[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vertebral-fracture\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vertebral-fracture":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,38,65,90,119,144,165,198],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100550643","a-prospective-observational-study-of-artificial-intelligence-morphometric-evaluation-of-vertebral-fractures-100550643",false,"NCT06449742","A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures","Inclusion Criteria:\n\n1. Male subjects\n2. Age ≥ 50 years\n3. Clinical and medical history data available at abdomen-chest CT evaluation\n4. Signature of informed consent to the study\n\nExclusion Criteria:\n\n1. Hospitalized patients\n2. Patients known to have osteo-metabolic diseases.\n3. with primary and\u002For acquired immunodeficiency states, and\u002For severe impairment of general clinical condition (e.g. metastatic neoplasms; immunosuppressive therapies; worsening\u002Freacute\u002Fcompensated chronic diseases; moderate-severe renal failure)\n4. Patients unable to understand and sign the Informed Consent.","MALE","50 Years",{"count":18,"type":19},250,"ESTIMATED","OBSERVATIONAL","The study will be conducted as a monocentric observational prospective study design wants to evaluate the prevalence of vertebral fractures in the cohort of patients that perform a chest-abdomen CT for medical indication other than osteometabolic pathologies.",[23,24],"Vertebral Fracture","Osteoporosis","RECRUITING","2026-04-02",{"date":28,"type":29},"2026-04-08","ACTUAL",{"date":31,"type":29},"2025-03-01",{"date":33,"type":19},"2027-03-01",{"name":35,"class":36},"IRCCS San Raffaele","OTHER",1,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":46,"minAge":16,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":37},"100615136","chiropractor-delivered-virtual-intervention-after-vertebral-fracture-100615136","NCT07288684","Chiropractor Delivered Virtual Intervention After Vertebral frActure","Chiropractor Delivered Virtual Intervention After Vertebral frActure (VIVA)","VIVA","Inclusion Criteria:\n\n* Over the age of 50 (men or post-menopausal women)\n* Have had a vertebral fracture in the past two years\n* Willing to participate in twelve (12) virtual rehabilitation sessions for 10 weeks\n* Have access to internet and a smart device with a camera and microphone\n\nExclusion Criteria:\n\n* Cauda equina syndrome or spinal cord injury\n* Had a traumatic fracture (i.e., car accident)\n* An active infection\n* Active inflammatory arthritis with a flare up within the past two years\n* An inability to follow two-step commands or understand instructions and are without a caregiver to support participation\n* Been participating in a similar rehabilitation program for vertebral fractures delivered by a physical therapist, exercise physiologist or kinesiologist and includes exercise\n* Any surgeries planned or health problems that might cause their health to change significantly in the next 3 months","ALL",{"count":48,"type":19},15,"INTERVENTIONAL",[51],"NA","This study will determine feasibility of a chiropractor delivered virtual intervention for individuals following osteoporotic vertebral fracture.\n\nThis pilot trial will have two parallel groups with a 1:1 ratio. Participants will be randomized to: 1) immediate receipt; or 2) waitlist usual care control and delayed receipt of VIVA 10 weeks post-randomization.\n\nVIVA is an intervention for people with vertebral fractures that covers four areas: pain management, safe movement, exercise, and nutrition. It includes print and video resources, and a framework for goal setting, selecting exercises, and teaching body mechanics.\n\nA chiropractor (DC) completes a virtual assessment and then leads twelve 1:1 virtual sessions (via Zoom) over eight weeks. Sessions start with brief education on a topic (e.g., safe movement, pain management, exercise, nutrition), followed by training and modeling of exercise and safe movement strategies, then goal setting, and action planning.\n\nThis trial will be considered feasible if a) we recruit 14 people in eight months; b) 80% of participants complete the trial; and c) exercise adherence is 75%.",[24,23],[55],"Rehabilitation","2025-12-03",{"date":58,"type":29},"2025-12-17",{"date":60,"type":29},"2025-10-20",{"date":62,"type":19},"2026-06-01",{"name":64,"class":36},"University of Waterloo",{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":46,"minAge":72,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":89},"100544338","spine-bone-cements-outcomes---post-market-follow-up-100544338","NCT06367582","Spine Bone Cements Outcomes - Post Market Follow-up","Safety and Clinical Performance Assessment of Bone Cements and Injection Systems Used in Spine Surgery - A Post-Market Clinical Follow-Up","Inclusion Criteria:\n\n* Be 18 years or older\n* Be willing to sign an informed consent approved by Ethic Committee (when applicable) or not being opposed to the use of their clinical data in the study\n\n  o For prospective inclusion:\n* Be considered for treatment with one of the TEKNIMED Spine Range cement comprised in this study\n\n  o For retrospective inclusion:\n* Have undergone a surgery with a TEKNIMED Spine Range cement between the 1st of January 2016 and the date of the site initiation visit.\n* Be informed of the study and not being opposed to the use of their clinical data in the study or be willing to sign an informed consent during the first follow-up visit following the site initiation (when applicable).\n\nExclusion Criteria:\n\nPatients presenting one of the following conditions will not be included (contraindications per IFU):\n\n* Procedures other than those stated in the INDICATIONS section\n* Coagulation disorders, or severe cardiopulmonary disease\n* Unstable vertebral fractures\n* Compromise of the vertebral body or of the pedicle walls\n* Hypersensitivity or allergy to one of the constituents of the product\n* Patient clearly improving on more conservative treatment\n* Prophylactic use in spinal metastatic or osteoporotic patients with no evidence of acute fracture\n* Paediatric patients and pregnant or breast-feeding women.","18 Years",{"count":74,"type":19},500,"A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all their private labels.\n\nTEKNIMED bone cements are legacy products, some marketed for more than 10 years. Their performance and safety have already been demonstrated by Post-Market Surveillance and previous clinical studies. The current Post-Market Clinical Follow-Up study aims to confirm these claims by collecting data in a \"real-life\" setting.\n\nThe study is a retrospective and prospective global, single arm, non-controlled, multicentric, prospective observational study. Patients will be followed as per local standard medical care of the sites.",[23,77,78],"Compression Fracture","Osteoporotic Fractures","2025-09-02",{"date":81,"type":29},"2025-09-09",{"date":83,"type":29},"2019-09-04",{"date":85,"type":19},"2039-09-30",{"name":87,"class":88},"Teknimed","INDUSTRY",12,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":95,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":46,"minAge":72,"maxAge":4,"enrollmentInfo":97,"targetDuration":99,"studyType":20,"phases":4,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":108,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":118},"100586072","a-multicenter-prospective-observational-study-on-vertebral-fracture-risk-stratification-in-patients-with-vertebral-metastases-100586072","NCT06910618","A Multicenter Prospective Observational Study on Vertebral Fracture Risk Stratification in Patients With Vertebral Metastases","Valid-METASTRA","Inclusion Criteria:\n\n* Patient 18 years or older\n* Patient diagnosed with a metastatic tumor in the thoracic and\u002For lumbar spine (one or more vertebral metastases in the spinal region between T1 and L5 vertebrae)\n* Min. 1 vertebra is potentially unstable based on SINS score (SINS is 7-12) and it has not been surgically stabilized previously (level of interest - LOI)\n* Adjacent vertebrae are not surgically stabilized at the time of the enrollment\n* Patient willing to complete 6-month follow-up\n* Patient is willing and able to provide written informed consent after the nature of the study has been explained:\n\n  * Ability to understand the content of the patient information\u002F ICF\n  * Willingness and ability to participate in the study according to the protocol\n  * Signed and dated EC approved written informed consent\n\nExclusion Criteria:\n\n* Poor general status at baseline (Karnofsky scale less than 40%)\n* Expected life expectancy is less than 3 months at baseline\n* Spinal infection\n* Ongoing litigation\n* Participation in investigational clinical study at the same time or within 3 months\n* Vertebral lesion\u002Fmetastasis from a hematologic condition (e.g. multiple myeloma)",{"count":98,"type":19},300,"6 Months","Vertebral fracture is a common clinically significant skeletal related event in cancer patients. Stratification of patients diagnosed with one or more vertebral metastases according to the risk of pathological fracture is an unresolved problem despite the fact that fractures strongly influence the quality of life (QoL) and also the overall survival. The multidimensional nature and the strong patient specificity of the risk for fracture have not been considered in previously published risk estimation models and these methods were developed and validated only on retrospective data focusing on prevalence of life-time fracture which is not really relevant at the time of the diagnosis of a vertebral metastasis. To overcome these shortcomings, the METASTRA models (METASTRA-AI and METASTRA-VPH) and the decision support system (METASTRA-DSS) are developed considering the highest possible level of patient specificity to stratify the individuals according to their risk for fracture in a clinically considerable period (within next 6 months). The prospective data collection and analysis will provide reliability and validity results on the performance of METASTRA tools as well as structured information on user's experience helping the future integration of the developed patient-specific stratification tool into the everyday clinical practice.\n\nThe study is a prospective clinical data collection from minimum 200 patients to determine the validity (i.e. Precision) in fracture risk stratification of the METASTRA-AI and METASTRA-VPH computational models and to determine the reliability of METASTRA-AI and METASTRA-VPH as well as human decision making process in patient stratification.",[102,23],"Vertebral Metastases",[104,105,106,107],"vertebral metastasis","cancer","fracture","risk stratification","NOT_YET_RECRUITING","2025-03-28",{"date":111,"type":29},"2025-04-04",{"date":113,"type":19},"2025-04-01",{"date":115,"type":19},"2027-08-01",{"name":117,"class":36},"Buda Health Center",4,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":46,"minAge":16,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":49,"phases":129,"briefSummary":130,"conditions":131,"keywords":132,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":37},"100526933","percutaneous-vertebroplasty-vs-sham-for-osteoporotic-vertebral-compression-fractures-focusing-on-pain-and-economy-100526933","NCT06141187","Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy.","Percutaneous Vertebroplasty Vs. Sham for Osteoporotic Vertebral Compression Fractures Focusing on Pain and Economy: a Single-center, Double-blind Randomized Controlled Clinical Trial","VOPE2","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* PVP 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":128,"type":19},240,[51],"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.\n\nThe 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.",[78,23],[133,134],"vertebroplasty","Pain","2025-01-03",{"date":137,"type":29},"2025-01-06",{"date":139,"type":29},"2024-01-01",{"date":141,"type":19},"2030-12-31",{"name":143,"class":36},"Spine Centre of Southern Denmark",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":46,"minAge":72,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":49,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":37},"100403432","examination-of-vertebroplasty-in-addition-to-regular-treatment-of-patients-with-multiple-myeloma-100403432","NCT04533217","Examination of Vertebroplasty in Addition to Regular Treatment of Patients With Multiple Myeloma.","Palliative Treatment of Patients With Multiple Myeloma and Painful Vertebral Lesions. A Cross-sectoral Randomized Controlled Trial of Vertebroplasty in Addition to Regular Medical Treatment.","Inclusion Criteria:\n\n* known multiple myeloma\n* verified lesion(s) between Th6-L5\n* 4 or less fractures\n* relevant pain in 3 months or less\n* vertebroplasty can be performed in one procedure\n* VAS 5 or more\n\nExclusion Criteria:\n\n* presence of neurologic deficit\n* psychological or psychiatric disorder hat is expected to interfere with compliance",{"count":152,"type":19},90,[51],"Patients with newly diagnosed or known multiple myeloma with newly diagnosed vertebral lesion(s) will be invited to participate in a cross-sectoral randomized controlled trial. The trial will compare two groups of patients which either receive regular medical treatment of their vertebral lesion(s) or vertebroplasty in addition to regular medical treatment. Our goal is to investigate the effectiveness of vertebroplasty and determine the role of surgical treatment in the overall treatment of patients with multiple myeloma and vertebral lesion(s).",[23,156],"Multiple Myeloma","2024-11-27",{"date":159,"type":29},"2024-12-03",{"date":161,"type":29},"2021-03-29",{"date":163,"type":19},"2026-07-31",{"name":143,"class":36},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":46,"minAge":72,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":49,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":37},"100562489","clinical-evaluation-and-cost-effectiveness-analysis-of-3d-digital-surgery-in-traumatology-100562489","NCT06603831","Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology","Randomized, Prospective and Multicenter Clinical Study for the Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology and Orthopedic Surgery","Inclusion Criteria:\n\n\\- Patients that requires one of the following surgical procedures \u002F interventions: Radius osteotomy due to non-articular metaphyseal malunion Complex acetabular arthroplasty Thoracic-lumbar spine arthrodesis.\n\n-Patients that can understand the clinical study and that are able to read, understand and sign the consent form\n\nExclusion Criteria:\n\n* Patients that are not able to read, understand or sign the consent form.\n* Patients that can't or have no support to complete the clinical trial.\n* Patients with complex deformities or complications that would require mandatory personalized digital surgery treatment","80 Years",{"count":174,"type":19},180,[51],"Digital surgery, in combination with patient specific instrumentation (PSI) is being used more and more in traumatology due to its proven benefits and applications. Nowadays, medical case planning and an optimal preparation before surgery are still a challenge for surgeons. This lack of preparation is translated into longer surgical procedures, potential complications, unnecessary sterilization of materials and a high number of fluoroscopies. 2D techniques such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT) and X-rays remain essential for medical planning, however, in many cases, a 3D visualization is needed to achieve better results, especially in complex cases.The use of personalized medical instruments such as surgical guides has proven to increase clinical accuracy, assuring a better correction of bone deformities, and allowing a more precise location of implants and screw positioning. Furthermore, the use of 3D-printed patient-specific prosthesis can lead to better clinical outcomes as they reduce the number of complications as well as they present a longer lifespan compared to conventional generic implants.Despite the potential of 3D technology in the medical field, there is still a lack of robust studies that compares clinical benefits between digital surgery and conventional 2D surgery, and its economic impact is still unknown. Thus, the investigators propose this randomized, prospective and multi-center clinical study to evaluate the use of 3D technology in traumatology. The aim of this project is to prove that digital surgery is a cost-effective methodology and therefore it should be adopted by the public health system as a gold standard procedure.",[178,179,180,181,182,183,184,23,185,186,187,188],"Radius; Deformity","Hip Osteoarthritis","Hip Arthritis","Hip Arthropathy","Spine Injury","Radius; Anomaly","Vertebra; Degeneration","Hip Prosthesis Infection","Spinal Fusion","Spine Osteoarthritis","Spinal Deformity","2024-11-08",{"date":191,"type":29},"2024-11-12",{"date":193,"type":29},"2024-10-21",{"date":195,"type":19},"2027-12-31",{"name":197,"class":36},"Corporacion Parc Tauli",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":46,"minAge":72,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":206,"conditions":207,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":37},"100564347","study-of-the-prevalence-of-osteo-metabolic-complications-in-patients-with-thyroid-cancer-100564347","NCT06627998","Study of the Prevalence of Osteo-metabolic Complications in Patients With Thyroid Cancer","Inclusion Criteria:\n\n* age ≥ 18 years\n* Histological diagnosis of Thyroid Carcinoma\n* radiological data from chest x-ray in lateral projection in the preoperative evaluation on which the vertebral morphometry\n* Signing of the informed consent\n\nExclusion Criteria:\n\n* Subjects not falling within the previously described criteria are excluded",{"count":205,"type":19},82,"This is a multicenter retrospective observational study aimed to evaluate the prevalence of osteo-metabolic complications in patients with thyroid cancer.",[208,23,24],"Cancer of Thyroid","2024-10-03",{"date":211,"type":29},"2024-10-04",{"date":213,"type":29},"2023-04-12",{"date":215,"type":19},"2024-12",{"name":35,"class":36}]