6 Clinical Trials for Various Conditions
Pediatric patients with distal radius fractures are most commonly treated non-operatively with fracture reduction and cast immobilization. In order to prevent complications from increased swelling after the injury (or fracture manipulation) casts may be split along their length to relieve pressure. However, this can compromise the casts' structural integrity, predisposing fractures to loss of reduction. The goal of this study was to investigate if cast bivalving, or splitting the cast longitudinally on both sides, resulted in any immediate change to bony alignment and to assess if bivalving effected cast parameters associated with loss of reduction.
Distal radius fractures are one of the most commonly seen fractures in children. Traditionally, minimally angulated or non-displaced distal radius fractures are treated with short or long-arm cast immobilization for up to 8 weeks. The traditional fiberglass casts used must be kept dry to prevent inflammation and potential infection. If a fiberglass cast gets wet, it must be removed and replaced. In general, waterproof casting has been shown to improve patient comfort and overall satisfaction. We intend to explore the efficacy of a new, waterproof cast made of a hybrid mesh in the treatment of minimally angulated distal radius fractures in children using a randomized, controlled, cross-over study design. We will include patients between 4 and 14 years of age with minimally angulated distal radius fractures (\<15 degrees of angulation on sagittal or coronal planes) presented to the Orthopaedic Institute for Children Urgent Care Facility within 7 days of injury. As determined by a power analysis, a total of 26 patients will be enrolled in the study. Patients eligible for the study will be randomized into one of two equally sized (n=13) groups: patients in Group 1 will receive a short arm cast made of the waterproof hybrid mesh material and patients in Group 2 will receive a regular fiberglass cast. Both groups will follow-up at two weeks for clinical and radiological evaluation, after which they will be transitioned into a regular fiberglass cast (Group 1) or a hybrid mesh waterproof cast (Group 2) for an additional two weeks. This crossover will allow both groups to experience each type of cast. After four weeks of immobilization, patients in both groups will discontinue casting and be advised to avoid contact sports or strenuous activities until week 8. Patients in both groups will follow up 8 weeks after initial treatment for clinical and radiological evaluation to evaluate range of motion, pain, and fracture alignment. Physical function will be evaluated at weeks 1, 2, and 4 using the Activities Scale for Kids - Performance, a validated, highly reliable, self-reported measure that assesses physical function in children between 5 and 15 years. Pain will be evaluated using the Faces Pain Scale, a validated, highly reliable scale commonly used in the pediatric population. Patient satisfaction will be measured at Weeks 1, 2, and 4, and the radiographs at Week 8 will be compared with initial radiographs to assess fracture displacement and angulation. Skin changes will be assessed at week 2 and week 4 by an independent observer blinded to the type of cast that has been removed and digital photographs will be obtained and analyzed using ImageJ Image Processing and Analysis Software to calculate the surface area of any described skin changes as a percentage of total skin area originally covered by the cast. Itching will be assessed at weeks 1, 2, and 4 using a visual analogue scale in which a horizontal line of 100 mm will be presented to the patient with "no itching" at the left end of the scale and "strongest itching" at the right end. We hope to determine whether the new, waterproof cast can result in similar clinical outcomes and patient satisfaction for distal radius fractures as compared with the traditional fiberglass cast.
The goal of this clinical trial is to determine if a home management plan incorporating video education can effectively replace in-person visits for children aged 7-17 diagnosed with distal radius buckle fractures. The main questions it aims to answer are: Is a home management plan with video education non-inferior to in-person management for patient satisfaction? Is a home management plan superior to in-person management for reducing healthcare-related time, missed work/school, inappropriate care (e.g., rigid casting), and healthcare resource consumption? Researchers will compare the home management group to the in-person management group to see if video education can reduce healthcare costs and the burden on patients without compromising care quality. Participants will: Be randomized to either the in-person group or the video-based home management group. Complete a pediatric PROMIS assessment at baseline and 6 weeks. Complete a satisfaction survey at the conclusion of the study.
The aim of the study is to determine by multicenter randomized controlled trial whether short arm fiberglass casts are as effective as long arm casts for immobilizing displaced pediatric distal third forearm fractures that have undergone closed reduction. The primary outcome is loss of reduction requiring cast wedging, recasting, repeat reduction, or surgical intervention. Secondary outcomes will include Patient Reported Outcome Measures for physical function, such as Pedi-FABS, PROMIS (Patient Reported Outcomes Measurement Information System) Upper Extremities , and UCLA (University of California Los Angelos) Activity Scale, and pain/comfort levels,such as PROMIS Pediatric Pain Interference, PROMIS Pediatric Pain Intensity, and VAS ( Visual Analogue Scale) comfort in cast. In addition, secondary outcomes include complications (skin irritation, compartment syndrome, elbow stiffness, cast saw burns etc). The investigators will assess potential risk factors for loss of reduction including initial displacement, level of fracture (physeal, metaphyseal, meta-diaphyseal), initial translation, initial angulation, age, sex, cast index, padding index, adequacy of initial reduction, and provider level of training.
The primary objective of this study is to evaluate the sedative, and analgesic effects of intranasal (IN) Dexmedetomidine (DEX) in children presenting to a Pediatric Emergency Department (PED) who undergo conscious sedation for reduction of closed distal forearm fractures when compared to those receiving intravenous (IV) Ketamine. The secondary objective is to compare each sedation technique for safety and procedural outcomes.
The purpose of the study is to evaluate the sensitivity and specificity of using a diagnostic musculoskeletal ultrasound in pediatric distal radius fractures in an outpatient setting. Ultrasound reliability and accuracy will be tested. The result of the diagnostic ultrasound will be compared to x-ray diagnosis under routine conditions in the investigator's injury and fracture treatment evening clinic. Data will be collected and recorded during the duration of the 12 week study. Through the literature review and experience with ultrasound, the investigators anticipate that diagnostic ultrasound will provide very high sensitivity and specificity in diagnosing distal radius fractures in children.