[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteoporotic-vertebral-compression-fractures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteoporotic-vertebral-compression-fractures":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,53,80,109,135],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100644098","safety-and-efficacy-clinical-trial-of-the-vessel-x-bone-filling-container-system-100644098",false,"NCT07665424","Safety and Efficacy Clinical Trial of the Vessel-X® Bone Filling Container System","The Clinical Investigation to Evaluate the Safety and Efficacy of Vessel-X® Bone Filling Container System","CMT-VX","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for enrollment in this study:\n\n1. Male or female subjects aged ≥40 and ≤95 years.\n2. Subjects admitted with vertebral compression fractures (VCFs) caused by osteoporosis or trauma.\n3. Surgical site within the range of T6 to L5.\n4. Subjects with normal vital signs and hepatic and renal function values within 1.5 times the upper limit of normal (ULN), as determined by the investigator to be suitable for study participation.\n5. Subjects willing to comply with the study schedule and all required assessment procedures.\n6. Subjects who are conscious, cognitively intact, and able to provide written informed consent.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will be excluded from participation in this study:\n\n1. Pathological fractures caused by bone diseases, including benign or malignant tumors, tuberculosis, osteomyelitis, endocrine or metabolic bone disorders, or severe degenerative bone diseases.\n2. Active or severe systemic infections.\n3. Metabolic disorders (e.g., calcium metabolism disorders), immune system disorders, substance abuse, or alcoholism.\n4. Severe primary diseases involving the hematopoietic or endocrine systems, or psychiatric disorders.\n5. History of allergy to implant materials, hypersensitivity reactions, or allergies to multiple medications.\n6. Non-viable bone surrounding the surgical site or insufficient bone quality to support the implant.\n7. Active infection at or adjacent to the surgical site.\n8. Acute spinal instability.\n9. Unwillingness or inability to restrict physical activity or comply with medical instructions.\n10. Considered unsuitable for study participation by the investigator, or unable to provide independent informed consent.","ALL","40 Years","95 Years",{"count":21,"type":22},146,"ESTIMATED","INTERVENTIONAL",[25],"NA","Osteoporotic vertebral compression fractures (OVCFs) are a common and serious complication of osteoporosis, particularly among elderly and postmenopausal patients. OVCFs may result in severe pain, functional impairment, spinal deformity, and reduced quality of life. Conventional conservative treatments, including bed rest, analgesics, and bracing, may provide limited symptom relief. Minimally invasive vertebral augmentation procedures, such as vertebroplasty and kyphoplasty, have been widely used to improve clinical outcomes; however, risks including bone cement leakage and incomplete vertebral restoration remain concerns.\n\nThe Vessel-X® Bone Filling Container System, manufactured by Central Medical Technologies Inc. (CMT), is a third-generation vesselplasty technology designed for percutaneous vertebral augmentation procedures. The system utilizes an implantable biocompatible polyethylene terephthalate (PET) container with a microporous structure for controlled bone cement delivery. The implant remains within the vertebral body after cement injection and is designed to reduce cement leakage while maintaining vertebral height restoration and pain relief.\n\nThis post-market clinical study evaluates the safety and clinical effectiveness of the Vessel-X® Bone Filling Container System at two medical centers in Taiwan with a total target enrollment of 146 subjects:\n\nTri-Service General Hospital (TSGH): 86 subjects randomized in a 1:1 ratio to the experimental and control groups.\n\nTaoyuan General Hospital, Ministry of Health and Welfare (TYGH): 60 subjects randomized in a 1:1 ratio to the experimental and control groups.\n\nThe primary objective is to evaluate the safety of the device by assessing the incidence of unanticipated serious adverse device effects (USADEs). Secondary objectives include evaluation of pain reduction measured by the Visual Analogue Scale (VAS), functional recovery assessed by the Oswestry Disability Index (ODI), and radiographic outcomes including vertebral height restoration and kyphotic deformity correction.",[28,29],"Osteoporosis","Osteoporotic Vertebral Compression Fractures",[31,32,33,34,35,36,37,38,39],"Oswestry Disability Index","Visual Analogue Scale","Serious Adverse Device Effect","Last Observation Carry Forward","CMT Vessel-X® Bone Filling Container System","Vesselplasty","Kyphoplasty","Vertebroplasty","Osteoporotic vertebral compression fractures (OVCFs)","RECRUITING","2026-06-22",{"date":43,"type":44},"2026-06-24","ACTUAL",{"date":46,"type":44},"2021-04-20",{"date":48,"type":22},"2026-12-31",{"name":50,"class":51},"Juin-Hong Cherng","OTHER",2,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":64,"conditions":65,"keywords":66,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":77,"locationsCount":79},"100640314","standardized-study-protocol-of-percutaneous-vertebroplasty-based-on-pedicle-nine-grid-zoning-method-100640314","NCT07616583","Standardized Study Protocol of Percutaneous Vertebroplasty Based on Pedicle Nine-Grid Zoning Method","Inclusion Criteria:\n\n* Diagnosed with single-segment acute osteoporotic lumbar vertebral compression fracture (L1-L5), confirmed by typical MRI manifestations: low signal on T1-weighted imaging and high signal on T2-weighted and STIR sequences.\n* First-time reception of percutaneous vertebroplasty (PVP) surgery.\n* Complete preoperative imaging data including X-ray, CT, and MRI\u002Fbone scan.\n* Aged patients who voluntarily participate in the study and sign written informed consent.\n\nExclusion Criteria:\n\n* Patients with old vertebral compression fractures or congenital pedicle dysplasia and lesions.\n* With a history of bone tumors or other systematic bone metabolic diseases.\n* CT examination shows incomplete or ruptured posterior wall of the fractured vertebral body.\n* Failure to obtain signed informed consent.","50 Years","80 Years",{"count":62,"type":22},68,[25],"The goal of this clinical trial is to verify the safety and efficacy of the pedicle \"Nine-grid Zoning Method\" in assisting percutaneous vertebroplasty (PVP) for the treatment of lumbar osteoporotic vertebral compression fractures (OVCF) in adults. It also aims to standardize the puncture path of PVP and optimize the intraoperative operation process. The main questions it aims to answer are:\n\n* Does the \"Nine-grid Zoning Method\" significantly increase the rate of achieving ideal intraoperative puncture endpoints and reduce operative time compared with the traditional pedicle puncture method?\n* Does the novel puncture method reduce intraoperative fluoroscopy times, radiation exposure, and the incidence of postoperative bone cement leakage without increasing surgical risks? Researchers will compare the modified PVP assisted by the \"Nine-grid Zoning Method\" (experimental group) with conventional PVP adopting the traditional \"10 o'clock\u002F2 o'clock\" pedicle puncture point (control group) to confirm the clinical superiority and safety of the new standardized puncture path.\n\nParticipants will:\n\n* Receive unilateral transpedicular PVP surgery via either the nine-grid zoning puncture path or the traditional puncture path for single-segment acute lumbar OVCF\n* Complete preoperative baseline examinations including bone density detection, VAS pain score, ODI functional score and SF-36 quality of life score assessment\n* Receive standardized intraoperative data recording covering operative time, fluoroscopy frequency, radiation dose, bone cement filling and leakage conditions\n* Undergo postoperative follow-up at 1 day after surgery, discharge, 3 months, 6 months and 1 year after operation, with regular imaging re-examination and scale evaluation to monitor fracture recovery and postoperative complications",[29,38],[67,68,69,70],"Nine-grid Area Division Method","PVP","OVCF","Vertebral pedicle puncture","2026-05-27",{"date":73,"type":44},"2026-06-01",{"date":75,"type":44},"2024-01-01",{"date":48,"type":22},{"name":78,"class":51},"Beijing Friendship Hospital",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":79},"100594795","inspiratory-muscle-training-after-vertebroplasty-in-osteoporotic-fracture-patients-100594795","NCT07024095","Inspiratory Muscle Training After Vertebroplasty in Osteoporotic Fracture Patients","\"Effects of Inspiratory Muscle Training on Pulmonary Function, Functional Capacity, and Quality of Life After Percutaneous Vertebroplasty in Individuals With Osteoporotic Vertebral Compression Fracture\"","Inclusion Criteria:\n\n* Being 50 years of age or older at the time of the study,\n* Having a diagnosis of osteoporosis confirmed by a specialist physician,\n* Having undergone percutaneous vertebroplasty surgery due to an osteoporotic vertebral compression fracture in the thoracic region within the past 3 months,\n* Being cooperative with the questionnaires and assessment methods to be used in the study,\n* Being able to read and voluntarily agree to participate in the study by signing the informed consent form.\n\nExclusion Criteria:\n\n* Having a history of diagnosed unstable cardiac disease,\n* Having a diagnosed pulmonary or neurological disorder,\n* Having experienced an acute infection within the past 15 days,\n* Being unable to participate in exercise interventions due to mental or cognitive impairment.",{"count":88,"type":22},24,[25],"This study investigates the long-term effects of inspiratory muscle training (IMT) on pulmonary function, functional capacity, and quality of life in individuals with osteoporotic vertebral compression fractures who have undergone percutaneous vertebroplasty.\n\nParticipants aged 50 and older, diagnosed with osteoporosis and having undergone thoracic vertebroplasty within the past 3 months, will be randomly assigned to either an intervention group (IMT + standard rehabilitation) or a control group (standard rehabilitation only).\n\nThe primary outcome measure is spirometry-based pulmonary function. Secondary outcome measures include inspiratory muscle strength, functional walking capacity (6-minute walk test), diaphragmatic structure and elasticity, and quality of life (SGRQ, NHP).\n\nThis randomized controlled trial will be conducted at the Cardiopulmonary Rehabilitation Unit of Nuh Naci Yazgan University and aims to provide scientific evidence for integrating IMT into routine post-vertebroplasty rehabilitation protocols.",[29,92,93,94],"Restrictive Pulmonary Disorders","Inspiratory Muscle Weakness","Postoperative Pulmonary Function",[38,96,97,98,99],"Functional Capacity","Respiratory Muscle Training","Rehabilitation","Physical Fitness","2026-04-16",{"date":102,"type":44},"2026-04-21",{"date":104,"type":44},"2025-07-01",{"date":106,"type":22},"2026-04-30",{"name":108,"class":51},"Istinye University",{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":119,"phases":4,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":79},"100616534","ct-based-deep-learning-for-differentiating-acute-and-chronic-osteoporotic-vertebral-compression-fractures-100616534","NCT07306858","CT-Based Deep Learning for Differentiating Acute and Chronic Osteoporotic Vertebral Compression Fractures","A Deep Learning Model Based on CT Images for Differentiating Acute and Chronic Osteoporotic Vertebral Compression Fractures","CT-DL-OVCF","Inclusion Criteria:\n\n* Inclusion Criteria:\n* Patients diagnosed with osteoporotic vertebral compression fractures.\n* Patients who underwent both CT and MRI examinations of the spine, with an interval of less than 2 weeks between examinations.\n* Availability of complete CT and MRI imaging data in DICOM format.\n* Availability of complete clinical information, including age, sex, and dual-energy X-ray absorptiometry (DXA) results.\n* Age 50 years or older at the time of imaging.\n\nExclusion Criteria:\n\n* Vertebral compression fractures caused by infection or malignancy.\n* Presence of foreign materials, including bone cement or metallic hardware.\n* Poor image quality or significant imaging artifacts that affect analysis.",{"count":118,"type":22},276,"OBSERVATIONAL","Osteoporotic vertebral compression fractures are common in older adults and may present as either acute or chronic fractures. Correctly distinguishing acute from chronic fractures is clinically important because treatment strategies and management decisions differ depending on fracture chronicity. However, differentiating acute and chronic osteoporotic vertebral compression fractures based on imaging findings alone can be challenging in routine clinical practice.\n\nThis retrospective study aims to develop an intelligent diagnostic system based on computed tomography (CT) images to differentiate acute and chronic osteoporotic vertebral compression fractures. Clinical and imaging data from patients diagnosed with osteoporotic vertebral compression fractures will be collected from the First Affiliated Hospital of Chongqing Medical University and an additional medical center. A deep learning model will be trained to automatically analyze CT images and classify fractures as acute or chronic.\n\nThe results of this study may help improve the accuracy and efficiency of fracture chronicity assessment using CT images and provide supportive information for clinical decision-making regarding treatment selection in patients with osteoporotic vertebral compression fractures.",[29],[123,124],"Osteoporotic vertebral compression fracture","Deep learning","NOT_YET_RECRUITING","2025-12-26",{"date":128,"type":44},"2025-12-31",{"date":130,"type":22},"2025-12-16",{"date":132,"type":22},"2026-01-15",{"name":134,"class":51},"Xin Fan",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":23,"phases":145,"briefSummary":146,"conditions":147,"keywords":148,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":79},"100575724","continuous-mobility-and-physical-activity-in-vertebroplasty-vs-sham-for-osteoporotic-vertebral-fracture-100575724","NCT06776003","Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture","Continuous Mobility and Physical Activity in Vertebroplasty vs Sham for Osteoporotic Vertebral Fracture: a Single-center, Double-blind Randomized Controlled Clinical Trial","VOPE2 COMPAS","Inclusion Criteria:\n\n* Patients aged 50+ and diagnosed with symptomatic osteoporotic spinal compression fractures between T6 and L5 (incl).\n* Focal tenderness on the level of the vertebral fracture.\n* Fractures verified with oedema of the relevant vertebra on the MRI STIR sequence.\n* Osteoporotic Fractures type 1-4.\n* Fracture involves no more than 4 vertebral body levels.\n* Vertebroplasty can be done in one session.\n* Back pain score measured on a Visual Analog Scale (VAS, 0 to 100) ≥ 60.\n* Able to understand and read Danish.\n* Written informed consent.\n* Relevant pain started ≤ 3 months prior to enrollment.\n\nExclusion Criteria:\n\n* Contra-indications for spine surgery.\n* Platelets \\\u003C 30 mia\u002Fl.\n* Osteoporotic Fractures type 5 and Pincer-type.\n* Complete collapse of the vertebral body precluding insertion of needle.\n* Presence of neurologic deficit.\n* Contraindications for MRI scanning.\n* Psychological or psychiatric disorder that is expected to interfere with compliance.\n* Active malignancy.\n* Mini Mental State Examination (MMSE) test score below 24.\n* History of chronic back pain requiring ongoing opiate use.\n* Systemic or local infection of the spine.",{"count":144,"type":22},64,[25],"The aim of this clinical trial is to determine if vertebroplasty is an effective treatment for acute, painful vertebral fractures due to osteoporosis.\n\nThe focus of the study is on the physical activity and mobility of participants.\n\nThe main questions the trial aims to answer are:\n\n* Does vertebroplasty lead to increased physical activity as measured by accelerometer?\n* Does vertebroplasty lead to increased mobility as measured by GPS (global positioning system)?\n* Do physical activity and mobility correlate with pain, disability and quality of life?\n\nResearchers will compare vertebroplasty to sham (simulated surgery without active intervention) to understand if vertebroplasty improves physical activity and mobility.\n\nParticipants will\n\n* Undergo vertebroplasty or sham procedure\n* Wear an accelerometer and a GPS-reciever in a belt for 1 week before to 4 weeks after the surgery\n* Answer questionnaires regarding pain, disability and quality of life at regular intervals.\n\nThe knowledge gained from this can help determine who would benefit from vertebroplasty.",[29],[149,150,38,151,152,28,153,154,155,156,157],"Accelerometer","Global Positioning System","Physical Activity","Mobility","Spinal Surgery","ActiGraph","Accelerometry","GPS","Osteoporotic","2025-06-19",{"date":160,"type":44},"2025-06-25",{"date":162,"type":44},"2025-02-20",{"date":164,"type":22},"2026-12",{"name":166,"class":51},"Spine Centre of Southern Denmark"]