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Fractures, Bone clinical trials

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NCT ID: NCT05518279 Withdrawn - Hip Fractures Clinical Trials

Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures

Start date: September 2019
Phase: Phase 3
Study type: Interventional

The study is a prospective, randomized, double blinded, placebo controlled trial that aims to investigate the hypothesis that early administration of tranexamic acid (TXA) following diagnosis of hip fracture will lower pre and postoperative blood loss and transfusion rates. Patients who present to the hospital with a hip fracture will be recruited and randomized into two treatment arms. The treatment group will receive 1950mg of oral TXA (three tablets, 650 mg each) and the control group will be given three tablets of oral placebo while in the Emergency Department. Patients will then be admitted to the Orthopaedic Trauma service and treated surgically with cephalomedullary nail, hemiarthroplasty, sliding hip screw, percutaneous screws, or total hip arthroplasty.

NCT ID: NCT05515718 Completed - Femoral Fracture Clinical Trials

Effect of the Early Ultrasound-guided Femoral Nerve Block Performed by Emergency Physicians on Pre-operative Opioids Usage in Patients With Proximal Femoral Fractures

FORELEG
Start date: September 7, 2022
Phase: N/A
Study type: Interventional

In France, approximately 80,000 patients with a fracture of the upper extremity of the femur (femoral neck or trochanter) are admitted in the emergency department. This is a serious disease with a one-year mortality rate of 29% (i.e., 1 of 5 women and 1 of 3 men), and significant consequences on quality of life and autonomy. The morbidity of these fractures is closely related to the occurrence of altered mental status or delirium, before and after surgery. The diagnosis is based on clinical features and x-rays of the hip. These fractures are associated with severe level of pain, before and after the surgery. For emergency physicians, managing appropriately the pain is a common problem at the admission in the emergency room. Proper pain management is essential to ensure patients' comfort before surgery, but also to ensure their return to their previous functional and cognitive state after surgery. For patients, the goal of treatment is to regain walking as quickly as possible, while minimizing surgical and medical complications. However, severe pain induced by the fracture may lead to an acute altered mental status or delirium. In France, the latest guidelines about analgesia in emergency medicine reported that local anesthesia and loco-regional anesthesia (LRA) are useful and should be promoted in emergency medicine. In 2010, these guidelines proposed to perform LRA techniques such as iliofascial block more widely available. In 2016, the largest review of the literature on the use of regional nerve blocks for hip and femoral neck fractures in the emergency department [MEDLINE (1946-2014), EMBASE (1947-2014), CINAHL (1960-2014), and the Cochrane Central Register of Controlled Trials] indicated that the femoral nerve block was likely to be at least as effective as, if not superior to, standard analgesic practices for decreasing pain after ESF fracture. The authors of the meta-analysis suggested the superiority of ultrasound guidance compared to anatomic techniques or use of neurostimulation for an adequate needle placement. Despite the increasing availability of ultrasound in the emergency department, recent literature supporting the efficacy of ultrasound-guided femoral nerve block, and the improvement of ultrasound skills in routine emergency medicine practice, the literature lacks of data about the effective duration of action, medication influence, and the occurrence of complications when an ultrasound-guided femoral nerve block is used by emergency physicians at the admission. For patients with hip fractures, it is questioned if ultrasound-guided femoral block used early on admission in the emergency room is in more efficient than intravenous morphine titration in reducing opioid use before surgery? Our hypothesis is that early use of ultrasound-guided femoral nerve block in the emergency room decreases preoperative opioid use (intravenous and/or oral) in patients with proximal femoral fractures.

NCT ID: NCT05514405 Recruiting - Knee Osteoarthritis Clinical Trials

Effect of Remimazolam and Propofol on Postoperative Delirium

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

Remimazolam is an ultra-short acting benzodiazepine agonist which is used widely for general anesthesia and sedation. Remimazolam has several advantages. Remimazolam is rapidly metabolized by tissue esterase that it does not accumulate even after infusion for long periods of time. The presence of reversal agents (flumazenil) is also advantageous. Also, hemodynamic stability compared to propofol gives clinicians preference to use for geriatric anesthesia. However, the study on the effect of remimazolam compared to propofol on postoperative delirium have not been carried out. The purpose of the study is to compare the incidence of postoperative delirium and recovery profile in elderly patients undergoing orthopedic surgery using either remimazolam or propofol.

NCT ID: NCT05510232 Recruiting - Fractures, Bone Clinical Trials

Virtual Reality Distraction During Outpatient Pediatric Orthopedic Procedures

Start date: July 25, 2018
Phase: N/A
Study type: Interventional

Virtual Reality(VR) has had promising applications in science and medicine, including intervention delivery. The use of VR interventions has been studied in a wide range of medical conditions, including anxiety, phobias, obesity, chronic pain, and eating disorders. VR based simulation in pediatrics has grown rapidly in recent years and is expected to continue to grow. VR technology has become increasingly affordable, flexible, and portable, enabling its use in a broad range of environments including the outpatient clinical setting. Additionally, children are believed to have an inclination toward games of "pretend" or alternate realities further indicating the potential of this technology. While immersed in a game, they often become deeply absorbed and able to ignore aversive stimuli. VR is an engaging intervention that may help to detract from pain and anxiety for children undergoing painful procedures. Heart rate has been used as a means to objectively quantify the physiologic response to pain and anxiety. The purpose of the study is to conduct a randomized controlled study that assess the utility of Virtual Reality simulations compared to non immersive visual distraction in pediatric patients undergoing outpatient procedures including cast removal and surgical suture/pins removal. Primary outcomes will include changes in patient heart rate (an age-validated surrogate for pain and anxiety) and patient-reported changes in anxiety and pain. Secondary outcomes will include patient/parent-reported satisfaction.

NCT ID: NCT05506761 Recruiting - Rib Fractures Clinical Trials

Rhomboid Intercostal Block Combined With Sub-Serratus Plane Block Versus Erector Spinae Plane Block

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

The aim of this study is to assess the quality of analgesic efficacy and improvement of pulmonary function in patients with fracture ribs receiving either continuous rhomboid intercostal block combined with sub-serratus block or continuous erector spinae plane block by comparing and evaluating the differences between the two techniques.

NCT ID: NCT05506501 Not yet recruiting - Fracture Tibia Clinical Trials

Unilateral Epidural Block Versus Ultrasound Guided Combined Femoro-sciatic Nerves Block for Patients With Low Ejection Fraction

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

compare unilateral epidural anesthesia versus femoral/sciatic nerve block by ultrasound guided as anesthetic technique for cases with low ejection fraction undergoing insertion of nail tibia for fixation of fracture shaft tibia.

NCT ID: NCT05505604 Recruiting - Clinical trials for Femoral Neck Fractures

PENG vs FICB for Hip Fracture in ED Patients

Start date: September 30, 2022
Phase: N/A
Study type: Interventional

Regional anesthesia for hip fractures has been shown to decrease rates of delirium in elderly patients with hip fractures as well as improve pain compared to systemic opioids. The Pericapsular Nerve Group (PENG) block has recently received attention as an alternative approach to femoral nerve block and Fascia Iliaca Compartment Block (FICB). The investigators seek to evaluate if there is a difference between the PENG and FICB in terms of efficacy of pain control in ED patients presenting with hip fracture. We hypothesize that the PENG block may be superior based on previous research.

NCT ID: NCT05504304 Completed - Calcaneus Fracture Clinical Trials

Primary Subtalar Arthrodesis Versus Late Subtalar Arthrodesis in Sanders Type IV Calcaneal Fractures

Start date: September 30, 2019
Phase: N/A
Study type: Interventional

Fracture calcaneus accounts for up to 2% of all fractures. 75% of calcaneal fractures are displaced intra-articular fractures and historically have been associated with poor functional outcomes. When the talus applies an axial loading to the posterior facet, shear forces result in a primary fracture line between medial (sustentaculum tali) and lateral part of the calcaneus. As the axial force continues, a secondary fracture line will develop. According to the relation of the secondary fracture line's exit to insertion of tendo-achilis Essex-Lopresti classified that into two types joint depression and tongue. Numerous classifications exist in the literature but that by Sanders is the most prevalent and best suited for clinical practice and for research purposes. Sanders in his clinical trials found that as the number of articular fragments- based on axial and coronal CT scan cuts with the widest undersurface of the posterior facet of the talus- increase, the results and prognosis worsen. Up to 73% in the sanders type IV fractures eventually leads to subtalar fusion to manage post-traumatic subtalar arthritis. They are 5.5 times more likely to require subtalar arthrodesis than Sanders II fractures. Second surgeries increase the cost of management and delay the return of level of function for the patient. Some authors advocate that the fractures with a higher Sanders classification demonstrated no difference between operative and non-operative treatment. However, careful stratification of the patients may show better outcomes after surgical intervention in some groups. There is no consensus about how to manage calcaneal fractures but we can divide management into four broad categories: Non-operative, Open reduction and internal fixation, Minimally invasive reduction and fixation and finally Primary ORIF and subtalar arthrodesis. Our trial was conducted to add to the current evidence and our main questions are: does initial reduction and fixation of comminuted displaced intra-articular Sanders type IV calcaneal fractures matter in subtalar fusion?

NCT ID: NCT05502679 Recruiting - Clinical trials for Fracture of Tibia Proximal Plateau

Immediate Versus Late Weight Bearing After Tibial Plateau Fractures Internal Fixation

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

Postoperative rehabilitation for tibial plateau fracture generally involves prolonged non-weight bearing time while other protocols use partial weight-bearing and bracing before full weight-bearing is recommended at 9 to 12 weeks following surgical fixation. No study to date has investigated the effect of standardized pragmatic exercise protocol added to immediate weight bearing after tibial plateau fractures surgical fixation on patient's functional outcomes, knee ROM, pain, radiographic boney alignment, gait, and return to work.

NCT ID: NCT05501496 Not yet recruiting - Fracture of Tibia Clinical Trials

Conservative Versus Intramedullary Nailing for Pediatric Tibial Shaft Fractures

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

Tibial shaft fracture is a common fracture in the pediatric and adolescent population. The outcomes of both conservative and operative treatment are not clear and to date there is no randomized prospective trial comparing different methods of treatment. The investigators will conduct a multicenter, randomized non-inferiority trial comparing closed reduction and cast immobilization to intramedullary nailing in 6-15 year old children and adolescents with displaced tibial shaft fractures and open proximal tibial physis.