Clinical Research Directory

A Single-Center Phase 1 Study of ceAF for Knee Osteoarthritis (KOA)

Approximately 25 participants aged 18-70 years, with knee pain rated 4-7 on a 10-point visual analogue scale (VAS) and a disease duration of 6 months to 10 years, will be enrolled. The study has two parts. In Part 1, participants receive a single intra-articular injection of 1.0 mL, 1.5 mL or 2.0 mL of study product (3-5 participants per dose level, given in ascending order). In Part 2, the dose with the most favourable balance of efficacy and safety in Part 1 is given weekly by intra-articular injection for 2-3 doses to an additional 6-10 participants. Participants are followed for 12 weeks after the last injection. Safety is assessed through adverse events (graded by CTCAE v5.0), vital signs, physical examination, electrocardiogram, clinical laboratory tests (haematology, urinalysis, liver and kidney biochemistry, coagulation) and pregnancy testing. Efficacy is assessed by change from baseline in knee X-ray, knee MRI, the Knee injury and Osteoarthritis Outcome Score (KOOS), the WOMAC index, pain VAS and pain-free walking distance at 4 and 12 weeks after the last dose. The study has no placebo or active comparator group. There is no plan to market the product on the basis of this study.

Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain

The purpose of this superiority randomized controlled trial is to evaluate the effect of daily knee sleeve use on 5-year radiographic knee osteoarthritis progression and knee-related symptoms in older adults with chronic knee pain. The investigators will recruit 235 individuals aged 50-64 years at baseline with chronic (≥ 3 months) knee pain, randomized to daily use of an elasticized fabric knee sleeve versus no knee sleeve use. Participants will have knee radiographs at baseline and year 5 and will complete a survey including Knee injury and Osteoarthritis Outcome Score (KOOS) subscales for pain, knee function and quality of life at baseline, 3 months and annually. A prespecified interim analysis of the 1-year KOOS subscore data will be performed.

Extracorporeal Shock Wave Therapy in the Treatment of Periarticular Bone Marrow Edema in Patients With Knee Osteoarthritis

Bone marrow edema (BME) is a radiological finding characterized by increased fluid content and structural changes within the bone marrow. It most commonly affects weight-bearing joints such as the hip, knee, and ankle. Patients with BME may present with pain during activity or at rest, tenderness, swelling, joint effusion, and limitation of joint motion. Magnetic resonance imaging (MRI) is considered the gold standard for diagnosis. BME is commonly observed in patients with knee osteoarthritis (OA) and may be associated with increased pain, impaired joint function, and progression of structural joint damage. Therefore, recognition and treatment of BME may be clinically important in patients with knee OA. Treatment options for BME include conservative and surgical approaches. Standard conservative treatment generally includes activity and weight-bearing modification, analgesics and nonsteroidal anti-inflammatory drugs, and physical therapy modalities. Extracorporeal shock wave therapy (ESWT) is one of the non-invasive physical therapy options that can be added to standard conservative treatment. Surgical treatment, including core decompression, may be considered in patients who do not respond to conservative treatment. ESWT may exert beneficial effects by improving local blood flow, promoting angiogenesis, stimulating bone remodeling and regeneration, and providing analgesia. Previous studies in patients with knee-related BME have suggested that ESWT may reduce pain, improve functional outcomes, and decrease BME findings on MRI. Kang et al. reported more rapid improvements in pain, functional outcomes, and the MRI-detected area of BME within three months with ESWT compared with alendronate therapy. Sansone et al. found that ESWT resulted in greater reductions in pain and BME area, together with clinically meaningful improvement at three months, compared with conservative treatment consisting of unloading and analgesics. In a prospective randomized controlled trial, Gao et al. further showed that ESWT provided more favorable six-month outcomes in terms of pain, functional scores, and MRI-assessed BME area than intravenous prostacyclin combined with oral bisphosphonate therapy. Collectively, these findings suggest that ESWT may provide sustained clinical and radiological benefits in patients with knee BME. This study aims to investigate the effects of adding ESWT to standard conservative treatment in patients with knee osteoarthritis accompanied by bone marrow edema. Patients receiving active ESWT will be compared with those receiving sham ESWT in terms of pain, functional outcomes, patient satisfaction, and changes in bone marrow edema volume on MRI.

Quadriceps Muscle Quality and Clinical Outcomes in Knee Osteoarthritis

The purpose of this cross-sectional, observational study is to evaluate the relationship between quadriceps muscle quality-specifically muscle echogenicity and thickness change during isometric contraction-and clinical outcomes such as pain, physical function, quality of life, and Patient Global Assessment (PtGA) in female patients with knee osteoarthritis. Participants will undergo a non-invasive ultrasound evaluation of their thigh muscles and complete standard clinical questionnaires to help determine how muscle structural and functional properties impact the daily lives of patients with knee osteoarthritis.

Efficacy and Safety of GNSC-001 Intra-articular Injection for Knee Osteoarthritis

The goal of this clinical trial is to learn if GNSC-001 works to treat knee osteoarthritis in adults. It will also learn about the safety of GNSC-001. The main questions it aims to answer are: 1. Does GNSC-001 lower daily knee joint pain and improve function in participants? 2. What medical problems do participants have when taking GNSC-001? Researchers will compare GNSC-001 to a placebo (a look-alike substance that contains no drug) to see if GNSC-001 works to treat knee osteoarthritis. Participants will: 1. Receive a single injection of immune-modulation, and GNSC-001 or a placebo, in their knee 2. Take an oral immune-modulating pill every day for the first 22 days 3. Visit the clinic at least 9 times over 2 years for checkups and tests 4. Keep a diary of their symptoms and the number of times they use a rescue medication

Eccentric vs Low-Load Blood Flow Restriction Training in Knee Osteoarthritis in Knee Osteoarthritis

The aim of this randomized controlled trial is to find the effects of eccentric and low-load blood flow restriction training on neuromuscular adaptations, muscle strength, functional performance, and disability in patients with knee osteoarthritis

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.

Perturbation Based Balance Training Versus Progressive Neuromuscular Training as an Adjunct to Conventional Physiotherapy for Pain Reduction and Functional Improvement in Knee Osteoarthritis

This is an RCT aims to explore Perturbation-Based Balance Training versus Progressive Neuromuscular Training as an Adjunct to Conventional Physiotherapy for Pain Reduction and Functional Improvement in Knee Osteoarthritis.

Effects of Mobilized Balance Platform Exercises on Balance Parameters in Patients With Knee Osteoarthritis

This prospective single-blind randomized controlled study aims to investigate the effects of mobilized balance platform exercises on balance parameters, pain, functional status, fear of falling, and kinesiophobia in patients with knee osteoarthritis. A total of 36 patients diagnosed with knee osteoarthritis will be recruited from the outpatient clinic of Gaziler Physical Medicine and Rehabilitation Training and Research Hospital. Participants will be randomly assigned to one of two groups. The control group will receive conventional physical therapy including transcutaneous electrical nerve stimulation (TENS) and a home exercise program consisting of knee strengthening, balance, range of motion, proprioceptive, and stretching exercises. The intervention group will receive the same conventional treatment in addition to mobilized balance platform exercises using the Huber 360 system. Pain severity, functional status, balance parameters, fear of falling, and kinesiophobia will be evaluated before and after treatment by an assessor blinded to treatment allocation.

Platelet-Rich Plasma Composition and Clinical Effects in Knee Osteoarthritis

This is a prospective, observational cohort study involving 40 patients with primary knee osteoarthritis hospitalized in a rehabilitation hospital in Cluj-Napoca. All participants will receive intra-articular platelet-rich plasma (PRP) injections. The study aims to analyze PRP composition and inflammatory biomarkers to better understand disease mechanisms and evaluate treatment effectiveness.

Results Between Robotic-assisted and Manual Total Knee Arthroplasty With Kinematic Alignment

This randomised controlled trial will include patients with end-stage osteoarthritis of the knee undergoing primary TKR. Patients meeting the criteria that consent to be in the study will be randomised at a ratio of 1:1 to either manual TKR or robotic-assisted TKR. The primary objective will assess pre- and postoperative HKA angle, CPAK and range of motion using goniometer to compare two groups.The secondary objectives are to compare patient expectation, functional ability, quality of life using functional 48-point Oxford Knee Score and Forgotten joint score.

Knee Osteoarthritis Rehabilitation Through Rotational Inertia

This study is testing whether a new type of exercise program, called eccentric overload training using a flywheel device, can improve stair-climbing ability in people with knee osteoarthritis. The flywheel device provides resistance throughout the entire movement and gives extra challenge during the muscle-lengthening phase of exercise. This type of training may improve muscle structure, strength, and coordination more effectively than conventional methods. The study's central idea is that better muscle quality and improved coordination will lead to smoother, safer stair movement and reduce the risk of falls. Advanced tools such as ultrasound imaging and motion analysis will be used to measure muscle health and movement patterns in detail. The hypothesis is that individuals with knee osteoarthritis have poorer muscle quality and less coordinated stair-stepping compared to healthy adults, and that performing eccentric overload training will enhance muscle quality, improve movement coordination, and make stair navigation safer and more efficient.

The Perioperative Outcome of Epinephrine Infusion and Tranexamic Acid in Knee Arthroplasty Surgery

The aim of this clinical trial is to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative blood loss, thromboembolic complications, and hospitalization duration in patients undergoing knee joint arthroplasty. Also aim to evaluate the effect of administering low-dose epinephrine and tranexamic acid on perioperative thromboembolic complications, and hospitalization duration