Active clinical trials for "Fractures, Bone"

DXA scanners are routinely used to assess bone mineral density (BMD) and fracture risk in osteoporosis patients. They provide detailed bone imaging in a low radiation setting. Hologic manufactures scanners that are able to perform high definition instant vertebral fracture assessment (HD-IVA) used to screen at-risk patients for asymptomatic spine fractures instantly and reliably at the same time they are having their yearly BMD. We wish to investigate whether this same proven technology (HD-IVA scan mode) used on femurs (the scan mode is now called SE Femur scans) can be used to screen for atypical fractures of the femur in patients at risk for these debilitating fractures. In this proof of concept study, we propose to examine whether DXA scanners can provide a sensitive low radiation screening method to identify incomplete AFFs in patients with known incomplete AFFs and in patients at risk.

This trial will evaluate the impact of 6 weeks of postoperative essential amino acid (EAA)-based supplementation on muscle morphology after femoral fragility fracture. This trial will assess the ability of EAA-based to increase skeletal muscle metabolic activity, reduce inflammation, and induce muscle fiber hypertrophy, as well as preserve skeletal muscle mass and physical performance up to 3 months after injury. Participants will be randomized in a 1:1 ratio to 1) standard of care (no dietary intervention) or 2) EAA-based supplementation

The systemic effects of spinal anesthesia is not fully known. Our aim of this study is to assess whether there is a difference in hemodynamic effects if the spinal dose is given fast (15s) or slow (90s) in elderly patients with acute hip fracture (AHF). Ninety (n=90) patients with AHF planned for surgery within 72h at our hospital will be enrolled in the study and randomly devided into two groups. The patients will receive one predetermined dose of spinal anesthesia followed by an advanced minimally-invasive hemodynamic monitoring through an arterial line using FloTrac-system. The hemodynamic parameters will be conducted 10 minutes prior to the spinal anaesthesia and 30 minutes after the spinal block is given. Hypotension was defined as a fall in MAP > 30 % or a MAP <65mmHg.

Proximal humerus fracture patient's upper limb complete function restoration mainly depends on patient rehabilitation exercises. One time teaching in clinic is usually not sufficient for patients to learn their rehabilitation exercises. This leads to delayed patient recovery and dis-satisfaction to treatment provided by health care providers. Our aim is that mobile health technology might facilitate patient to easily access health related teaching information other than routine care to support patient in their self-health care management thus leading to proximal humerus fracture patient treatment outcome improvement. Hypothesis: Mobile health technology positively improves clinical and functional outcomes of proximal humerus fracture using validated outcome scoring scales. Objectives: Primary objective: To improve adult proximal humerus fracture patient's clinical and functional outcomes using validated outcome scoring scales resulting in timely recovery with the help of patient self-health care capacity using mobile health app. To compare patient clinical and functional outcomes by validated scoring scales between using mobile health app versus standard care. Secondary Objective: To increase patient and doctor satisfaction rate in perspective with treatment provision usefully by digital technology application. Methods: Study design: Patient-centered, open labelled, parallel (1:1), pilot randomized controlled trial. Total 60 subjects required with 30 in each arm in 24-month duration. Study procedures: Proximal humerus rehabilitation exercises video will be prepared after obtaining written informed consent from designated orthopaedic residents/surgeon. Patients of 18 to 58 years of age with trauma associated proximal humerus fractures, who or their attendants are willing to participate. Patients who requires special care, patient not willing to exercise at home without physiotherapist support or participate in survey questionnaire and patients who does not have facility of classic blue tooth connectivity will be excluded. Written informed consent will be administered the study subjects as per GCP guideline. Each eligible patient will be randomized into intervention or control group. Intervention group: Classic Blue tooth technology will be utilized for interoperable solution of teaching video information sharing from doctor to patient. The end users will be enrolled trauma associated proximal humerus fracture patients whether treated surgically or conservatively. Control group: Routine care will be provided to control group and as per routine. The patient will be followed at 6 weeks, 3 and 6 months. Data will be collected on Case report form by assigned person. Clinical and functional outcomes will be assessed by assigned person using Quick DASH and Oxford shoulder score. Researchers will be trained on data collection form prior to data collection. In case of lost to follow-up, patients will be contacted by telephone. Patient satisfaction questionnaire: Administered to intervention group only about impact of digital technology application on their health improvement and care outcomes. Doctor satisfaction questionnaire: To assess treating surgeon satisfaction rate for digital technology application impact on intervention group patients' care and outcomes. The research study does not seem to have any potential health hazard. As per Food and Drug Administration and GCP recommendations for Serious/Adverse event (SAE/AE), any patient who experience SAE/AE, will receive good clinical care at earliest and all relevant reporting bodies will be notified. Data management will be carried out at the Department of Surgery. Subject data confidentiality will be maintained. After study completion, data will be archived and retained for maximum years. Statistical Consideration: Quantitative variables will be expressed as mean ± standard deviation and qualitative variables as frequencies (percentages). The efficacy on the basis of clinical and functional outcome and the AEs/SAEs will be assessed by intention to treat analysis. For group comparisons of clinical and functional categorical outcomes, chi-square test or Fisher Exact will be applied. p-values of less than 0.05 will be considered as statistically significant with a confidence interval of 95%. Patient and doctor satisfaction scores will be analyzed using regression analysis. For Assessment of outcomes, repeated measure ANOVA and generalized estimating equation will be used. Multiple regression will be used to assess the association between multiple covariates.

The aim of this study is to evaluate of the effectiveness of a Smartphone application in aiding post-operative rehabilitation of an intra-articular distal radius (wrist) fracture. This study will focus on healthy patients operated on for isolated wrist fractures (intra articular fracture of the distal radius with or without fracture of the distal ulna/cubitus) using plate and screw. The PhysiApp application is a secure smartphone application that enables therapists to transmit personalized rehabilitation exercises to patients. Its effectiveness in patients undergoing surgery for intra-articular fractures of the distal radius fracture. The aim of our research project is to determine the effectiveness of this application for patients undergoing intra-articular distal radius fracture surgery at the Cantonal Hospital of Fribourg in Switzerland. The operation itself will be carried out in the usual way. However, rehabilitation will be carried out with the help of the application, in addition to the usual follow-up by a hand therapist. The aim is to improve wrist mobility and function. Once wrist surgery has been performed (plate and screw osteosynthesis), post-operative rehabilitation will either take place in the company of a hand therapist, using the smartphone application, or will consist solely of conventional rehabilitation by a hand therapist only. Only the patient and the therapist will be aware of the use of the application. The follow-up doctor will receive no information on the treatment methods (single-blind procedure), to enhance the scientific quality of the results of this study. During the 3 months following the operation, wrist mobility will be measured and questionnaires on wrist function will be completed by patients.

Why the investigators are doing this study? The best approach to rehabilitation after a broken hip is not known. A new approach could improve outcomes by tailoring rehabilitation to patient needs. This approach identifies subgroups of patients within a population who have different risks of poor outcomes. These subgroups are then matched to treatments better tailored to their needs. Survivors of a broken hip describe a tailored approach as key to recovery. Further, the NHS recommends this approach as central to healthcare progress. This study wants to see if it is possible for the NHS to deliver this new approach to rehabilitation for older adults who break their hip. What will be done? The investigators worked with patients to plan this study. Patients will keep helping the investigators during the study. Sixty older people who had surgery to fix a broken hip will be invited to take part. Participants will be given a level of risk (low, medium, or high) based on an online calculator (www.stratifyhip.co.uk). All 60 participants will get usual care provided locally. Half, selected by chance, will get extra rehabilitation during their hospital stay including a self-managed exercise programme for the low-risk subgroup, education, a goal-orientated mobility programme and enhanced discharge planning for the medium-risk subgroup, and education, a goal-orientated activity of daily living programme, orientation, and enhanced assessment for the high-risk subgroup. The investigators will collect information from the 60 people taking part, at the beginning, middle, and end of the study and again 12- weeks later. What will the next step be? If this small study shows this extra rehabilitation can be provided in the NHS, and it may help patients, then the investigators plan to do a larger study. The larger study will see if this extra rehabilitation works to help older people get back home and feel happier.

The purposes of this study are to determine the benefits of a pre-operative aerobic exercise program and an 8-week postoperative aerobic exercise program with a portable upper extremity cycle-ergometer in patients with hip fracture.

Tibial plateau fractures are often complex fractures and need a good preoperative planning. The investigators think that a 3D virtual planning software will help the surgeons to get a better understanding of the fracture and therefore want to study the value of 3D virtual planning software in the preoperative planning of tibial plateau fractures. The investigators hypothesize that this software will shorten the duration of surgery, decrease the peroperative bloodloss and the number of complications. Patients with tibial plateau fractures who need surgical treatment will be asked to participate in this study. After participants have given informed consent, they will be randomized between a 'traditional preoperative planning' and a '3D virtual preoperative planning' group. Surgeons will plan their surgery using traditional planning tools (X-rays and CT scan) or traditional planning tools ánd the 3D virtual planning software. 6 weeks, 3 months and 6 months after surgery, participants will be asked to fill in 2 questionnaires about knee pain and knee function. After surgery a CT scan or X-ray will be performed conform standard of care in the hospital.

Implant anchorage is difficult in patient with osteoporotic bone. To improve the implant bone interface, the ISS stabilization system has been developed. The goal of the study is to investigate the efficacy the ISS augmentation compared to the standard PMMA augmentation of pedicle screws in the treatment of patients suffering from osteoporotic/osteopenic thoracolumbar fracture. The study has two phases, a pilot phase followed by a pivotal phase. The data will be used to measure clinical and radiological performance and usability of both systems.

The goal of this pilot study of a clinical trial is to learn about the acceptability and feasibility of a virtual smoking cessation program in both the perioperative and fracture clinic settings. The main questions this study aims to answer are: The number of people that participate in the virtual smoking cessation program The acceptability of the number, length, content, and delivery of the email messages provided by the program. Participants will be asked to subscribe to our virtual intervention which will include: A smoking cessation e-learning module component to provide education on the risks of smoking in the surgical or fracture clinic setting, and An emailing program component that will provide tailored email messages over a 30-45 day period depending on a patient's Fagerstrom test for nicotine dependence score and motivation to quit smoking. Researchers will also compare the virtual smoking cessation program to standard care to see if there are any differences shown between both groups in the Fagerstrom test for nicotine dependence scores, number of cigarettes smoked, number of quit attempts, complication rates, and re-admission rates at the 7 day and 30 day time points.