Loading clinical trials...
Loading clinical trials...
Showing 1-20 of 142 trials
NCT07049484
The anterior cruciate ligament (ACL) is one of the main stabilizers of the knee joint, and its injury is among the most common soft tissue injuries of the knee. Several surgical reconstruction techniques are available, utilizing various tissues as a graft for the neo-ligament, including both autografts and allografts. The "Over-the-top single-bundle technique with gracilis and semitendinosus tendons combined with lateral extra-articular tenodesis (LET)" was developed in 1998 by Prof. Marcacci and Prof. Zaffagnini, and it is still the preferred method for ACL reconstruction at the Second Clinic of the Rizzoli Orthopaedic Institute. Cadaveric biomechanical studies have shown that combining LET with ACL reconstruction improves knee joint stability in both the anteroposterior and rotational planes. However, a recent in vivo study has challenged this hypothesis, showing that in patients undergoing surgery, the addition of LET enhances knee stability only in the anteroposterior direction and only for a limited period of six months. At twelve months postoperatively, joint laxity appeared similar to that of patients who did not undergo the additional procedure. Furthermore, the same study did not assess rotational instability using the pivot-shift test, an essential parameter as it is closely linked to knee stability and the patient's subjective perception of surgical success. Despite the increasing use of LET in conjunction with ACL reconstruction, few studies have analyzed the short-term postoperative effects of lateral extra-articular tenodesis and its potential benefits during the early stages of rehabilitation and return to sport. This study was conceived in response to this clinical question, with the goal of evaluating anteroposterior and rotational laxity in a group of patients who underwent ACL reconstruction combined with LET, in order to analyze clinical outcomes and, most importantly, any changes in stability during the early postoperative period. The results aim to improve understanding of knee stability in the initial phase following surgery, providing valuable information for rehabilitation teams to optimize recovery protocols and more effectively guide return-to-sport decisions for patients undergoing both procedures.
NCT07347275
This study is intended to demonstrate the efficacy and safety of the DIALIVE Liver Dialysis Device when incorporated into the standard management plan for participants with A-TANGO ACLF grade 2-4. A total of 72 evaluable participants, aged 18-70, will be enrolled in up to 12 clinical centres in the United Kingdom. Participants must have a history of liver cirrhosis and a deterioration within four weeks due to a precipitating event, leading to A-TANGO ACLF grade 2-4. Multicenter, individually randomised, controlled, open-label, parallel group trial using double-arm design. The control group will receive SoC for participants with ACLF. The DIALIVE 2.0 treatment group will receive SoC with the addition of up to 7 (seven) daily DIALIVE 2.0 treatment sessions within the 10-day treatment window. Seventy-two participants with ACLF (60% A-TANGO ACLF grade 2 at randomisation, and 40% A-TANGO ACLF grade 3 \& 4 at randomisation) will be randomised 1:1 to receive either SoC or SoC + DIALIVE 2.0. This allows for 5% loss due to drop-out, and 5% censoring due to liver transplantation within 28 days. All randomised participants will be included in the intention to treat (ITT) analysis while all participants that receive at least one treatment cycle will be used for the safety population. For each participant, the study duration will be up to 105 days (screening: 5 days; treatment up to 10 days; follow up 90 days). The total study duration is estimated to be approximately 18 months from screening of first participant until study completion of the last participant.
NCT07184866
This study is testing whether Vitamin C can help improve kidney function and survival in very sick patients with liver disease. Patients with acute-on-chronic liver failure (ACLF) often develop serious infections that can lead to septic shock and kidney injury, which are major causes of death. In this randomized controlled trial, patients with ACLF and septic shock will be assigned to receive either: 1. Standard medical treatment alone, or 2. Standard medical treatment plus intravenous Vitamin C. Vitamin C is a safe, inexpensive antioxidant that may reduce inflammation, improve circulation, and protect the kidneys. The study will compare how well patients recover from septic shock and kidney injury in the two groups. Blood and urine samples will also be collected to look for biological markers that can predict outcomes.
NCT07480057
Liver transplantation (LT) remains the ultimate option to cure intractable end stage liver disease. Nutritional deficiencies are very common among CLD patients and due to this these patients suffer from low bone mineral density leading to osteoporosis and osteopenia. It has been observed that there is substantial reduction in bone density , especially within the first year of LT. The incidence of fractures among LT recipients has been reported to be around 3.5% with vertebral spine being the most common site. Multiple risk factors for osteoporosis after LT has been identified. Some of these include female sex, DM, sedentary lifestyle, pretransplant hypogonadism, Vit-D deficiency and pre-existing bone mineral abnormalities. Patients with CLD are also reported as having osteoblastic dysfunction by many factors, like unconjugated hyperbilirubinemia, decreased synthesis of collagen matrix, and decreased availability of insulin like growth factors. Post-transplant factors among LT recipients include: choice of immunosuppressive therapy like Glucocorticoid and CNIs therapy. This Observational study aims to analyze the changes in bone mineral metabolism After Liver Transplantation by Bone Mineral Densitometry preoperatively and postoperatively. All eligible adult patients with Chronic Liver Disease undergoing Liver Transplant during the study period will be included in the study. These patients bone mineral density will be assessed using DEXA scan both preop and on Post op at 3 and 6 months. The association between the changes in BMM and various variables such as the sex of the patients, age of patients, etiology of CLD, presence of hepatocellular carcinoma (HCC), ICU stay, Hospital stay will be studied. Pre-operative, intra-operative and post-operative data will be collected from medical records, electronic hospital information system (HIS) and radiological images collected from the hospital Picture archiving and communication system(PACS). The enrolled subjects will be followed up till for a period of 6 months after the Liver Transplant and the bone mineral density will be compared between these patients along with other parameters.
NCT07475351
The purpose of this randomized study is to compare donor site morbidity and clinical and functional outcomes of both surgery techniques (bone-patellar tendon-bone (BPTB) graft versus bone-patellar tendon without patellar bone plug (PT) graft) for anterior cruciate ligament reconstruction (ACLR) in athletes. The main questions it aims to answer are: * Does PT graft reduce donor site morbidity compared to the standard BPTB graft? * Does PT technique provide clinical and functional results comparable to the BPTB technique? Researchers will compare the incidence of complications and clinical and functional outcomes between the BPTB and PT grafts groups. Patients will: * Undergo ACLR surgical intervention using one of the two assigned techniques (BPTB or PT) * Follow a two-year assessment program, including visits at three, eight, 12 and 24 months after surgery.
NCT07470359
This prospective RCT investigates if a single 4 ml intra-articular PRP injection improves knee function after ACL reconstruction using peroneus longus autograft. In Pakistan's resource-limited context, 88 patients (18-50 years) with isolated ACL tears receive either PRP or saline during surgery, then randomized equally. KOOS4 scores compared at 3, 6, and 12 months via ANCOVA (adjusted baseline, α=0.05). Positive results could establish affordable enhancement for recovery and guide practice in similar settings.
NCT07386327
D5W) has long been used as an intravenous fluid for hydration and energy supplementation and has recently gained increasing clinical interest in perineural injection therapies and ultrasound-guided hydrodissection. D5W has been shown to improve pain and functional outcomes in entrapment neuropathies by mechanically releasing perineural adhesions and potentially modulating neurogenic inflammation. In contrast, 0.9% sodium chloride (normal saline) is routinely used as a dilution medium for local anesthetics in peripheral nerve blocks; however, emerging evidence suggests that alternative diluents such as D5W may influence block onset and efficacy. The infraclavicular block is a commonly used ultrasound-guided technique for brachial plexus anesthesia, providing reliable anesthesia and postoperative analgesia for upper extremity surgery. This study aims to compare the effects of diluting bupivacaine with either D5W or 0.9% NaCl on block success and duration of analgesia in patients undergoing infraclavicular block. Secondary outcomes include block onset characteristics, sensory and motor block profiles, and perioperative analgesic requirements. The findings may help determine whether D5W represents a safe and effective alternative diluent to saline in routine regional anesthesia practice.
NCT06285253
The clinical trial will assess the safety of miroliverELAP for the treatment of acute liver failure, severe acute alcohol-associated hepatitis, or acute on chronic liver failure. miroliverELAP is an external liver assist combination product consisting of a single-use MIRO-001 bioengineered liver graft and an extracorporeal blood circuit. miroliverELAP Is intended to support the native (failed) liver for up to 48-hours of continuous treatment to allow time for liver recovery or to identify a transplantable liver.
NCT07418476
This study is designed to compare standard anterior cruciate ligament (ACL) reconstruction using hamstring autograft with ACL reconstruction augmented using the Tape Active Reconstruction System (TARS). Eligible patients aged 18 to 44 years with a complete ACL rupture will be prospectively enrolled and randomized in a 1:1 ratio into two study groups. Participants will be evaluated preoperatively and postoperatively at regular follow-up visits, with the final assessment performed at 12 months after surgery. Outcome assessments will include patient-reported outcome measures, objective clinical examination of knee stability, instrumented laxity measurements, and radiological evaluation.
NCT07097077
Lower limb injuries represent the majority of sports-related injuries, with knee injuries being among the most common. In particular, anterior cruciate ligament (ACL) injuries are considered highly devastating and career-threatening for both professional and amateur athletes. Current surgical and rehabilitation treatments often fail to provide fully satisfactory short- and long-term outcomes. A very high risk of re-injury exists, especially in younger patients, with up to 35% experiencing a second ACL injury, alongside a significant long-term risk of early knee osteoarthritis. Most ACL injuries are non-contact or indirect contact injuries, implicating biomechanical factors and neuromuscular control as key determinants of injury mechanisms. Recent literature shows that patients suffering a non-contact ACL injury have a higher risk of re-injury compared to those with contact injuries, suggesting a significant cognitive component in injury processing, surgery, rehabilitation, and return to sport. Recent rehabilitation studies have introduced targeted neuromotor training designed to "rebuild" biomechanical and neuromuscular patterns to avoid mechanisms leading to re-injury. Movement quality tests are used post-training to confirm the reduction of risky biomechanical patterns, often resulting in a score indicating movement quality. Given the brain's involvement in such injuries, pioneering studies have used functional magnetic resonance imaging (fMRI) to investigate changes in cortical brain areas following ACL injury and reconstruction. Evidence shows adaptations in both central and peripheral nervous systems, with altered sensorimotor cortex activation in patients during simple motor tasks, differing from healthy subjects. Prefrontal cortex alterations correlate with severe quadriceps muscle activation asymmetries, linking these brain patterns to post-injury return-to-sport outcomes. However, no studies have yet evaluated the interaction between cortical activation (neural compensations) measured by fMRI and outcomes from targeted neuromotor training during ACL rehabilitation. Understanding brain activation implications is crucial for developing large-scale rehabilitation protocols to reduce the risk of a second, potentially more devastating, knee injury. This study aims to reveal whether a neuromotor training protocol can positively influence cognitive brain areas related to human movement, particularly by reducing risky injury patterns. It will be the first to test whether dedicated neuromuscular training effectively reduces neural compensations and cortical activation related to non-automated movement, favoring automation areas important for a safe return to sport. Patients will directly benefit from participating in the innovative neuromotor training program, with functional MRI scans conducted before training begins (post-surgery) and after training completion. Indirectly, the study will assess whether neuromotor training can adapt patient neuromotor patterns to reduce re-injury risk, ultimately benefiting future patients undergoing ACL reconstruction.
NCT07406763
The goal of this clinical trial is to learn whether adding blood flow restriction (BFR) training to a traditional rehabilitation protocol (TRP) can improve muscle strength, knee proprioception, range of motion, pain, and lower limb function after anterior cruciate ligament reconstruction (ACLR). This study is conducted in male and female adults aged 18-35 years who underwent ACLR using a semitendinosus tendon autograft. The main questions it aims to answer are: Does adding BFR to a traditional rehabilitation protocol improve quadriceps and hamstring muscle strength after ACLR? Does adding BFR improve knee joint proprioception, range of motion, pain, and lower limb function after ACLR? Researchers compared a traditional rehabilitation protocol alone (control group) with the same protocol combined with blood flow restriction training (BFR group) to see if BFR provides superior improvements in postoperative outcomes. Participants was: randomly assigned to either a traditional rehabilitation group or a BFR-assisted rehabilitation group Perform supervised rehabilitation exercises from the 2nd to the 12th postoperative week Undergo assessments of muscle strength, knee proprioception, range of motion, pain, and function Be evaluated 1 week before surgery and at 1.5 and 3 months after ACL reconstruction
NCT07142369
The purpose of this study is to determine what effects the withdrawal of excess knee joint fluid or the injection of a factor from the blood has on swelling after a sudden anterior cruciate ligament (ACL) rupture of the knee.
NCT06635668
This is a prospective, observational cohort study aimed at establishing a database of normative biomechanics for healthy athletes and surveying these athletes for one year following baseline testing for the occurrence of new musculoskeletal injuries, with a particular emphasis on ACL injuries.
NCT06987968
A Phase 2, Randomized, Controlled, Open-Label, Adaptive Dose Design, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Two Different Dwell Times of VS-01 on Top of Standard of Care versus Standard of Care Alone in Patients with Overt Hepatic Encephalopathy
NCT06761326
Central venous cannulation is an essential procedure in the anaesthetic and critical care practice. Ultrasound has revolutionized the practice favoring the internal jugular cannulation to the other sites .Subcalvian vein cannulation has fallen out of favor mainly due to the difficult visualization with the ultrasound, especially in obese patients and the inevitable position of the clavicle acting as a bony obstacle , in addition to the anatomical position in vicinity to the pleura which might raise the risk of pneumothorax . Indeed the subclavian vein cannulation is more comfortable and tolerated by the patient especially those requiring long term intravenous therapy, with less rates of infection and thrombosis. This mandated the development of a safer and efficient technique for the cannulation empowered by the ultrasound technology. The infracalvicular approach or the proximal axillary vein cannulation has been described but is not popular. It provides a potentially safer and successful technique with less complication both in "experienced" and "less experienced"operators . All the patients will receive general anaesthesia with laryngeal mask insertion . Careful sterilization of the surgical site and strict aseptic techniques for the handling of the ultrasound probe will be pursued
NCT05273463
The purpose of this research is to find out whether the way information about surgery is presented to patients affects patient satisfaction, knowledge retention, and surgical outcomes such as anxiety
NCT05391672
Clinical evaluation for the patients with partial ACL tear who had ACL augmentation
NCT07190456
Kinesiophobia, defined as an excessive and irrational fear of physical movement due to perceived vulnerability to injury, has gained significant attention in clinical and scientific communities. This condition can act as a barrier to physical activity, negatively impacting patients' disability, quality of life, and the implementation of rehabilitation programs. It is particularly prevalent after anterior cruciate ligament reconstruction (ACLR), affecting physical function, return to sport rates, and patient performance. While the Tampa Scale for Kinesiophobia (TSK) is considered a gold standard for assessing kinesiophobia, recent studies have raised concerns about its validity, especially in ACLR patients. The TSK may not adequately capture fear of specific sports activities, which is more common in ACLR patients than a general phobia of movement. Some researchers argue for an assessment approach similar to that used for pain experiences, emphasizing the subjective nature of fear. Based on the specific phobia model, assessing kinesiophobia in the presence of a trigger, such as visualizing or confronting the movement associated with the injury, may be more relevant. This approach is supported by evidence showing that sports situations evoking the greatest fear after ACLR are cutting, jumping, and contact. Further research is needed to investigate alternative methodologies for assessing fear of movement in ACLR patients, considering the prevalence and repercussions of kinesiophobia in this population. The objectives of this study are threefold: * To compare the magnitude of kinesiophobia through the TSK, the subjective feeling of fear when visualising feared movements, and the subjective feeling of fear in anticipation of the feared situation. * Evaluate the impact of focusing on feared activities on motor behavior and Autonomic Nervous System (ANS) markers. * To assess the relation between the three methods of assessing fear of movement and indicators of motor behaviour, ANS activity, fear-avoidance beliefs, anxiety, avoidance behaviour, and physical function.
NCT07276568
To evaluate the safety, tolerability, and preliminary efficacy of intramuscular injection of hepatocyte-like cells into the rectus sheath in patients with liver failure (including acute liver failure, acute-on-chronic liver failure, and chronic liver failure) and small-for-size syndrome, with the ultimate goal of improving survival rates.
NCT07043569
With the intention of improving rehabilitation after anterior cruciate ligament reconstruction, the present project investigates the influence of a targeted strength and blood flow restriction training intervention (BFR training) on the regeneration of muscle mass, strength and functionality of the knee joint. BFR training is characterized by the combination of external venous vascular occlusion with light strength training and still enables users to achieve gains in muscle mass and strength that are comparable to training with high mechanical loads. The positive effects of BFR training in the course of knee arthroplasty have already been demonstrated by our working group as a prehabilitative approach, i.e. as a training intervention prior to surgery. In the present project, the framework conditions of outpatient rehabilitation at the Bonn Center for Outpatient Rehabilitation will now be used to prove whether sports science-controlled strength and BFR training has a similar effect in the postoperative rehabilitation phase. The interventions are carried out as part of the exercise therapy units in outpatient rehabilitation ETM01 in accordance with the S2k guideline on anterior cruciate ligament rupture. Strength and BFR training in medical training therapy supplements the daily exercise therapy to ensure implementation in the rehabilitation process in line with the guidelines.