Fracture

Researchers are investigating the relationship between functional measures of balance and gait and objective kinetic and kinematic parameters in people with Multiple Sclerosis (MS). This cross-sectional observational study aims to understand how biomechanical gait and balance data collected through the Vicon motion analysis system relate to clinical assessments of balance, gait, and physical performance. The study seeks to identify which biomechanical factors are most closely linked to functional abilities and mobility challenges in MS. Participants will attend a single laboratory session where they will undergo biomechanical analysis of balance and gait using the Vicon motion capture system. They will also complete standardized functional tests including the Mini Balance Evaluation Systems Test, Functional Gait Assessment, Short Physical Performance Battery, and a 2-Minute Walk Test. Additionally, they will fill out questionnaires assessing fear of falling and fatigue and have their lower-limb spasticity evaluated with the modified Ashworth Scale. During the session, which takes about 40 minutes for the primary kinetic and kinematic analysis and additional time for functional assessments, researchers will collect detailed movement data alongside clinical measures. This data will be analyzed to explore correlations between biomechanical parameters and functional outcomes. The study includes assessments of postural control, gait performance, physical endurance, fatigue, and spasticity. The findings aim to improve understanding of movement impairments in MS and support better clinical assessments and rehabilitation approaches.

Researchers are evaluating two different local anesthetic methods for pain control during closed reduction of distal radius fractures, focusing on elderly and adult patients. The study compares ultrasound-guided supracondylar block of the radial nerve with hematoma block to determine which provides better pain relief during the procedure. The trial also assesses the quality of bone reduction using radiographic measurements and monitors adverse events for safety. Participants receive either a hematoma block or an ultrasound-guided supracondylar radial nerve block before the closed reduction maneuver. Both groups receive pain medication with diclofenac or acetaminophen if NSAIDs are contraindicated. After a 10-minute wait following the analgesic administration, the closed reduction is performed manually, and the wrist is immobilized with a cast or splint. Radiographs are taken before and after reduction to measure bone alignment. During the study, demographic and clinical data are collected, including pain levels before and after analgesia and reduction, using a numeric pain scale. Researchers record radiographic outcomes such as radial height and dorsal tilt, as well as any complications or adverse effects occurring up to three hours post-intervention. The trial includes blinded data analysis and an interim evaluation to monitor safety and effectiveness, with results intended for publication.

Researchers are studying the use of the TRUMATCH Graft Cage to repair large segmental defects in long bones such as the humerus, femur, and tibia. This observational case series includes patients aged 18 and older who have these critical-sized bone defects requiring surgical fixation. The goal is to collect data over three years to better understand the healing process, complications, and recovery outcomes associated with this device. Participants who agree to join will receive the TRUMATCH Graft Cage during surgery to repair their long bone defects. The study focuses on collecting information about healing rates, complication rates, reoperation rates, pain levels, and the time it takes to return to normal activities. Data collection will occur over two years following the procedure to evaluate early outcomes of using the graft cage. During the study, participants will be monitored regularly to track their healing progress and any complications. Researchers will assess pain scores, need for additional surgeries, and functional recovery. The study will analyze this information after three years of data collection to provide insights on the graft cage's usefulness for managing complex long bone injuries. Participation involves follow-up visits and evaluations related to their surgical repair and recovery.

Researchers are evaluating the safety and effectiveness of the VCFix Spinal System as a treatment for Vertebral Compression Fractures. The study focuses on reducing pain related to vertebral fractures and improving physical function and mobility. It also ensures the absence of serious adverse events caused by the device or procedure. This clinical investigation is prospective and conducted at multiple centers, sponsored by Amber Implants B.V. The treatment involves the use of the VCFix Spinal System in a stand-alone configuration. This device allows in situ adjustment to restore vertebral height and correct spinal alignment. It features a titanium structure designed to promote natural bone healing without the use of bone cement, potentially reducing side effects. The system also stabilizes the vertebra by connecting different parts of the spine using a pedicle screw component. Participants receive this device through a surgical procedure. Participants will be involved in assessments measuring pain reduction, physical function, vertebral height restoration, spinal angles, and quality of life at various time points including discharge, 1, 3, 6, 12, and 24 months after the procedure. Safety monitoring includes tracking serious adverse device effects up to one month post-procedure and adverse events up to 24 months. The total duration of participation covers these follow-up visits to evaluate long-term outcomes and device performance.

This research aims to evaluate interventions to support family members who act as surrogate decision makers for critically ill patients in Intensive Care Units (ICUs). These surrogates often face intense grief and stress that can affect their mental health and the quality of decisions made for their loved ones near end-of-life. The study focuses on reducing symptoms of prolonged grief disorder (PGD), post-traumatic stress disorder (PTSD), and related emotional challenges through a psychological intervention called EMPOWER. The study compares two approaches: the EMPOWER intervention, which is a brief, cognitive-behavioral and acceptance-based treatment delivered by trained mental health professionals, and a Supportive Conversation (SC) that provides empathetic support without specific skill-building. EMPOWER includes six 15-minute modules and two booster phone sessions, totaling about 90 minutes plus follow-ups, while the Supportive Conversation matches this time with supportive interaction and follow-up calls. Participants are assessed up to four times before and after the intervention within three months. Participants, who are surrogate decision makers of ICU patients near end-of-life, will complete assessments on grief, PTSD, depression, regret, anxiety, and distress before the intervention, immediately after, and at 3 and 12 months follow-up. The study also includes interviews with some participants to better understand the intervention's effects and contextual factors during the COVID-19 pandemic. The primary outcomes focus on changes in grief and PTSD symptoms over twelve months, with safety and mental health monitored throughout the study period.

Researchers are comparing two types of internal fixation devices used to treat femoral neck fractures classified as AO 31-B. This study aims to evaluate and compare the failure rates and fracture healing outcomes between patients treated with the Femoral Neck System (FNS) and those treated with Multiple Cancellous Screws (MCS) over a two-year follow-up period. The study is a prospective multicenter cohort design, led by Peking University Third Hospital, and seeks to gather clinical data on FNS use in the Chinese population while assessing its safety and effectiveness. Participants are assigned to one of two groups based on the internal fixation method they choose: Group 1 receives the FNS device, which combines features of the dynamic hip screw and cancellous screws, designed to allow controlled fracture compression with a smaller implant footprint. Group 2 receives three cancellous screws arranged in an inverted triangle pattern to fix the femoral neck fracture. All procedures follow product instructions, and only cases suitable for closed reduction are included. After surgery, standard nursing and rehabilitation protocols are followed, with detailed recording of operation time, fluoroscopy use, and postoperative care. Patients will be monitored regularly over two years with clinical assessments and imaging such as X-rays and CT scans to evaluate internal fixation failure, bone healing, and adverse events like avascular necrosis or infection. Outcomes measured include the internal fixation failure rate, bone nonunion, hip function scores, operation details, and postoperative complications. The study uses independent radiological evaluation to determine implant performance and fracture healing, aiming to provide comprehensive safety and prognosis data for both fixation methods.

Researchers are conducting a monocentric observational prospective study to assess how common vertebral fractures are among male patients aged 50 years and older who undergo chest-abdomen CT scans for reasons other than bone metabolic diseases. The study aims to use advanced imaging techniques combined with artificial intelligence to identify fractures that may otherwise be unnoticed. Participants will have their CT scans evaluated both by radiologists using automatic 3D reconstruction of the thoracic and lumbar spine and by AI software called NanoxAIHealthVCF from NANO-X IMAGING LTD. The study plans to enroll about 250 patients between March 1, 2025, and February 28, 2026. If one or more vertebral fractures are detected by either method, the patient will be referred for further evaluation in an Endocrinology Unit as part of standard care. Participants will provide clinical, body measurement, and medical history data at the time of their CT scan. The study involves only one evaluation during the CT scan visit, with no additional study visits unless a fracture is found. The main outcome measured is the number of vertebral fractures detected by the combined AI and 3D reconstruction method during the specified enrollment period. The study is observational, so no experimental treatment is given, and patient care follows usual medical practices.

Researchers are comparing two rehabilitation methods for patients who have had surgery to treat malleolar fractures, specifically focusing on immediate complete weight-bearing versus delayed weight-bearing. The study targets patients with more stable lateral malleolar fractures, classified as Weber A and Weber B, to safely evaluate if immediate weight-bearing can speed up ankle functional recovery without increasing complications. This randomized controlled trial plans to enroll about 100 patients to detect meaningful differences in recovery scores six weeks after surgery. After surgery, patients will be assigned to one of two groups. The experimental group will begin full weight-bearing immediately, performing daily activities without limits or walking aids while wearing an ankle brace for protection. The control group will delay full weight-bearing for six weeks, limiting weight on the ankle to 20-30% of their body weight using crutches, also with an ankle brace. Follow-up visits occur at 2, 6, 12, and 24 weeks post-surgery, with extended monitoring up to 48 weeks if fracture healing is delayed. Participants will undergo clinical assessments including subjective and objective ankle function, pain levels, quality of life, and radiological evaluations at scheduled visits. Researchers will measure changes in functional recovery using the Olerud-Molander Ankle Score primarily at six weeks. Safety will be monitored throughout, and patient satisfaction will be recorded. The study duration is approximately two and a half years, covering enrollment and follow-up periods.

Researchers are evaluating a new approach to improve care coordination between hospitals and primary care for patients aged 75 or older who have suffered a hip fracture. The study focuses on osteoporosis treatment using zoledronic acid infusions combined with vitamin D and calcium supplements to prevent further fractures. The trial aims to test if ambulant nurses assisting general practitioners (GPs) can increase the number of patients receiving recommended annual zoledronic acid infusions over three years after their fracture. Participants receive an initial infusion of zoledronic acid 5 mg at the hospital after their femoral neck fracture and are then followed in one of two ways based on their region. In intervention regions, ambulant nurses support GPs with administering zoledronic acid yearly for three years. In control regions, patients receive usual care where GPs are responsible for follow-up and annual infusions guided by discharge summaries. The study is designed as a cluster randomized controlled trial with regions assigned to intervention or control groups. During the study, patients from both groups are asked to complete a questionnaire after one year, reporting if they received zoledronic acid as recommended. The main outcome is whether patients are offered treatment at the one-year follow-up. The trial includes safety monitoring and data collection over three years, with an estimated total of 200 patients to account for mortality. It seeks to establish practical procedures for nurse-assisted osteoporosis treatment in primary care settings to improve patient care continuity after hospital discharge.

Researchers are evaluating the use of the ADAPT system, a computer navigation tool that creates a 3D reconstruction of the femoral head during surgery, to improve the treatment of proximal femur fractures. This study compares intramedullary nailing procedures done with the ADAPT system to those done without it, aiming to improve screw placement, reduce surgery time, and lower radiation exposure. The trial is a randomized controlled study involving patients aged 50 to 85 years with specific types of femoral fractures. Participants will be randomly assigned to one of two groups: one group will receive intramedullary nailing assisted by the ADAPT system, which provides real-time tracking of screw placement, and the other group will undergo standard intramedullary nailing without this navigation aid. Both groups will have their surgeries assessed under blinded conditions, and the study will enroll a total of 96 patients. Data collected will include surgery duration, blood loss, radiation exposure, and surgeon satisfaction. During the one-year participation, patients will have follow-up visits to evaluate fracture healing, complications such as screw cut-out or cut-through, pain levels using a visual scale, and hip function through the Oxford Hip Score. The primary outcome is the tip to apex distance measured on X-rays immediately after surgery. Safety and adverse events related to treatment will be monitored throughout the follow-up period, which lasts up to 12 months after surgery.