolerability, and effectiveness of this treatment. It is a Phase 1 clinical study with two parts: Phase Ia, which is randomized and single-blind, and Phase Ib, which is randomized and double-blind with parallel groups. Participants receive a single 2 ml injection of BBM-A101 directly into the knee joint. In Phase Ia, there are low, middle, and high dose groups along with a placebo group. In Phase Ib, participants are assigned to either low or high dose groups or a placebo group. The study compares these groups to evaluate the treatment effects and safety. During the study, participants undergo regular assessments including monitoring of adverse events and serious adverse events for up to one year. Researchers will also measure gene expression protein levels, virus shedding in various bodily fluids, changes in knee joint space by X-ray, and antibody responses over a period of up to five years. Participants are followed closely with lab tests, imaging, and clinical evaluations to track outcomes and safety throughout the study duration.

Researchers are evaluating the safety and effectiveness of an intra-articular injectable filler called ALLOHEAL in patients with knee osteoarthritis. This trial aims to show that ALLOHEAL is not less effective than the control device, Conjuran®, in reducing joint pain caused by mechanical friction. The trial focuses on adults aged 40 to 80 years who have been diagnosed with knee osteoarthritis and experience significant knee pain. Participants will receive injections of either ALLOHEAL or the active comparator Conjuran® directly into the knee joint. The study includes a follow-up period of 24 weeks to assess both the safety and pain-relief effects of the treatments. Evaluations will take place at 6, 10, 16, and 24 weeks after the initial injection, with the primary endpoint being the change in knee pain measured by the Visual Analog Scale (VAS) at 16 weeks. During the study, participants will undergo clinical assessments including pain evaluations using the VAS scale. Safety data related to the components of ALLOHEAL, including sodium polynucleotide, chitosan, and type I collagen, will be collected throughout the 24-week period. Participants will need to attend scheduled visits for these assessments and comply with study procedures. The total participation time spans approximately six months.

This research aims to compare myoelectric and bionic prosthetic hands to understand differences in upper limb function, body image, and user satisfaction among individuals with upper limb amputations. It focuses on answering whether the functional abilities differ between these two types of prosthetic devices used by people with amputations. The study is observational and involves adults aged 18 to 65 who regularly use prosthetic hands. Participants will either use advanced bionic prosthetic hands featuring multi-articulating structures and enhanced control systems designed to improve function and dexterity or myoelectric prosthetic hands controlled by muscle signals from the residual limb that provide basic powered hand movements. These groups allow comparison of the newer bionic technology against conventional myoelectric devices. During the study, participants will complete assessments including the Upper Limb Functional Index-15, Amputee Body Image Scale, and Orthotics and Prosthetics Users' Survey at baseline. These measures will help evaluate hand function, body image perception, and satisfaction with prosthetic use. The study is led by Gulhane School of Medicine and participation spans from November 2025 to March 2026, involving adults with unilateral upper limb amputation who have been using prostheses for at least six months.

Researchers are conducting a master protocol study to evaluate multiple independent pain treatments for people with chronic pain conditions such as osteoarthritis of the knee, diabetic neuropathic pain, and chronic low back pain. This study aims to compare different interventions within a structured framework that includes specific criteria and unique assessments for each condition. The study is designed as a randomized, placebo-controlled Phase 2 clinical trial to better understand these treatments. Participants are randomly assigned to receive one of several investigational drugs or matching placebos. These drugs include LY3016859, administered intravenously, and LY3556050, LY3526318, and LY3857210, all given orally. The interventions are organized in separate appendices focusing on each pain condition, allowing some to begin independently as they become available for testing. During the study, participants will be monitored from baseline up to 8 weeks to track allocation to each intervention-specific appendix. Researchers will assess pain levels, functional status, and safety through various scales and tests. The study involves maintaining stable non-drug therapies and discontinuing current pain medications except rescue medications. Participants will undergo physical exams, lab tests, and screening for medical history to ensure safety throughout the trial, which is led by Eli Lilly and Company and is expected to continue until April 2027.

Researchers are studying people aged 50 and older with knee osteoarthritis who also experience foot pain. The study aims to assess the feasibility and early effects of shoe-worn insoles on symptoms and biomechanics at both the knee and foot joints. This multi-center randomized pilot trial is led by the University of British Columbia to explore ways to relieve pain and improve function in affected individuals. Two types of insoles are being tested. One group receives lateral wedge insoles (LWIs) that have a 6-degree wedge on the outer edge. The other group receives lateral wedge plus custom arch support (LWAS) insoles, which combine the 6-degree wedge with a tailored arch support made using advanced 3D scanning and printing technology. Participants will wear their assigned insoles in their own shoes for at least 5 hours daily over 3 months. During the study, participants will undergo assessments at the start and after 3 months, including self-reported knee and foot pain, physical and foot function, and walking speed. Biomechanical measurements such as knee moments and foot motion will also be recorded. Researchers will track recruitment, retention, and the time needed to deliver insoles. This comprehensive approach will help determine the insoles' impact and the study's feasibility over the trial period.

Researchers are evaluating the safety, reliability, reproducibility, and accuracy of the Canary canturioTM tibial extension in patients who have undergone total knee arthroplasty (TKA) due to knee osteoarthritis. This observational study compares outcomes between patients receiving the Zimmer Persona Personalized Knee System with the Canary canturioTM tibial extension and those receiving the Zimmer Persona system with a standard 14 mm +30 mm stem extension. The study aims to monitor safety risks and gait performance over five years post-TKA. Participants are divided into two groups: one with the Canary canturioTM tibial extension and one with a standard stem extension. Safety endpoints include revision surgeries, loosening, fractures, and radiologic changes within five years after surgery. Secondary endpoints assess data collection on step counts and gait parameters, as well as patient-reported pain, knee function, and quality of life. A subgroup of patients will have detailed gait lab assessments at one and two years post-TKA. During the study, participants will be monitored for adverse events and their gait will be tracked using wearable technology to collect step count and walking data. Patient-reported outcomes such as pain scores and quality of life questionnaires will be completed regularly. The study lasts five years from the time of knee replacement surgery, with continuous data collection and periodic evaluations to assess the performance and safety of the knee systems.

Researchers are evaluating the safety and effectiveness of JointStem, an autologous adipose tissue derived mesenchymal stem cell (AdMSC) treatment, in patients diagnosed with knee osteoarthritis. This double-blind, randomized, placebo-controlled, multi-center study aims to compare JointStem with a placebo to determine its benefit for knee osteoarthritis symptoms and function over nearly one year. Participants will be randomly assigned to receive either JointStem or a placebo consisting of normal saline with autologous serum. The study includes a screening period, baseline visit with lipoaspiration to collect fat tissue, treatment by intra-articular injection, and follow-up visits at 4, 12, 24, 36, and 48 weeks after treatment. After the 48-week visit, the study data will be reviewed and unblinded for analysis. During the study, participants will undergo assessments including the Western Ontario and McMaster Universities Arthritis Index (WOMAC) function and pain scores, Visual Analog Scale (VAS) for pain, International Knee Documentation Committee (IKDC) score, and health surveys. Radiographic evaluations and tracking of rescue medication use will also be conducted. Participants will be monitored regularly through scheduled visits over 48 weeks to assess treatment effects and safety.