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Showing 1-20 of 61 trials
NCT07548385
This is a prospective, randomized study. The purpose of this study is to evaluate if the addition of Suzetrigine, a new pain medication, to well established peri-operative pain regimen used for total knee replacement surgery will effect pain control. 1. Does Suzetrigine given pre-operatively decrease the total opioid consumed after total knee replacement surgery? 2. Dose Suzetrigine given pre-operatively decrease the visual analog pain scale pain scores after total knee replacement surgery? Study participants will be randomly assigned to receive either Suzetrigine medication or placebo medication.
NCT07471243
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.
NCT06089291
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.
NCT07437469
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).
NCT06929871
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.
NCT07010809
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.
NCT06180486
The goal of this pilot study is to develop a randomized control trial study with sufficient power to definitely address if a preop mindfulness meditation intervention can improve post-total knee arthroplasty mental well-being or physical health compared to controls, and if a preop mindfulness meditation intervention can train resilience. The main questions it aims to answer are: 1. Is this preoperative mindfulness meditation study feasible at Hospital for Special Surgery? 2. Can we estimate a control and intervention group central tendency and variability to be used to determine sample size in future study? 3. Does a preoperative mindfulness meditation interventions improve post-total knee arthroplasty mental well-being or physical health compared to controls? Can preoperative a mindfulness meditation intervention train resilience (as measured by increased resilience score)? Participants will be randomly assigned to be in the intervention group or the waitlist control group. The intervention group gets the mindfulness mediation intervention prior to their day of surgery, and the control group will be given the mindfulness meditation intervention 90 days after their day of surgery. The waitlist control group allows for comparison between those who got the mindfulness meditation intervention prior to surgery and those who did not while still offering the potential benefits of the intervention after 90 days.
NCT07330765
Analgesic Efficacy of Pre-Operative Dose of palmitoylethanolamide in Patients Undergoing total Knee Arthroplasty, A Randomized Double-Blinded Controlled Trial.
NCT07023185
The purpose of this study is to compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups pre-surgically, daily after surgery for 14 days, then weekly after surgery for 3 months, and at 6 months post-surgery.
NCT05642260
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.
NCT04107649
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.
NCT04432012
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.
NCT06815445
Postoperative pain and blood loss of non-use compared to partial-use of a tourniquet in bilateral total knee replacement: A Randomized- Control Trial This study aimed to compare the effects of non-use (NTU) and partial-use (before osteotomy to skin closure; BOO) of a tourniquet in bilateral total knee arthroplasty (TKA) on postoperative pain and complications.
NCT05279092
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.
NCT04384913
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.
NCT02118272
The aim of this study is to assess the clinical, radiographic and patient-reported outcome measures (PROMs) after total knee replacement with Physica KR, define the survivorship of the implants and identify possible risk factors that may lead to failure.
NCT06831682
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.
NCT04872855
The aim of this study is to assess the long-term performance and safety of HLS KneeTec cementless and hybrid fixation knee prosthesis when used in standard medical practice.
NCT06720012
The goal of this randomized study is to see if using patient-specific instruments (PSI) during total knee replacement surgery improves outcomes compared to standard instruments. The study focuses on adults with knee osteoarthritis who need knee replacement surgery. Specifically, it aims to answer the following questions: Does using PSI improve knee function and stability as experienced by the patient? Does PSI lead to more normal knee motion during bending and straightening? Does PSI result in at least as good tibial (shin bone) component fixation as standard instruments? Is PSI more cost-effective than standard instruments? Researchers will compare PSI with standard instruments in 70 patients. Half will receive knee replacement surgery using PSI, and the other half with standard instruments. Patients will be randomly assigned to each group. Participants will: Undergo knee replacement surgery with either PSI or standard instruments. Have a series of follow-ups, including assessments of knee function, satisfaction, and alignment of the knee implant, conducted before surgery and at 3 months, 1 year, 2 years, and 5 years after surgery. The study will include patients aged 40-75 with primary osteoarthritis, a body mass index (BMI) below 35, and no other major medical conditions that could impact surgery. Patients will also need to be willing to undergo necessary imaging, such as magnetic resonance imageing (MRI) scans and standing X-rays. Outcomes will be measured using various assessment tools, including the Oxford Knee Score, Knee Society Score, and a patient satisfaction survey. Researchers will also record surgery details, such as operating time, blood loss, and knee implant size. Imaging methods, including MRI, computed tomgraphy (CT) scans, and specialized X-rays, will be used to evaluate knee alignment and stability over time. The results of this study are expected to provide insights into whether patient-specific instruments offer clinical or economic advantages over traditional tools in knee replacement surgery.
NCT00493792
The goal of this clinical trial is to compare two types of polyethylene (Stryker Orthopaedics N2Vac and their X3 polyethylene) prostheses that are used in total knee replacements. The primary outcome will analyze whether or not prostheses require a revision surgery 10 years post knee replacement. Other outcomes such as reoperation rate, complications, radiographic results, and clinical outcomes will be collected. It is hypothesized that X3 would perform equally well to N2Vac at 10 years.