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Arthroplasty, Replacement, Knee clinical trials

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NCT ID: NCT06293352 Not yet recruiting - Clinical trials for Arthroplasty, Replacement, Knee

Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection

Start date: March 2024
Phase: N/A
Study type: Interventional

In the US, if you get an infection in your artificial knee joint that doesn't heal with antibiotics alone, the standard treatment is a two-stage revision of the artificial knee. In the first stage, your surgeon will remove your artificial knee and clean out the area around the knee. They will then place an antibiotic spacer. An antibiotic spacer is a type of artificial joint that will release antibiotics in to the knee space continuously over time. The spacer allows only very basic function of the knee. You may need to use crutches or a walker while the antibiotic spacer is in place. After surgery to place the antibiotic spacer, your surgeon may prescribe a course of antibiotics as well. Because the antibiotic spacer is not as durable as a regular artificial joint, after the infection is gone, another surgery is required to take the spacer out and put a new artificial knee joint in. There is another way for artificial joint infections to be treated. This is a one-stage revision. In this treatment, the surgeon will remove your artificial knee and clean out the area around the knee. Then they will place a new artificial knee in using a special kind of cement that contains antibiotics. The cement will release antibiotics in to the knee space continuously over time (your surgeon may prescribe a course of antibiotics as well). The new artificial joint with antibiotic cement will function almost the same as your original artificial knee. This means that while the infection is healing you will be able to do most of your regular daily activities. However, the antibiotic cement is not as durable as what is normally used to implant an artificial knee. The artificial knee with the antibiotic cement may need to be replaced with a regular artificial knee. When replacement will need to be done is dependent on your weight, bone strength and activity level, among other things. When it is time to replace the antibiotic cement artificial knee, you will have another surgery where the surgeon will take the antibiotic cement artificial knee and but a new artificial knee joint in. We know that both the one- and two-stage revision work equally well to heal the infection, but we don't know which patients prefer or which provides better function after many years. This study will randomly assign patients to receive either a one-stage or two-stage revision and then follow them for 5 years to ask them about pain, function, and satisfaction.

NCT ID: NCT06208553 Not yet recruiting - Clinical trials for Arthroplasty, Replacement, Knee

Testing Implementation of Total Joint Replacement Rehabilitation Quality Indicator Toolkits

Start date: January 2024
Phase: N/A
Study type: Interventional

The goal of this feasibility study is to test the procedures for implementing quality indicator toolkits for hip and knee replacement rehabilitation in clinical settings. The main questions it aims to answer are: - Are the EQUIP (for patients) and QUICK (for clinicians) toolkit resources feasible (accessible, acceptable, usable) in real world clinical settings? - Are study procedures including recruitment and retention, informed consent, clinical site tracking, audit and feedback, training and data collection feasible? - What effect does toolkit implementation have on patient experiences, quality of care and patient-reported outcomes? Participants will be asked to provide consent at time of discharge from rehabilitation to have their clinical records audited and to complete an online questionnaire about their physical function, quality of care they received, and overall rehabilitation experience and satisfaction. Rehabilitation providers will also be asked to complete a questionnaire on their adherence to ten post-acute rehabilitation quality indicators after a 3-month baseline period and 6-month implementation phase.

NCT ID: NCT06054750 Not yet recruiting - Clinical trials for Arthroplasty, Replacement, Knee

Testing Regional Anesthesia Techniques for Up and Early Discharge Following Knee Arthroplasty

TRUE KnORTH 2
Start date: July 1, 2024
Phase: Phase 4
Study type: Interventional

To assess postoperative patient-reported quality of recovery after total knee arthroplasty (TKA) with periarticular joint injection (PAI) ± single shot adductor canal block with or without adductor canal catheter infusion.

NCT ID: NCT05992064 Not yet recruiting - Clinical trials for Arthroplasty, Replacement, Knee

Wearable Sensors for Monitoring Recovery After Total Knee Arthroplasty

Start date: October 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to investigate the potential of wearable sensors for monitoring the postoperative recovery of patients after TKA. The main question the study aims to answer is: • whether alterations in gait characteristics and the changes in PA levels measured by wearable PA trackers can accurately reflect a patient's postoperative recovery status and provide clinically relevant information to aid their management. Participants will wear PA trackers during the perioperative period of TKA (2 weeks before until 3 months after, and then agin for 2 weeks one year after the surgery) and we will analyze their gait and PA and correlate them with their recovery after surgery.

NCT ID: NCT05592847 Not yet recruiting - Heart Failure Clinical Trials

A Study of the Effect of a Nurse Navigator Program on High Risk Patients

Start date: April 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to examine if educational intervention in high risk patients can lead to decreased hospital readmissions when compared to patients who are not in the intervention program. Additionally, to determine patient satisfaction with the educational program.

NCT ID: NCT05582460 Not yet recruiting - Clinical trials for Arthroplasty, Replacement, Knee

Exploring Novel Diagnostic Tools for Periprosthetic Joint Infection

VECTOR-PJI
Start date: November 1, 2022
Phase:
Study type: Observational

Joint replacement is a valuable surgical intervention that improves quality of life, provides pain relief, and restores function of patients. However, some patients need revision surgery due to failure of the implant, with periprosthetic joint infection (PJI) remaining a rare but serious complication following total hip (THA) and knee (TKA) arthroplasty. Diagnosing PJI is a major challenge as no diagnostic test with absolute accuracy exists. The diagnosis is based on a combination of clinical findings, laboratory results from peripheral blood and synovial fluid, microbiological culture, histological evaluation of periprosthetic tissue, and intraoperative findings. However, the preoperative diagnosis can be inconclusive and operative criteria are required for the definitive diagnosis. Therefore, novel diagnosing tools for identification of PJI are necessary. A recent study using a gene reporter assay, identified biomarkers in synovial fluid that define joint states in patients with osteoarthritis.However, no previous studies have investigated cellular signaling in synovial fluid of patients with PJI. With this study we want to explore the potential of a reporter gene assay of synovial fluid in patients with PJI and without PJI of their TKA and THA. Also, flow cytometry analysis of biological fluids has recently received increased attention as a potentially valuable method in diagnosing infections. For example, the method is already used to analyze urine samples for urinary tract infections. Recently, researchers have now also used this method to screen for the presence of bacteria. The most important limitation of flow cytometry analysis of synovial fluids for bacteria to date is that it is unclear as to which bacteria count value - the cutoff value - represent patients with PJI and which represent patients without PJI. With this study we want to explore the potential of flow cytometry analysis of synovial fluid in categorizing patients with PJI and without PJI. Our primary objective is to explore the value of synovial fluid analysis using a reporter gene assay and flow cytometry in the detection of a periprosthetic joint infection.

NCT ID: NCT04976400 Not yet recruiting - Clinical trials for Arthroplasty, Replacement, Knee

Men and Women With Different Designs and Semi-individual Total Knee Replacement

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

This study aims to evaluate the effectiveness of femoral condyle prosthesis, tibial tray prosthesis and meniscus prosthesis of semi-individualized total knee replacement prostheses designed with gender differences; and compare and analyze with the current classic prostheses, showing gender differences. The designed semi-personalized total knee replacement prosthesis lays the foundation for clinical application, including: 1. Compared with the classic osteotomy method, compare whether the semi-individualized total knee arthroplasty with a gender-specific design has advantages and better safety in the osteotomy method. 2. To evaluate the difference between the amount of osteotomy in the semi-individualized total knee arthroplasty designed for gender differences and the amount of classic osteotomy. 3. Compared with classic prostheses in the market, verify the clinical effects of semi-individualized total knee replacement prostheses designed for gender differences, and provide a basis for their clinical promotion and application.

NCT ID: NCT04896892 Not yet recruiting - Clinical trials for Arthroplasty, Replacement, Knee

Sleep Patterns After Total Joint Replacement Surgery

Start date: January 2024
Phase:
Study type: Observational

The purpose of this study is to determine sleep patterns and sleep quality following total joint arthroplasty, in order to understand when patients should expect to return to baseline or improved sleep following total joint arthroplasty. Patients prospectively enrolled in this study are to undergo total knee arthroplasty (TKA) or total hip arthroplasty (THA). Patients will receive the SleepScore Max device and smart device app to track their sleep patterns starting one week prior to surgery and until six months after surgery. The SleepScore Max device tracks duration of sleep, time to fall asleep, number of nightly awakenings, rapid eye movement sleep, light sleep, deep sleep, and room temperature and light levels. Through the associated application, patients will also record caffeine and alcohol consumption and exercise. In addition to sleep tracking, patients will fill out Pittsburgh Sleep Quality Index (PSQI), PROMIS, Hip Disability and Osteoarthritis Outcome Score (HOOS), and Knee Injury and Osteoarthritis Outcome Score (KOOS) surveys at specified visits. Secondarily, Visual Analog Pain (VAP) scores and opioid consumption measure in milligram morphine equivalents (MME) will be measured during hospital stay and at subsequent post-operative clinic visits. The clinical goal of this study is to better under sleep patterns in patients undergoing TKA and THA and hopefully provide this patient population improved sleep recommendations and interventions.

NCT ID: NCT04884542 Not yet recruiting - Clinical trials for Arthroplasty, Replacement, Knee

Multigen Plus H Study

Start date: July 2021
Phase:
Study type: Observational

The aim of this study is to assess the clinical, patient-reported, and radiographic outcomes of a revision Total Knee Arthroplasty with Multigen Plus H.

NCT ID: NCT04768764 Not yet recruiting - Pain, Postoperative Clinical Trials

Comparison Of Femoral Block And Middle Adductor Canal Block In Patients With Knee Arthroplasty

Start date: April 16, 2021
Phase: Phase 4
Study type: Interventional

Femoral and adductor nerve blocks with ultrasonography(USG) guidance are used effectively and efficiently in post-operative pain management in lower extremity surgical procedures. However, the superiority of these two blocks to each other is still controversial. In this prospective, randomized, double-blind study, patients who underwent elective unilateral knee arthroplasty under spinal anesthesia, will be performed postoperative femoral block or middle adductor canal block with the guidance of USG.Patients who underwent spinal anesthesia and needed sedoanalgesia and who had to switch to general anesthesia will be excluded from the study. The patients will be divided into two groups by simple randomization. Since a total of 52 patients should be included in the study as a result of the power analysis (G-power 3.1); It is planned to take approximately 26 patients for each group.The anesthesiologist, who follows the pain control and mobilization after the block, will not know which study group the patient is in. The blocks will be performed behind the cover while the patient is under spinal anesthesia (Thus, the point of application of the block will not be noticed). In this way, the patient and the anesthesiologist who follows the parameters after the block will be blind to patient's arm. In the first group, 0.25% 20 ml of local anesthetic and middle adductor canal block, in the second group 0.25% 20 ml of local anesthetic and femoral nerve block will be applied We will compare these two blocks in terms of early mobilization, postoperative pain control, motor, and sensory block.