Clinical Research Directory

Effects of Core Stabilization Exercises in Female Patients With Gonarthrosis

Osteoarthritis (OA) is a non-inflammatory degenerative disease characterized by progressive deterioration of cartilage tissue, synovial membrane, and joint capsule, primarily affecting weight-bearing joints. Individuals with knee osteoarthritis exhibit weakness in the trunk and periarticular muscles. This loss of strength in the trunk and periarticular muscles increases the load on the joint, contributing to the development and progression of the disease. This study aimed to investigate the effects of core stabilization, applied in addition to knee muscle exercise programs, on clinical symptoms and functional capacity in individuals with knee osteoarthritis.

Pilot and Feasibility Study of Intra-articular Anti-CD14 for the Treatment of Knee Osteoarthritis

Knee osteoarthritis (KOA) is a leading cause of chronic pain and disability among Veterans, which contributes significantly to reduced mobility, impaired quality of life, and increased health care utilization. First-line therapies, including non-steroidal anti-inflammatory drugs, physical therapy, and intra-articular corticosteroids, provide modest and short-term relief, while being associated with other side effects (i.e., potential for hastened cartilage loss) and no disease-modifying potential. Total knee arthroplasty, although effective, is not suitable for all patients and carries surgical risks. There is an unmet need for effective, durable, and locally-targeted therapies that can alleviate pain and improve function. The development of new therapies for this condition is thus a priority for the VA. While the therapy has been used in humans in other contexts, to date there are no data on the safety, feasibility, and potential efficacy of intra-articular IC14 administration in patients with KOA. A small-scale, Phase I "first-in-joint" pilot and feasibility trial is therefore critical to inform the design and implementation of larger, definitive studies. Specifically, preliminary data are needed to (1) determine the appropriate inclusion/exclusion criteria, (2) solidify the study design and study processes,(3) assess patient tolerance and acceptability of i.a. mAb injection, (4) evaluate safety profiles of the localized biologic intervention. Participants will be randomized into one of three arms, (a placebo arm, a low-dose arm, and a high-dose arm) and will be followed to evaluate the safety and feasibility of this treatment.

Recombinant Human Growth Hormone (rHGH) for Knee Osteoarthritis (KORR)

The goal of this clinical trial is to see if people with knee osteoarthritis would be willing to comply and adhere to incorporating Recombinant Human Growth Hormone (rHGH), specifically Saizen Somatropin solution, into their treatment plan. Participants will be asked to: * Self-inject the treatment solution (placebo or somatropin) into the abdominal or gluteal area once per day for a total of 6 weeks. * Complete questionnaires related to their knee pain and activities of daily living. * Provide blood tests. * Complete various measurements including: circumference of thigh, calf, and abdomen; strength of thigh and knee; range of motion of both knees; and gait analysis.

Advanced Brain Imaging-TKA (fMRI-TKA)

Knee replacement surgery is a common and effective treatment for pain and mobility loss, yet up to 1 in 5 patients remain dissatisfied after surgery due to ongoing pain or difficulty with daily activities. Currently, clinicians cannot reliably predict which patients will experience these challenges. This study uses MRI scan of the brain to investigate whether specific patterns of brain activity can predict patient satisfaction after total knee arthroplasty (TKA). By comparing brain networks before surgery and afterward, and linking these changes to patient-reported pain and function, we aim to identify brain-based markers that can help predict outcomes, to improve satisfaction after knee replacement surgery.

Evaluation of the Effects of Pulsed Electromagnetic Field on Inflammatory Knee Osteoarthritis

This study will assess the efficacy of pulsed electromagnetic field therapy in patients with inflammatory knee osteoarthritis confirmed by MRI-detected effusion-synovitis. Fifty participants will be randomly allocated into two groups. One group will receive active PEMF therapy at a specific optimized parameter twice a week for 8 weeks, while the other group will receive sham treatment using the same device without PEMF signal. The primary outcome is the change in WOMAC pain score, and secondary outcomes include knee function, stiffness, quality of life, and MRI-quantified structural changes.

Analysis of the Loss of Muscle Force, Power and Motor Control to Predict the Risk of Falls in Patients With Knee OA

The twofold goal of this study is to understand the link between muscle power, muscle strength, and muscle control degradation with the risk of falling, and to develop a framework for the comprehensive and quantitative assessment of muscle power (and strength) in an elderly population of patients with knee osteoarthritis, who are at higher risk of falling. The main question it aims to answer is: ● Are muscle power and motor control degradation better predictors of falls than muscle strength in the aging population? Participants will undergo: * Muscle force assessment on a dynamometer * Muscle power assessment on a dynamometer and on isntrumented stairs * Home-based mobility monitoring * Full lower limb MRI acquisition * Gait assessment

A Phase II/III Randomized Double-Blind Multicenter Study Comparing UC-MSC-Derived Secretome and Sodium Hyaluronate in Patients With Knee Osteoarthritis

This study is a randomized, double-blind, multicenter Phase II/III clinical trial designed to evaluate the effectiveness and safety of umbilical cord-derived mesenchymal stem cell (UC-MSC) secretome compared with sodium hyaluronate in patients with knee osteoarthritis. Knee osteoarthritis is a common degenerative joint disease that causes chronic pain and functional limitation. Participants will be randomly assigned to receive intra-articular injections of either UC-MSC-derived secretome or sodium hyaluronate. The study aims to assess improvements in knee pain, physical function, and overall clinical outcomes, as well as to evaluate the safety of the interventions over the study period.

An Implementation Science Approach to Evaluating Self-Administered Acupressure for Knee Osteoarthritis in Older-Aged Adults in the Community

This study aims to evaluate the implementation and effectiveness of a self-administered acupressure (SAA) program for knee osteoarthritis (OA) among older adults in Hong Kong community centers. Using a pragmatic cluster randomized controlled trial (RCT) and mixed-methods approach, the research will assess the reach, adoption, implementation, maintenance, and effectiveness of the SAA program in real-world settings, with the goal of informing scalable interventions for knee OA management.

Drain Removal Before Versus After CPM in Primary Total Knee Arthroplasty

The aim of this prospective randomized controlled study was to determine whether the timing of drain removal in relation to continuous passive motion (CPM) application influences postoperative residual hematoma formation following primary total knee arthroplasty (TKA). Our primary hypothesis was that removing the drain after initiating CPM would result in less residual hematoma, as CPM-induced intra-articular fluid and blood mobilization would be evacuated through the drain before its removal, thereby reducing postoperative fluid accumulation.

Intelligent Precision Knee Preservation System for Knee Osteoarthritis

The goal of this clinical trial is to verify whether the "dynamic dual-mode alignment optimization + intelligent precision knee-preserving system" (integrating static/kinematic target alignment, CT-based preoperative three-dimensional \[3D\] planning, 3D-printed guide plates, and intraoperative augmented reality \[AR\] real-time feedback) achieves a greater relative reduction in peak knee adduction moment (KAM) at 12 months postoperatively, while maintaining or improving knee clinical function and without increasing perioperative or long-term complication rates, compared with traditional knee-preserving strategies. The target population is patients aged 40-70 years with knee osteoarthritis (KOA; Kellgren-Lawrence grade II-III) who require high tibial osteotomy (HTO) for unilateral medial-compartment disease with mild-to-moderate varus deformity and who meet the inclusion and exclusion criteria. The main questions are: * Can the dynamic dual-mode alignment + intelligent precision system achieve a greater relative reduction in peak KAM at 12 months postoperatively than traditional knee-preserving strategies? * Can this system improve static alignment accuracy, dynamic load parameters (e.g., KAM impulse and varus thrust), and patient-reported outcome (PRO) scores without increasing complication rates? * Can 3D-printed patient-specific instrumentation (PSI) guide plates and real-time AR feedback reduce intraoperative radiation exposure and shorten operative time compared with traditional methods? Researchers will compare: Kinematic alignment (KA), traditional mechanical alignment (MA), and dynamic dual-mode alignment (DA) to evaluate the relative performance of alignment strategies; 3D-printed PSI-guided HTO versus traditional fluoroscopy-guided HTO to assess the efficacy of PSI; and AR-assisted intraoperative adjustment versus traditional fluoroscopy-based adjustment to evaluate the precision of AR navigation. Participants will: * Complete preoperative assessments, including laboratory tests (complete blood count, biochemistry, coagulation), imaging (full-length, weight-bearing lower-limb radiographs; knee CT and/or MRI as indicated), 3D gait analysis (to measure KAM, KAM impulse, and varus thrust), and PRO assessments (KOOS, WOMAC, and Lysholm scores) * Receive assigned surgical interventions: the DA group will undergo HTO guided by dual-mode alignment plus 3D-printed PSI and intraoperative AR feedback; the MA and KA groups will undergo HTO based on traditional or kinematic alignment, respectively; the traditional HTO group will undergo surgery relying on intraoperative fluoroscopy and surgeon experience. * Attend follow-up visits at 6 weeks, 3 months, 6 months, and 12 months postoperatively, including imaging to assess alignment accuracy and bone healing, gait analysis, PRO assessments, and complication monitoring. * Record medication use and rehabilitation compliance throughout the study period.

Randomized Controlled Study Evaluating Genicular Artery Embolization Against Intra-Articular Corticosteroid Knee Injection for Osteoarthritic Knee Pain

Multi-center, prospective, randomized trial of GAE using Nexsphere-F against steroid injection

Study in Patients With Knee Osteoarthritis Treated by Embolization Using NBGM200

Study in patients with knee osteoarthritis treated by embolization using NBGM200

Validation and Reliability of the Vietnamese Pain Self-Efficacy Questionnaire in Knee Osteoarthritis

This study aims to evaluate the reliability and convergent validity of the Vietnamese version of the Pain Self-Efficacy Questionnaire (VIET-PSEQ) in patients with knee osteoarthritis (KOA). Pain self-efficacy refers to a person's confidence in managing their pain and maintaining daily activities despite it. A total of 173 patients with KOA will be recruited at Gia Dinh People's Hospital using a convenient sampling method. Eligible participants are 50 years or older, diagnosed with KOA, and experiencing chronic knee pain. They will complete the VIET-PSEQ and other health-related questionnaires during an in-person interview. The study will assess internal consistency (using Cronbach's alpha), test-retest reliability (by re-assessing a subgroup after 72 hours), and convergent validity by correlating VIET-PSEQ scores with EQ-5D-5L utility index. Additionally, linear regression analysis will examine how age, sex, pain severity, and education level influence pain self-efficacy. The goal is to determine whether VIET-PSEQ is a reliable and valid tool for measuring pain self-efficacy in Vietnamese patients with KOA.

A Study to Assess the Efficacy and Safety of Vutiglabridin in Knee Osteoarthritis Patients

1. Study Objective To Explore the Efficacy and Evaluate the Safety of Vutiglabridin in Knee Osteoarthritis Patients 2. Background Glaceum Inc. has evaluated the safety, tolerability, and pharmacokinetic/pharmacodynamic properties of vutiglabridin in healthy subjects through its Phase 1 trials, and is planning to perform this Phase 2a trial to assess the efficacy and safety of vutiglabridin in Knee Osteoarthritis Patients 3. Study Design and Protocol This study is a randomized, double-blind, placebo-controlled, parallel-group trial. Subjects deemed eligible to participate in this study based on the inclusion/exclusion criteria will be assigned a subject number and randomized to one of the 3 treatment groups - 1 group receiving a placebo - in a 1:1:1 ratio. Subjects will be randomized to double-blind treatments and will receive a once-daily oral dose of the investigational product for 26 weeks according to the study protocol. Several parameters (i.e., 100mm VAS, WOMAC pain subscale, X-ray, MRI, BMI) will be evaluated to assess the efficacy of vutiglabridin. Assessments including measurement of vital signs, 12-lead ECG, clinical laboratory test, pregnancy test, physical examination, and adverse event monitoring will be performed to evaluate the safety and tolerability of vutiglabridin. Blood samples will be collected for pharmacokinetic assessment.

Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis

Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomized sham-controlled trial (RCT). The influence of psychosocial and psychocognitive factors, changes in analgesic use, and conditions of knee joint cartilage and effusion will similarly be explored to determine their impacts on perceived pain response to GAE.

Knee OsteoArthritis Long-term Assessment

The goal of this clinical study is to learn if Hydrogel OA 2% injection is safe and whether it works to improve symptoms of diagnosed knee osteoarthritis in adults when compared to Hyaluronic Acid (Durolane), a treatment that is currently often used for treatment of knee osteoarthritis. The main question it aims to answer is: \- How many study participants will experience side effects related to Hydrogel OA 2% during the study when compared to Hyaluronic Acid (Durolane)? All study participants will receive either one Hydrogel OA 2% or Hyaluronic Acid (Durolane) injection in their knee during the clinical study. Study participants will not know which treatment they have received. Study participants will also receive a call from the researchers and visit the clinic three times to report whether they have experienced any side effects, and complete a questionnaire that will ask questions on whether their symptoms have improved since they received an injection.

Retro-walking Versus Forward-walking Training Using Underwater Treadmill in Patients With Knee Osteoarthritis

The purpose of this study Will investigate and compare the effects of retro-walking and forward-walking underwater treadmill training on pain, function and ROM in subjects with chronic knee OA

Effects of Feldenkrais Exercises in Knee Osteoarthritis Patients

The primary objective of the study is to determine the effects of Feldenkrais Exercises on Pain, Range of Motion, and Disability in Patients with Knee osteoarthritis. Knee osteoarthritis poses significant challenges in pain management, mobility improvement, and disability reduction among middle-aged to older adults. Feldenkrais Method offers benefits comparable to back school lessons or core stability exercises. This study, conducted as a Randomized Controlled Trial at RIPHAH Rehabilitation Clinic, aims to assess the efficacy of Feldenkrais exercises compared to conventional physical therapy in addressing pain, range of motion, and disability in knee osteoarthritis patients aged 40-60 years. A non-probability convenience sampling method will recruit 32 participants meeting specific criteria for osteoarthritis severity and functional ability. Participants will be randomly assigned to Group A (Feldenkrais exercises) or Group B (conventional therapy), with interventions delivered over four weeks. Group A will engage in Feldenkrais exercises targeting pelvic and lower limb mobility, while Group B will receive standard treatments including knee isometrics, mobilization, transcutaneous electric nerve stimulation, and heating pad applications. Pain severity will be measured using the Numeric Pain Rating Scale, Range of Motion assessed via goniometry, and disability evaluated using the Western Ontario McMaster Universities Osteoarthritis Index. Statistical analysis using SPSS will compare outcomes between groups at baseline, post-treatment, and follow-up assessments.

Muscle Isometric Contraction for the Treatment of Knee Osteoarthritis

This study compares the effects of three different intensities of Muscle Isometric Contraction (MIC) on balance ability, proprioception, muscle strength, KOA symptoms, and inflammatory factors in synovial fluid among elderly individuals with Knee Osteoarthritis (KOA).

Reflexology and Mulligan Mobilization for Knee Osteoarthritis

to investigate the effect of adding Reflexlogy to mulligan mobilization and the conventional treatment for patients with Osteoarthritis knees

Creation of a Prospective Data Collecting Registry for Genicular Artery Embolization for Arthritis

The goal of this study is to create a prospective registry (\<100 patients) to show the effectiveness of the genicular artery embolization procedure overtime in reducing bilateral or unilateral osteoarthritic knee pain as measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score.

Efficacy and Safety of Tongren-Dahuoluo Bolus in Patients with Knee Osteoarthritis

The clinical trial has a research cycle of 24 weeks. The first 12 weeks are multicenter, randomized, double-blind, controlled trials. A total of 72 patients with knee osteoarthritis with liver-kidney deficiency syndrome and/or cold-dampness arthralgia syndrome are planned to be enrolled and randomly assigned to the control group (Tongren-Dahuoluo Bolus) and the treatment group (Tongren-Dahuoluo Bolus Placebo) in a 1:1 ratio. The purpose is to compare the safety and efficacy of Tongren-Dahuoluo Bolus and placebo in treating knee osteoarthritis. A long-term blind extension study will be conducted in the next 12 weeks. All subjects will take Tongren-Dahuoluo Bolus orally to evaluate the long-term safety, tolerability, and efficacy of Tongren-Dahuoluo Pills in treating patients with knee osteoarthritis.