Clinical Research Directory

Comparative Effectiveness and Safety of Two Hyaluronic Acid Products in Knee Osteoarthritis

Knee osteoarthritis is a condition that causes pain, stiffness, and difficulty moving the knee. Some people continue to have symptoms despite receiving usual treatments, such as pain medications, exercise, and physical therapy. One treatment option is viscosupplementation, which involves injecting a gel-like substance called hyaluronic acid into the knee joint. Different products are available, but it is not clear whether they provide similar benefits, have similar side effects, or differ in cost. The goal of this study is to compare two hyaluronic acid products, Mesoheal and Synvisc, in adults with knee osteoarthritis. The researchers want to find out: * How well each product reduces knee pain. * How much each product improves knee movement and daily activities. * What side effects may occur. * How the costs of the two treatments compare with their benefits. The study will include approximately 160 adults who need viscosupplementation as part of their usual medical care. Each person's doctor will choose the treatment based on their medical needs and routine clinical practice. The researchers will not assign treatments. Participants will be followed for six months. During this time, researchers will assess changes in pain, knee function, and any side effects that may occur. The results may help doctors and healthcare providers better understand the benefits, safety, and costs of these treatments in routine clinical care.

Boosting Exercise Adherence in Knee Osteoarthritis

This project, conducted within the Department of Veterans Affairs Healthcare System (VHA), will test the effectiveness of an intervention to improve adherence to home exercise among Veterans receiving physical therapy (PT) for knee osteoarthritis (OA). The intervention, "Boosting Exercise Adherence in Knee Osteoarthritis" (BOOST-OA), has two phases. During the initiation phase (first 3 months of PT care), patients will receive tools and activities to address outcome expectations, action self-efficacy, goal-setting and monitoring. During the behavior maintenance phase (starting after PT care and continuing for 9 months), patients will receive health coaching calls that address satisfaction with outcomes, relapse prevention planning and independent monitoring. There are three main study aims: (1) examine improvements in patient outcomes, such as physical function, following BOOST-OA; (2) explore patient characteristics that lead to difference in reported improvements; and (3) interview participants and clinicians about their experience with BOOST-OA to inform future implementation.

PPV-06 Vaccine in Inflammatory Knee Osteoarthritis

PPV-06 targets interleukin-6, a key molecule implicated in many inflammatory diseases such osteoarthritis. PPV-06 is used to induce the production of antibodies directed against IL-6. The antibodies produced will neutralize the interleukine-6 involved in the body's inflammatory process. The goal of this clinical trial is to test the safety and efficacy of PPV-06 in participants with Knee Osteoarthritis. The main questions are to evaluate if PPV-06 can reduce pain and improve functioning in participants with knee osteoarthritis, and to evaluate if ¨PPV-06 is safe when administered to participants. Participants will be administered with 6 subcutaneous injections of either PPV-06 or placebo, over a two-year period.

GENIVS Block Versus Adductor Canal Block After Total Knee Arthroplasty

The goal of this clinical trial is to learn whether the ultrasound-guided GENIVS block is not worse than (non-inferior to) the adductor canal block in reducing opioid use after total knee arthroplasty performed under spinal anesthesia. The main question it aims to answer is: \- Is total opioid consumption (intravenous tramadol, mg) in the first 24 hours after surgery with the GENIVS block not clinically worse than with the adductor canal block? Researchers will also compare pain scores, time to the first analgesic request, the need for rescue pain medication, mobilization (Timed Up and Go test and stair climbing), quality of recovery (QoR-15) and opioid-related side effects between the two groups. Participants will: * have elective, primary, one-sided knee replacement surgery under spinal anesthesia; * be randomly assigned to receive either a GENIVS block or an adductor canal block, with the same local anesthetic dose, at the end of surgery; * use an intravenous tramadol patient-controlled analgesia pump and receive standard pain treatment for 72 hours; * rate their pain and complete mobility tests and questionnaires at scheduled times during the first 72 hours after surgery.

Robotic-Assisted Versus Conventional Total Knee Arthroplasty With Virtual Home-Based Rehabilitation

The goal of this clinical trial is to learn whether robotic-assisted total knee replacement improves recovery compared with conventional total knee replacement in adults with knee osteoarthritis when both groups follow the same structured home-based rehabilitation program. Robotic-assisted and conventional (non-robotic) total knee replacement are both widely used as part of routine clinical care. This study will compare recovery during the first six weeks after surgery. The main questions the study aims to answer are: 1. Does robotic-assisted total knee replacement improve knee pain and knee function six weeks after surgery compared with conventional total knee replacement? 2. Does robotic-assisted surgery improve physical function, walking ability, leg strength, quality of life, and participants' perception of their overall change since the start of the study? 3. Are there any differences in recovery, length of hospital stay, or safety between the two surgical approaches? Researchers will compare robotic-assisted total knee replacement with conventional total knee replacement. Both groups will complete the same rehabilitation program before and after surgery so that any differences in recovery are more likely to be related to the type of surgery rather than differences in rehabilitation. Participants will: * Be randomly assigned (by chance, similar to flipping a coin) to receive either robotic-assisted or conventional total knee replacement surgery. * Complete a structured rehabilitation program that includes education and exercises during the four weeks before surgery and a home-based exercise program for six weeks after surgery. * Use a study-provided seated exercise bike, receive support from a physiotherapist through telehealth appointments, secure messaging, and home visits where required, and use a digital application to guide the rehabilitation program and record exercise completion and symptoms. * Complete questionnaires about knee pain, knee function, general health, quality of life, and overall change since the start of the study. * Attend study assessments before surgery, immediately before surgery after completing the pre-surgery program, and about six weeks after surgery. These assessments include simple physical activities such as standing up from a chair, walking, cycling, and measuring leg strength. * Allow information about their surgery and hospital stay, such as the duration of surgery and the number of nights spent in hospital, to be recorded for the study. The results of this study will help researchers understand whether robotic-assisted total knee replacement provides additional benefits over conventional total knee replacement when both are combined with the same structured home-based rehabilitation program. The findings may help patients, healthcare professionals, and health services make informed decisions about the use of robotic-assisted knee replacement surgery.

SVF Cellular Composition, Secretome, and Responses in Knee Osteoarthritis

This prospective, single-center observational study will enroll 20 adults aged 40 to 75 years with Kellgren-Lawrence grade II or III knee osteoarthritis who have already been scheduled for an intra-articular injection of autologous adipose-derived stromal vascular fraction (SVF) as clinical care. The study does not assign treatment, use a control group, or randomize participants. After preparation of the therapeutic SVF, residual adipose tissue will be processed independently with a new disposable kit to obtain research-only SVF. No additional adipose tissue will be harvested for research, and research-only SVF will not be injected. Cellular composition and secretome characteristics of research-only SVF will be measured. Synovial fluid biomarkers will be assessed before injection and at 6 months using the same 12-analyte panel. Patient-reported outcomes and knee radiographs will also be compared between baseline and 6 months. CGBio provides research funding and research-only processing kits without involvement in study conduct, analysis, or publication decisions.

Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial

The primary aim of this study is to investigate whether low-dose radiotherapy is an effective treatment to reduce the pain of knee osteoarthritis. A secondary aim is to determine whether patients experience any more measurable side effects than those receiving sham treatments.

Undenatured Type II Collagen for Knee Osteoarthritis Pain

This randomized, controlled, double-blind, three-arm parallel clinical trial will evaluate the efficacy and safety of undenatured type II collagen products on joint pain in adults diagnosed with knee osteoarthritis. Participants will be randomized to Nuvicol II (nuvicol® II), Nuvicol SII (nuvicol® S II), or placebo and will consume one capsule daily for 4 months. Pain, quality of life, knee muscle function, concomitant analgesic medication use, cartilage degradation biomarkers, safety laboratory variables, and adverse events will be assessed during follow-up.

Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty

Prospective, randomized, single-blind, multinational, long-term study for the evaluation of the clinical outcome, oxidation profile and wear analysis of medium cross-linked Polyethylene with and without Vitamin E for total knee arthroplasty

Subchondral Drilling Diameter During CARTISTEM Implantation for Knee Cartilage Defects

This prospective, randomized study at Severance Hospital compares two subchondral drilling techniques during CARTISTEM implantation for symptomatic medial-compartment knee articular cartilage defects. Sixty participants will be allocated 1:1 to drilling with a 2-mm drill alone or sequential drilling with 4-mm and 2-mm drills. CARTISTEM preparation and implantation will be the same in both groups. High tibial osteotomy may be performed when needed to correct alignment. The primary endpoint is the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation score at 12 months after surgery. The study will assess non-inferiority of the 2-mm technique using a prespecified margin of 10.3 points. Secondary assessments include pain and knee function, MRI cartilage repair and subchondral bone findings, radiographic osteoarthritis and alignment, and second-look arthroscopy in participants undergoing plate removal after high tibial osteotomy.

Cooling of the Knee After Total Knee Arthroplasty

This study investigates whether cooling the knee after total knee replacement surgery can reduce pain and improve early recovery. After surgery, patients are randomly assigned to one of three groups: cooling with a liquid cooling bandage, cooling with an ice pack, or standard postoperative care without cooling. Cooling begins 24 hours after surgery and continues for two weeks. Pain levels, use of pain medication, blood values, knee swelling, knee movement, and length of hospital stay are recorded. The goal is to determine whether postoperative knee cooling provides additional benefits compared with standard care.

Persona OsseoTi Keel Compatibility Study (Total Knee Arthroplasty)

The main objective of the study is to evaluate the safety, performance and clinical benefits of the Persona implant and its instrumentation in primary total knee arthroplasty

Preventing Injured Knees From osteoArthritis: Severity Outcomes

This study is being done to find out if metformin is effective at reducing pain by delaying the onset of post-traumatic osteoarthritis (PTOA) after anterior cruciate ligament (ACL) reconstruction. This research study will compare metformin to placebo. The placebo tablet looks exactly like metformin, but contains no metformin. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons. Metformin is approved by the U.S. Food and Drug Administration (FDA) to treat type II diabetes. Notably, it also has anti-inflammatory effects, suggesting it could benefit people who have an ACL injury and are undergoing ACL reconstruction.

Evaluation of the Effect of Triamcinolone at Different Doses on LIA During TKA

To evaluate the efficacy and safety of different doses of triamcinolone for local infiltration analgesia during total knee replacement

A Randomized Comparison of the Efficacy of the IPACK Block Versus the Popliteal Plexus Block for Posterior Knee Analgesia, in Patients Undergoing a Total Knee Arthroplasty and Receiving a Continuous Distal Femoral Triangle Block

Total knee arthroplasty (TKA) is commonly associated with significant postoperative pain, including pain arising from the posterior aspect of the knee. Regional anesthesia techniques are frequently used as part of a multimodal analgesic strategy to improve pain control, reduce opioid requirements, and facilitate early functional recovery. This prospective, randomized, double-blind, superiority clinical trial will compare the analgesic efficacy of the interspace between the popliteal artery and capsule of the posterior knee (iPACK) block with the popliteal plexus block in adult patients undergoing elective unilateral primary total knee arthroplasty. All participants will receive a continuous femoral triangle block and a standardized multimodal postoperative analgesic regimen. Participants will be randomly assigned to receive either an ultrasound-guided iPACK block or an ultrasound-guided popliteal plexus block. The primary outcome will be cumulative intravenous morphine consumption delivered through a patient-controlled analgesia (PCA) device during the first 24 hours after surgery. Secondary outcomes will include cumulative morphine consumption during the first 12 hours, posterior knee pain at rest and during movement, time to first PCA morphine administration, quality of recovery assessed with the QoR-15 questionnaire, distal motor function, early functional recovery, block performance time, postoperative adverse effects, and neurological symptoms. The study hypothesis is that the popliteal plexus block will provide superior opioid-sparing analgesia compared with the iPACK block when both techniques are combined with a continuous femoral triangle block, while preserving distal motor function and maintaining an acceptable safety profile.

Knee Osteoarthritis Treatment With Zilretta vs. Kenalog in the Context of Type II Diabetes

A Phase 2 Randomized Study to Evaluate the Effects of triamcinolone acetonide extended-release (TA-ER; Zilretta) vs. triamcinolone acetonide immediate-release (TA-IR; Kenalog) on Blood Glucose Levels in Diabetic Subjects with Knee Osteoarthritis. Subjects should have Type 2 Diabetes Mellitus (T2DM) with HbA1C ≤9 that is managed without insulin and have been diagnosed with symptomatic unilateral or bilateral osteoarthritis (OA) of the knee, based on clinical and radiological criteria (if bilateral, then a target knee will be selected).Total study duration for individual subject will be about 4 months, which includes 3 weeks of Screening period, 10 days of pretreatment phase, treatment day, and 12 weeks of post-treatment period.

Generate and Test the Reliability of a PD Model of OXT on Pupillary Hippus as a Measure of CNS Activity

The purpose of this research is to evaluate the effects of oxytocin (naturally occurring hormone) given by an intramuscular (IM; into the muscle) injection, has on your parasympathetic nervous system. The parasympathetic nervous system is the part of the involuntary nervous system that is sometimes called the "rest and digest" system; the parasympathetic system conserves energy as it slightly slows the heart rate, increases intestinal and gland activity, and relaxes sphincter muscles in the gastrointestinal tract.

Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA)

This is a trial of tirzepatide in people with obesity and knee osteoarthritis. The main purpose of this study is to see if tirzepatide can reduce number of these participants who require a knee replacement. Participants will be randomized to take a weekly injection of tirzepatide or a placebo for a total of 72 weeks.

Intravenous (IV) Hydrocortisone for TKA (Total Knee Arthroplasty)

In this study, total knee replacement patients will be determined to be stiff or non-stiff preoperatively. Stiffness designation is determined by preoperative range of motion (if flexion is \< 100 degrees, or extension lag is \> 10 degrees). The stiff and non-stiff groups will both be randomized to two groups to receive either intravenous hydrocortisone or a placebo at 3 intervals postoperatively. Patients will be followed up with in hospital and via the phone on postoperative day (POD) 1 and 2, as well as 6 weeks, 6 months, 1 year, and 2 years postoperatively. Patients will also have blood drawn preoperatively in the OR, on POD1, at their 6 week followup, and at their 1 and 2 year follow ups. This blood will be processed and analyzed.

US-Guided Saphenous Block in Knee OA

The purpose of this prospective, randomized, open-label, active-controlled clinical trial is to evaluate the clinical and sonographic effects of ultrasound-guided (US-guided) high-volume saphenous nerve block combined with intra-articular corticosteroid injection compared to intra-articular corticosteroid injection alone in patients with Kellgren-Lawrence Grade 3-4 medial compartment knee osteoarthritis (OA) refractory to conservative treatment. A total of 60 participants aged 45-75 years will be randomly assigned (1:1) into two treatment arms: * Group 1: US-guided intra-articular corticosteroid injection (40 mg triamcinolone acetonide + 1 mL saline) + home exercise program. * Group 2: US-guided intra-articular corticosteroid injection + US-guided high-volume saphenous nerve block (10 mL 0.2% bupivacaine solution) + home exercise program. Clinical assessments (WOMAC, VAS, and SF-36) will be conducted at baseline (T0), 1st month (T1), 3rd month (T2), and 6th month (T3). Sonographic evaluations, including saphenous nerve cross-sectional area (CSA) and perineural vascularity via Power Doppler US, will be performed at baseline (T0), 1st month (T1), and 6th month (T3). The primary outcome is functional improvement measured by the change in WOMAC total score.

Efficacy of High-Intensity Laser Therapy in Early-Stage Symptomatic Knee Osteoarthritis

This randomized, double-blind, sham-controlled clinical trial evaluated the effectiveness of high-intensity laser therapy (HILT) in patients with early-stage symptomatic knee osteoarthritis. A total of 39 participants were randomly assigned to receive either HILT combined with a standardized home exercise program or sham laser therapy combined with the same exercise program. Laser or sham treatment was administered over 10 weekday sessions during a two-week period. Participants were assessed at baseline, immediately after treatment, and at the three-month follow-up. Assessments included pain intensity, physical function, health-related quality of life, walking performance, knee range of motion, and muscle strength. The aim was to determine whether adding HILT to exercise provides additional clinical benefits compared with sham laser therapy combined with exercise.

Effect Of The Use Of Navigation In The Alignment Obtained When Performing A Total Knee Arthroplasty In Obese Patients

NAOBE is a randomized, open and prospective clinical trial that evaluates the accuracy to achieve an adequate mechanical axis of the lower extremity in obese patients after total knee replacement.

A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.

Comparative Study of CT and Fluoroscopic Guided Genicular Nerve Ablation in the Treatment of Knee Osteoarthritis

The goal of this study is to evaluate the comparative effectiveness of CT-guided and fluoroscopic-guided genicular nerve ablation in reducing knee pain and improving function in adults diagnosed with knee osteoarthritis refractory to conservative treatment. The main questions it aims to answer are: * Does CT-guided genicular nerve ablation provide superior pain relief compared to fluoroscopic-guided genicular nerve ablation? * Is there a significant difference in functional improvement between the two techniques? Researchers will compare the outcomes between the CT-guided and fluoroscopic-guided groups to determine which method achieves better pain relief, functional enhancement, safety profile, and patient satisfaction. Participants will: * Undergo either CT-guided or fluoroscopic-guided genicular nerve ablation. * Attend scheduled follow-up visits to assess pain levels, knee function, and any adverse events. * Complete standardized questionnaires to provide feedback on pain relief, functional improvement, and overall satisfaction with the procedure.