Clinical Research Directory

Cooling of the Knee After Total Knee Arthroplasty

This study investigates whether cooling the knee after total knee replacement surgery can reduce pain and improve early recovery. After surgery, patients are randomly assigned to one of three groups: cooling with a liquid cooling bandage, cooling with an ice pack, or standard postoperative care without cooling. Cooling begins 24 hours after surgery and continues for two weeks. Pain levels, use of pain medication, blood values, knee swelling, knee movement, and length of hospital stay are recorded. The goal is to determine whether postoperative knee cooling provides additional benefits compared with standard care.

TKR Rehabilitation Through the Immersive Virtual Reality in Aquatic Scenarios

This study is a multicenter non-randomized single-blind controlled trial, aimed at investigating the feasibility and efficacy of hydrotherapy based on IVR, for the patients with TKR(Total Knee Replacement), on the function, gait performance, postural balance control, and knee edema reduction. The protocol was draft according to the Consolidated Standards of Reporting Trials (CONSORT ) checklists. A total of 96patients with total knee prosthesis will be recruited and divided into three groups, to receive a traditional rehabilitation (TR) program, traditional hydrotherapy (TH)or hydrotherapy through immersive virtual reality (HIVR) using Bts-Nirvana. Assessments will be performed at baseline and at the end of treatment.

Suzetrigine in TKA

Total knee replacements are among the most common and painful orthopedic procedures performed worldwide, often requiring intensive analgesia to support early ambulation and recovery. Despite widespread use of multimodal regimens, many patients still rely on opioids, which can cause sedation, nausea, constipation, and long-term dependency. Evaluating suzetrigine in this high-need population may improve recovery trajectories, reduce opioid consumption, and support enhanced recovery protocols. Given the growing surgical volume and the emphasis on opioid-sparing strategies, rigorous investigation of suzetrigine's efficacy in total knee replacement is of high clinical value. In this confirmatory (phase III) trial, patients undergoing primary total knee replacement will be randomized to receive either suzetrigine or placebo for 2 weeks (14 days), with the loading dose administered prior to surgery. The primary outcome is cumulative 48-hour opioid consumption in oral morphine equivalents starting from entry into the post-anesthesia care unit (PACU).

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).

Telerehabilitation Versus Clinic-Based Rehabilitation for Functional Recovery Following Primary Total Knee Arthroplasty

The goal of this clinical trial is to determine if rehabilitation delivered by telehealth works as well as rehabilitation delivered in person at a clinic, for people recovering from total knee replacement surgery. The main question it aims to answer is: • Does rehabilitation by video call lead to knee-related quality of life that is just as good as rehabilitation completed in person at a clinic? Researchers will compare a telehealth group to a clinic group to see if telehealth rehabilitation works as well as in-person rehabilitation. Participants will: * Take part in 9 rehabilitation sessions over 6 weeks, either by video call from home or in person at a clinic * Follow a home exercise program using an online app * Answer questions about their knee and daily activities before surgery, and again at 7 weeks, 6 months, and 12 months after surgery * Have their knee movement and physical abilities, such as walking speed and climbing stairs, measured by a therapist before surgery, and again at 7 weeks, and 12 months after surgery

Comparison of the Effects of Apixaban on Thrombin Generation in Patients With de Novo Multiple Myeloma

Patients with multiple myeloma (MM) are at high risk of venous thromboembolism (VTE) and these patients require adequate thromboprophylaxis. Following the publication of the AVERT clinical study, Apixaban is strongly recommended as a prophylactic treatment option for patients with cancer, based on high quality of evidence and a favorable efficacy/safety profile. A multicenter and ancillary study - APIXABOR - that measured the plasmatic concentration of Apixaban in patients with MM and treated with preventive dose has been conducted. The peak drug concentration was superior in MM plasma, as compared to non-myeloma patients under prophylaxis. Therefore, the present study evaluated whether differences in pharmacokinetics have an impact on pharmacodynamics (i.e. decrease in coagulability in MM patients as compared to non-MM patients undergoing a surgery for total knee replacement who also have VTE prophylaxis). In fine, this study may inform to better manage thromboprophylaxis in MM patients.

A Study to Compare Different Ways of Steroid Administration After Total Knee Implantation

We are going to evaluate the difference between perioperative intravenous steroid supplementation, perioperative periarticular steroid supplementation, and standard anaesthesia protocols. We'll evaluate the outcome of patients with knee osteoarthritis who are undergoing Total Knee Arthroplasty to understand which of the three treatments give more benefits to the patient.

Femoral Component TKA: Extramedullary vs Conventional Intramedullary Guide

The study wants to evaluate the performance of this EM guide in comparison to a traditional IM guide. 75 patients will be included in the extramedullary group (to be compared with a corresponding previous group of 75 patients treated with intramedullary guide).

An Open Label Data Collection Study of My Connect Post-Op, a Post-Operative Communication Tool

This open label, multi-center study will collect data from the participant's use of My Connect Post-Op Software as a post-operative communication solution in supporting patient recovery through Technology-Assisted Conversation (TAC). The application will be tested by patients who have undergone total joint replacement as a post-op communication tool. Data will be collected on how effectively the product guides patients through their recovery, identifying potential complications, and providing appropriate recommendations based on structured question pairs.

The Feasibility of a Nurse-Initiated Weighted Blanket in Orthopedic Surgical Patients Undergoing Total Knee Arthroplasty

The purpose of this study is to explore the acceptability and feasibility of weighted blankets in total knee replacement (TKR) patients. The study also aims to measure the difference in anxiety of adult orthopedic patients in need of total knee arthroplasty surgery who receive weighted blanket before and after surgery compared to those who receive a non-weighted blanket.

Dressing-related Experiences and Surgical Site Self-care in Hip and Knee Replacement: an Observational Cohort Study

The goal of this prospective observational cohort study is to investigate dressing-related experiences and surgical site self-care in patients who are undergoing a total hip or knee replacement. The main objectives of the study are: * To evaluate patient adherence to the ISWCAP self-care checklist after total hip or knee replacement within an ERAS pathway. * To explore patient-reported outcomes related to the performance and comfort of advanced dressings. * To assess the perceived adequacy and usefulness of post-discharge wound care education. * To identify the incidence and types of wound-related complications in the 12 weeks following surgery. Participants will give informed consent before surgery and will start the study once the dressing has been applied following surgery. There will be follow up study visits at discharge, 7 days, 12 days, 6 weeks and 12 weeks post-surgery. Data relating to vital signs, medical history, surgery and medication will be taken from routine data.

Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2

The objective of this study is to investigate the efficacy of Dexamethasone sodium phosphate plus Methylprednisolone acetate in combination with plain bupivacaine ((B-DEX-MPA) compared with Liposomal Bupivacaine in combination with plain bupivacaine (B-LB) on post-surgical pain control among patients undergoing bilateral total knee arthroplasty (TKA) to asses if perineural B-DEX-MPA will result in superior analgesia efficacy as compared to B-LB. This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.

Yale Steroid Enhanced Versus Exparel Nerveblock TKA RCT Study

The objective of this phase 2 study is to investigate the efficacy of Dexamethasone sodium phosphate (DEX) plus Methylprednisolone acetate (MPA) in combination with plain bupivacaine (B) compared with Liposomal Bupivacaine (LB) in combination with plain bupivacaine on post-surgical pain control among patients undergoing unilateral total knee arthroplasty (TKA) to asses if perineural B-DEX-MPA will result in superior analgesia efficacy as compared to B-LB. This study will also assess if perineural B-DEX-MPA results in improved quality of postoperative recovery as compared to B-LB.

Digitally Supported Short-Term Prehabilitation Before Total Knee Replacement

This study evaluates the feasibility of a short-term, digitally supported prehabilitation program for patients scheduled for elective total knee replacement (TKR). Osteoarthritis is a leading cause of disability, and recovery following TKR remains heterogeneous, with a substantial proportion of patients experiencing delayed functional recovery. Prehabilitation may improve perioperative outcomes, but its implementation is often limited by short preoperative time windows. The Prehab2Rehab-KneeTEP trial is a single-center, two-arm, randomized controlled feasibility study conducted in Austria. Patients will be randomized (1:1) to either a multimodal video-supported prehabilitation program or usual care. The intervention consists of a 10 to 14-day preoperative exercise program including strength, endurance, coordination, and gait training, supported by a digital application, and is complemented by a digitally supported transition phase after hospital discharge until the start of inpatient rehabilitation. The primary objective is to assess feasibility in terms of recruitment, retention, adherence, fidelity, acceptability, and safety. Secondary exploratory outcomes include clinical recovery indicators, functional performance, and patient-reported outcomes assessed across the perioperative pathway.

Metal Ion Concentrations After Total Knee Arthroplasty

The purpose of this study is to analyze the metal ion concentrations in the patients blood following robotic-assisted total knee arthroplasty (TKA) compared to conventional total knee arthroplasty using cutting guides.

Circulatory Exercise After Total Knee Replacement

Total knee replacement is commonly associated with early postoperative inflammation, edema, pain, and reduced mobility. This randomized controlled trial will evaluate whether adding a simple circulatory exercise program to standard postoperative rehabilitation reduces early limb edema and inflammatory response after unilateral primary total knee replacement. Participants will be randomized to standard rehabilitation alone or standard rehabilitation plus seated and supine knee-extension exercises with alternating ankle dorsiflexion. The primary endpoint is change in limb edema measured by standardized limb circumference at postoperative day 14.

In-Clinic Versus Tele-Rehabilitation in Women With Knee Osteoarthritis

* To compare the effectiveness of in clinic rehabilitation versus tele rehabilitation in improving knee function in women diagnosed with knee OA. * To assess the impact of both rehabilitation approaches on improving strength. * To evaluate the effects of in-clinic and tele-rehabilitation on pain reduction in women with knee osteoarthritis.

Morphine Consumption in Joint Replacement Patients, With or Without Gabapentin Treatment

Total knee arthroplasty is amongst the most painful procedures postoperatively, and pain management can be a challenge. Different measures have been introduced to manage severe postoperative pain int hese patients. Previous studies have investigated gabapentin in acute postoperative pain and demonstrated reducted pain, postoperative morphine consumption, morphine related side effects, and postoperative pain scores. To date, this analgesia adjunct has yet to be investigated in total joint arthroplasty patients.

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.

Effect of Physical Therapy Rehabilitation on Gait and Plantar Pressure in Patients After Total Knee Replacement

This study aims to investigate the effects of a structured physical therapy and rehabilitation program on gait temporospatial parameters and plantar pressure distribution in patients who have undergone total knee replacement surgery. Patients undergoing total knee replacement often experience alterations in gait patterns and weight distribution, which may affect functional mobility and recovery outcomes. This study will evaluate whether a targeted rehabilitation program can improve walking performance and restore more symmetrical plantar pressure distribution. Participants will be assessed before and after the intervention using objective gait analysis and plantar pressure measurement tools. The findings of this study may help improve rehabilitation strategies and enhance functional recovery following knee replacement surgery.

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.

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.

Analgesic Efficacy of Pre-Operative Dose of Palmitoylethanolamide in Patients Undergoing Total Knee Arthroplasty

Analgesic Efficacy of Pre-Operative Dose of palmitoylethanolamide in Patients Undergoing total Knee Arthroplasty, A Randomized Double-Blinded Controlled Trial.

Total Knee Replacement Under Spinal Anesthesia, Comparison of Postoperative Recovery Versus General Anesthesia

Intraoperative anesthetic management for total knee replacement (TKR) can be performed under general or spinal anesthesia. These two techniques have their own characteristics and may impact postoperative recovery differently. However, there are no studies in the literature analyzing postoperative functional recovery after TKR surgery according to the type of anesthesia. The objective of this study is to compare postoperative recovery, assessed by the QoR-15F score, in patients undergoing TKR under spinal anesthesia versus surgery under general anesthesia.