Clinical Research Directory

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.

Autologous BMA vs Saline and LAM + LP-PRP vs Saline Evaluations in Knee OA

ABLE OA is a Health Canada authorized (phase II/III) trial \[Parent Control #: 263591\]. A multi-center, prospective, double-blinded, randomized, placebo-controlled adaptive trial to evaluate the efficacy of two minimally manipulated autologous cellular preparations i) bone marrow aspirate (BMA) injection; and, ii) combined lipoaspirate micronized (LAM) and leukocyte poor (LP) platelet-rich plasma (PRP) injections for the treatment of knee osteoarthritis (OA). BMA, LAM from lipoaspirate (LA), and LP-PRP from whole blood will be prepared using the Cervos Marrow Cellution™ Bone Marrow Aspiration System, Cervos LIPO-PRO™ Adipose Transfer System, and Cervos KEYPRP Platelet Separator System, respectively. Patient-reported outcome (PRO) measures will be collected using web- or paper-based questionnaires administered at baseline (pre-injection) as well as at 3, 6 and 12 months (post-injection). Blood, synovial fluid, and urine samples will be collected at baseline pre-injection and 6 months post-injection only.

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.

MOON Onsite MRI 10 Years After ACL Reconstruction

In this study, a total of 219 subjects from the MOON nested cohort will be studied at CCF, Vanderbilt and OSU, Table 1. Among them, some will have added MRI during their 10-year visit for the MOON study. Some subjects who finished their 10-year visit for the MOON Onsite study already will be called back to have MRI. PROMs and other information of these subjects will be collected through the MOON study.

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.

A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain

The main purpose of this study is to test the safety and efficacy of study drug for the treatment of knee pain due to osteoarthritis (OA). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292), which is a protocol to accelerate the development of new treatments for chronic pain.

Added Value of Cognitive Behavioural Therapy for Insomnia in Persons With Knee Osteoarthritis

Knee osteoarthritis (KOA) is the leading and fastest increasing cause of disability in older adults. It is a serious health issue related with a high health care utilisation. The first-line KOA management is nonsurgical care, with education and exercise therapy as key elements. Nevertheless, treatment effects of exercise therapy and behavioral pain management on improvements in pain, function and quality of life are small to moderate at best. This shows that there is an urgent need for better KOA care. The innovative solution may lie in thinking beyond joints, by targeting KOA subgroups through comorbidity-specific interventions, which fits well in the global move towards precision medicine. With a prevalence rate up to 50%, the presence of insomnia symptoms is a highly prevalent KOA comorbidity, contributing to symptom severity. If left untreated, it represents a barrier for effective conservative management. Since insomnia is nowadays hardly addressed in the often joint-targeted KOA care, the scientific objectives of the study are to assess 1) if cognitive behavioral therapy for insomnia (CBT-I) integrated in best-evidence usual care, consisting of education and exercise therapy, (CBTi-UC) is more effective than best-evidence usual care alone (UC), i.e. education and exercise therapy, at 6 months follow-up in improving clinical outcomes and 2) if CBTi-UC is more cost-effective than UC in KOA patients with comorbid insomnia.

Digitalization of Osteoarthritis Care

The overall aim of this study is to compare three different care models for patients with hip- and knee osteoarthritis. The primary aim is to evaluate whether an app-based care model is more beneficial for improving function in daily life than a web-based care model and standard care for patients with hip and / or knee osteoarthritis

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.

AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain

This study is being done to look at the safety and effect of NNC0487-0111 in people with excess body weight and knee osteoarthritis when compared to placebo. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Effect of Nonsteroidal Anti-Inflammatory Drug Restriction on the Efficacy of Platelet-Rich Plasma in Knee Osteoarthritis

The goal of this randomized clinical trial is to learn whether taking ibuprofen, a nonsteroidal anti-inflammatory drug, after a platelet-rich plasma (PRP) injection changes pain relief and knee function in adults with knee osteoarthritis. The main questions it aims to answer are: Does ibuprofen change the improvement in knee pain six months after a PRP injection compared with acetaminophen? Does ibuprofen change knee function or the need for additional pain medicine during follow-up? Researchers will compare PRP followed by ibuprofen with PRP followed by acetaminophen. Participants will receive one ultrasound-guided PRP injection and take the assigned medication every eight hours for five days. They will complete assessments of pain, knee function, additional pain medicine use, and safety. Participants and the physician performing the injection will not know which medication was assigned.

Positive Minds Strong Joints for Knee Osteoarthritis

The aim of this research study is to test the feasibility of a physical and mental health intervention (Positive Minds, Strong Joints or PMSJ) for Black adults with knee osteoarthritis (OA).

Pre-emptive Insulin to Prevent High Glucose After a Knee Steroid Injection in Adults With Type 2 Diabetes

Steroid injections used to treat painful joints can temporarily increase glucose levels in people with type 2 diabetes. This study will test whether a short course of pre-emptive neutral protamine Hagedorn, NPH, insulin can reduce high glucose after a standard corticosteroid injection into the knee. Adults with type 2 diabetes who are scheduled to receive one intra-articular injection of triamcinolone acetonide 40 mg for knee osteoarthritis will be randomly assigned to one of two groups. The experimental group will receive a prespecified NPH insulin regimen beginning immediately after the injection and continuing for three doses. The comparison group will continue usual reactive diabetes management without pre-emptive NPH insulin. Both groups will use blinded continuous glucose monitoring and scheduled capillary glucose testing. The main outcome is the percentage of continuous glucose monitoring time above 180 mg/dL during the first 72 hours after the corticosteroid injection. Hypoglycaemia, rescue treatment, healthcare contacts, treatment burden, acceptability and adverse events will also be assessed.

Customized Knee Arthroplasty With or Without Posterior Cruciate Ligament Retention: A CR-PS Approach

Background and Rationale: Conventional mechanical implantation of total knee arthroplasty (TKA) aims to establish a lower-limb mechanical axis of 180°. Computer-assisted personalized implantation aims to restore a pre-arthritic alignment while respecting the soft-tissue envelope of the knee. Depending on design, TKA implants may either retain or sacrifice the posterior cruciate ligament (PCL). In mechanically implanted TKAs, functional outcomes of cruciate-retaining (CR) and posterior-stabilized (PS) designs are reported as comparable in the literature. However, these two designs have not been compared within a computer-assisted personalized implantation workflow. Objective and Hypothesis: The objective of this randomized comparative study is to compare functional outcomes (patient-reported outcome measures - PROMs) at 24 months postoperatively following CR versus PS knee arthroplasty implanted with a personalized technique. The hypothesis is that there is no significant difference in functional outcomes between CR and PS prostheses implanted using a personalized technique. Study Design: Single-center, open-label, randomized, two-arm parallel-group trial comparing a group of patients receiving a cruciate-retaining (CR) total knee prosthesis to a group receiving a posterior-stabilized (PS) total knee prosthesis.

Monopolar Versus Biopolar Radiofrequency in OA Knee Pain

This is a prospective randomized controlled trial study will aim to evaluate the the efficacy and procedural pain of BRFA and to compare it with conventional technique (MRFA). And to compare the complications and time taken to complete the procedures.

Comparing Local Anesthetic Injections to Nerve Blocks for Pain Control After Total Knee Replacement

Why are we doing this study? People who have knee replacement surgery often feel pain afterward. Doctors use different methods to control this pain. One method is an injection of numbing medicine directly into the knee during surgery, called local infiltration analgesia (LIA). Another method uses a thin tube (catheter) placed near nerves in the leg to continuously deliver numbing medicine, called a nerve block. This study compares these two pain control methods after knee replacement surgery, to find out whether the injection method (LIA) works at least as well as the nerve block method for controlling pain. Who can take part in this study? Adults aged 18 to 90 years who need a first-time (primary) knee replacement because of knee arthritis can take part. Participants must be able to walk before surgery, be in generally stable health, and be able to give informed consent. People with a knee injury (rather than arthritis), people who use a wheelchair, and people unable to give consent were not included. What happens during this study? 78 participants were randomly assigned, like a coin flip, to receive either the injection into the knee (LIA) or the nerve block through a catheter for pain relief after surgery. Both groups also received the same standard pain medicines by mouth or vein as needed. Researchers measured pain levels using a 0-10 pain scale before surgery and at 24, 48, 72, and 96 hours afterward. They also measured knee movement (range of motion), how much extra pain medicine was needed, and how satisfied participants were with their pain control. The study took place at one hospital, the Elisabethinen Hospital in Klagenfurt, Austria, between June 2025 and January 2026.

Moving Well for Total Knee Arthroplasty (TKA)

The purpose of this study is to assess the efficacy of a behavioral intervention, Moving Well, in improving levels of anxiety and depression for patients undergoing total knee arthroplasty (TKA).

A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis

This study is a double-blind, randomized, placebo controlled, multi-center, superiority study to evaluate the efficacy and safety of JointStem, autologous adipose tissue derived mesenchymal stem cells (AdMSC), in patients diagnosed as knee osteoarthritis. Following a 2-week screening period, approximately 140 subjects will be randomly assigned into one of the following two arms in a 1:1 ratio (1 JointStem : 1 Placebo). After each subject completes 48-Weeks visit (Visit 8) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.

Virtual Reality Therapy and Non-Sleep Deep Rest Relaxation After Joint Arthroplasty

The aim of this study is to compare the effectiveness of Virtual Reality therapy (VR therapy), Non-Sleep Deep Rest relaxation (NSDR relaxation) each delivered as an adjunct to standard postoperative rehabilitation, in older adults following hip or knee arthroplasty, focusing on reducing psychological stress and improving functional recovery.

All Polyethylene Versus Metal Backed Tibial Components in Knee Replacement

Total knee arthroplasty (TKA) is one of the most commonly performed orthopaedic procedures. Approximately 84,000 knee replacement procedures were recorded in the UK in 2012. The main goal of TKA is to relieve the disabling pain of arthritic disease. Patient satisfaction following TKA is related to quick recovery and return to daily activities. This can be dependent on the design of the implant used in the knee. Improvements in implant design and surgical technique mean many modern designs offer implant survival rates beyond 10 - 15 years. As cost pressure increases in the NHS the unit cost of implants is now being scrutinised, particularly with regard to cost effectiveness. The Press-Fit Condylar (PFC) Sigma implant can be used with either a conventional metal backed or alternatively an all polyethylene tibial component (part fitted to the shin bone), the latter considerably cheaper to manufacture. Four small prospective randomised trials and one large regional registry study with long follow up support the safe use of all polyethylene tibial components in TKA. The investigators will therefore undertake a prospective randomised controlled trial comparing the results of all polyethylene tibial components with those of conventional metal backed tibial components in patients aged 75 or over, comparing both clinical outcome and radiological survivorship. The type of knee replacement used for each patient (metal-backed or polyethylene) will be chosen at random once a patient has agreed to take part in the study. Data will be collected by means of follow-up appointments and questionnaires and clinical tests both before the operation 1 year, 2 years and 5 years postoperatively. This will allow us to see how both types of knee replacement perform over time and if one performs better than the other in terms of patients movement, pain and functional activities.

Calypso Knee System Clinical Study, OUS

A study to evaluate the safety and effectiveness of the Calypso Knee System when used in subjects with symptomatic osteoarthritis of the medial compartment of the knee.

Calypso Knee System Clinical Study

A clinical study to evaluate the safety and effectiveness of the Calypso Knee System when used in subjects with symptomatic osteoarthritis of the medial compartment of the knee.

Probiotic Supplements in Osteoarthritis

The current study aims to evaluate the effectiveness of adding probiotics to the standard of care in improving OA patient-related outcomes such as pain, stiffness, and physical activity.

The Osteoarthritis Prevention Study

The goal of this study is to establish the efficacy of an intervention of dietary weight loss, exercise, and weight-loss maintenance for knee Osteoarthritis (OA) prevention in adult females aged ≥ 50 years with obesity and no or infrequent knee pain. The primary aim is to compare the effects of a dietary weight loss, exercise, and weight-loss maintenance to an attention control group in preventing the development of structural Magnetic Resonance Imaging (MRI) knee OA. Secondary aims will determine the intervention effects on pain, mobility, health-related quality of life, knee joint compressive forces, inflammatory measures, weight loss, exercise self-efficacy, and cost-effectiveness of this intervention.