Bone Fracture

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 evaluating the quality of 3D hand modelization using the EOS imaging system compared to the standard computed tomography CT scans. The study focuses on patients who require CT imaging of the hand or wrist to assess the accuracy and potential benefits of the EOS imaging device. Participants will undergo EOS hand imaging, and these images will be compared directly with their standard CT images. The primary goal is to collect and analyze data from both imaging methods at 60 days to determine how well the EOS system performs in creating 3D models of the hand. During the study, participants will have imaging procedures and data collection focused on the hand or wrist area. Researchers will monitor and compare the imaging outcomes from both EOS and CT methods. The total participation duration includes data evaluation at day 60, with no additional treatment or long-term follow-up specified.

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 cages 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, a medical device designed to treat specific spinal fractures called vertebral compression fractures VCFs in adults aged 21 to 85 years. This study involves up to 8 hospitals in Europe and aims to assess how well the device works and how safe it is for patients with these fractures. The study compares two groups one receiving the VCFix implant with bone cement and the other without cement. Participants will receive the VCFix device implant either with or without the use of PMMA bone cement, according to their assigned study group. The device features in situ adjustment to realign vertebrae, a titanium structure allowing natural bone healing, and the potential to stabilize severe fractures through a pedicle screw component. Treatment will follow intended use guidelines, and researchers will monitor outcomes including pain reduction, function improvement, and device-related complications. During the study, participants will be assessed for changes in back pain and daily functioning at 6 months compared to before treatment. Additional measures include vertebral height restoration, spinal angle improvements, and health-related quality of life at various time points up to 24 months. Safety will be monitored through serious adverse device effects during the first month and adverse events up to two years. The total participation duration extends through follow-up assessments to evaluate both effectiveness and safety.

Researchers are evaluating whether giving children intravenous lidocaine during surgery can reduce the amount of opioid pain medicine needed and improve pain control after surgery. This randomized, double-blind trial involves children aged 3 to 18 years undergoing surgery to fix upper arm bone fractures under general anesthesia. The study aims to find safer ways to manage pain using fewer opioids during pediatric orthopedic procedures. Participants will be randomly assigned to receive either a lidocaine infusion or a placebo normal saline during their surgery. All children will receive standard anesthesia and pain care afterward. The study will compare total opioid use within 60 minutes after arrival in the recovery room between the two groups. Additional measures include pain scores at various times, length of recovery room stay, use of anti-nausea medication, and how infusion duration relates to outcomes. During the study, children will be closely watched for any side effects or signs of lidocaine toxicity. Researchers will collect data on opioid consumption and pain levels during and after surgery. The primary focus is on opioid use in the first hour after surgery. The study will continue through the recovery period, monitoring safety and effectiveness, with participation lasting from surgery through early recovery.

This research aims to explore the clinical significance and causes of generalized vulnerability in older adult men with serious diseases including various cancers and fractures. It seeks to establish how common these causes are among patients with severe non-cancerous diseases, local and advanced cancers, and how these vulnerabilities affect the time to fully palliative care, overall survival, and quality of life. The study also evaluates how well common screening tools used in non-cancer patients detect vulnerability in older adults with cancer. Participants are men diagnosed with conditions such as prostate cancer, lung cancer, brain metastasis, pelvic fracture, chronic subdural hematoma, or those undergoing high-dose chemotherapy and stem cell transplantation. The study is observational and involves tests designed to determine vulnerability. Patients are required to have recent cross-sectional imaging and study procedures within defined timeframes relative to treatment or hospitalization. No experimental treatments are administered. During the study, participants will undergo assessments to detect causes of vulnerability around the time of study procedures. Researchers will monitor survival, timing of palliative care adoption, and patient-reported quality of life. The study will collect clinical data and imaging results. Participation involves observational data collection without additional treatment, with the study continuing until December 2030.

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.

Musculoskeletal disorders and injuries cause significant disability worldwide, affecting people of all ages and leading to pain, limited mobility, and reduced quality of life. This ongoing open-label, single-arm phase IIIa study is evaluating the safety of a human allogeneic bone marrow-derived mesenchymal stromal cell product called StromaForte in patients with musculoskeletal injuries andor degeneration. The study aims to assess safety and changes in pain over one year after treatment with these stem cells. Participants receive 50 million StromaForte cells locally injected under ultrasound guidance at the injury or degeneration site, combined with or without 100 million cells given intravenously over about 30 minutes. If local injection is not possible, only the systemic intravenous treatment is given. Additional doses may be administered with specified minimum intervals between local and systemic doses. Four subgroups based on connective tissue injury or degeneration type are included. During the study, patients are monitored for adverse events up to one year after treatment. Researchers assess pain levels in each injured or degenerated area, quality of life measures using questionnaires, and changes in pain between treatment subgroups. Follow-up can be face-to-face or remote. This comprehensive evaluation will provide data on safety and patient-reported outcomes following StromaForte administration for musculoskeletal conditions.

Researchers are evaluating post-operative management approaches after a modified Lapidus arthrodesis surgery for hallux valgus, with or without additional surgeries such as Akin or WeilHohmann procedures. The study aims to compare the effectiveness and safety of immediate full weight-bearing versus partial weight-bearing 10-15 kg during rehabilitation. This randomized controlled trial explores a new rehabilitation method following foot surgery to improve recovery. Participants will be randomly assigned to one of two groups after surgery one group will follow partial weight-bearing with a specialized VACOPASO shoe and use crutches along with antithrombotic medication for 6 weeks, while the other group will have immediate complete weight-bearing with the same shoe and medication for the same period. The surgical operation follows standard clinical practices for hallux valgus correction. During the study, healing progress will be monitored through standard X-rays at 6, 12, and 24 weeks to check bone healing, hardware fixation, and fracture alignment. Pain will be measured using a Visual Analogue Scale at the day of surgery and at follow-up visits. Quality of life and functional recovery will be assessed through established foot and ankle scoring systems at multiple time points. The main outcome is the subjective functional recovery measured by the Olerud and Molander Ankle Score at 6 weeks post-surgery.

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.