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Knee Arthroplasty, Total clinical trials

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NCT ID: NCT06389435 Recruiting - Clinical trials for Osteoarthritis of the Knee

RObotic-assisted Versus Conventional Knee Endoprosthetic Techniques

ROCKETS
Start date: March 4, 2024
Phase: N/A
Study type: Interventional

Rationale for conducting the study: The study aims to systematically evaluate the clinical and economic impacts of Robotic-Assisted Total Knee Replacement (RTKR) compared to conventional Total Knee Replacement (TKR). It focuses on the potential benefits of RTKR, including improved precision in surgery, potentially leading to better patient outcomes and reduced healthcare costs. Our primary endpoint is the Forgotten Joint Score (FJS), aimed at measuring patients awareness of their knee joint in everyday life, indicating the success of the knee replacement surgery in restoring natural joint function. Secondary endpoints include patient-reported outcome measures (PROMs), patient activity levels, the accuracy of implant positioning on x-ray, and the incidence of adverse events. Study design: Multicentre,, preference-tolerant, randomized, controlled, superiority trial with two treatment arms that compares the outcomes of RTKR with traditional TKR techniques. Study population: Adult patients aged 18 years and older who are eligible for TKR as per local guidelines and who have given informed consent to participate in the study. Number of patients: 400 Inclusion criteria: Patients must be adults aged 18 years and older, eligible for TKR according to local guidelines, and willing to participate in the study. Exclusion criteria: Patients with extreme malalignment requiring special implants or techniques, patients unfit for surgery due to medical reasons, and those deemed unsuitable to participate in the study for other reasons. Primary outcome variables: The Forgotten Joint Score (FJS) at 2 years after surgery

NCT ID: NCT06180889 Recruiting - Clinical trials for Knee Arthroplasty, Total

Factor XI inhibiTion for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty

Start date: December 20, 2023
Phase: Phase 2
Study type: Interventional

This study was to compare the study drug KN060 to enoxaparin, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA).

NCT ID: NCT06162208 Recruiting - Telerehabilitation Clinical Trials

Action Observation Therapy Via Telerehabilitation on Total Knee Arthroplasty Surgery

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare patient-reported and performance-based outcomes of patients followed with a standard exercise program based on telerehabilitation and patients followed with action observation therapy program added to a standard exercise program based on telerehabilitation after total knee arthroplasty surgery. The main questions it aims to answer are: - [What is the effect of action observation therapy added to a telerehabilitation-based standard exercise program on patient-reported outcomes after total knee arthroplasty surgery?] - [What is the effect of action observation therapy added to a telerehabilitation-based standardized exercise program on performance-based outcomes after total knee arthroplasty surgery?] Participants will be divided into three groups by computer-assisted randomization method: Group 1: home exercise with information leaflet group, Group 2: information leaflet + telerehabilitation-based standard exercise program group, Group 3: information leaflet + telerehabilitation-based standard exercise program + action observation therapy group. Patients in the second and third groups will be followed up with the telerehabilitation method accompanied by a physiotherapist for 30 minutes 3 days a week for 6 weeks after discharge. The third group will receive a standard exercise program 3 days a week and 15 minutes of action observation therapy via video conferencing.

NCT ID: NCT06108063 Recruiting - Clinical trials for Knee Arthroplasty, Total

Mitigation of Arthrofibrosis After Total Knee Arthroplasty Using Losartan

Start date: March 6, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of Losartan use post-operatively for reducing or preventing the development of arthrofibrosis and the associated adverse impacts on clinical outcomes.

NCT ID: NCT05877261 Recruiting - Knee Osteoarthritis Clinical Trials

Cementless Triathlon 5YR Follow-Up

Start date: May 25, 2023
Phase:
Study type: Observational

All artificial joint implants need to be solidly held (fixed) within the bone. Cementless fixation has become a popular method to achieve fixation for total knee replacements where the bone grows directly onto the implanted device instead of using bone cement. The primary purpose of this study is to assess long-term implant survivorship and clinical outcomes of a previous study cohort that received a cementless knee replacement. As this study cohort approaches 5 years post-operation, the investigators will re-examine the stability of participant implants using specialized x-rays, called "radiostereometric analysis". The study will use weight-bearing computed tomography (CT) to measure bone density and texture features and correlate that with implant stability. The investigators will collect stool samples to assess participant gut microbiomes for biomarkers of poor bone quality that could correlate to implant stability. All 33 participants from the original study cohort will be invited to participate in this study.

NCT ID: NCT05653102 Recruiting - Clinical trials for Knee Arthroplasty, Total

A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System

Start date: January 23, 2019
Phase:
Study type: Observational

A Post-Market Domestic (US) and International Data Collection to Assess the Truliant® Knee System

NCT ID: NCT05516381 Recruiting - Clinical trials for Knee Arthroplasty, Total

Evaluation of Navigation-Assisted TKA Using Mechanical vs. Restricted Kinematic Alignment

Start date: May 15, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate both clinical measures and PROMs in patients undergoing total knee arthroplasty (TKA) using restricted inverse kinematic alignment (iKA) compared to mechanical alignment (MA), both using surgical navigation assistance.

NCT ID: NCT05100706 Recruiting - Acute Pain Clinical Trials

Continuous Adductor Canal Block in Outpatient Total Knee Arthroplasty

Start date: October 1, 2023
Phase: N/A
Study type: Interventional

Total knee arthroplasty (TKA) is a frequent performed surgery. Many institutions are implementing outpatient programs for this surgery and adequate pain management is an important feature. Analgesic duration of single shot nerve blocks is limited to no more than 24h. Conversely, the use of continuous nerve block (CNB) through a perineural catheter and infusion of local anesthetic may increase duration of analgesia and provide better outcomes. The purpose of this study is to evaluate effectiveness and safety of using CNB in patients undergoing ambulatory TKA, and its effects on patients' quality of recovery. We hypothesize that continuous adductor canal block would lead to a better quality of recovery in patients undergoing outpatient TKA.

NCT ID: NCT04564729 Recruiting - Analgesia Clinical Trials

Shared Decision Aid for Post-Total Knee Arthroplasty Opioid Prescribing

Start date: November 2, 2020
Phase: N/A
Study type: Interventional

This will be a randomized controlled clinical trial in patients who have undergone primary unilateral total knee arthroplasty at Brigham and Women's Faulkner Hospital, Brigham and Women's Hospital and University of Chicago Medical Center. Study subjects will receive either a shared decision aid (SDA) about pain management or standard of care at the time of discharge. The impact of the SDA on the number of leftover opioid pills on postoperative day 30 and average NRS pain score on postoperative day 7 will be assessed.

NCT ID: NCT04226339 Recruiting - Clinical trials for Knee Arthroplasty, Total

Evaluation of Walking Analysis After a Total Knee Arthroplasty With Kinematic Alignment Versus Mechanical Alignment

KneeKG Sphere
Start date: September 7, 2020
Phase: N/A
Study type: Interventional

Total knee arthroplasty (TKA) is a treatment for advanced femoro-tibial osteoarthritis. This surgery is justified in case of significant discomfort and failure of medical treatment. The functional results of TKA are good with a recovery of 6 months - 1 year. Nevertheless, very few patients forget their prostheses. A United Kingdom study assessed patient satisfaction in a cohort of 10,000 patients more than one year after TKA: nearly 20% were not satisfied with their TKA. The knee is indeed a complex articulation that works differently in the three space plans. Current knee prostheses are trying to replicate this biomechanics and get as close as possible to the anatomy of a native knee. Bellemans et al. found in 250 asymptomatic patients 32% of men with a constitutional varus greater than 3 ° and 17% of women. Restoration of normal knee function can also be achieved by restoring a moderate constitutional deformity present preoperatively. The objective of the femorotibial alignment was dogmatically fixed at 180° (mechanical femorotibial alignment). In recent years, some surgical teams have attempted to reproduce the preoperative constitutional deformity in varus or valgus with the prosthesis. This femorotibial alignment is called kinematic alignment. This kinematic alignment has already been studied in several randomized studies and has demonstrated improved functional scores. However, these studies focused on specific TKA, which are posterior cruciate TKA, and the assessment was subjective through functional scores. In addition, these TKA were often made with patient specific instrumentation (PSI). Some studies have evaluated walking kinematics after TKA with kinematic alignment. But it was again TKA retaining the posterior cruciate ligament. The investigators would like to prospectively evaluate the restoration of the medially stabilized TKA walking kinematics (medial-stable TKA or ball in socket stability) implanted with a kinematic alignment compared to a mechanical alignment.