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Active clinical trials for "Fractures, Bone"

Results 11-20 of 2160

Virtual Reality Distraction During Outpatient Pediatric Orthopedic Procedures

FracturesBone1 more

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.

Recruiting7 enrollment criteria

LOQTEQ® Antibacterial Pre-Market Study

FracturesOpen4 more

aap001 is a randomized, controlled, subject and observer-blinded, multi-center study to show the safety of the LOQTEQ® antibacterial silver-coated system is non-inferior in comparison with the uncoated LOQTEQ® system

Recruiting22 enrollment criteria

PENG Block vs Fascia Iliaca Block for Emergency Department Analgesia in Hip Fractures

Hip Fractures

Pain management is a crucial aspect of the care of hip fracture patients. Patients with poorly controlled pain have an increased risk of delirium, long-term functional impairment, and remain hospitalized longer. Today, to relieve hip fracture pain, fascia iliaca block is routinely performed in the emergency department in addition to other pain medications administered by vein or by mouth. Several studies have questioned the analgesic efficacy of this block, suggesting the superiority of the newer PENG block. The purpose of this multicenter, randomized study is to compare the analgesic efficacy of PENG block versus fascia iliaca block, hypothesizing the superiority of the new approach over the gold standard. Participants will be blindly assigned in a 1:1 ratio to the study or control group, recruited from the Emergency Departments of IRCCS Policlinico San Matteo and Colchester Hospital (UK). The main outcome is represented by the reduction of pain after the two blocks, measured as %SPID (percentage of "pain intensity difference"), a value derived from VAS scale measurements in the first hour post-procedure. Secondly, we will evaluate the proportion of patients with satisfactory pain control, the amount of opioids used and the safety profile of the two approaches.

Recruiting16 enrollment criteria

Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the...

Pelvic FractureInsufficiency Fractures1 more

Many approaches to the surgical treatment of OF-P have been tried, but no one method has stood out as particularly successful. The placement of three implants, including implants that could minimise motion in the sacroiliac joint through early fixation and long-term fusion of the sacroiliac joint, can prevent micromotion in the fracture and thereby improve the clinical outcome of OF-Ps. The iFuse-3D implant was shown to be safe and effective for chronic sacroiliac pain in non-osteoporotic patients. The primary aim is to assess the proportion of patients operated on using iFuse-3D in conjunction with transiliac-transsacral screws who regain pre-fracture mobility by the time of hospital discharge.

Recruiting22 enrollment criteria

FEA, Biomechanical and Clinical Study of R.O. Peritrochanteric Fractures With PFLP vs Cephalomedullary...

Pertrochanteric Fracture of FemurClosed

Hip fractures are the second most common fracture regardless of age, while at the same time its incidence is on the rise and it is expected to keep increasing in the future. In addition, hip fractures oppose a serious problem for both patients and clinicians, as they are associated with high rates of morbidity, reduced quality of life, impeded independent functionality and higher institutionalization rates. Several osteosynthesis techniques have been proposed for surgical correction of hip fractures which can be grouped into 3 main categories: a) Dynamic Hip Screw (DHS) extramedullary systems, b) Proximal femoral nail N [PN] PFNA], γ-nail [GN] or other implants) and (c) Dynamic Condylar Screw, Angled blade plates, Proximal Femur Locking Plate (PFLP). This study will compare the use of anatomical proximal femur locking plates ( PeriLock, Smith& Nephew) with an intramedullary nailing system, one of the most common and literature supported implants for the reduction of reverse oblique intertrochanteric fractures, classified as A31- 1,3 according to AO. The study will include Biomechanical testing and finite element analysis of the implants in an experimental setup using artificial bones performed at the Laboratory of Technology and Strength of Materials of the Department of Mechanical Engineering and Aeronautics of the University of Patras. and a pilot, prospective, randomized clinical study in a sample of 30 patients divided into 2 groups, where comparison of perioperative and intraoperative data will be accessed. The purpose of this study is to evaluate the efficacy and mechanical stability as wells as the clinical and radiological parameters as well as quality-of-life indicators in patients with reverse oblique hip fractures The primary goal of to investigate whether there are statistically significant differences in the main radiological parameters (cut-out, misalignment of the femoral head, loss of alignment, defective posture, non-union), while The second primary goal is to assess the functional and general health status of patients up to 24 weeks postoperatively, using special clinical evaluation scales (Harris Hip score-HHS and Oxford hip score-OHS), as well as pain levels perioperatively

Recruiting9 enrollment criteria

Randomized Controlled Trial for Ankle Fracture Pain Control

Ankle Fractures

This project is a multicenter, three armed, prospective randomized control trial studying the effectiveness of a long-acting local anesthetic "cocktail" in patients undergoing operative fixation of ankle fractures.

Recruiting17 enrollment criteria

Supracondylar Post-Operative Pain Study

Supracondylar Humerus Fracture

The purpose of this study to investigate post-operative pain control in pediatric patients with closed supracondylar humerus fracture who undergo closed reduction and percutaneous pinning. Currently, it is standard of care that patients receive a narcotic prescription for post-operative pain control. All patients will initially be seen in our pediatric urgent care and recruited at the time of surgery. Patients will be randomized to receiving acetaminophen and ibuprofen or acetaminophen and oxycodone. Parents will not be blinded to the acetaminophen but both investigators, parents and the patients will be blinded to the study drug (ibuprofen or oxycodone). Pain level will be assessed using the Wong-Baker FACES scale and parents will be asked to fill out a questionnaire regarding their satisfaction with the surgery and pain control. Parents will also fill out a medication log until the patient no longer requires pain medication. The duration of participation in the study is approximately 1 week and requires 2 visits (time of recruitment at surgery to 1st post-op visit). This study is being conducted in hopes of reducing opioid prescription after surgical fixation of uncomplicated supracondylar humerus fractures if our study can show that patient's pain levels post-operatively and parent/patient satisfaction are unchanged or improved in the acetaminophen and ibuprofen arm.

Recruiting13 enrollment criteria

Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC)

Pilon Fracture

High energy intra-articular fractures of the distal tibia, or Pilon fracture, is a devastating injury with multiple short and long term complications. The incidence of these injuries is increasing as survival rates after motor vehicle collisions increase. The current standard of care for high energy pilon fractures is to place an external fixator at the time of injury and then provide definitive internal fixation when the soft tissue envelope allows, which is usually around 10-14 days. Arguably, the most debilitating long term complication after a high energy pilon fracture is the development of post-traumatic osteoarthritis (PTOA), which occurs in 50% or more of pilon fractures within the first 2 years of surgery. The development of osteoarthritis occurs even in the presence of adequate restoration of the tibial plafond. Part of this issue lies in the fact that ankle joint cartilage is the thinnest of any major articular joint and sustains a great deal of damage at the time of injury. This impaction and injury initiates a cascade of events that ultimately result in cartilage cell death, or chondrolysis. Chondrolysis occurs via necrosis or apoptosis. Apoptosis occurs via a caspase pathway, while necrosis of chondrocytes likely occurs secondary to overproduction of reactive oxidant species (ROS). Recent animal models have demonstrated several things: chondrocyte death is highest along fracture lines, and likely undergo necrosis as opposed to apoptosis. The reason that PTOA likely occurs in such a high percentage of pilon fractures is because of this chondrolysis, and if a method can be developed to decrease the rate of chrondrocyte necrosis, then the rate of PTOA could potentially improve and improve patient outcomes overall. A recent bovine model examined the injection of N-acetylcysteine (NAC) after an intra-articular knee fracture and its effect on the cartilage cell viability. Their study demonstrated that chondrocyte cell viability after an injection of NAC within four hours of injury decreased chondrolysis from roughly 60% to about 30% at 48hrs. The effect was greater the closer to injury the injection occurred, and was statistically significant for 2 weeks. This indicates that free radical scavengers can potentially improve cartilage cell viability and help prevent the development of PTOA. No studies have been published on humans regarding injection of NAC after a fracture. However, a recent article examined the injection of NAC into osteoarthritic knees and found that it was effective in lowering certain cartilage degradation markers and was comparable to hyaluronic acid for both pain and function. NAC has been proven safe for both intra-articular injections and systemic injections in humans. Our study will focus on the improvement of cartilage cell viability with an injection of NAC. Our hypothesis is that the NAC intra-articular injection will increase the percentage of viable cartilage cell after sustaining a pilon fracture, when compared to a placebo injection of saline. The goal of this study is to examine the effects of an intra-articular injection of the amino acid NAC on cartilage cells after an intra-articular fracture of the ankle joint. The long-term clinical goal of this research is to reduce the incidence of post-traumatic osteoarthritis in the ankle joint after fracture.

Recruiting8 enrollment criteria

The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly

Proximal Humeral Fracture

The Nordic DeltaCon Trial is a prospective, single-blinded, randomized, controlled, multi-center and multi-national trial comparing reverse prosthesis and non-operative treatment in displaced proximal humerus fractures, in the elderly patients aged 65 to 85 years with displaced OTA/AO group B2 or C2 fractures (According to the new 2018 revision: AO/OTA (Orthopaedic Trauma Association) group 11-B1.1, 11-B1.2 and 11-C1.1, 11-C3.1. )

Recruiting13 enrollment criteria

Use of Weightbearing Radiographs to Determine Treatment of bi- and Trimalleolar Ankle Fractures...

Ankle FractureBimalleolar2 more

The aim of this study is to evaluate the outcomes after non-operative treatment of weightbearing stable bi-and trimalleolar ankle fractures.

Recruiting18 enrollment criteria
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