Clinical Research Directory

Application of Perinatal Derivatives in Total Knee Arthroplasty

This pilot study investigators whether the use of perinatal derivatives during knee replacement, in the form of an injection around the joint and patch over the knee joint incision, improves patient outcomes (including survey-based measures, functional outcomes and wound healing). Perinatal derivatives are materials derived from donor placental tissue, including amnion, chorion and umbilical cord. The perinatal derivatives used in this study do not contain living cells. Forty-eight patients aged 40 to 75 years undergoing knee replacement will be enrolled in this study and randomized to either receive or not receive perinatal derivatives during knee replacement. Participants will follow-up in clinic at Week 2, Week 6 and Month 3 after surgery. An additional remote visit will be conducted at Year 1 after surgery. Outcomes that will be assessed include the visual analogue scale (VAS) for pain, Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Oxford Knee Score (OKS) and wound healing (using a standard wound healing assessment).

Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty

This is a prospective, single-center, randomized, double-blind controlled trial. The purpose of this study is to determine whether depth-controlled anesthesia with ciprofol guided by Bispectral Index (BIS) can improve early postoperative recovery quality in elderly patients undergoing knee replacement surgery. A total of 130 eligible participants aged 60 years or older will be enrolled. Participants will be randomly assigned to two groups using block randomization based on the Charlson Comorbidity Index (CCI): Deep-anesthesia group: general anesthesia maintained with ciprofol targeting a BIS value of 35-50. Light-anesthesia group: general anesthesia maintained with ciprofol targeting a BIS value of 50-65. Intraoperative BIS values will be continuously monitored, and ciprofol infusion rates will be adjusted to keep BIS within the target range in each group. Standardized pain management including peripheral nerve blocks and postoperative ultrasound-guided continuous femoral nerve block will be provided for all participants. Blood pressure will be managed following the same protocol in both groups. The primary outcome is postoperative recovery quality assessed by the Quality of Recovery-15 (QOR-15) questionnaire on the first day after surgery. Investigators will also collect QOR-15 scores on postoperative day 2 and day 3, and record other clinical outcomes including intraoperative hemodynamic events, postoperative delirium, nausea and vomiting, pain level, sleep quality and hospital length of stay. This study aims to compare postoperative recovery between two different BIS-targeted anesthesia depths for older adults receiving joint-replacement surgery.

Nutrition and Swelling

This study is looking at whether taking a nutritional supplement before and after knee replacement surgery affects normal recovery. The supplement is Xcelerated Recovery (XR), an over-the-counter supplement made with essential amino acids (EAAs), which are building blocks of protein that the body cannot make on its own. Participants aged 65 and older with planned knee replacement surgery, and signs of nutritional risk or reduced muscle strength on short screening questionnaires, will be invited to join. Participants are assigned by chance to one of two groups. One group receives usual care plus the XR supplement, taken twice a day starting 7 days before surgery and continuing for 14 days after surgery. The other group receives usual care without the supplement. Everyone in the study wears a small temporary skin sensor (similar to a temporary tattoo) on the knee and uses a smartphone app to take scans that measure knee size. Participants also have in-person visits before surgery and 2 weeks and 1 month after surgery. The main goal is to measure how knee and leg size (circumference) changes after surgery in each group. Researchers will also look at muscle strength, knee movement, walking and mobility tests, and reported pain. This study is not testing the supplement as a treatment for any disease or medical condition. The results may help researchers better understand how nutrition relates to normal recovery after knee replacement surgery.

The Effect of Mind Mapping-Based Education on Postoperative Pain, Kinesiophobia, and Discharge Readiness in Patients Undergoing Total Knee Arthroplasty

Total knee arthroplasty is a surgical procedure used to relieve pain and improve function in patients with severe knee joint problems. However, patients may experience pain, fear of movement (kinesiophobia), and difficulties in feeling ready to leave the hospital after surgery. The purpose of this study is to evaluate the effect of mind mapping-based education on postoperative pain, kinesiophobia, and discharge readiness in patients undergoing total knee arthroplasty. In this study, patients will receive education based on mind mapping in addition to routine care, or routine care alone, according to their assigned study group. Mind mapping is a visual learning method that presents information using connected words, concepts, and diagrams. The study will compare the outcomes of the groups to determine whether mind mapping-based education improves patients' postoperative experiences and readiness for discharge. Postoperative pain, fear of movement, and discharge readiness will be assessed using appropriate measurement tools. The findings may help improve patient education and support recovery after total knee arthroplasty.

Smartphone Video-Based AI Gait Analysis Reports to Support Remote Follow-up After Total Knee Arthroplasty

This study evaluates whether an artificial intelligence (AI)-assisted gait report generated from smartphone walking videos can support remote follow-up after total knee arthroplasty (TKA). Patients complete standardized walking video recordings and symptom assessments before surgery and at approximately 6 and 12 weeks after surgery. The system analyzes the videos and provides gait information, including walking speed, step characteristics, gait symmetry, gait phases, knee movement, and changes over time. A separate clinician evaluation examines whether these AI-generated gait reports improve remote clinical decision-making. Clinicians review postoperative cases using either usual remote information, including patient-reported symptoms and the original walking video, or the same information supplemented with the AI-generated gait report. The study evaluates the clinical acceptability of management recommendations, agreement with in-person clinical assessments, clinician confidence, need for additional information, and decision time. The study also evaluates the feasibility, usability, and trust associated with home-based smartphone gait assessment from both patient and clinician perspectives. The AI gait report is intended to support postoperative monitoring and communication and does not replace clinical diagnosis or scheduled in-person follow-up.

Virtual Reality During Passive Motion After Knee Surgery

The purpose of this study is to investigate the effects of virtual reality on pain, anxiety, and comfort during continuous passive motion following total knee arthroplasty

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.

Comparison of DOACs and LMWH for Thromboprophylaxis After Total Knee Arthroplasty

Yes. For these two fields, I would enter the following in English, based on your study protocol. 1\. Brief Summary Copy and paste: This study aims to compare three thromboprophylaxis regimens in adults undergoing primary total knee arthroplasty: rivaroxaban 10 mg once daily, apixaban 2.5 mg twice daily, and low-molecular-weight heparin (LMWH) once daily. The study will assess venous blood flow in the lower limbs using Doppler ultrasound and determine whether blood flow differs between the three treatment groups. Participants will be randomly assigned to one of the three treatment groups and followed for 28 days after surgery. Doppler ultrasound examinations will be performed at baseline and on Days 7, 15, 21, and 28. Additional assessments will include rehabilitation progress, postoperative bleeding, suspected venous thromboembolism, cardiovascular complications, and other postoperative complications. The study is being conducted at the Department of Anesthesiology, Principal Military Hospital of Instruction of Tunis.

Improvement of Total Knee Arthroplasty Effectiveness Using Preoperative Prehabilitation

Total knee arthroplasty (TKA) is the most effective treatment for stage III-IV knee osteoarthritis (OA). However, up to 30% of patients remain dissatisfied due to periarticular functional insufficiency, pain, and movement limitations. This study aims to improve TKA outcomes by developing and implementing a multimodal prehabilitation approach based on OA phenotypes (chronic pain, inflammatory, biomechanical) to correct clinical and functional disorders preoperatively, thereby enhancing postoperative recovery and quality of life.

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.

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.

Personalized Information Before and After Total Knee Arthroplasty: PAK-study

Despite positive results following total knee arthroplasty (TKA), some patients are dissatisfied after recovery. Unfulfilled expectations is a key predictor of dissatisfaction. The aim of this study is to investigate if more patients fulfil or exceed their preoperative expectations one year after TKA when personal feedback on their PROs is given.

Balance, Fall Risk, and Gait in Women With Total Knee Arthroplasty

Total knee arthroplasty (TKA) is a commonly performed surgical procedure aimed at reducing pain, restoring joint function, and improving quality of life, particularly among older women. Despite improvements in pain and functional outcomes following TKA, findings regarding balance, fall risk, and gait performance remain inconsistent. Impairments in these parameters may adversely affect daily activities, independence, and overall quality of life. Unlike previous studies that have primarily focused on one or two outcomes, this study will comprehensively evaluate balance, fall risk, gait performance, and quality of life in postmenopausal women who have undergone TKA. The findings are expected to provide a more holistic understanding of long-term functional outcomes following TKA and contribute to the planning of rehabilitation programs. Therefore, the aim of this study is to compare balance, fall risk, gait performance, and quality of life between postmenopausal women who have undergone TKA and healthy postmenopausal women.

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.

Continuous Adductor Canal Block (CACB) Combined With İnfiltration Between the Popliteal Artery and Capsule of the Knee (iPACK) Block vs Continuous Adductor Canal Block Alone After Total Knee Arthroplasty

This study compares the effects of adding an infiltration between the popliteal artery and capsule of the knee (iPACK) block to a continuous adductor canal block (CACB) versus continuous adductor canal block alone on postoperative analgesia, opioid consumption, early mobilization, and length of hospital stay in patients undergoing total knee arthroplasty. This is a prospective, randomized, double-blind study with 54 patients allocated 1:1 into two groups.

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).

Effectiveness of Exparel Anesthetic Administered by the Surgeon During Knee Surgery

Intra-articular Posteromedial Surgeon Administered (IPSA) Block in this study describes a new type of medical procedure where a surgeon provides anesthetic medication directly into a specific area inside a knee joint to numb the pain during knee surgery. Intra-articular refers to inside of knee joint, posteromedial refers to the back and inner side of a knee joint, and surgeon administered means a surgeon is performing the procedure. Patients You will be randomly assigned to one of these three treatment groups: Group 1: Patients in this group will receive IPSA block and Local Infiltration Analgesia (LIA). IPSA block is a pain numbing medication given by surgeon and injected inside the back and inner side of the knee joint. Local Infiltration Analgesia is a pain numbing medication injection given by the surgeon around the surgical knee area. The medications used in the procedure will be EXPAREL, and Bupivacaine HCL. Group 2 (Control): Patients in this group will receive Adductor Canal Block (ACB) and Local Infiltration Analgesia (LIA). ACB is a pain numbing injection given by anesthesiologist near the adductor canal, a passage in the mid-thigh that contains nerves connecting the knee region. Local Infiltration Analgesia is a pain numbing medication injection given by the surgeon around the surgical knee area. The medications used in the procedure will be EXPAREL, and Bupivacaine HCL. Group 3: Patients in this group will receive Local Infiltration Analgesia (LIA). Local Infiltration Analgesia is a pain numbing medication injection given by the surgeon around the surgical knee area. The medications used in the procedure will be EXPAREL, and Bupivacaine HCL. The study will evaluate; * How effective the pain relief is after surgery. * How much extra pain medication you need. * Your satisfaction with pain management and recovery * Any side effects.

Immediate Effects of Low-Intensity Plantar Proprioceptive Stimulation of the Affected Limb on Stable Versus Unstable Surfaces on Modified Sit-to-Stand Time and Gait Following Total Knee Arthroplasty

This randomized controlled study will investigate the immediate effects of low-intensity plantar proprioceptive stimulation performed on an unstable versus stable surface in patients during early rehabilitation after unilateral total knee arthroplasty (TKA). Participants will be randomly assigned to either an unstable-surface group or a stable-surface group. While seated, participants will apply low-intensity pressure through the operated foot using a standardized repeated pressing task. The unstable-surface group will perform the task with the operated foot placed on a balance pad, whereas the stable-surface group will perform the same task on a firm surface. The primary outcome will be the time required to perform a modified sit-to-stand task. Secondary outcomes will include walking performance, pain, and knee range of motion. The study aims to determine whether providing additional plantar proprioceptive input through an unstable surface can produce an immediate improvement in functional performance during early rehabilitation after TKA.

Surgery Induced Trauma After Total Versus Medial Unicompartmental Knee Arthroplasty (SITA)

Osteoarthritis (OA) is the most common type of arthritis, characterized by pain and physical disability. More than 10% of persons \> 55 years have symptomatic OA, primarily involving the knees. Knee arthroplasty is considered a successful orthopaedic procedure in progressed knee OA (KOA) with severe pain and disability where non-surgical treatments have been tried. It has long been recognized that injury to the body, either from trauma or surgery causes an inflammatory response. As TKA is considered a more invasive procedure compared with UKA, TKA and UKA may not trigger inflammatory reactions of the same magnitude. Differences in inflammatory response between TKA and UKA could help explain why differences in outcome are present, despite both procedures being technically successful. Even though knee arthroplasty is a very common and successful procedure, there are no existing studies comparing the invasiveness of TKA and UKA. As morbidity and mortality rates differ between the groups, the aim of this prospective cohort study is to investigate whether the post-operative inflammatory responses differ between TKA and UKA, and secondarily whether this difference can explain the difference in outcome between the two procedures. The investigators hypothesize that TKA generates a larger postoperative systemic inflammatory response compared with UKA due to more extensive periarticular soft tissue and bone trauma. The study's primary outcome is C-reactive Protein (CRP) measured in blood 24 hours after surgery (22-26 hours after surgery \~ day 1). Participants which are candidates for either a TKA or a UKA will through serial blood test measurement have their postoperative systemic inflammatory response measured. This further will be correlated to the clinical and functional outcomes over a 2-years postoperative follow-up period.

NitrX Total Knee Arthroplasty RSA

Metal hypersensitivity is a recognized complication in some patients following total joint arthroplasty. This can result in a reaction to metal particles from the implants placed in the joint and cause tissue injury. The Evolution® NitrX™ (MicroPort Orthopaedics, Memphis, TN) knee implant was designed with the addition of a coating meant to create a barrier against the release of metal ions. The primary purpose of this study is to compare the Evolution and Evolution NitrX implant (implants your surgeon uses in total knee arthroplasty surgery). This study will compare the stability of these knee implants (any movement the implant makes after surgery) through the use of specialized xrays, called "radiostereometric analysis" (RSA for short). The investigators will also compare levels of circulating metal particles with blood draws and the effects of any circulating metal with MR imaging. The investigators will also be looking at the participants clinical outcomes using joint function and patient satisfaction questionnaires. A total of 50 patients will be enrolled into the study.

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.

Patient-navigation-based Preoperative Rehabilitation Exercise Program in Patients Undergoing TKA

This study aimed to assess the effectiveness of a patient navigation-based preoperative rehabilitation exercise program for patients undergoing total knee arthroplasty.

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.

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.