Clinical Research Directory

The Effect of Continuous Care Counseling Based on the Roy Adaptation Model on Comfort and Quality of Life in Patients Undergoing Total Knee Arthroplasty

Osteoarthritis is a common joint disease that leads to problems such as pain, restricted mobility, and decreased quality of life in the knee joint, especially among elderly individuals. In advanced-stage knee osteoarthritis, total knee arthroplasty (TKA) is performed to reduce pain and loss of function. However, in the postoperative period, patients may encounter various problems such as pain, sleep disturbances, anxiety, and difficulties in daily living activities. This study investigates how continuous care counseling based on Roy's Adaptation Model affects the comfort and quality of life of patients undergoing total knee arthroplasty. Roy's Adaptation Model is a widely used approach in nursing that supports individuals in adapting to changes they experience. Counseling and education provided in line with this model aim to help patients cope with the physical and psychological problems they face before and after surgery. In the study, specially designed training and counseling services were provided to patients undergoing surgery, and the effects of these interventions on comfort and quality of life were evaluated. The study aims to contribute to the enhancement of postoperative care practices and patient-centered nursing interventions for individuals undergoing total knee arthroplasty.

E-Type - Early Wear of Polyethylene Liners Used in DMC

This is a single-centre, randomized, double-blinded controlled non-inferiority trial that will be conducted at the Orthopaedic Department at Uppsala University Hospital, Uppsala. The aim of the study is to evaluate the performance of a dual mobility acetabular component with a Vitamin E-infused highly crosslinked polyethylene (VEPE) liner compared to a conventional polyethylene (PE) liner in adult patients with symptomatic osteoarthritis, osteonecrosis, or dysplasia of the hip requiring a hip replacement. The assessments will focus on early wear, cup migration, adverse events, and clinical outcomes. Measurements will be conducted using Computed Tomography Radiostereometric Analysis (CT-RSA) instead of traditional radiostereometric analysis. The study hypothesis is that the PE liner will be non-inferior to the VEPE liner in terms of early wear over a two-year period.

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

The GZPT master protocol will support two independent studies, J2A-MC-GZT1 and J2A-MC-GZT2. Each study will see how well and safely orforglipron works in people with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 74 weeks.

Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight

The YDAN master protocol will support two independent studies, J3R-MC-YOA1 and J3R-MC-YOA2. Each study will investigate how well and safely Eloralintide (LY3841136) works in adults with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 75 weeks, including screening.

Long-Term Study of CartiPRO for Knee Pain Due to Osteoarthritis or Cartilage Damage

This clinical trial aims to evaluate and compare the efficacy and safety of CartiPRO, an approved intra-articular atelocollagen injection, versus Synovian injection for the relief of knee pain in patients with knee osteoarthritis. The investigational device is administered intra-articularly, with a second injection given 24 weeks after the first dose. Primary and secondary endpoints include changes in pain scores (VAS), functional assessments (WOMAC, SF-36), and safety evaluations over a 36-week period.

Post-op Prednisone and Glucose Monitoring in TKA

This study compares the efficacy of a 5-day post-operative oral prednisone regimen (40 mg daily) with the standard intraoperative steroid regimen, focusing on pain, swelling, range of motion, opioid use, and glucose levels monitored continuously.

Ketoprofen Topical Patch, 20% in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee

The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with Osteoarthritis Flare of the Knee.

Zimmer Continuum Metal on Polyethylene (MoP) PostMarket Clinical Followup (PMCF) Study

This is a prospective, multi-center, non-randomized, non-controlled study designed to obtain survival and outcome data on the Continuum Metal on Polyethylene Acetabular System when used in primary total hip arthroplasty.

14022 ATTUNE Cementless RP Clinical Performance Evaluation

The primary objective of this study is to examine the change from pre-operative baseline to two year postoperative functional performance improvement for the ATTUNE primary, cementless TKA RP system as measured with the KOOS questionnaire (KOOS-ADL sub-score). This will be carried out for two configurations: cruciate retaining rotating platform (ATTUNE Cementless CR RP) and posterior stabilized rotating platform (ATTUNE Cementless PS RP).

EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))

The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYS™ acetabular shell (also called a hip 'cup') placement in total hip replacement surgery using a non-invasive surgical navigation system called VELYS™ hip navigation system with CUPTIMIZE™ Advanced Hip-Spine Analysis software. Data collected in this study will be compared with data collected from implantations using different cup positioning instrumentation and techniques to assess performance.

AI-Based Phenome Data Analysis for Predicting the Onset of Major Diseases

This study aims to develop and validate an artificial intelligence (AI)-based predictive model to estimate the risk of incident onset of five major diseases or conditions: cardiovascular disease, type 2 diabetes mellitus, breast cancer, low back pain, and osteoarthritis, in adults aged 30 to 65 years. For each participant, an index date will be defined as the date of a prior health screening or another protocol-defined baseline clinical date. Incident disease status for each target disease or condition will be ascertained by retrospective review of electronic medical records for up to 10 years after the index date. The study integrates retrospective clinical, health screening, laboratory, imaging, and electronic medical record data with prospectively collected biospecimen, proteomic, genomic, questionnaire, lifestyle, and digital health data. Prospective study procedures will be completed over approximately 1 week, with up to 2 additional weeks if needed. By combining multimodal data, this study seeks to improve disease risk prediction and to identify clinical and biological factors associated with disease onset, ultimately supporting personalized risk stratification and preventive healthcare strategies.

Unicompartmental Versus Total Knee Replacement for Medial Compartment Knee Osteoarthritis

For patients with osteoarthritis affecting only the inner part of the knee, surgeons can offer either a partial knee replacement, which resurfaces the worn compartment alone, or a total knee replacement. Both are recommended treatments, but there is no agreement on when to choose one over the other. Partial knee replacement preserves the anterior cruciate ligament and more of the natural knee, and recovery is usually quicker, but it is used in only about one in ten knee replacements in the United Kingdom. Studies comparing the two have mostly relied on patient questionnaires, which may not be sensitive enough to detect differences in how the knee actually functions. Studies that have measured movement directly have concentrated on level walking, which is not demanding enough to separate the two operations. Difficulty with stairs is one of the longest lasting problems patients report after knee replacement. The FLEX-UNI trial will compare the two operations using three-dimensional motion analysis during more demanding everyday activities. Forty patients who are suitable for a partial knee replacement will be randomly allocated to receive either a partial or a total knee replacement. Patients and the researchers measuring their movement will not know which operation was performed. The main measurement is how far the operated knee bends while stepping down from a 20 cm step, measured one year after surgery. Movement during walking, stair climbing, slopes, sitting and standing, and balance will also be measured, along with questionnaires, x-rays, and complications. Results will be compared against measurements from people with healthy knees.

The Effectiveness of Strength Training and Self-management in Reducing Symptoms for Individuals With Knee Osteoarthritis

This study aims to investigate the effectiveness of an intervention combining strength training and self-management education in improving symptoms, sleep quality, emotional well-being, and quality of life in patients with knee osteoarthritis. This study employs a quasi-experimental design. Participants diagnosed with knee osteoarthritis were recruited from the outpatient orthopedics and rehabilitation departments of a public regional teaching hospital in southern Taiwan. They were randomly assigned to either an experimental group (n = 50) or a control group (n = 50). Due to the nature of the intervention, blinding was not feasible, and participants were aware of their group assignment. The experimental group also participated in a home-based strength training program, while the control group received conventional osteoarthritis routine care. Data were collected at baseline, one month, and three months post-intervention during follow-up appointments.

Preoperative Correction of Vitamin D Deficiency in Total Joint Arthroplasty (TJA)

The purpose of this study is being conducted to determine whether correcting low levels of vitamin D with a single high-dose supplement reduces complications after the participant's primary TJA.

Sequential Genicular Nerve Ablation Prior to Geniculate Artery Embolization in Knee Pain

The goal of this clinical trial is to evaluate whether performing genicular nerve ablation (GNA) before geniculate artery embolization (GAE) improves pain relief and knee function in patients with chronic knee pain. The main questions it aims to answer are: * Does performing GNA prior to GAE enhance pain relief, as measured by the Visual Analog Scale (VAS), at 3 months post-procedure? * Does the sequential approach improve knee function as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)? Study investigators will compare two groups to see if the sequential approach (GNA followed by GAE) provides better outcomes compared to GAE alone. Participants will: * Undergo either sequential GNA followed by GAE or GAE alone * Have their knee pain and function assessed at baseline, 1 month, 3 months, and 6 months post-procedure * Complete a structured patient satisfaction questionnaire (PSQ) at 3 months post-procedure * Be monitored for procedure-related adverse events up to 6 months post-procedure,

Verifying the Effectiveness of the NUsurface® System

The NUsurface® Meniscus Implant Randomized Study is a multi-center, prospective randomized, interventional clinical trial to test the hypothesis that the NUsurface implant is superior to the non-surgical standard of care in treating the target population.The rationale for performing this clinical study is to gather clinical data to evaluate the safety and effectiveness of the NUsurface device compared to the Standard of Care.

Clinical Trial on the Efficacy and Safety of ALT001 in Osteoarthritis

This clinical trial will focus on the core efficacy endpoints including relief of pain intensity, improvement of joint motor function and enhancement of quality of life in patients. Meanwhile, it will strictly monitor key safety indicators such as the occurrence of various adverse events after medication, the severity and duration of adverse reactions, and conduct a multi-dimensional and multi-level comprehensive assessment. The study aims to clarify the clinical benefit profile and safety risks of the investigational product ALT001, and provide scientific, detailed and reliable evidence-based medical data to support the optimization of clinical treatment guidelines and the formulation of individualized treatment regimens for knee osteoarthritis. Patients enrolled in the trial will receive investigational product treatment on the basis of conventional therapy. They will be randomly assigned to the placebo group, low-dose group and high-dose group at a ratio of 1:1:1. For each treatment course, patients in all groups will receive an injection of 2 vials of the investigational product into a single knee joint (for bilateral knee osteoarthritis, both knees may be injected, with one fixed knee joint selected for subsequent assessments). The injection will be administered once every 2 weeks for a total of 6 administrations.

Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test

The goal of this clinical trial is to understand how people make decisions about imaging tests for common musculoskeletal problems (like arthritis, tendon problems, or nerve compression). The study involves adult patients attending a musculoskeletal specialty clinic. The main questions it aims to answer are: 1. Does having a structured conversation about the pros and cons of a test affect how much a person wants to have that test? 2. Does that conversation help people feel more confident and less conflicted about their decision? Researchers will compare patients who have a values-based discussion with a researcher to those who receive brief written information about the test, to see if these approaches affect how people feel about having the test. Participants will: * Read a brief scenario about a proposed diagnostic imaging test (like an X-ray, MRI, CT, or ultrasound). * Either take part in a short structured conversation or read brief information about the test. * Answer a short survey about their thoughts on the test. This study does not involve actual medical testing or affect your clinical care. It is for research purposes only.

Persona Ti-Nidium Post-Market Clinical Follow-up

The main objectives of this study are to evaluate overall clinical performance and safety of the Persona Ti-Nidium implant in total knee arthroplasty.

Integrated Healthy Lifestyle and Pain Care for People With Musculoskeletal Conditions Living in Rural Areas.

This study aims to compare the effects of an in-person physiotherapist-led lifestyle-focused pain care intervention with a virtual multidisciplinary lifestyle-focused pain care intervention on pain impact in people with musculoskeletal conditions and lifestyle risks. Adults residing in rural and regional locations in New South Wales (AUS) with musculoskeletal conditions (low back, knee or hip pain) recruited from hospital outpatient services (physiotherapy, emergency or orthopaedics) or in response to social media advertisements. Eligible consenting participants will be randomised in a 1:1 ratio to receive either in-person physiotherapy lifestyle intervention or the virtual enabled multidisciplinary intervention. Randomisation will be conducted using an electronic central randomisation service to ensure concealment of treatment allocation. Participants in both arms (in-person and virtual care) will have up to 10 consultations over six months and follow similar principles based on the previous Healthy Lifestyle for Pain (HeLP) intervention, but differ in their mode of delivery and access to multidisciplinary care. Participant data will be collected at baseline and weeks 12, 26, 39 and 52. The primary outcome will be Pain Impact measured using the Patient-Reported Outcomes Measurement Information System (PROMIS-29). The secondary outcomes will include participant's health behaviors and mediating outcomes, economic outcomes, process outcomes and adverse events.

Attune With TruMatch TM Personalized Solutions Instruments

The purpose of our study is to determine, using a prospective, randomized-controlled trial, the economic viability and clinical outcomes associated with patient-specific instrumentation (PSI) for total knee arthroplasty in an obese patient population.

Effects of Acetyl L-Carnitine Supplementation on Clinical, Metabolic and Inflammatory Symptoms in Obese, Diabetic, Postmenopausal Women With Osteoarthritis

OA is a degenerative bone disease more common in postmenopausal women. Diabetes and obesity are common risk factors for the development of OA. The common symptoms include pain and disability of the affected joint, leading to mobility issues. Acetyl L-carnitine due to its known anti-inflammatory, chondroprotective, and improved insulin-sensitizing effects may help in alleviating the symptoms and progression of OA in obese diabetic postmenopausal women.

Conversations in Health Literacy Using AI Technology for Osteoarthritis Patients

The goal of this clinical trial is to assess the use of a generative artificial intelligence large language model chatbot in improving decision making factors in patients with hip and knee osteoarthritis. The main questions it aims to answer are: Does the use of an artificial intelligence chatbot have an effect on decisional conflict and anxiety related to decision making? Are changes in decisional conflict correlated with changes in patient reported outcomes? Are changes in decisional conflict correlated with health literacy? Participants will interact with an artificial intelligence chatbot prior to their clinic visit with an orthopaedic surgeon, using a structured prompt.

Manual Arthroplasty Versus VELYS Robotic-Assisted Solution Functional Alignment Arthroplasty for Knee Osteoarthritis

The goal of this clinical trial is to learn if the VELYS Robotic-Assisted Solution (VRAS) device helps to improve outcomes from total knee replacement, when compared to regular non-robotic-assisted total knee replacement in the treatment of osteoarthritis. It will also aim to review the longer-term safety and efficiency effects of using this device. The main questions it aims to answer are: 1. Does VRAS device-assisted total knee replacement improve patient outcomes (such as their function, satisfaction, and pain) when compared to non-robotic-assisted total knee replacement? 2. Does VRAS device-assisted total knee replacement improve clinical outcomes (such as revision risk, complications, and hospital length of stay) when compared to non-robotic-assisted total knee replacement? 3. Does VRAS device-assisted total knee replacement improve functional outcomes (including biomechanical motion analysis) when compared to non-robotic-assisted total knee replacement? 4. What are the economic and efficiency effects of VRAS device-assisted total knee replacement compared to non-robotic-assisted total knee replacement? 5. What are the human factor and learning curve effects of introducing VRAS device-assisted total knee replacement into healthcare teams? 6. Are there any differences in safety and adverse event incidence between VRAS device-assisted total knee replacement and non-robotic-assisted total knee replacement? Participants will: * Be randomised to receive a total knee replacement using either regular non-robotic-assisted methods, or with the use of the VRAS device. * Be assessed pre-operatively at the clinic, and then at 6 weeks, 6 months, and 12 months following date of operation. At these appointments patients will answer questionnaires, receive an x-ray (pre-operatively, and at 6 months post-operatively), and a subgroup will be reviewed in the motion analysis laboratory (pre-operatively, and at 6 months post-operatively). * Have their longer-term outcomes including any revision operations monitored out to 10 years through national registry data linkage (no actual follow-up for patients after 12 months).