View clinical trials related to Fracture.
Filter by:The primary objective of this study will be the collection of preliminary clinical evidence to indicate that Cast21 Short Arm Product is no worse than the current standard of care arm immobilization devices in pediatric patients. A secondary objective will be to characterize the clinician and patient experience with the Cast21 Short Arm Product.
Daily living activities are an essential part of a child's development, providing endless opportunities for play, learning, and imaginative expression. The desired result as the child get bored after a while so we use it for benefits. Proprioceptive Neuromuscular Facilitation is a stretching technique utilized to improve muscle elasticity and has been shown to have a positive effect on active and passive range of motions. In clinical settings, PNF is already utilized by therapists to restore functional range of motion (ROM) and increase strength in patients who have sustained soft tissue damage or received invasive surgeries.
This study has been added as a sub study to the Simulation Training for Emergency Department Imaging 2 study (ClinicalTrials.gov ID NCT05427838). This work aims to evaluate the impact of an Artificial Intelligence (AI)-enhanced algorithm called Boneview on the diagnostic accuracy of clinicians in the detection of fractures on plain XR (X-Ray). The study will create a dataset of 500 plain X-Rays involving standard images of all bones other than the skull and cervical spine, with 50% normal cases and 50% containing fractures. A reference 'ground truth' for each image to confirm the presence or absence of a fracture will be established by a senior radiologist panel. This dataset will then be inferenced by the Gleamer Boneview algorithm to identify fractures. Performance of the algorithm will be compared against the reference standard. The study will then undertake a Multiple-Reader Multiple-Case study in which clinicians interpret all images without AI and then subsequently with access to the output of the AI algorithm. 18 clinicians will be recruited as readers with 3 from each of six distinct clinical groups: Emergency Medicine, Trauma and Orthopedic Surgery, Emergency Nurse Practitioners, Physiotherapy, Radiology and Radiographers, with three levels of seniority in each group. Changes in reporting accuracy (sensitivity, specificity), confidence, and speed of readers in two sessions will be compared. The results will be analyzed in a pooled analysis for all readers as well as for the following subgroups: Clinical role, Level of seniority, Pathological finding, Difficulty of image. The study will demonstrate the impact of an AI interpretation as compared with interpretation by clinicians, and as compared with clinicians using the AI as an adjunct to their interpretation. The study will represent a range of professional backgrounds and levels of experience among the clinical element. The study will use plain film x-rays that will represent a range of anatomical views and pathological presentations, however x-rays will present equal numbers of pathological and non-pathological x-rays, giving equal weight to assessment of specificity and sensitivity. Ethics approval has already been granted, and the study will be disseminated through publication in peer-reviewed journals and presentation at relevant conferences.
Background: Fall-related injuries like fractures are on the rise among older adults in New Brunswick. These injuries can lead to hospitalization and adverse health effects. Moreover, transitions from acute care can be complicated and overwhelming, especially for patients and their families. Researching patient navigators as a means of enhancing inpatient care, while also ensuring successful transitions in care for patients, may have positive impacts and help older adults successfully age in place. Objective: This study seeks to investigate the effects of having support from patient navigators in helping older adults admitted to the Orthopedic Unit with a fracture. Specifically, the objectives are to investigate whether there are differences between patients with patient navigators and those patients receiving standard of care, regarding: the length of stay in acute care; healthcare utilization post-discharge; patient and family experience and satisfaction with care; and, healthcare provider experiences working with patient navigators. Methods: This study uses a mixed-method concurrent embedded design, in which the quantitative randomized control trial has an embedded qualitative component. Potential Benefits/Risks: This study is considered low risk. Potential benefits of this study include a better understanding of the impact of support from a patient navigator on inpatient care and patient transitions. This information will be used to inform the development of practical recommendations for policymakers and clinicians on how to enhance inpatient acute care and successful transitions for older adults.
This is a post-marketing surveillance on Medacta Shoulder System
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.
Objective: To verify the efficacy and safety of denosumab in the prevention and treatment of CKD-MBD in CKD patients with high risk of fracture. Methods: A cohort of CKD patients with high risk of fracture was established and followed up for long periods (≥24 months). Patients with CKD3b-5D stage and fracture risk assessment tool (FRAX) scores at high risk or very high risk of fracture were enrolled. A multicenter, prospective, open-label, randomised controlled, interventional study was conducted. The patients were divided into two groups. The patients in the denosumab group received subcutaneous injection of denosumab 60mg once every 6 months, and the patients in the non-denosumab group received conventional treatment. Bone metabolic markers (serum calcium, phosphorus, vitamin D, parathyroid hormone, alkaline phosphatase, tartrate-resistant acid phosphatase 5b, osteocalcin, total N-terminal propeptide of type I collagen, etc.), bone mineral density (dual-energy X-ray, quantitative CT), and vascular calcification score were regularly monitored. All adverse events (all-cause death, cardiovascular death, cardiac events, fracture, hospitalization, emergency department visits, etc.) were recorded during the follow-up period. Bone mineral density and clinical parameters were compared between the two groups.
The objective of this study is to collect and evaluate long-term clinical and radiographic outcomes data in order to better understand the safety and performance of the shoulder arthroplasty over time. This study will follow subjects long-term for a minimum of 10-years, without an early-term restriction on the amount of time they will be followed.
Background. Consensus is lacking regarding the use of tranexamic acid (TXA) in calcaneal fracture surgery. This study aims to investigate the hypothesis that local infiltration of TXA in the post-operation would maintain hemoglobin (Hb) level, reduce incision drainage volume and risk of infection in patients with displaced intra-articular calcaneal fractures. Methods. A total of 120 patients with displaced intra-articular calcaneal fractures who received extensible lateral L-shaped approach were included in this trial and equally randomized to receive one single dose of 1g TXA or 1g normal saline after closing incision. The demographic data and fracture characteristics, intra-operative indicators, laboratory tests and Visual Analogue Scale (VAS) scores, incision drainage volume, and incision-related complications were collected and compared between the two groups.
Wrist arthroscopy (WA) is a potentially useful adjuvant procedure in the surgical treatment (osteosynthesis) of distal radius fractures (DRFs). Previous research on the contribution of WA to DRF treatment has shown different results. Objectives of the study: (1) Validate wrist functional outcome questionnaires; (2) To determine whether arthroscopically assisted repositioning of fracture fragments in articular DRFs leads to a better treatment outcome; (3) To determine whether arthroscopic observation and treatment of associated soft tissue and / or cartilage injuries in articular DRFs leads to a better treatment outcome; (4) To determine whether arthroscopic observation and treatment of associated soft tissue and / or cartilage injuries in extraarticular DRFs leads to a better treatment outcome. Research hypotheses: (1) Validated questionnaires will have satisfactory measurement properties (validity, reliability) and will be able to be used in a WA randomized controlled trial; (2) WA as an adjunct to DRF osteosynthesis improves the clinical outcome of treatment. Subjects: 56 female patients with indication for DRF osteosynthesis aged 50-69 years divided into 2 groups: 1. examined - 28 patients with indication for DRF osteosynthesis (14 patients with extraarticular DRF and 14 patients with intraarticular DRF) with associated WA, and 2. control - 28 patients with indication for DRF osteosynthesis (14 patients with extraarticular DRF and 14 patients with intraarticular DRF) without associated WA. Methods: As a primary outcome measure, functional outcomes of treatment will be analyzed with the Disabilities of the Arm, Shoulder and Hand (DASH) Score at 3 and 6 months after surgery. As a secondary outcome measures it will be analyzed pain level according to a visual analog scale (VAS), preoperative and postoperative radiographic parameters of distal radius, and clinical outcomes of treatment with the Mayo Wrist Score (MWS) and Patient-Rated Wrist Evaluation (PRWE) score at 3 and 6 months after surgery. Expected scientific contribution: providing answers on the role of WA in the treatment of DRF and associated injuries as well as its impact on treatment outcome.