Clinical Research Directory

Hydrogel Assessment for Local Treatment of Osteoarthritis

The study aims to evaluate the safety and tolerability of one intra-articular injection of Hydrogel OA 2% for the symptomatic treatment of osteoarthritis of the knee.

Long Duration High Frequency Ultrasound for the Treatment of Osteoarthritis

The purpose of this study is to assess the ability of long-duration high-frequency continuous-wave therapeutic ultrasound to alleviate knee Osteoarthritis pain over an 12-week period. The primary objective of this study is to evaluate the analgesic effect of ultrasound treatment in subjects suffering from knee Osteoarthritis pain. Secondary objectives are to assess the ability of ultrasound treatment to improve joint function.

The Effectiveness of BETY in Knee Osteoarthritis With Intra-Articular Injections

Osteoarthritis (OA) is the most common condition in middle-aged and elderly populations; it causes pain and physical disability and is characterized by cartilage degeneration, changes in bone tissue, inflammation of the synovial membrane, and an increased inflammatory response. Because pain and depression often co-occur in individuals diagnosed with OA, the concepts of disability and health-related quality of life caused by the disease have become more decisive than radiological joint damage. The chronic nature of the disease, like other chronic conditions, encompasses a range of biopsychosocial impacts, including pain, fatigue, sleep disturbances, functional loss, anxiety, depression, and social isolation. This complex structure is accompanied by a pattern in which inflammatory processes are triggered. Recently, intra-articular injections (such as Platelet-Rich Plasma Therapy (PRP), Hyaluronic Acid (HA), PRP+HA combinations, Corticosteroids, Prolotherapy, and Stem Cells) have been accepted as a treatment for OA. Regarding the mechanism of these intra-articular injections, it has been reported that a combination of various anabolic and anti-inflammatory cytokines may treat inflammation associated with the early stages of OA. It has been demonstrated that, through the effects of various growth factors, these treatments have a positive impact on chondrogenesis and mesenchymal stem cell proliferation by increasing anti-inflammatory mediators and reducing pro-inflammatory mediators. Bilişsel Egzersiz Terapi Yaklaşımı - BETY (Cognitive Exercise Therapy Approach in english) is an exercise approach based on the biopsychosocial model. BETY consists of innovations in function-oriented body stabilization exercises (FoGSE), chronic pain management (BETY-Nociplastic Pain Management (BETY-NPM)), emotion-mood information management (dance therapy-authentic movement), and sexuality information management. The aim of this study is to investigate the effectiveness of BETY, which is often initiated following intra-articular injections-a treatment frequently chosen for individuals diagnosed with knee osteoarthritis (OA).

Persona SoluTion PPS Femur PMCF

The goal of this study is to generate clinical evidence and evaluate the safety and performance of the Persona® SoluTion® PPS Femurs in the US market, with data supporting global regulatory submissions, including CE marking under EU MDR. The target population consists of adults undergoing knee arthroplasty with the Persona SoluTion femoral component paired with a Medial Congruent (MC) or Posterior Stabilized (PS) articulating surface in line with its current cleared Instructions for Use (IFU). The primary endpoint is the assessment of clinical performance and benefits by evaluating the average change in the KOOS JR score between pre-operative and 2-year post-operative follow-up.

Home-Based Leg Dexterity Trainer for Management of Knee Osteoarthritis

Rationale: Roughly 14 million adults aged 60 or older (10% male/13% female) in the United States experience symptoms of knee osteoarthritis (OA). Knee OA pain progressively impacts aging, reducing mobility and increasing morbidity. Nonsurgical self-management of knee OA includes exercise to promote proper knee mechanics, non-steroidal anti-inflammatory drugs (NSAIDs), cortisone injections, and weight loss to reduce pain and retain function. As OA has no cure, self-management progresses to \~1 million joint replacements per year. Critically, home-based devices are lacking for specifically training the low-level proprioceptive and neuromuscular circuitry for proper knee mechanics in a safe, focused, mechanistic way. Such devices would supplement exercises for strength, mobility, and whole-body loading and movement. Initially considered a wear-and-tear condition, knee OA is now understood as a complex disease involving inflammatory responses to mechanical loading and neuromuscular feedback loops among pain, joint damage, and dynamic loading. Home-based exercises remain a primary nonpharmacological and nonsurgical approach to managing chronic pain in OA that fundamentally disrupts proprioception and neuromuscular control of the joint, which accelerates articular degeneration. Neuromuscular Dynamics, LLC has developed a simple, safe, quick, and effective Leg Dexterity System that is portable, wireless, and coupled to HIPAA-compliant cloud analytics. A seated participant uses their foot to compress a platform atop a slender spring, which becomes unstable as it begins to buckle at low forces. The participant must then control their leg dexterity (i.e., via short-latency sensorimotor circuits) to stabilize the unstable dynamic foot-ground interactions. A tablet computer connected to the device provides feedback during use and uploads the participant's activity data to the server for analysis and reporting, accessible to users and clinicians. The investigators have successfully tested Leg Dexterity in control participants in multiple publications. The Leg Dexterity test is safe and poses minimal risk as the forces needed to do it are very low, does not involve full weight- bearing maneuvers, and is performed while seated without the risk of falling. Study: The investigators will conduct a randomized home-based clinical trial in knee OA to demonstrate the efficacy of leg dexterity training to reduce pain and improve function compared to currently prescribed dynamic exercise on a wobble board (a commonly used approach for improving proprioception and balance). Successful completion of this study will justify the adoption of the Leg Dexterity System as an effective at-home supplement to any nonsurgical management of knee OA. The investigators propose a longitudinal double-blind dose-matched trial comparing 8 weeks of leg dexterity training (Treatment using a slender, unstable spring system that engages short-latency sensorimotor control, 42 participants) vs. at-home wobble board exercises (Control, 42 participants) at the Steadman Philippon Research Institute.

Percutaneous Transcatheter Genicular Embolization in Osteoarthritis

This clinical study investigates a minimally invasive treatment called percutaneous transcatheter embolization of knee arteries for patients with chronic knee pain caused by advanced knee osteoarthritis or persistent pain after total knee replacement. Osteoarthritis of the knee is a common degenerative condition that can lead to long-term pain, reduced mobility, and decreased quality of life, and some patients do not achieve sufficient relief with standard treatments. The study is based on the hypothesis that targeted embolization of small arteries supplying the inflamed tissues of the knee can safely reduce abnormal blood flow associated with inflammation, leading to pain relief and improved knee function. During the procedure, a thin catheter is guided through the blood vessels to the affected area of the knee, where a temporary embolic agent is administered to reduce pathological blood supply. The aim of the study is to evaluate the safety and effectiveness of this procedure by assessing changes in pain intensity, knee function, and quality of life over a follow-up period of up to 24 months. The results of this study may help determine whether this minimally invasive approach can offer a new treatment option for patients who have limited alternatives for managing chronic knee pain

Rehabilitation Approaches Used in Total Knee Replacement

In this study, we will investigate the rehabilitation approaches commonly used by physiotherapists in Pakistan following total knee replacement. Total knee replacement is a frequently performed surgical procedure, and effective postoperative rehabilitation is essential for improving pain, mobility, and functional outcomes. A web-based cross-sectional survey will be conducted among practicing physiotherapists from different provinces of Pakistan. Data will be collected using a structured questionnaire to explore demographic characteristics, rehabilitation techniques employed at various stages of recovery, and challenges faced in post-TKR rehabilitation. The collected data will be analyzed using appropriate descriptive and inferential statistical methods. The findings will help identify prevailing rehabilitation practices and variations among physiotherapists. This study will contribute to understanding current clinical trends, identifying gaps in practice, and promoting the use of evidence-based and standardized rehabilitation protocols. Ultimately, the results will support improved patient recovery, guide professional training, and assist in developing consistent post-TKR rehabilitation strategies in Pakistan.

Combination of Nerve Blocks and Local Infiltration Analgesia in Knee Arthroplasty

The aim of this clinical randomized trial is to compare local infiltration analgesia (LIA) alone versus the combination of LIA with saphenous nerve (SN) block, block of the nerve to vastus medialis (NVM), and anterior femoral cutaneous nerve (AFCN) block in participants undergoing total knee arthroplasty (TKA). The primary outcome is pain intensity, measured using the Numerical Rating Scale (NRS) at multiple time points after surgery. Secondary outcomes include opioid consumption, time to mobilization, postoperative nausea and vomiting, length of hospital stay, neurological complications and differences in opioid consumption and NRS pain scores between general and spinal anesthesia.

Clinical Investigation of Sensovisc

This clinical investigation aims to investigate the safety and performance of Sensovisc. Sensovisc is used to reduce osteoarthritis (OA) related pain in the joints by supporting synovial fluid by intra-articular injection and allowing the synovial fluid to restore its viscoelastic properties. It increases the joint mobility by reducing or eliminating the pain. This Clinical Investigation was designed as a cross-sectional, interventional, and prospective study.

"Bimodal vs Unimodal High-Intensity Pulsed Electromagnetic Field Therapy in Older Adults With Knee Osteoarthritis"

This randomized, double-blind clinical trial aims to evaluate the effect of high-intensity pulsed electromagnetic field therapy (HI-PEMF) applied either exclusively on the knee joint or bimodally on the knee and quadriceps, in older adults with knee osteoarthritis. Both groups will also receive a structured home-based exercise program. The primary outcome is pain reduction, and secondary outcomes include functional performance.

Role of Methotrexate in Ultrasound Proven Synovitis in Primary Knee OA

Background: Osteoarthritis (OA) is a leading cause of disability worldwide, with limited treatment options and many patients suffering from chronic pain. Modern imaging has revealed that OA involves complex changes in cartilage, subchondral bone, and synovium. Pain in OA is often linked to synovitis, which is common in the condition. Methotrexate (MTX), a proven treatment for synovitis in inflammatory arthritis like rheumatoid arthritis and has a well-known safety profile. The proposal suggests that using MTX may have potential to treat symptomatic knee OA with USG (musculoskeletal ultrasound) proven synovitis by reducing synovitis and as a result, alleviate pain. Objectives: To assess the role of methotrexate in primary knee osteoarthritis associated with ultrasound proven synovitis. Methods: This randomized Controlled trial will be conducted in the department of Rheumatology, Bangladesh Medical University (BMU) from July 2025 to June 2026. A total of 70 patients will be enrolled with primary knee OA diagnosed on the basis of ACR Criteria for Knee OA with informed written consent. MSK USG examinations of knee joint and scoring (OMERACT SCORE) will be performed to detect synovitis by a rheumatologist expert in MSK US. Then randomization will be done into group A and group B following a randomization table, each consisting of 35 patients. Consecutive sampling techniques will be followed. One group will receive MTX (start with 15 mg per week for the first 2 weeks then increase to 20 mg and continue for the remaining period if tolerated) and Both groups of patients will be allowed to take NSAIDs on a requirement basis with documentation and follow non-pharmacological treatment of OA. At the end of 3rd and 6th month pain and functional status will be assessed by WOMAC, VAS and quality of life will be assessed by using Bangla version of SF-12. At the end of 6th month improvement of synovitis will be seen by MSK USG of involved knees with OMERACT scoring. Primary endpoint for efficacy will be assessed at the end of 24th week by WOMAC. Secondary endpoints will be determined by VAS and SF-12. Adverse effects will be assessed by history, physical examinations and investigations. The data will be analyzed by using the latest version SPSS software (Version 29). Results will be recorded using means and standard deviations. Results will be compared among two groups with a 95% confidence interval and a p- value of \< 0.05 will be considered statistically significant. The degrees of statistical significance between groups will be analyzed by unpaired t test (for quantitative normally distributed data) and Mann Whitney U test if there is skewed distribution. Qualitative data in between groups will be analyzed by the chi square test. Probabilities of associations will be assessed by calculating Pearson's rank correlation coefficient. P-value \<0.05 will be regarded as statistically significant. The nature, purpose and implication of the study as well as the entire spectrum of benefits and risks of study will be explained to the patients. Privacy and confidentiality of the subject will be maintained. Each patient will enjoy the right to participate and or withdraw from the study at any point of the study period. Ethical clearance will be obtained from the institutional Review Board (IRB) of BMU.

Comparison of Distal IPACK and Popliteal Plexus Block Combined With Femoral Triangle Block After Total Knee Arthroplasty

This study aims to investigate the effect of femoral triangle block combined with popliteal plexus block and distal IPACK block on postoperative pain after total knee arthroplasty (TKA)

Dinalbuphine Sebacate in Postoperative Pain Control After TKA

To evaluate the effectiveness of Dinalbuphine Sebacate for controlling subacute pain after total knee arthroplasty