Clinical Research Directory

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.

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.

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).

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.

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.

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.

Effects of Fall Prevention Program on the Number of Falls Among Elderly Following Total Knee Replacement

the aim of the proposed research is to investigate the short and long-term effects of integrating a comprehensive fall prevention programme into conventional physiotherapy on the number of falls, balance, and functional ability among elderly following TKR. the investigator hypothesize that conventional physiotherapy integrated with a fall prevention program is more effective than conventional physiotherapy alone in improving balance and functional ability and preventing the occurrence of falls among elderly following TKR. Study type: The proposed study is a parallel group prospective (24 weeks) randomised single-blinded pragmatic controlled trial. Participants: Older adults operated for TKR at Al-Razi orthopedic hospital, who met the inclusion criteria.

Knee Arthroplasty Activity Trial

Total knee replacement (TKR) is a common and costly procedure widely used to relieve pain and improve function in patients with symptomatic advanced knee osteoarthritis (OA). As of 2013, the annual incidence of TKR was over 680,000 surgeries and annual costs exceeded $11 billion. Growing evidence suggests that while pain and functional status improve following TKR, physical activity (PA) typically does not surpass pre-TKR levels. Engagement in PA can meaningfully improve quality of life (QoL), pain, and function. Given the large investment in TKR, the effectiveness and cost-effectiveness of TKR could be substantially increased if TKR recipients became more physically active. The Knee Arthroplasty Activity Trial (KArAT) is a randomized controlled trial and participants will be randomly assigned to one of three arms. Participants across all arms will receive usual post-operative care for TKR surgery. Participants in the first arm will complete basic study activities, such as responding to surveys and attending two in-person clinic visits. Participants in the second arm will do the same and also receive a wrist-based physical activity tracker intervention. Participants in the third arm will receive a telephonic active coaching (motivational interviewing) and financial incentives (for reaching physical activity goals) (TAC(MI)+FI) based intervention, as well as a wrist-based physical activity tracker intervention. The second and third arms will be eligible to receive lottery-based financial rewards for wearing a wrist-worn activity tracker for twenty-four months during the study.

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.

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.

The Effect of TENS on Early Patient Outcomes After Total Knee Arthroplasty

The Effect of TENS on Early Outcomes in Incisional Wounds After Total Knee Replacement Incisional wounds heal within 3 to 4 weeks, consistent with the normal healing process. However, pain is experienced during the wound healing phase, which can negatively impact patients' recovery. Pharmacological and non-pharmacological methods are used to control pain in the early postoperative period. TENS, in particular, is notable as a non-invasive method, aiming to alleviate pain with low-voltage electrical currents. Studies report that TENS significantly reduces postoperative incisional wound pain. However, the literature demonstrates a limited number of studies on comprehensive pain assessment of incisional wounds using TENS. However, because postoperative incision pain negatively impacts patient outcomes (e.g., pain, mobilization, coughing, sleep), the effectiveness of the analgesia method must be measured. Early pain should be comprehensively assessed to plan effective treatments and improve patient recovery. In this context, the aim of the study was to evaluate the effect of TENS on early pain management in incisional wounds after total knee replacement. The study was designed as a randomized controlled trial. Patients meeting the study's sample criteria will be included. Data collection tools will be a Personal Information Form and the Revised American Pain Society Patient Outcomes Questionnaire (GGAADHSA), which measures the patient's pain assessment in the first 24 hours. TENS will be applied twice (12 hours apart) for 30 minutes each time within the first 24 hours after surgery to the experimental group, while the control group will receive standard treatment. The GGAADHSA questionnaire will be administered once to both groups 24 hours later. The study will evaluate the effect of TENS on early patient outcomes in incisional wounds and contribute to clinical practice in terms of postoperative recovery.

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.

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.

TRabecular Metal Economic and Clinical Knee Trial

To compare the differences, if any, in clinical outcome, patient satisfaction and survivorship between cemented and uncemented Total Knee Replacements (TKR)? To investigate if there are health economic implications of using uncemented TKRs in the NHS?

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.

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.

Kinematic Versus Mechanical Alignment in Total Knee Replacement

This prospective controlled double-blind randomized study compares kinematic and mechanical alignment in TKA (Total knee arthroplasty). A total of 120 patients will be included and the surgery will be performed using CT based 3D printed PSI(Patient Specific Instruments) Cutting guides.

Movement Dynamics of Knee Osteoarthritis and Total Knee Replacement

This research aims to explore differences in walking and functional movement mechanics, exercise response, and physical activity between people with osteoarthritis (OA), those who have undergone total joint replacement, and healthy individuals.

Efficacy of Kinesiotaping During Rehabilitation Following Total Knee Replacement Surgery

The aim of this study was to examine the efficacy of Kinesiotaping (KT) within postoperative rehabilitation after Total Knee Replacement (TKR) surgery by determining whether KT enhances early postoperative outcomes, in terms of reduction of swelling, pain relief and improvement in the function of the knee joint, compared to conventional rehabilitation without the use of KT.

Comparison of Pivotal Medial Polyethylene Versus Ultra-congruent in Total Knee Arthroplasty

The aim of this study is to compare the forgotten joint score for the medial pivot polyethylene and ultra-congruent polyethylene which are used in total prosthetic replacement of the knee

Remote Multichannel Monitoring of Patients With Chronic DIseAses Using Speech technoLogies Based On Artificial intelliGence

DIALOG is a study to assess the efficacy and safety of remote patient monitoring using virtual operator voice technologies and a business intelligence (BI) system for timely detection, prevention of early complications, worsening of the condition, and other adverse events in patients who have been discharged from the hospital.