Clinical Research Directory

Effect of AI-Assisted Anatomical Visualization on Anxiety and Kinesiophobia in Knee Arthroplasty Patients

Total knee arthroplasty (TDA) is an effective surgical method applied to reduce pain, improve joint function, and enhance quality of life in patients with advanced osteoarthritis or joint degeneration. However, it is known that surgical success is not limited to the operation itself; pre- and post-operative processes are at least as important as the surgical technique. In particular, active patient participation, early mobilization, and adherence to exercises during the rehabilitation period directly affect treatment outcomes. Patient education plays a critical role in this process. Accurate and sufficient information reduces patients' anxieties about the surgical process and increases their confidence in the recovery process. It also prevents the development of kinesiophobia (fear of movement), supporting patients in participating in physical activity more quickly and safely. Patient education can be provided through various methods. Traditional approaches include face-to-face clinical training, verbal information provided by nurses or physiotherapists, written brochures, and visual materials. While this standard clinical training is effective in conveying basic information, it may have limitations in patients' ability to recall information and adapt it to daily life. In recent years, technology-based training methods have gained increasing importance. In particular, AI-assisted video-based anatomical visualization training can present the structure of the surgery, the placement of the prosthesis, and the movement mechanism to patients in a more understandable and visual way. Such interactive and visually rich training offers advantages in terms of increasing patients' knowledge levels, reducing anxiety, and strengthening their participation in treatment. In conclusion, success after total knee arthroplasty depends not only on the surgical intervention but also on effective patient education. Comparing standard clinical training with AI-assisted visual training methods constitutes an important area of research for improving patient outcomes.

Cryoneurolysis Prior to Total Knee Arthroplasty

Knee osteoarthritis is a major issue worldwide with limited treatment options. Many patients receive knee joint replacement surgery which is considered effective and safe. Nonetheless the period post-surgery is characterized by moderate to severe pain inhibiting early ambulation, motivation and range of motion, compromising rehabilitation, patient satisfaction, and overall outcomes. An optimal strategy of postoperative pain treatment after knee replacement surgery has not yet been established. Recently, our research center and others have shown that is possible to target the nerves surrounding the knee with a novel treatment called cryoneurolysis. Cryoneurolysis apply low temperatures \[-20°C ; -100°C\] to a target nerve, which disrupts nerve function and provides potential pain relief. This suggest a potential for cryoneurolysis to significantly improve rehabilitation, reduce opioid intake and overall outcomes after knee replacement surgery. The primary objective of the current project is to determine the effectiveness of cryoneurolysis in its proposed ability to reduce opioid intake and postoperative pain after knee replacement surgery. The study is a randomized controlled study with two groups. Group CRYO receives cryoneurolysis prior to knee replacement surgery and group SHAM receives a sham treatment prior to knee replacement surgery. Both groups receive surgery, analgesics and postoperative rehabilitation as per usual. Efficacy of treatment is evaluated using the change in opioid intake in the CRYO group compared to the SHAM group 14 days after knee replacement surgery. Participants will also be assessed at 90 and 180 days after knee replacement surgery and will include measures on pain, quality of life and function.

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.

Intraosseous Tranexamic Acid for Reducing Blood Loss in Total Knee Arthroplasty

This prospective, single-center, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of local intraosseous tranexamic acid administration for reducing perioperative blood loss in patients undergoing primary unilateral total knee arthroplasty (TKA). A total of 70 patients with primary knee osteoarthritis will be randomly assigned in a 1:1 ratio to either the tranexamic acid group or the placebo control group. Before skin incision, participants in the experimental group will receive local intraosseous tranexamic acid, while participants in the control group will receive an equal volume of normal saline using the same injection procedure. The primary outcome is total perioperative blood loss. Secondary outcomes include postoperative hemoglobin reduction, transfusion requirements, pain, knee swelling, range of motion, functional recovery, length of hospital stay, and postoperative complications. Participants will be followed for up to 3 months after surgery.

Investigation of the Effect of Proximal and Distal Adductor Canal Block in Knee Replacement Surgery

to investigate the effect of adductor canal block applied with two different approaches in the treatment of pain after TKA surgery on pain control and functional mobility.

Remote Tai Chi for Knee Osteoarthritis

The goal of this pragmatic randomized trial is to evaluate the effectiveness of remote Tai Chi to treat knee pain in adults with knee osteoarthritis. The main questions the trial aims to answer are: * Compared to routine care, will patients with Knee OA receiving remote Tai Chi exhibit greater improvement in knee-related pain (WOMAC pain score, primary outcome), pain interference (PROMIS-Pain Interference, secondary outcome), and health-related quality of life at 3 months? * Does remote tai chi decreases healthcare utilization and analgesic use over the one-year study period? Researchers will compare remote Tai Chi added to routine care to routine care alone to see if remote tai chi works to treat knee osteoarthritis pain. Participants will participate in remotely delivered web-based tai chi sessions, twice a week for 12 weeks, or will continue to receive routine care. Participants will be followed for 12 months after randomization.

The Bone Cement Penetration in Medial Fixed-bearing Unicompartmental Knee Arthroplasty

During Medial Fixed-bearing Unicompartmental Knee Arthroplasty, pulsed lavage combined with moderate pressurization achieves deeper cement penetration into cancellous bone than manual rinsing, optimizing the bone-cement-implant interface. Although 3-month clinical outcomes were comparable between groups, long-term follow-up is warranted to evaluate its impact on prosthetic survivorship.

Anatomic Congruent Prosthetic Knee Design

This double-blinded randomized control study will use kinematic and kinetic measures to compare an anatomical congruent prosthetic knee design to a standard prosthetic knee design. The patients will be measured pre- and post-operative and compared to a healthy non-osteoarthritis control group.

Assessing the Association Between WBCT PFJ Morphological Metrics and Knee Symptoms

Patellofemoral joint (PFJ) pain is a common, often chronic, aching pain behind or around the kneecap, frequently called "runner's knee". It occurs when the kneecap does not glide smoothly over the thigh bone, often due to muscle weakness or overuse. It makes sitting for long periods, climbing stairs, or kneeling painful. Symptomatic knee osteoarthritis (OA) is a common, long-term condition where the protective cartilage in the knee joint wears away, causing the bones to rub together, leading to daily pain and stiffness. In simple terms, it is a "wear-and-tear" disease of the entire joint that makes walking, climbing stairs, or bending the knee difficult. The PFJ is where the patella (kneecap) meets the femoral trochlea (front part of the lower thigh bone) at the front of the knee. Patellar tracking refers to the movement of the patella that begins to engage in the distal femoral trochlear groove (smooth, U-shaped groove at the bottom of the thigh bone). By doing this study, we hope to advance clinical knowledge of the PTJ features in a more natural position by using weight-bearing computed tomography (WBCT) images while the leg is straight and slightly bent. Determining links between specific knee symptoms and the PTJ structure on WBCT images could enable providers to effectively target the underlying causes and to develop targeted treatments.

Comparison of Leucocyte-rich PRP and Leucocyte-poor PRP in Treating Mild to Moderate Knee Osteoarthritis

The purpose of this study is to show that there is no difference in patient clinical scores when patients with knee pain are treated with joint application of high dose white blood cell PRP (platelet-rich plasma) and low dose white blood cell PRP for knee osteoarthritis. Participants will be selected based on presenting knee pain lasting for 6 months or longer. Before being recruited, they will undergo radiological examinations (X-ray and MRI), based on which they will be recruited. Before application and subjection to randomization, all patients will fill out clinical questionnaires (KOOS,WOMAC,VAS). Afterwards, the participants will be divided randomly into two groups, one receiving high dose white blood cell PRP and the other group receiving low dose white blood cell PRP. Participants will not be aware of which group they are divided into. They will have blood drawn, the blood will be processed into a PRP blood product. The blood product will then be applied into the joint space with the help of ultrasound. The patients will again fill out clinical scores (KOOS,WOMAC,VAS) at the follow-up intervals (1,3,6,12 months). At the end of the study, participants will be allowed to discover which PRP product they received.

Knee Joint Position Sense in Knee Osteoarthritis

The aim of this study was to compare knee joint position sense between sitting with visual input and prone without visual input in individuals with knee osteoarthritis.

Anatomical Axis on X-Ray and Its Relationship With Pain and Kinesiophobia in Knee Osteoarthritis

Knee osteoarthritis is a common joint disease that causes pain, stiffness, and limitations in daily activities, especially in older adults. Changes in the alignment of the lower limb, called the anatomical axis, can increase the mechanical load on the knee joint and may affect pain and mobility. This study aims to investigate the relationship between the anatomical axis measured on knee X-rays and patients' pain levels, functional status, quality of life, and fear of movement (kinesiophobia). This is a single-center, observational, cross-sectional study. Adult patients diagnosed with knee osteoarthritis who have a standard knee X-ray taken within the last 6 months and who volunteer to participate will be included. Pain will be measured with the Visual Analog Scale (VAS), functional status with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), quality of life with the 36-Item Short Form Health Survey (SF-36), and kinesiophobia with the Tampa Scale for Kinesiophobia (TSK). The femoro-tibial angle and joint space width will be measured on X-rays by two independent observers. By examining the relationship between radiographic alignment and clinical findings, this study may provide new insights into the comprehensive evaluation of knee osteoarthritis and help guide treatment planning for patients.

3-Needle vs 5-Needle of Genicular Nerve Block on Pain and Quality of Life in Knee Osteoarthritis

This study aims to compare the 3-needle and 5-needle of genicular nerve block on pain and quality of life in Knee osteoarthritis (KOA).

taVNS in Veterans With Knee OA (AVAHCS)

The objectives of this study are to identify an optimal transcutaneous auricular vagus nerve stimulation (taVNS) dosing regimen for pain relief and anti-inflammatory effects in Veterans with knee osteoarthritis (OA), compared to corticosteroid injection (CSI), and lay the groundwork for future combinatorial therapies with cell-based approaches. The population for this study is Veterans with osteoarthritis (OA). This single-center, randomized pilot study will enroll participants with knee OA, who will be allocated to CSI (n=10), high-dose taVNS (n=15; 1-2 hours/day, 7 days/week), or low-dose taVNS (n=15; 30-60 min/day, 3 days/week) for 12 weeks. Synovial fluid and blood samples will be collected at baseline, 4, and 12 weeks for biomarker analysis (pro-inflammatory cytokines: TNF-, IL-6, IL-1 ; anti-inflammatory mediators: IL-10, TGF-). The approximate study duration for each individual participant is 12 weeks of treatment with assessment visits at baseline, one month, and three months. Participants will be recruited at the Atlanta VA. The anticipated total enrollment is 40 participants. No specimens or data will be banked for future research use. Informed consent will be obtained from participants in person via signatures on written informed consent forms.

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.

How Does the Addition of Adductor Canal Block to Local Infiltration Affect Recovery in Patients Undergoing Total Knee Arthroplasty? A Feasibility Study.

The use of periarticular injection and adductor canal block are well-established techniques used both in combination or in isolation in the management of postoperative pain for patients undergoing total knee arthroplasty. The aim of this study is to investigate whether combining these two techniques have an added benefit, compared to periarticular injection alone, with respect to quality of recovery, functional return, discharge readiness, and short and long term post-operative narcotic use.

Impact of Mesenchymal Stem Cells in Knee Osteoarthritis

Many patients with osteoarthritis of the knee fail non-operative measures and elect to have knee arthroplasty to improve their quality of life. If successful, intra-articular mesenchymal stem cell (MSC) injections into the knee may offer another viable non-operative treatment modality. Additionally, this modality may have reparative or regenerative potential, which could lead to the first treatment for osteoarthritis that treats the underlying disease as opposed to symptomatic control. Additionally, there are no acceptable non-surgical treatments for focal chondral defects of the knee. Surgical treatments that do exist have diminished outcomes if performed on patients older than age 30-40 years. If successful, intra-articular MSC injections into the knee would represent the first non-operative treatment for focal chondral defects and also represent a potential option for treatment in patients over the age of 30-40 years. This trial will be a prospective, single-center phase I pilot study to evaluate the safety and tolerability of a single intra-articular injection of autologous bone marrow-derived MSCs in 16 subjects, 8 who have knee osteoarthritis and 8 who have a focal chondral defect in the knee. Patients will undergo a bone marrow harvest procedure at the Dahms Clinical Research Unit (DCRU) of University Hospitals Cleveland Medical Center. MSCs will be isolated and expanded. After approximately 2-3 weeks, patients will return for an intra-articular injection of 50x106 MSCs Subsequent study visits will occur on post-injection day 7 and months 2, 6, 12, and 24. Safety of intra-articular injection of MSCs will be evaluated at study visits by interval history, physical examination and assessment of any adverse events that are observed/reported. Additionally, efficacy will be evaluated by having patients complete functional outcome measures including: Visual Analog Score (VAS) for pain, Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) Subjective Knee Form, and Lysholm Knee Scale. These will be completed at the pre-treatment visit and then repeated at the 2, 6, 12, and 24-month follow-up visits. Lastly, T1 rho and T2 mapping on magnetic resonance imaging (MRI) will be used to assess for improved cartilage quality after intra-articular injection of MSCs. An MRI will be obtained at the pre-treatment visit. At the 12 and 24 month follow up visit, additional MRIs will be obtained and analyzed to compare the pre-treatment MRI to post-treatment MRIs.

Effect of iPACK and BiFeS Blocks on Quality of Recovery After Total Knee Arthroplasty

This prospective, randomized, double-blind clinical trial aims to compare the effects of two different posterior knee analgesia techniques-iPACK block (Interspace Between the Popliteal Artery and the Capsule of the posterior Knee) and the Biceps Femoris Short Head (BiFeS) block-when combined with an adductor canal block (ACB) in patients undergoing elective unilateral total knee arthroplasty (TKA). Effective postoperative analgesia is essential for early mobilization, enhanced recovery, and patient satisfaction after TKA. Although ACB provides good anterior knee analgesia while preserving quadriceps strength, additional posterior knee analgesia is often required. The iPACK block is a commonly used technique that targets the posterior knee capsule, whereas the newer BiFeS block aims to provide more selective posterolateral sensory blockade with potentially reduced risk of motor involvement. However, comparative clinical data between these two techniques are limited. The primary objective of this study is to evaluate the difference between the iPACK and BiFeS blocks in terms of Quality of Recovery-15 (QoR-15) scores at 24 hours postoperatively. Secondary objectives include comparisons of postoperative pain scores, opioid consumption, time to first analgesic request, quadriceps and anterior tibialis muscle strength, functional test performance, time to mobilization, active range of motion, and the incidence of adverse events. A total of 74 adult patients scheduled for elective unilateral TKA under spinal anesthesia will be randomized in a 1:1 ratio into two groups: ACB + iPACK block or ACB + BiFeS block. All blocks will be performed under ultrasound guidance by an experienced anesthesiologist. Outcome assessments will be conducted by blinded investigators. The study aims to provide high-quality clinical evidence regarding the effectiveness of the BiFeS block compared to the widely used iPACK technique.

The personalKNEE Trial

Robotic knee surgery makes it possible to adopt different alignment philosophies in total knee arthroplasty. The classical operation where the knee is placed in a neutral manner, the so called mechanical alignment, has been used for decades. The kinematical alignment has recently won popularity. With this technique the focus is to render the natural knee anatomy even if this means to end up with a varus or valgus position. In this study, the investigators will compare the mechanical alignment and kinematical alignment and test the patients clinically and with a special CT scan to see if this technique gives equal or better longevity of the implants.

Feasibility of an Early Home-based Cycling Intervention After Knee Arthroplasty

The goal of this pilot clinical trial is to evaluate whether an early, home-based stationary cycling programme, provided in addition to standard postoperative home exercises, is feasible and acceptable for patients recovering from knee arthroplasty. It will also inform the design of a larger clinical trial examining the effects of adding early cycling to standard postoperative home exercises on postoperative outcomes. The main questions it aims to answer are: * Can the cycling programme and planned study procedures be delivered as intended? * Are participants willing and able to take part in the study and follow the planned interventions? * Do participants find the cycling programme and outcome assessments acceptable? * What changes, if any, are needed before conducting a larger clinical trial? Researchers will compare an early home-based stationary cycling programme provided in addition to standard postoperative home exercises with standard postoperative home exercises alone. Participants will: * Be randomly assigned to either the cycling group or the standard exercise group (control group) two weeks after surgery. * If assigned to the cycling group, perform 30 minutes of stationary cycling at home at least five days per week for eight weeks in addition to the standard postoperative home exercise programme. * If assigned to the control group, follow the standard postoperative home exercise programme and refrain from structured cycling during the eight-week intervention period. * Complete questionnaires and physical assessments at baseline and follow-up visits. * Complete selected patient-reported outcome measures at 6 and 12 months after surgery.

Risk Assessment and Management Program (RAMP) on Knee Osteoarthritis in Primary Care

The goal of this clinical trial is to determine the clinical effectiveness of a Chronic Care Model (CCM) named Risk Assessment and Management Program on Knee OA (RAMP-Knee OA) in adults with knee Osteoarthritis (Knee OA) at 52 weeks. Participants will be screened for eligibility to participate. After confirming eligibility, participants will complete the baseline assessment and be randomized into one of the following groups (n=114 for each group): 1. RAMP Knee-OA group 2. Usual care group Outcomes will be measured at baseline, week 16, week 32, and week 52.

Targeting Osteosarcopaenia and Multimorbidity for Frailty Prevention

The aging population and its accompanying burden from non-communicable chronic diseases predicts an increasing impact imposed by frailty on healthcare systems. This is due to a lack of normative data for older adults and reliable risk stratification methods to develop effective approaches to the prevention of frailty. In this study, the investigators plan to form a common dataset for phenotype identification, risk stratification of frailty and its targeted treatment plans in the at-risk and mildly frail population.

Cryoneurolysis Versus Bipolar Radiofrequency Ablation of Genicular Nerves for Pain Relief in Symptomatic Knee Osteoarthritis

This study aims to compare the reduction in knee pain between ultrasound-guided cryoneurolysis and bipolar radiofrequency ablation (RFA), as measured by the Numerical Rating Scale (NRS) at predefined follow-up intervals.

Effect of Foot Massage on Pain and Analgesic Consumption in Total Knee Prosthesis

This randomized controlled trial aims to examine the effects of foot massage combined with cold application on postoperative pain, patient satisfaction, and analgesic consumption in individuals undergoing Total Knee Arthroplasty (TKA). The study will be conducted in the Orthopedics and Traumatology Department of Çukurova University Balcalı Hospital, which includes an 18-bed orthopedic unit. Eligible patients will be randomly assigned to either the intervention group or the control group. * Intervention group: Patients will receive both cold application and foot massage. Cold therapy will be administered for 20 minutes every 2 hours for the first 48 hours postoperatively. Foot massage will be performed twice daily (morning and evening) for two days following drain removal, using standardized massage techniques. * Control group: Patients will receive only cold application following the same schedule and procedure as the intervention group. Data will be collected using the Patient Information Form, the Short Form of the Brief Pain Inventory, the Numeric Rating Scale, and the Newcastle Satisfaction with Nursing Care Scale. Statistical analyses will be conducted using SPSS, and findings will be interpreted at a 95% confidence level (p \< 0.05). Ethical approval has been granted by the Çukurova University Non-Interventional Clinical Research Ethics Committee. Institutional permission will be obtained prior to data collection. Participation will be voluntary, and all data will be treated confidentially.