Clinical Research Directory

"Transarterial Microembolization (TAME) in Inflammatory Knee Pathology"

Patients with knee OA and chronic pain refractory to at least 3 months of conventional conservative therapy will be included in the study, which will evaluate the clinical results obtained after treatment with selective arterial embolization (selection and enrollment, treatment with selective arterial embolization, follow-up checks). Forty-three patients will be included in the study and will undergo the transarterial microembolization procedure after signing the informed consent form for participation in the study and the collection of anamnestic data. Subsequently, patients will be followed up with clinical evaluation at 1, 3, 6, 12, and 24 months of follow-up or until possible dropout for other treatment.

The Validity and Reliability of the OMERACT in the Turkish Population

Knee osteoarthritis is a chronic disease common in middle-aged and older adults, characterized by functional impairment and reduced quality of life due to pain. While physical examination and radiographic Kellgren-Lawrence grading are frequently used in clinical evaluation, the severity of pain does not always correlate with the degree of structural degeneration. Ultrasonography is gaining prominence in osteoarthritis research due to its advantage of simultaneously evaluating both inflammatory and structural components, such as synovial hypertrophy, effusion, power Doppler signal, and osteophytes. The Outcome Measures in Rheumatology (OMERACT) working group has developed a standardized, multidimensional ultrasound scoring system for knee osteoarthritis, and this method is frequently used in the literature. This method consists of a diagnostic ultrasound examination lasting approximately 8-10 minutes. The examination evaluates the anatomical structures of the knee and also includes soft tissue examinations such as synovial hypertrophy. With this method, a diagnostic ultrasound examination lasting approximately 8-10 minutes is performed. The examination evaluates the anatomical structures of the knee and also includes soft tissue examinations such as synovial hypertrophy. Considering the differences between societies in cultural, genetic, biomechanical, body mass index distribution, and healthcare system practices, direct validity, clinical interpretability, and inter-study comparability are of significant importance. The validity, reliability, and applicability of the OMERACT osteoarthritis ultrasound scoring system have been reported in a study conducted on the Egyptian population. However, there is no data on the validity and reliability of OMERACT ultrasound scoring in the Turkish population. This study is the first prospective validation study aimed at establishing standardization for use in clinical practice in Turkey.

Pilot Exploration of Platelet Characterization of Platelet Rich Plasma Created by Two Different Systems

The investigators would like to study the differences in the quality of Platelet Rich Plasma (PRP) between two different machines in those with knee osteoarthritis. Knee osteoarthritis means your cartilage has been worn down, and it affects your knee joint. Both machines, the APEX Biologix XCELL PRP System and the Emcyte PurePRP Supraphysiologic Concentrating System, are FDA approved, commercially available, and makes PRP. The investigators will check if the platelets in the PRP have different amounts or work differently. The investigators will also assess participants symptoms after the injection and compare the two different preparation systems.

The Efficacy and Safety of a Single-Dose Hyaluronic Acid Injection in the Treatment of Knee Osteoarthritis

HA therapy typically consists of several intra-articular injections administered at weekly intervals. A single-dose IA-HA treatment offers patients and physicians a treatment option that involves both lower costs and fewer clinic visits. Furthermore, considering the administration procedure, we believe that single-dose therapy helps reduce the risk of potential side effects. In light of this information, our study aims to retrospectively evaluate the efficacy and safety of HA in patients with symptomatic knee OA who have received a single-dose intra-articular HA injection.

Blood Flow Restriction Training in Knee Osteoarthritic Patients

The aim of this study was to compare the effect of band tissue flossing method and traditional cuff method for blood flow restriction training on pain, range of motion, muscle strength and functional status in patients with knee osteoarthritis. Symptoms of this condition limit patient's ability to perform high load strengthening. Blood flow restraining training allows strengthening with lower loads. 46 subjects will be divided in two groups, 23 subjects in each group. knee extension and knee press exercises will be performed. In group A floss band was tied on thigh and in group B pneumatic cuff was applied on thigh. 40-60 years individual with knee osteoarthritis will be included. outcome measures will be assessed at baseline, after 1st session, after 2nd week and after 4th week.

Daily Activity and Clinical Outcome Measurement of Arthrosamid® Administration in Symptomatic Knee Osteoarthritis.

This study is a prospective, monocentric, interventional post-market study evaluating the effects of a single intra-articular injection of Arthrosamid in patients with symptomatic knee osteoarthritis. Arthrosamid is a polyacrylamide hydrogel consisting of 97.5% sterile water and 2.5% cross-linked polyacrylamide that integrates into the synovial tissue and is used for the symptomatic treatment of knee osteoarthritis. The study will include 30 eligible patients receiving a single Arthrosamid injection and will be followed for up to 12 months. The primary objective is to evaluate the performance of Arthrosamid in terms of daily activities and clinical outcomes in patients with symptomatic knee osteoarthritis. The primary endpoint assesses the percentage change from baseline in daily activity levels at 6 months after injection, measured using an activity tracker combined with a digital rehabilitation tool. Additional assessments include patient-reported outcome measures and clinical follow-up visits conducted as part of standard care.

Comparing Articular Noise and Its Perception Between Two Different Types of Total Knee Arthroplasty

Some patients complain of articular noise (such as clicking, snapping, cracking or popping) after a total knee replacement. Controversy remains about whether there is a correlation between articular noise and worse outcomes following a knee replacement. A study by Nam et al. on 1540 patients revealed an association between noise and residual symptoms 30 days after they received a total knee replacement. Conversely, a study by Kuriyama et al. on 60 patients revealed no correlation between noise and patient satisfaction after 1 year of receiving a total knee replacement. The incidence of noise following a knee replacement has rarely been studied as a primary outcome. Like pain, it could be considered an important patient-reported outcome to assess patient satisfaction. The study aims to compare the prevalence of patient-perceived noise of an ultra-congruent total knee prosthesis (Score 2, Amplitude) versus a posterior-stabilized total knee prosthesis (Anatomic, Amplitude).

Close Chain and Open Chain Exercises With Blood Flow Restriction in Knee Osteoarthritis

The aim of this research is to find and compare the effect of close chain and open chain exercises with blood flow restriction in knee osteoarthritis on pain, range of motion, strength and functional performance in patients with knee osteoarthritis. Randomized controlled trials done at Railway General Hospital and Medistic Medical and Dental Center, Rawalpindi. The sample size was 40. The subjects were divided in two groups, 20 subjects in close chain exercises with blood flow restriction group and 20 in open chain exercises with blood flow restriction group. Study duration was of 4 weeks. Sampling technique applied was purposive non probability sampling technique. Only 45-75 years individual with grade 1 or 2 knee osteoarthritis were included. Tools used in the study are Numeric pain rating scale (NPRS), Western Ontario and McMaster Universities Arthritis Index (WOMAC), goniometer, crane scale (dynamometer), 30 s chair stand test. Data was analyzed through SPSS 21.

Hemi-tibial Plateau Osteotomy Combined With Arthroscopic Repair for Medial Meniscus Posterior Root Tears in Varus Knees

This is a single-center clinical trial started by the study team. The goal is to compare two surgeries for people who have a varus knee alignment and a tear at the back attachment of the medial meniscus. Researchers want to learn how the newer bone-cut procedure with arthroscopic meniscus repair compares to the standard bone-cut procedure with arthroscopic meniscus repair. Researchers will also track safety and hospital-related costs. Main questions the study aims to answer: * At 12 months after surgery, how does the improvement in knee function compare between the newer-surgery group and the standard-surgery group? The study will evaluate preliminary trends in clinical efficacy using the Lysholm knee function score. * Do the two groups differ in pain relief, imaging findings, meniscus healing, complications, and hospital stay and preliminary cost-effectiveness? The study plans to enroll about 20 participants at Sun Yat-sen University Eighth Affiliated Hospital (Shenzhen Futian). Participants will be assigned by chance, like drawing lots, in a one-to-one ratio. This is an pilot study with a PROBE (Prospective Randomized Open-label Blinded-Endpoint) design. While participants and surgeons will know which surgery is performed, the research assistant responsible for collecting patient-reported outcomes will be blinded to group allocation to minimize observer bias. Study groups: * Experimental group: hemi-tibial plateau osteotomy plus arthroscopic meniscus repair. * Control group: high tibial osteotomy plus arthroscopic meniscus repair. Who may join: * Age 35 to 65 years, with no restriction on sex; * Diagnosed with a medial meniscus posterior root tear; * Presence of varus knee deformity; * Imaging findings support the diagnosis (e.g., knee MRI); * Failure of conservative treatment: no meaningful improvement after more than 1 month of non-surgical management (e.g., rest, medication, or physical therapy); * Varus alignment angle less than 10 degrees; * The deformity is predominantly tibial in origin; * Knee radiographs do not show the most severe osteoarthritis (Kellgren-Lawrence grade other than IV). Who cannot join: * A knee that is chronically "locked," meaning it cannot bend or straighten normally. * The most severe level of knee arthritis on knee X-ray. * Severe arthritis in the hip or ankle that could affect knee function testing. * Inflammatory or infectious conditions that can affect the knee, or abnormal inflammation blood tests that make participation unsafe. * Knee instability or poorly functioning prior ligament reconstruction, based on the study doctor's judgment. * Any prior surgery on the target knee, or on other joints of the same-side lower limb. * Serious heart, liver, or kidney disease, cancer, bleeding disorders, immune deficiency, or severe mental health conditions that make participation unsafe. * Body mass index of 30 or higher. * Pregnancy or breastfeeding, or not willing to use birth control during the study. * Participation in another clinical study within the past 3 months (except registry studies). * Any other reason the study doctor believes makes participation unsafe or not appropriate. What participants will do: * Complete screening and baseline assessments within about 30 days before surgery and sign informed consent. * Receive the assigned surgery during the hospital stay. * Return for follow-up visits at 3 months, 6 months, and 12 months after surgery. * Complete knee function and symptom questionnaires and rate pain at each follow-up visit. * Have standing knee X-rays and full-length leg X-rays at 3, 6, and 12 months. * Have an MRI of the operated knee at 3, 6, and 12 months to assess meniscus healing and meniscus extrusion. Outcomes: * Primary outcome: change from baseline to 12 months in the Lysholm knee function score. * Secondary outcomes: changes in the Lysholm score at 3 and 6 months; changes in the WOMAC knee arthritis symptom score at 3, 6, and 12 months; changes in pain rating on a standard pain scale at 3, 6, and 12 months; imaging measures and bone healing on X-rays; meniscus healing and extrusion on MRI; surgery time and blood loss; complications during and after surgery; length of hospital stay and hospital costs; and quality of life utility value from a standard health questionnaire.

Effects of Diagonal Proprioceptive Neuromuscular Facilitation Patterns on Pain and Functional Outcomes in Patients With Knee Osteoarthritis

A randomized controlled trial will be conducted at the Department of Physiotherapy, Dr. Ziauddin Hospital and Al-Rayaz Hospital, Karachi, Pakistan. A total of 150 patients diagnosed with knee osteoarthritis, aged between 40-60 years, will be recruited through a non-probability purposive sampling technique. Written informed consent will be obtained from all eligible participants prior to enrollment. The participants will be randomly allocated by the help of computer generated randomization sheet, into two groups i.e. experimental and the control group, with 75 participants in each group. Group A (experimental group) will receive diagonal proprioceptive neuromuscular facilitation (PNF) pattern exercises, while Group B (control group) will receive conventional strength training exercises. Heat therapy will be administered to both groups. All participants will be assessed using a standardized assessment form. Outcome measures will include pain intensity, knee range of motion, functional disability, hamstring flexibility, dynamic balance, and fatigue level. A single blinded assessor will assess all participants at baseline and at post intervention. Treatment sessions will be given thrice a week on alternate days for 6 weeks.

Feasibility of Resting Intervals During Exercise Programs for Individuals With Knee Osteoarthritis

This pilot randomize trial tests the feasibility of administering two different exercise programs in people with knee osteoarthritis. One group receives the exercise program administered as usual, and the other group received the exercise program with resting intervals.

Prospective Registry For Genicular Artery Embolization At The Joint & Vascular Institute

The goal of this observational study (prospective registry) is to collect long-term real-world data on the effectiveness and safety of genicular artery embolization (GAE) for knee osteoarthritis in adults aged 18 years or older with symptomatic KOA that has not responded to medical therapy. The main questions it aims to answer are: 1. Does GAE lead to sustained improvement in pain (WOMAC, VAS) and quality-of-life scores over 12-36 months? 2. What patient or procedural factors are associated with better outcomes after GAE? Participants will: * Undergo GAE as part of their routine clinical care. * Complete clinical follow-up assessments at 1, 3, 6, 12, 18, 24, and 36 months after treatment, including symptom and quality-of-life questionnaires. * Have safety outcomes tracked according to Society of Interventional Radiology guidelines. There is no comparison group; results will be analyzed to identify predictors of success and inform best practices for patient selection and treatment.

Neuropathic Pain in Knee Osteoarthritis: Pain Severity and Functional Status

Osteoarthritis (OA) is a degenerative joint disease characterized by structural changes such as cartilage loss and osteophyte formation, leading to functional limitations and disability. Pain in knee OA involves a complex pathophysiological structure including both nociceptive and neuropathic mechanisms. Identifying the neuropathic pain component is clinically significant for improving quality of life and functional recovery. This cross-sectional controlled clinical study aims to determine the prevalence of neuropathic pain in patients with knee OA and evaluate its impact on pain severity and functional status. Patients will be categorized based on the Douleur Neuropathique 4 (DN4) questionnaire and assessed using various pain and functional scales.

TcPRF for Knee Osteoarthritis

Objectives * Primary Objective: To evaluate the efficacy of transcutaneous PRF treatment in reducing knee pain compared to a sham intervention * Secondary Objectives: To assess the improvement in functional outcomes and patient satisfaction following PRF treatment. Study Design * Type: Randomized, double-blind, sham-controlled study. * Duration: 6 months * Study Population: Adults aged 40-75 years with chronic knee pain (lasting ≥ 6 months) due to osteoarthritis (OA). * How many patients in each group: 25 patients in each group (according to Janssens et al, 2024) Inclusion Criteria * Diagnosed with knee osteoarthritis according to NICE criteria. * Chronic knee pain (Visual Analogue Scale \[VAS\] ≥ 4). * Failure to respond adequately to conventional treatments (e.g., NSAIDs, physical therapy). * Willingness to comply with study procedures. Exclusion Criteria * Previous PRF/RF treatment for knee pain. * Hyaluronic acid injection for knee pain in the past 6 months * Knee surgery within the last 6 months. * Severe cardiovascular, neurological, or psychiatric conditions. * Active systemic infections or local skin infections at the knee. * Pregnancy or lactation.

Molecular Mechanisms Underlying Hip and Knee Osteoarthritis in Patients Undergoing Primary Elective Arthroplasty

The aim of this observational study is to determine content of rare metals and other elements, along with the levels of selected immunological parameters, in the tissue of the hip or knee joint in the course of degenerative diseases. Determining potential disturbances in the levels or functions of these parameters may in the future contribute to improving treatment - for example, through supplementation of deficient metals or modulation at the immunological level. The main question it aims to answer is: Are selected rare metals, trace elements and other selected immunological parameters lowered in the tissue of the hip or knee joint as well as in serum in the course of osteoarthritis?

Comparative Effectiveness of Genicular Nerve Radiofrequency Thermocoagulation and Intra-Articular Pulsed Radiofrequency in the Management of Knee Osteoarthritis Pain

Osteoarthritis (OA) is a degenerative disease characterized by progressive cartilage deterioration, osteophyte formation, subchondral sclerosis, and a number of biochemical and morphological changes in weight-bearing joints that are affected by genetic, mechanical, and biochemical factors. The prevalence of secondary chronic knee pain in OA is more than 12% in individuals over the age of 60. It is one of the most common musculoskeletal disorders in elderly patients and has become a global health problem. Standard treatments for OA include physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), tramadol, opioids, intra-articular hyaluronic acid, or steroids. In more severe cases, surgical knee arthroplasty should be considered. But long-term use of NSAIDs is associated with stomach bleeding, adverse cardiovascular events, and kidney failure. Opioids are often used, but a large number of side effects are encountered, especially in the elderly. Knee surgery is not always possible and can cause complications such as hematomas, infections, and damage to the surrounding tissue. Radiofrequency (RF) application (pulsed or continuous) is a neuromodulatory or neurolytic technique that represents an alternative in pain due to osteoarthritis. RF therapy is one of the conservative treatments that has many advantages, such as minimal invasiveness, rapid recovery, and less negative response. Radiofrequency thermocoagulation (RFT) destroys the integrity of peripheral nerves using hyperthermia and thereby blocks the transmission of pain signals, while pulsed radiofrequency (PRF) regulates neurological functions or inhibits the production of immunoinflammatory factors (e.g., IL-1β, TNF-α, IL-6) by using electric fields to affect their production, thereby relieving pain in patients. Genicular nerve radiofrequency thermocoagulation application and knee intra-articular pulsed radiofrequency application are the two radiofrequency methods routinely applied in the treatment of gonarthrosis-induced pain in our clinic. In this study, it is aimed to evaluate the effectiveness of these two methods and compare their outcomes.

Femoral Nerve Mobilization for Patients With Knee Osteoarthritis

Background: Knee osteoarthritis (KO) is considered as a cause of disability among the elderly, causing pain, reduced quality of life, and decreased functionality. There is a limited knowledge about using femoral nerve mobilization in treating patients with arthritic changes. Objectives: This study will be designed to determine the efficacy of adding of femoral nerve mobilization on pain intensity, function, quality of life and central sensitization in patients with knee osteoarthritis Methods: Thirty patients (aged ≥50 years with KO Kellgren-Lawrence grades I-II) will be included in this study: Patients will randomly be assigned into two groups: group A will receive traditional physical therapy while group B will receive femoral nerve mobilization in addition to traditional physical therapy. Three sessions will be performed for four weeks by 3 session /week. Patients will be evaluated for pain intensity using the numerical rating scale (NRS), knee function by WOMAC scale, quality of life by 12-item Short Form Survey questionnaire (SF-12) and central sensitization by the Arabic version of central sensitization inventory (CSI).

Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis

Evaluation of intra-articular injections in knee osteoarthritis using frozen-stored PRP. Compared with intra-articular injections of PRP applied at the time of collection.

Accelerated Rehabilitation in Individuals After Total Knee Arthroplasty

The primary aim of this double-blind randomized controlled trial is to evaluate the effectiveness of an accelerated rehabilitation protocol on knee joint function and quality of life in individuals undergoing TKA compared to conventional rehabilitation in Dali, Yunan, China. The study will include patients aged 50-80 years who are scheduled for primary unilateral TKA. Participants will be randomly assigned to either an accelerated rehabilitation group or conventional rehabilitation group. The primary outcomes will include knee joint function, assessed using the KOOS and quality of life measures using the SF-36 surveys. The study will follow participants for 6 months post-surgery to assess longer-term outcomes. This study will not include individuals undergoing revision TKA or those with severe comorbid conditions. The results will provide critical insights into the role of accelerated rehabilitation in improving post-operative recovery, functional outcomes, and overall quality of life for TKA patients.

The NTU JO-SMART Study

This study recruits patients with coexisting obesity and knee osteoarthritis (KOA) to implement the NTU-JO Smart Program, an innovative intervention integrating AI-assisted community-based exercise with continuous glucose monitoring (CGM). The primary objective is to investigate whether this intervention can improve glycemic control in this comorbid population. Other outcome measures include the risk of total knee arthroplasty (TKA), body weight changes, pain intensity scores, bone mineral density (BMD), cognitive function, as well as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Patient-Reported Outcomes Measurement Information System (PROMIS) scores, which reflect the patients' overall functional status. The project also sought to explore the long-term association of the NTU-JO Smart Program with the development of type 2 diabetes (T2D) and major renal events, thereby facilitating patient-centered early treatment.

Treatment of Post Traumatic Knee Osteoarthritis With Extracorporeal Shockwave Therapy

This study is recruiting current or former athletes who had ACL reconstruction surgery over a year ago and have been diagnosed with knee osteoarthritis (OA). We are doing the research to investigate the effects of extracorporeal shockwave therapy (ESWT) on pain, function, biomechanics, knee range of motion and strength, inflammation, and joint structure and integrity of the knee.

Effect Of Sensory Motor Training Versus Resistance Training Among Individuals With Knee Osteoarthritis.

This study aims to address this gap by comparing the effects of sensory-motor training versus resistance training on pain, balance and functional activities, specifically in patients with early-stage knee osteoarthritis. In Pakistan, Knee Osteoarthritis is a common condition that significantly impacts many individuals' quality of life. While research exists on various exercise interventions for knee osteoarthritis, there is limited focus on patients with Grade 1 and 2 osteoarthritis. Understanding the most effective training method for this group will provide valuable insights for developing targeted rehabilitation programs, ultimately improving patient outcomes and quality of life.

Return to Sports After Knee Arthroplasty

The ability to return to sports after joint arthroplasty is increasingly becoming an important factor for patients in terms of their perceived quality of life. In sports orthopaedics, standardized functional tests have already been established - particularly for anterior cruciate ligament injuries - to assess athletic performance and prevent re-injury. These tests allow a stepwise evaluation of a subject's physical readiness for sports. In the field of arthroplasty, and despite increasing sports activity among patients with joint arthroplasty such structured assessment is still lacking. As a result, patients with arthroplasty typically resume sports activities based solely on individual recommendations from the surgeon or treating therapist. However, an objective evaluation of sports capability is currently not available. Therefore the amendment intends to expand the current testing protocol of the already registered and ongoing study (Protocol ID: UBonn\_TKA\_FollowUp) to include additional standardized, evidence-based return-to-sprort-tests.

Impact of Tissue Flossing and Therapeutic Exercises in Patient With Knee Osteoarthritis

Knee osteoarthritis (OA) is a common degenerative joint disease that primarily affects individuals aged 40 years and older, and results in painful symptoms along with limited range of motion (ROM) and muscle weakness(1). Therapeutic exercise covers a range of targeted physical activities that directly aim to improve muscle strength, neuromotor control, joint range of motion and aerobic fitness. One of the main aims of exercise is to improve muscle strength, given that weakness is common in knee OA. Exercise, especially isometric ROM exercises and step-ups as therapeutic exercise, are very important in OA patients, because they not only maintain the activity of the joint but also treat the pain and strengthen the joint (2).Use of tissue flossing, in which an elastic band is wrapped around muscles and joints to enhance blood flow and reduce pain(3).It has been on the rise as an adjunct to rehabilitation, but its efficacy when combined with therapeutic exercise is not well-known. The objective of this non-blinded randomized controlled trial is to compare the effects of tissue flossing combined with therapeutic exercises versus therapeutic exercises alone on pain, ROM, and muscle strength in patients with knee OA. The study will be conducted over a period of 4 weeks, with two sessions per week at Sheikh Khalifa Bin Zayed Hospital, Quetta. Initially, participants aged 40-70 years with diagnosed Grade 1,2and 3 knee OA will be screened for eligibility based on inclusion and exclusion criteria. Eligible participants will be informed about the study objectives and procedures, and written informed consent will be obtained. Participants will then be randomly allocated into two groups using the envelope method for group randomization. Baseline assessment will include knee ROM measurement, muscle strength assessment using Manual Muscle Testing (MMT), pain evaluation using the Numeric Pain Rating Scale (NPRS), Group A will receive tissue flossing in addition to therapeutic exercises, while Group B will receive only therapeutic exercises. All outcome measures will be reassessed after 4 weeks of intervention to evaluate the effects of the intervention. Data will be entered and analyzed using SPSS v.22.