Clinical Research Directory

Holistic Healing for Knee Osteoarthritis

This study is a single-center, three-arm, open-label randomized controlled trial designed to compare the effectiveness of integrated care, standard medical care, and Ayurvedic care in adults with early knee osteoarthritis (Kellgren-Lawrence grades I-II). Knee osteoarthritis is a leading cause of pain, functional limitation, and reduced quality of life, and current management often provides incomplete symptom relief. Although conventional medical and Ayurvedic interventions are widely used in clinical practice, comparative evidence evaluating these treatment approaches individually and in combination remains limited. A total of 300 participants aged 30-65 years with primary knee osteoarthritis will be randomly allocated in a 1:1:1 ratio to receive standard medical care, Ayurvedic care, or integrated care. The standard medical care group will receive oral paracetamol, topical diclofenac spray, transcutaneous electrical nerve stimulation (TENS), and superficial heat or cold therapy. The Ayurvedic care group will receive Trayodashang Guggulu, Ashwagandha Churna, Janubasti therapy, and topical application of Mahanarayana Taila. The integrated care group will receive Trayodashang Guggulu, Ashwagandha Churna, topical diclofenac spray, and portable transcutaneous electrical nerve stimulation (TENS). Participants will be followed for 24 weeks. Primary outcome measures include changes in knee pain intensity, knee osteoarthritis symptoms, knee joint surface temperature, and gait kinematic parameters. Secondary outcome measures include changes in erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). The findings of this study are expected to provide evidence regarding the comparative effectiveness of integrated care, standard medical care, and Ayurvedic care in the management of early knee osteoarthritis.

Efficacy of Platelet-Rich Plasma Added to Hyaluronic Acid in Knee Osteoarthritis

This prospective, randomized, open-label, single-centre post-market clinical follow-up (PMCF) study evaluates the clinical performance and safety of a single intra-articular injection of hyaluronic acid (HA) combined with autologous platelet-rich plasma (PRP) compared with a single intra-articular injection of HA alone in adults with symptomatic knee osteoarthritis (Kellgren-Lawrence grade II or III). Knee osteoarthritis is a chronic degenerative joint disease associated with pain, functional limitations, and reduced quality of life. Hyaluronic acid is widely used as viscosupplementation therapy, while platelet-rich plasma provides autologous growth factors that may contribute to the modulation of inflammatory processes and tissue healing. The combination of HA and PRP may provide complementary effects and may offer additional clinical benefit compared with HA alone. A total of 50 participants will be randomized in a 1:1 ratio to receive either a single intra-articular injection of 3.8 mL HA combined with 1 mL autologous PRP or a single intra-articular injection of 4.8 mL HA. Participants will be followed for 18 months. The primary endpoint is the between-group difference in change in knee pain measured using the Numeric Rating Scale (NRS) from baseline to Month 6. Secondary outcomes include changes in pain intensity, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and Osteoarthritis Outcome Score (KOOS), quality of life measures, and safety assessments throughout the follow-up period. Both medical devices are CE-marked and are used for their intended purpose. The study is conducted as a PMCF investigation in accordance with Regulation (EU) 2017/745 (MDR).

Efficacy of Platelet-Rich Plasma Combined With Hyaluronic Acid in Knee Osteoarthritis

This prospective, randomized, open-label, single-centre post-market clinical follow-up (PMCF) study evaluates the clinical performance and safety of a single intra-articular injection of hyaluronic acid (HA) combined with autologous platelet-rich plasma (PRP) compared with a single intra-articular injection of HA alone in adults with symptomatic knee osteoarthritis (Kellgren-Lawrence grade II or III). Knee osteoarthritis is a chronic degenerative joint disease associated with pain, functional limitations, and reduced quality of life. Hyaluronic acid is widely used as viscosupplementation therapy, while platelet-rich plasma provides autologous growth factors that may contribute to the modulation of inflammatory processes and tissue healing. The combination of HA and PRP may provide complementary effects and may offer additional clinical benefit compared with HA alone. A total of 50 participants will be randomized in a 1:1 ratio to receive either a single intra-articular injection of 3.8 mL HA combined with 1 mL autologous PRP or a single intra-articular injection of 4.8 mL HA. Participants will be followed for 18 months. The primary endpoint is the between-group difference in the change in knee pain, measured using the Numeric Rating Scale (NRS), from baseline to Month 6. Secondary outcomes include changes in pain intensity, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Injury and Osteoarthritis Outcome Score (KOOS), quality-of-life measures, and safety assessments throughout the follow-up period. Both medical devices are CE-marked and are used for their intended purpose. The study is conducted as a PMCF investigation in accordance with Regulation (EU) 2017/745 (MDR).

Evaluation of a Preoperative Education in Total Knee Arthroplasty

The benefit of preoperative rehabilitation treatment combining physiotherapy and targeted education for patient undergoing Total Knee replacement (TKR) is now well known. Thus, there is lack of validated booklet containing evidence based informations. Our aim is to assess the impact of an evidence based education pre-operative booklet on patient's knowledge and beliefs. The secondary objectives are to assess the impact of the booklet on patient's satisfaction on the information received, the length of stay in orthopedic surgery and the transfer rate to rehabilitation wards. To show a difference of 2 points on the knowledge score (range 0-10) between the two groups, with a = 0.05 and a power of 90%, we considered that 44 patients are needed. The evaluations will take place at baseline, the day before surgery and 6 weeks post-surgery on knowledge and beliefs scores at each visit and on a satisfaction score on the last one. Quantitative data will be compared between groups by the Kruskal-Wallis and qualitative parameters via Fisher exact test. The study protocol was approved by the local Ethic Committee.

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.

Effects of Pressure Biofeedback Training Versus Bolster Foam Roll Training for Pain, Muscles Activation, and Quality of Life Among Knee Osteoarthritis Patients

The current study will be a single-blinded, two-arm parallel group randomized clinical trial involving 48 participants. The trial will compare Pressure Biofeedback training with Bolster Foam Roll training. Interventions will be delivered three times per week for eight weeks. The primary outcomes will include pain intensity, functional status, and muscle activation. Assessments will be conducted at baseline (week 0), mid-intervention (week 4), post-intervention (week 8), and follow-up (week 12). The study will be conducted at the outpatient departments of Sir Ganga Ram Hospital (SGRH) and Mayo Hospital Lahore. The hypothesis is that there is a difference between Pressure Biofeedback Training and Bolster Foam Feedback Training regarding pain reduction, muscle activation, and patient-reported quality of life compared to Bolster Foam rolling training among knee osteoarthritis patients.

Effect of Inspiratory Muscle Training on Knee Osteoarthritis Pain

Knee osteoarthritis (KOA) is a common joint disease that causes chronic pain and limits daily activities. Current treatments, such as painkillers or surgery, have limitations like side effects or high costs. This study will test whether a safe, non-drug intervention-inspiratory muscle training (breathing exercises against resistance)-can reduce knee pain in people with KOA. The training may work by lowering inflammation and improving the brain's modulation of pain. Eighty patients aged ≥55 years with confirmed KOA and frequent knee pain will be enrolled. Participants will be randomly assigned to either an 8-week inspiratory muscle training program (5 sessions per week, with gradually increasing resistance) or a sham (very low resistance) training program. Neither the patients nor the researchers assessing the outcomes will know who is in which group. The main outcome is change in knee pain measured by a visual analog scale (VAS). Secondary outcomes include blood markers of inflammation (TNF-α, IL-6, IL1β), physical function, the Knee injury and Osteoarthritis Outcome Score (KOOS), inspiratory muscle strength, activity level, sleep quality, and quality of life. To explore underlying mechanisms, outcomes included heart rate variability (HRV) as an indicator of autonomic nervous system function, and brain functional connectivity in the prefrontal cortex using functional near-infrared spectroscopy (fNIRS) are collected. These mechanistic assessments will be performed at baseline and at the end of 8-week intervention. Additional follow-up assessments for clinical outcomes will be done at 3 and 6 months after the training ends. Any side effects or adverse events will be recorded. This study will provide high-quality evidence on whether inspiratory muscle training is an effective and safe complementary treatment for knee pain in people with knee OA, and will offer new insights into the mechanisms underlying its analgesic effects.

Pilot and Feasibility Study of 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 IC14 administration in patients with KOA. A small-scale, Phase I 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 infusion for KOA, (4) evaluate safety profiles of the localized biologic intervention. Participants will be randomized into one of two arms, (a placebo arm, and active atibuclimab arm (2 mg/kg)) and will be followed to evaluate the safety and feasibility of this treatment.

Effects of Resveratrol Supplementation Combined With a Low-Calorie Diet in Postmenopausal Women With Obesity and Knee Osteoarthritis

Obesity is a major modifiable risk factor for knee osteoarthritis and is associated with chronic low-grade inflammation, pain, functional impairment, and cartilage degradation. Weight reduction is recommended as a core component of osteoarthritis management, while resveratrol has demonstrated anti-inflammatory and chondroprotective properties in experimental and clinical studies. However, the potential additional benefit of resveratrol supplementation when combined with dietary intervention remains uncertain. This randomized controlled trial evaluated the effects of 150 mg/day trans-resveratrol supplementation as an adjunct to a low-calorie diet in postmenopausal women with obesity and knee osteoarthritis. Ninety-seven participants were randomized to receive either a low-calorie diet alone or the same diet combined with resveratrol for 10 days. Outcomes included pain intensity, functional status, urinary C-terminal telopeptide of type II collagen (CTX-II), anthropometric parameters, body composition, metabolic markers, lipid profile, and inflammatory biomarkers.

Comparing the Effects of Macquarie Injury Management Group Protocol and Targeted Knee Exercise Program on Pain, Range of Motion and Functional Disability in Patients With Grade II Knee Osteoarthritis

The goal of this clinical trial is to learn if the macquire injury management group protocol and targeted knee exercise program works to treat knee osteoarthritis grade 2.This clinical trial compares the effects of macquire injury management group protocol and targeted knee exercise program on pain and range of motion and functional disability in patients with knee osteoarthritis grade 2.Adults with knee osteoarthritis grade 2 were included in this study. A total of 84 participants were divided into two groups with 42 patients in each group. One group received macquire injury management group protocol and the other group received targeted knee exercise program. Pain was assessed using the numeric pain rating scale and functional disability was measured using WOMAC index. Range of motion was also evaluated before and after treatment by universal goniometer.

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.

Phase II/III Randomized Trial of UC-MSC Secretome vs Sodium Hyaluronate in 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.

Neuromuscular Control and Motor Unit Behavior in Patients With Knee Osteoarthritis

This study aims to examine the effects of moderate-intensity strength training, performed with or without an unloading knee orthosis (valgus-corrective or sham mode), on muscle function, motor unit behavior, and force modulation in patients with moderate knee osteoarthritis

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.

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.

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

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.