View clinical trials related to Fractures, Bone.
Filter by:fracture shfat tibia in adults treated by interlocking intramedullary nail by primary dynamic versus standard ways
The HIFSAT study will compare the standard direct lateral approach to hemiarthroplasty to a new muscle sparing approach (SPAIRE) in femoral neck fracture patients.
The purpose of this randomized double-blind clinical trial is to determine the efficacy of percutaneous vertebroplasty (PVP) in relieving severe pain in patients with MRI-verified acute or sub-acute osteoporotic vertebral compression fractures (OVCFs) compared to sham as well as examine the socio-economic implications associated with performing vertebroplasty. The primary outcome is improvement of pain intensity as measured on a Visual Analog Scale (VAS, 0 to100) 12 weeks after treatment. Secondary outcomes include patient-reported back-related disability, patient-reported quality of life, spinal sagittal balance, complications associated with the procedure, incidence of new OVCFs and socioeconomic costs.
The goal of this clinical trial is to investigate the new bone formation around a metal device in the femoral head in patients with osteoporotic hip fractures undergoing surgical treatment with nails. These surgeries have a high risk of fixation failure in patients with osteoporosis due to low bone quality. The main question we aim to answer are whether promoting new bone formation around the implant is possible with a bone graft substitute (CERAMENTâ„¢ Bone Void Filler) and systemic osteoporosis drug (zoledronic acid) combination, which can strengthen the surgical fixation of the fracture. Participants will consist of patients suffering hip fracture and already scheduled for surgical treatment with a nail. One group will undergo conventional surgery. While the other group will also undergo the same surgery, they will receive CERAMENTâ„¢ Bone Void Filler around the implant as a short, extra step during surgery. This will allow the researchers to see whether new bone is formed during a 6-month follow-up.
With the aging of the world population, osteoporosis and fragility fractures have become global public health concerns. It has been estimated the population of people ≥60 years of age will increase from 229 million (16.2%) in 2017 to 479 million (35.1%) by 2050 in China. Because age is an important predictor of osteoporosis and fragility fracture, the incidence of fragility fracture has increased dramatically in China over the past decades. Timely treatment of osteoporosis is an effective way to decrease additional fracture risk among patients with fragility fractures, but anti-osteoporosis treatment rate is relatively low in China. Effective fracture prevention intervention is urgently needed in China. As a potential way to achieve effective risk communication, shared decision-making allows patients to be active participants in the management of osteoporosis. The investigators designed a multifaceted intervention, which was named as "Precise Education + Shared Decision-Making" program for the secondary prevention of fragility fractures based on behavioral theories, and assessed the effectiveness for fracture prevention using a pilot cluster randomized controlled trial among several hospitals in China. The aim of this pilot study is to test the acceptability and feasibility as well as preliminary efficacy of this program in patients with fragility fractures.
The purpose of this study is to evaluate compare postoperative range of motion in patients who are given a sling for comfort only and allowed to start early active range of motion compared to patients who are placed in a sling for 4 weeks with passive range of motion only. Once enrolled, the patients will be randomized through computer randomization then placed in paper packets into either the immobilization group or the early range of motion group.
The goal of this randomized clinical trial is to compare how a program of proprioceptive exercises for the wrist could influence in pain, functionality and quality of life in people that have suffered a wrist fracture. The main questions it aims to answer are: - Evaluate the effect of a specific proprioceptive program on pain and functionality. - Study the relationship between proprioception deficit and functionality. Intervention will be: - Control group: participants of this group are going to receive only standard rehabilitation program after wrist fracture. - Experimental group: participants of this group are going to receive standard rehabilitation program after distal radius fracture and a specific proprioceptive program. Researchers will compare control and experimental group to see if a implantation of a proprioceptive program for the wrist has benefits on pain, function and quality of life.
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.
This double-blind, randomized controlled clinical study aims to evaluate the effects of PBM on the functional recovery of participants with surgically treated PHF using special locking plates. The 42 participants will be randomized (1:1) into two groups: the Control group (standard physical therapy combined with simulated PBM) and the PBM group (standard physical therapy combined with active PBM). Participants will apply PBM at home daily for 10 minutes using a device containing 318 light-emitting diodes (LEDs), with 159 LEDs at 660 nm (28.5 mW; 12 J/cm2; 17 J per LED) and 159 LEDs at 850 nm (23 mW; 10 J/cm2; 14 J per LED). PBM and physical therapy sessions (30 minutes, twice a week) will be conducted over 12 weeks. Participants will be unaware of their group allocation and will be assessed at 24 hours, 1, 2, 4, 8, and 12 weeks after surgery by four examiners who are also blinded to each participant's allocation. The primary outcome, assessed at all time points, will be shoulder function recovery using the Quick-DASH functional scale. Secondary outcomes will include shoulder range of motion assessments with a digital goniometer, quality of life using the SF-6 questionnaire, and the occurrence of adverse effects at all time points. Spontaneous pain, pressure pain (measured with a dolorimeter), nighttime pain, and analgesic use will be evaluated at 1, 2, 4, 8, and 12 weeks. Fracture consolidation will be assessed at 4, 8, and 12 weeks through radiographic examinations, and muscle strength will be evaluated by progressive dumbbell support at 8 and 12 weeks. In addition to the scheduled assessments, participants will be contacted daily by phone.
An open reduction and internal fixation is a painful procedure requiring intensive postoperative pain management. Traditionally, opioid analgesia has been the gold standard for postoperative pain control. However, given the harmful side effect profile and opioid epidemic in the United States, it is advantageous to use alternate forms of analgesia. Multimodal pain control captures the effectiveness of different analgesic modalities and maximizes analgesia while minimizing side effects. The theory behind their use is that agents with different mechanisms of action work synergistically in preventing acute pain. Objective: To measure postoperative pain control in patients in two treatment arms of ORIF of the clavicle: a treatment group given a nonopioid pain control regimen, and a standard of care control group given standard opioid pain control regimen. Study Design: A randomized single blinded standard of care controlled clinical trial comparing pain management interventions. All adult patients scheduled for an ORIF following a traumatic fracture by fellowship trained Trauma surgeons will be eligible for inclusion. Patients will be excluded if their medical history presents known allergies or intolerance to Motrin, Lyrica, Tylenol, Zanaflex, substantial alcohol or drug abuse, and pregnancy, history of narcotics within 6 months of surgery, renal impairment, peptic ulcer disease, GI bleeding. On the day of surgery, patients will be randomized to receive a nonopioid pain control regimen or an opioid regimen using a computer-generated sequence. If pain is uncontrolled, patients will also be sent home with a prescription with 10 pills of 5 mg of Oxycodone for breakthrough pain. The amount of oxycodone taken will be recorded. Patients can call the resident on call, available 24-hours per day, if additional pain control is needed. Treatment: All patients will undergo previously scheduled ORIF of the clavicle in standard fashion and be randomized to the non-narcotic pain regimen vs the narcotic pain regimen.