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.

This research aims to compare two surgical methods for treating hip labral tears, a condition affecting the cartilage around the hip joint. The study focuses on patients with femoroacetabular impingement and traumatic labral tears to evaluate which treatment may lead to better hip function and pain relief. The trial is a randomized, double-blind comparison conducted by Ain Shams University. Participants will undergo hip arthroscopy under general anesthesia, where surgeons will use two portals to access the hip joint under fluoroscopic guidance. Patients will be randomly assigned to receive either arthroscopic labral repair, which uses suture anchors to fix the tear, or arthroscopic labral debridement, which involves removing damaged tissue using electrocautery. Both procedures address any labral, cartilage, or bony issues present during surgery. Participants' hip function and pain levels will be assessed before surgery and at 1, 3, and 6 months, as well as at 1 year after the procedure, using the Hip Outcome Score, Harris Hip Score, and Visual Analog Scale. These evaluations will help measure changes in hip function and pain over time. The study follows patients for a total of one year after surgery to monitor recovery and outcomes.

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.

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.

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 I/IIa study is evaluating the safety of a human allogeneic bone marrow-derived mesenchymal stromal cell product called StromaForte in patients with musculoskeletal injuries and/or 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 Weil/Hohmann 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.