Clinical Research Directory

Comparison of Two Different Regional Anesthetic Methods in Total Knee Arthroplasty Patients

Total Knee Arthroplasty patients are among the orthopedic cases that experience severe postoperative pain. In these cases, pain must be controlled. If pain is not controlled, early mobilization cannot be achieved. This can result in delayed physical therapy, prolonged hospital stays, the development of nosocomial infections, and impaired cognitive function. All of these factors contribute to increased patient care costs. Multimodal analgesia methods are used to control this pain. One of these methods is peripheral nerve blocks. Peripheral nerve blocks provide pain control and reduce the likelihood of opioid use and related side effects such as nausea, vomiting, and constipation. Current studies recommend Adductor Canal Blocks and iPACK (space between the popliteal artery and the posterior knee capsule) blocks for Total Knee Arthroplasty patients. In addition, studies are also being conducted on the application of the Suprainguinal Fascia-Iliaca Block in Total Knee Arthroplasty patients. The differences in postoperative analgesic effects between these methods are a matter of interest. No study has been conducted comparing the effects of these two approaches, which are routinely applied in our clinic and comply with guidelines, on the postoperative stress response. Regional anesthesia provides adequate pain control and has a positive effect on the stress response. The investigators aim to see a similar effect in peripheral nerve blocks. Therefore, comparing the methods that mentioned will contribute to the literature. In this study, the effects of these two different approaches on postoperative stress response and analgesic efficacy will be compared in terms of patients' postoperative opioid consumption, pain at rest and with movement, time to first analgesic need and development of motor block. IL-6 and CRP values will be examined pre-operatively and post-operatively to measure the effects on the stress response.

Intra-Articular Catheter Total Knee Arthroplasty

This is a prospective, randomized clinical trial evaluating three groups. The groups are: Group 1 (Control): Subjects that receive only the existing standard-of-care multimodal pain management protocol and do not receive post-operative intra-articular catheter. Group 2 (Investigational Treatment/Intervention): Subjects that receive the brand 1 intra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-operative period. Group 3 (Investigational Treatment/Intervention): Subjects that receive the newer brand 2 intra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-operative period.

REST-Knee: A Pilot RCT of 72-Hour Knee Immobilization and Pain Outcomes

Postoperative pain following total knee arthroplasty (TKA) is often difficult to manage, particularly with the increasing use of outpatient surgery where patients recover at home. This study aims to evaluate whether wearing a knee extension brace for the first 72 hours after surgery can reduce pain and improve recovery. This pilot randomized controlled trial will compare two groups of patients undergoing primary unilateral TKA: one group will wear an extension brace continuously for 72 hours after surgery, while the control group will follow standard care with early mobilization. Participants will be followed for up to 12 months. The primary objective of this pilot study is to assess the feasibility of conducting a larger trial, including recruitment rates, adherence to the intervention, follow-up completion, safety, and acceptability. Clinical outcomes will also be explored, including pain at 2 and 6 weeks after surgery (measured using a visual analog scale), knee function, range of motion, opioid consumption, complications, healthcare use, and quality of life. The study hypothesizes that short-term immobilization of the knee in full extension will reduce postoperative pain and may improve early recovery outcomes. Findings from this pilot study will inform the design of a larger definitive trial and may contribute to improving postoperative care and pain management after knee replacement surgery.

The Benefits Of Cryoablation In Patients Undergoing Total Knee Arthroplasty

The purpose of this study is to evaluate the efficacy of cryoablation use on patient-reported outcomes (PROMs) and opioid consumption following total knee arthroplasty. This is a randomized study that will involve a 1:1 randomization to total knee arthroplasty +/- cryoablation.

AI-based Rehabilitation for Hip and Knee Surgery Patients

This study aims to evaluate the efficacy and safety of an AI-based home rehabilitation application ("Exersite Rehab") for patients who have undergone hip or knee arthroplasty(Total Knee Arthroplasty (TKA), Total Hip Arthroplasty (THA) or hip fracture surgery). Following surgery, effective rehabilitation is crucial for functional recovery; however, many patients face barriers to consistent in-hospital exercise. This interventional study divides participants into two groups to compare outcomes. The experimental group will perform a 12-week home-based rehabilitation program guided by an AI application that provides real-time posture correction and monitoring. In contrast, the control group will perform the same exercise protocol using traditional printed educational brochures.The primary objective is to determine if the AI-based digital healthcare solution significantly improves physical function, measured by the Functional Ambulatory Category(FAC), compared to conventional methods. Secondary outcomes including pain levels(Visual Analog Scale (VAS)) and joint-specific functional scores (Knee Society Score (KSS), Harris Hip Score (HHS)) will also be assessed over the 12-week period.

Adductor Canal Block Methods in Bilateral Total Knee Arthroplasty

This study aims to compare the analgesic efficacy of surgeon-performed intraoperative adductor canal block (ACB) and ultrasound-guided anesthesiologist-performed ACB in patients undergoing bilateral total knee arthroplasty (TKA). In a prospective, randomized paired design, each patient will receive surgeon-performed ACB on one knee and anesthesiologist-performed ACB on the contralateral knee. The primary outcome is postoperative pain measured using the Numeric Rating Scale (NRS), and the study is designed to evaluate the non-inferiority of surgeon-performed ACB. Secondary outcomes include opioid consumption, time to first ambulation, length of hospital stay, postoperative complications, and patient-reported outcome measures (PROMs). Additionally, postoperative ultrasound evaluation will be performed to assess the distribution pattern of local anesthetic within the adductor canal, including cross-sectional area and longitudinal spread. This study is expected to provide evidence regarding the clinical effectiveness and technical accuracy of surgeon-performed ACB in comparison with the conventional ultrasound-guided technique.

Improving Rehabilitation for Veterans After Total Knee Arthroplasty Using Individualized Recovery Trajectories

This study will examine the impact of a new clinical decision support tool for rehabilitation after total knee arthroplasty (TKA). Typically, TKA rehabilitation is generic with most patients receiving the same dosage and contents of rehabilitation despite notable diversity among patients who undergo TKA. The investigators clinical support decision tool is designed to help physical therapists tailor rehabilitation treatments and dosages to the individual needs, goals, and preferences of Veterans recovering from TKA. This study has the potential to improve Veterans' functional recovery after TKA, while simultaneously reducing the average number of physical therapy visits Veterans attend after surgery by tailoring rehabilitation dosage based upon need. This will ensure the Veterans Health Administration (VHA) has the resources and capacity to provide adequate rehabilitation to every Veteran seeking TKA in the VHA system. Additionally, if successful, this clinical decision support tool could be used to improve outcomes and access for additional patient populations in the future.

A RCT Using Methadone in the Management of Post-Operative Pain in Total Knee Replacement

The goal of this study is to determine whether one dose of IV methadone given right before surgery will help patients' pain management after a total knee replacement and reduce the amount of pain medications taken in the weeks after surgery.

Observation of Wheeled Device Use After TKA

Maneuverability is currently under appreciated by patients who are seeking mobility. This pilot study is examining how patients maneuverability and mobility will change with this novel mobility tool.

Local Infiltration Analgesia Versus Quadruple Nerve Blocks in Total Knee Arthroplasty.

Total knee arthroplasty (TKA) is one of the most common orthopedic surgical procedures and is associated with severe pain in the immediate postoperative period, thus limiting early recovery. Optimal postoperative pain management after TKA is not fully defined. While multimodal analgesia is standard, the choice of associated regional anesthesia techniques is debated. Local infiltration analgesia (LIA) is widely used and provides effective pain relief without impairing early mobilization. Peripheral nerve blocks have been discussed due to the risk of motor blockade, but low-concentration local anesthetics, such as 0.1% ropivacaine, allow sensory blockade while preserving motor function. Preliminary studies suggest that this concentration is effective and safe. The main objective of this monocenter, prospective, randomized, open-label, controlled trial is to compare the analgesic efficacy of a quadruple nerve blocks (femoral, sciatic, obturator, and lateral femoral cutaneous nerves) using 0.1% ropivacaine versus standard LIA in patients undergoing TKA.

Utilization of a 3D Printed Mechanical Balancer During Total Knee Arthroplasty (TKA)

The aim of this study is to test a 3D-printed mechanical balancer in a clinical setting during surgery to further evaluate the utility of the device. This will be a pilot prospective study of 50 patients undergoing primary total knee arthroplasty. Surgeons will utilize the device intraoperatively in addition to the standard of care practices of mechanical balancing. It will not guide clinical decision making.

Oral vs Intravenous Dexamethasone in Total Knee Arthroplasty

This prospective observational cohort study aims to evaluate the association between perioperative dexamethasone administration and early postoperative recovery following primary total knee arthroplasty. In routine clinical practice, dexamethasone may be administered orally, intravenously, or not administered, depending on the surgeon's established perioperative protocol. The primary objective is to assess early postoperative recovery in terms of pain intensity, functional mobility, and knee joint range of motion. Secondary objectives include evaluation of inflammatory response, postoperative metabolic changes, opioid requirement, and the severity of postoperative nausea and vomiting (PONV). Group allocation is non-randomized and determined solely by the standard perioperative management approach routinely applied by the surgeon selected by the patient. No additional interventions are introduced for research purposes. All outcomes are assessed prospectively during the early postoperative period.

Persona IQ Cohort Study

A prospective multicenter longitudinal cohort study of Zimmer Biomet (ZB) Persona IQ The Smart Knee which consists of the Persona Personalized Knee (PPK) System with mymobility® platform that is attempting to develop correlative measures to assist surgeons in understanding and managing risk in their patient populations. Specifically comparing kinematic metrics captured via Remote Therapeutic Monitoring (RTM) utilizing the CANARY canturio te (CTE) and canturio se (CSE) sensors in combination with the mymobility® App. The purpose of this study is to evaluate safety, functional performance, and effectiveness of the implant. Primary Objective: Assess Persona IQ kinematic metrics captured via the CTE/CSE sensor to assist surgeons in understanding and managing recovery through post-operative gait metrics. Secondary Objective: Evaluate the value of Remote Therapeutic Monitoring (RTM) and healthcare utilization. Exploratory Objective: Exploratory analyses will be performed using these data to direct future product feature development, data algorithm products, and research. This includes but is not limited to participants implanted utilizing ROSA® Robotics and other ZBEdge technologies.

Binaural Beats for Postoperative Pain and Anxiety Reduction

To deliver a 30-minute binaural beats audio intervention in PACU and collect pain and anxiety outcomes immediately following surgery, and 4 hours following surgery completion in adults undergoing ambulatory total knee arthroplasty and total hip arthroplasty (TKA and THA).

Oral Tranexamic Acid After Total Knee Arthroplasty

This is a prospective, double-blind, randomized controlled trial evaluating the efficacy of oral tranexamic acid (TXA) in total knee arthroplasty (TKA). The study will assess pain, function, and range of motion (ROM) over a 2-year period, with key evaluations at 6 weeks and 90 days postoperatively. Hypothesis: Patients receiving 1.95g oral TXA for 3 or 7 days post-op will show improved pain, function, and ROM at 6 weeks and 90 days, with similar blood loss and transfusion rates as the control group.

Mako Cementless TKA vs Mako Cemented TKA

The overall aims of this prospective, randomised, single-blinded controlled trial are to compare functional, radiological and clinical outcomes in Mako robotic-arm assisted cementless Total Knee Arthroplasty (TKA) versus Mako robotic-arm assisted cemented TKA.

The Effects of Dual-Task Exercises on Parameters After Total Knee Arthroplasty

Introduction: Total knee arthroplasty (TKA) is a widely used surgical treatment method worldwide for advanced pain and functional loss resulting from osteoarthritis and other degenerative knee pathologies. The aim of TKA is to reduce pain, restore joint function, and improve quality of life. Although many patients experience a significant reduction in pain after surgery, balance problems, risk of falls, and functional limitations may persist in the postoperative period.In addition, loss of performance may occur in daily tasks requiring motor-cognitive interaction (e.g., talking while walking, changing direction while carrying objects).The dual-task paradigm describes exercises and assessments that require the simultaneous execution of both motor and cognitive tasks; in rehabilitation, it aims to improve daily living functions by targeting the simultaneous functioning of motor and cognitive systems.In the literature, studies on dual-task assessment and training in individuals with knee osteoarthritis and TKA are limited, and the findings are heterogeneous. Studies in elderly and osteoarthritic populations have reported that both single-task and dual-task training improve balance performance, but dual-task training does not always show a clear superiority compared to single-task training. These studies have generally focused on balance and gait parameters; evidence on how other clinically important variables such as pain, reaction time, and fear of movement (kinesiophobia) change with dual-task interventions is insufficient and inconsistent. Method: The effect size of the WOMAC Osteoarthritis Index assessment parameter in the reference article is 1.02. It was calculated that a minimum of 20 individuals in total, 10 in each group, were required for a study with 80% power, using a type I error of α=0.05 and a type II error of β=0.20.After obtaining informed consent from all participants, their sociodemographic information will be recorded. Subsequently, their cognitive status will be assessed using the Mini Mental State Test (MMSE).Pain will be assessed using the Numerical Pain Rating Scale (NPRS). Functional mobility will be assessed using the Timed Up and Go (TUG). Dynamic balance will be assessed using the Functional Reach Test. Static balance will be assessed using the Berg Balance Scale (BBS). Functionality will be assessed using the WOMAC Osteoarthritis Index. Kinesiophobia will be assessed using the Tampa Kinesiophobia Scale (TKS). Lower extremity reaction time will be assessed using the Fitlight Trainer (FITLIGHT Sports Corp., Ontario, Canada), a wireless system consisting of 8 sensors.Interventions: After participants were randomly divided into two groups, those in the control group would perform a physiotherapy program consisting of strengthening and balance exercises at home, provided by us, and would not participate in any other exercise program during the study period. Exercises would be taught to the control group in person by a physiotherapist at the time of the initial assessment, and follow-up sessions would be video-recorded. The intervention group's program would be a dual-task exercise program, in addition to the exercises provided in the home exercise program. Interventions would last for 8 weeks, 2 days a week, and the program would be updated weekly.

Comparing Temperature in Burr vs Saw Cutting for Knee Arthroplasty

We will assess the temperatures achieved during bone cutting in total knee replacements, comparing burr and saw techniques. Our study involves recruiting 20 patients from East Suffolk and North Essex NHS Foundation Trust (Colchester site). Patients will be recruited from the orthopaedic outpatient clinic, with 10 undergoing Robotic total knee arthroplasty (burr cutting) and 10 undergoing conventional total knee arthroplasty (saw cutting). Temperatures will be measured using a visual infrared thermometer placed outside the surgical field while a consultant surgeon performs the procedure. Importantly, these temperature recordings will have no impact on which treatment the patient received as the standard of care.

Safety and Performance Using Legion™ CR Oxinium and CoCr Femoral Implants Combined With Legion™/Genesis™ II XLPE High Flex Tibial Inserts

The purpose of this research is to collect data on patients that had the Legion CR Oxinium and CoCr Femoral Implant and the Legion/Genesis II XLPE High Flex Tibial Inserts implanted in the past. Smith \& Nephew will evaluate the safety and performance of these implants.

Minimal Sedation During Knee Replacement Surgery

This study will test the use of active noise cancelling headphones with music or a movie during knee replacement surgery. Feedback from the surgical team and from patients regarding the headset system will be gathered to see if using it can reduce the amount of sedation needed during knee replacement procedures that use localized anesthesia.

Prediction of Postoperative Outcomes After TKA Using Instrumented Insoles and DNN

This multicenter prospective observational study aims to evaluate whether preoperative clinical variables and wearable sensor-derived gait features can predict postoperative improvement after total knee arthroplasty (TKA). Participants will undergo standardized gait assessments using instrumented insoles and complete validated patient-reported outcome measures (PROMs). Prediction models including linear regression, random forest, and deep neural networks will be applied and their performance compared.

Infiltration or Nerve Blocks in Addition to Adductor Canal Block

The aim of this study is to evaluate the analgesic efficacy of this quadruple sensory block compared with the currently recommended procedure (adductor canal block + infiltration).

Enhanced Recovery After Major Surgery and Chronic Pain for Total Knee Arthroplasty

The goal of this interventional clinical trial is to assess opioid consumption 24-48 hrs post anesthesia block among patients undergoing total knee arthroplasty. The main question it aims to answer is: 1\. Is there a difference in opioid consumption 24-48 hours post block administration among patients that receive an adductor canal catheter (ACC) versus adductor canal block (ACB)? Participants will be: * Randomized to receive an adductor canal catheter (ACC) or a sham adductor canal catheter. * Asked to use the Diagnotes application to communicate with the pain doctor while the catheter is in place. * Follow up for up to 6 months post-operation. Researchers will compare the interventional group (ACC) to the control group (sham ACC + ACB) to see if there is difference in opioid consumption and chronic pain at 6 months post-operation.

ERAS-Based Preoperative Nutrition and Fasting in Total Knee Arthroplasty

The aim of this randomized controlled study is to investigate the effect of implementing a preoperative nutrition education and fasting protocol prepared in accordance with Enhanced Recovery After Surgery (ERAS) guidelines during the 24-hour preoperative period on postoperative hydration status and the incidence of nausea and vomiting in patients scheduled for total knee arthroplasty. Total knee arthroplasty is a commonly performed surgical procedure, particularly in older adults, and postoperative recovery may be negatively affected by surgical stress, anesthesia-related complications, dehydration, and postoperative nausea and vomiting. ERAS protocols emphasize the optimization of preoperative nutrition and hydration as key components to improve postoperative outcomes. In this study, patients undergoing elective total knee arthroplasty will be randomly assigned to an intervention group or a control group. Patients in the intervention group will receive ERAS-based preoperative nutrition education and a standardized fasting protocol during the 24 hours prior to surgery, while patients in the control group will receive routine standard care. Postoperative hydration status, nausea and vomiting severity, and fluid intake-output balance will be assessed and compared between the two groups. The findings of this study are expected to contribute to improving perioperative nursing care practices and enhancing patient recovery and comfort following total knee arthroplasty.