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Showing 1-20 of 612 trials
NCT07667231
This randomized clinical trial aims to evaluate and compare the analgesic efficacy and functional outcomes of the quadro-iliac plane block (QIPB) and the pericapsular nerve group (PENG) block combined with lateral femoral cutaneous nerve(LFCN) block in patients undergoing total hip arthroplasty. The primary outcome is the Numeric Rating Scale (NRS) within the first 48 hours after surgery. Secondary outcomes include postoperative total opioid consumption, ıncidence of quadriceps motor block, time to first ambulation, block performance time, falls, length of hospital stay, block- related complications(hematoma,local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, and incidence of postoperative nausea and vomiting.
NCT07020312
After orthopedic surgeries like knee or hip replacement, some patients struggle to fully activate their muscles due to a condition called Arthrogenic Muscle Inhibition (AMI). AMI can slow recovery and make physical therapy less effective. This clinical trial is testing whether a special type of brain training-called neurofeedback visualization training-can help improve muscle activation and speed up recovery. In this study, patients will receive standard physical therapy after surgery. Half of them will also use a device that helps them "visualize" exercises while wearing a cap that reads brain signals (EEG). The cap tracks brain activity when patients imagine doing specific movements. A computer then shows a virtual avatar performing the movements, giving feedback in real time-like a video game controlled by the brain. The study includes patients recovering from one of four surgeries: 1. Anterior cruciate ligament reconstruction (ACLR) 2. Total knee arthroplasty (TKA) 3. Total hip arthroplasty (THA) 4. Hip arthroscopy (HA) for femoroacetabular impingement (FAI) The goal is to see if this training improves muscle strength, movement, and daily function more than standard therapy alone. The study will take place at Rush University Medical Center in Chicago and enroll 240 adults, with 60 patients per type of surgery. Each participant will be followed for up to 6 months after surgery and complete strength tests, movement assessments, and questionnaires about their recovery. The hope is that combining brain training with physical therapy will lead to faster, more complete recoveries and improve how patients move after surgery.
NCT07655388
Surgical wound complications following primary total hip arthroplasty remain a significant clinical challenge despite advances in wound care technologies. The optimal choice of dressing and frequency of dressing changes remain insufficiently investigated, particularly regarding their influence on wound healing and the wound microenvironment. This prospective, randomized, controlled clinical trial aims to evaluate the impact of dressing type and dressing change frequency on surgical wound healing in patients undergoing primary total hip arthroplasty. Ninety patients will be allocated into three treatment groups receiving either a capillary-action dressing system (VACUTEX™) or standard dressings with different dressing change intervals. The study will assess time to complete wound epithelialization, postoperative wound complications, pain intensity, wound temperature, exudate pH, length of hospital stay, and time to suture removal. In addition, the study will investigate the potential role of wound temperature and exudate pH as early indicators of impaired healing and postoperative complications.
NCT07589127
The goal of this clinical trial is to learn whether a preoperative genicular nerve block (GNB) can reduce pain after knee replacement surgery in adults with knee osteoarthritis (OA) undergoing total knee arthroplasty (TKA). It will also assess whether this treatment can reduce opioid use and improve recovery. The main questions it aims to answer are: * Does a preoperative GNB reduce pain during movement 24 hours after surgery compared with placebo? * Does it reduce opioid consumption and improve physical activity and functional outcomes after surgery? Researchers will compare patients receiving a GNB to patients receiving a placebo injection to see if the nerve block improves postoperative pain and recovery. Participants will: * Be randomly assigned to receive either a GNB or a placebo injection before surgery * Undergo standard knee replacement surgery and postoperative care * Report pain levels at regular intervals after surgery * Complete questionnaires on function, quality of life, and recovery * Wear an activity monitor to measure physical activity after surgery * Attend follow-up assessments at 1 week, 1 month, and 3 months
NCT07586436
This randomized controlled trial aims to evaluate the effects of stress ball use and breathing exercises on procedural pain and vital signs during drain removal in patients undergoing total knee arthroplasty. Although drain removal is a short procedure, it is often associated with sudden and intense pain and may trigger physiological stress responses such as increased heart rate, blood pressure, and respiratory rate. A total of 105 patients will be randomly assigned to three groups: stress ball group, breathing exercise group, and standard care group. The interventions will be applied starting one minute before drain removal, continuing throughout the procedure, and for two minutes afterward. Pain levels will be assessed using the Numeric Rating Scale (NRS), and vital signs (heart rate, blood pressure, respiratory rate, and oxygen saturation) will be measured at predefined time points before, during, and after the procedure. The findings of this study are expected to provide evidence on the effectiveness of simple, non-pharmacological interventions in reducing procedural pain and improving physiological stability during drain removal
NCT03965897
Primary Aim: To examine the superior efficacy of ACT versus Attention Control (AC) on postoperative pain intensity and functioning in at-risk Veterans undergoing TKA. Changes in pain intensity and functioning from baseline to 6 weeks, 3 months and 6 months post-TKA will be compared. Level of pain intensity will be measured using the Brief Pain Inventory (BPI) Pain Severity Subscale and level of functioning will be measured using the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living and Quality Of Life Subscales. Secondary Aims: A) To examine the superior efficacy of ACT versus AC on the severity of anxiety and depressive symptoms and improvements in coping skills. Changes from baseline to 6 weeks, 3 months and 6 months post-TKA will be compared. Anxiety and depressive symptoms will be measured with the Hamilton Rating Scales (Ham-A and Ham-D, respectively). Coping skills (i.e. Pain Acceptance and Engagement in Values-Based Behavior) will be measured with the Chronic Pain Acceptance Questionnaire and the Chronic Pain Values Inventory. B) To evaluate whether decreases in distress-based symptoms and increases in coping skills mediate changes in pain and functioning at 6 months in Veterans receiving ACT. Changes in anxiety symptoms, depressive symptoms, pain acceptance and engagement in values-based behavior from baseline to 6 weeks and 3 months will be used as potential mediators for changes in pain and functioning at 6 months. Exploratory Aim: Describe the pharmacological and non-pharmacological strategies Veterans are using to manage pain and their perceived helpfulness. This will provide insights into the effects of the current opioid restrictions on pain management strategies. These strategies \& their perceived helpfulness will be assessed using the Pain Management Strategies Survey at baseline, 6 weeks, 3, and 6 months.
NCT07568106
Total knee arthroplasty is associated with moderate to severe postoperative pain, which may delay mobilization and recovery. Multimodal analgesia including regional anesthesia techniques is widely used to improve outcomes. The adductor canal block (ACB) provides anteromedial knee analgesia but may not adequately cover the posterolateral region. The biceps femoris short head (BiFeS) block is a novel motor-sparing regional anesthesia technique targeting the posterolateral capsule of the knee. This randomized controlled trial aims to compare the analgesic efficacy and functional outcomes of ACB combined with BiFeS block versus ACB alone in patients undergoing total knee arthroplasty. The primary outcome is posterior knee pain at postoperative 6 hours. Secondary outcomes include pain scores within 48 hours, opioid consumption, early and late functional recovery, and opioid-related adverse effects.
NCT04258267
The aim of this study is to investigate pre-, intra- and post-operative factors that influence post-operative outcome (shoulder pain, shoulder function and quality of life) after shoulder arthroplasty.
NCT06626490
The study design is confirmative for non-inferiority of the functional outcome of the implants and is intended to examine the safety and performance of the Prevision hip stem. The study is an observational post-market clinical follow-up study, and the study sites chose the stem variant depending on their own routine and indication.
NCT05828810
The goal of this clinical trial is to compare two types of skin preparation solutions (chlorhexidine gluconate-alcohol solution and povidone-iodine solution) that help eliminate harmful bacteria on the skin at the time of surgery for patients having revision arthroplasty surgery of the hip or knee. The main outcome of interest for the definitive study is the need for re-operation for a wound complication or an infection of the prosthetic joint within one year after surgery. For the pilot trial, our main interest is to determine feasibility of a definitive trial. Feasibility outcomes will include: ability to recruit patients, ability to randomize patients, ability to collect complete data, estimate the event rate of our primary outcome, ability to carry out data linkages and determine the accuracy of collected data. Participants will be contacted at two time points after surgery to complete a 5-minute survey: after 30 days, and after 1 year.
NCT05449327
Venous thromboembolism is a serious complication after total hip replacement (THR) and total knee replacement (TKR). Previous studies have reported the incidence of both asymptomatic and symptomatic deep vein thrombosis (DVT) after TKR were higher in Taiwan than other countries in Asia. Therefore, the usage of prophylactic antithrombotics should be considered. The efficacy and safety of Xarelto (Rivaroxaban) for preventing venous thromboembolism has been proved. However, there is a lack of study using prospective design to evaluate the efficacy and safety of Xarelto after THR and TKR for Taiwanese. In this study, the investigators use a randomized controlled trial design comparing the incidence of DVT, pulmonary embolism, and complications between intervention and control groups.
NCT06941558
An ankle replacement procedure consists of replacing the worn-out joint surfaces of the ankle with metal and plastic components that are shaped to allow continued movement of the ankle. There are several different types of ankle replacement available. Infinity ankle implants are already routinely used in NHS hospitals. The INFINITY™ with ADAPTIS™ and EVERLAST™ ankle replacement system is a development of the Infinity ankle implant, designed to attach to the bone better and to wear out more slowly. The purpose of the UK ADAPTIS™ Study is to assess the performance and function of the newly introduced INFINITY™ with ADAPTIS™ and EVERLAST™ technology Total Ankle System for total ankle replacement (TAR) or arthroplasty (TAA) and EVERLAST™ Poly Insert that modernises and streamlines Stryker's TAA/TAR portfolio. UK ADAPTIS is a prospective multi-centre cohort series of INFINITY™ with ADAPTIS™ and EVERLAST™ Technology with Poly Insert for patients requiring primary total ankle replacement (TAR) i.e. Total Ankle Arthroplasty (TAA). Patients meeting the criteria for the study will be asked to enrol by providing written informed consent. The patients will be monitored clinically by post-operative follow-up examinations and Patient reported outcome measures (PROMs) (Manchester Oxford Foot \& Ankle Questionnaire (MOXFQ), Ankle Osteoarthritis Scale (AOS), EQ5D-5L). Intended use: It is intended to give a patient limited mobility by reducing pain, restoring alignment, and replacing flexion and extension movement in the ankle joint. Indications for use: * Patients with ankle joints damaged by severe rheumatoid, post-traumatic, or degenerative arthritis. * Patients with a failed previous ankle surgery.
NCT07360392
The Biceps Femoris Short Head (BiFeS) block is a new fascial plane block technique targeting the sensory innervation of the posterolateral capsule of the knee while preserving motor function. The aim of this study is to evaluate the postoperative analgesic efficacy of the BiFeS block combined with the adductor canal block (ACB) in patients undergoing total knee arthroplasty, compared to ACB + iPACK block. The study is planned as a prospective, randomized, double-blind, parallel two-group trial. Patients will be randomized in a 1:1 ratio to receive ACB + iPACK (Group A) or ACB + BiFeS (Group B). Postoperative pain scores (VAS), opioid consumption, early mobilization, and quality of recovery (QoR-15) outcomes will be compared.
NCT04294693
The primary purpose of this study is to examine the functional ability and quality of life in those patients who received a total joint arthroplasty (TJA) for reasons other than having a solid tumor at the location of the joint.
NCT05097976
The purpose of this study is to evaluate the efficacy of an oral methylprednisolone taper on acute postoperative pain, function, opioid consumption, nausea, and complications following outpatient total knee arthroplasty (TKA). We hypothesize that administration of an oral methylprednisolone taper starting on postoperative day 1 (POD 1) following TKA will be associated with improved pain and decreased opioid use, nausea, and complications at POD1-7, as compared to similar patients who receive placebo. Additionally, those taking methylprednisolone will report decreased pain and greater objective functional outcomes at 3 and 6 weeks postoperatively as compared to controls.
NCT06917365
XPEO-E liner is CE marked under MDD 93/42/CEE by equivalency with CI E liner. No pertaining data on XPEO-E liner is yet available. However, clinical evaluation concludes on a reaching of performance and safety and compliance with essential requirements. This study intends to collect data on XPEO-E in order to allow a transit to MDR 2017/745 (EU). XPEO-E liner is intended to be used with NOVAE cups and SERF femoral heads and Stems. XPEO-E liner will be used according to their CE marking. These devices are intended for hip replacements with the aim of improving quality of life and reducing pain by replacing a damaged joint. The follow-up visits are established according to the current practice. Additional procedure will only consist on questionnaires that will be filled by the patient and/or the surgeons.
NCT06580899
This is a prospective, randomized clinical trial evaluating three groups. The groups are: Group 1 (Control): Subjects that receive only the existing standard-of-care multimodal pain management protocol and do not receive post-operative intra-articular catheter. Group 2 (Investigational Treatment/Intervention): Subjects that receive the brand 1 intra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-operative period. Group 3 (Investigational Treatment/Intervention): Subjects that receive the newer brand 2 intra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-operative period.
NCT06991231
The purpose of this study is to evaluate the efficacy of cryoablation use on patient-reported outcomes (PROMs) and opioid consumption following total knee arthroplasty. This is a randomized study that will involve a 1:1 randomization to total knee arthroplasty +/- cryoablation.
NCT04849884
To evaluate the performance of the CORI™ KNEE TENSIONER as an accessory to the CORI™ Surgical System.
NCT07191964
This prospective, triple-blinded, sham-controlled randomized trial evaluates the additive effect of Supra-Sartorial Subcutaneous Infiltration (SSSI) combined with intermittent adductor canal block (iACB) and posterior capsule local infiltration analgesia (PC-LIA) for pain management in total knee arthroplasty (TKA). SSSI, a simpler alternative to targeted anterior femoral cutaneous nerve (AFCN) block, is tested in 90 adults (45-90 years) randomized into two arms: sham SSSI + active iACB + PC-LIA versus all active interventions. Primary outcome is pain scores on postoperative day 0; secondary outcomes include daily pain trajectory, opioid use, functional recovery, and complications over days 0-3.