[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526933":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":61,"collaborators":25,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":25,"enrollmentInfo":73,"targetDuration":25,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Spine Centre of Southern Denmark","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vertebroplasty","ACTIVE_COMPARATOR","Polymethyl-methacrylate (PMMA) cement is prepared and injected slowly into the vertebral body under constant bi-plane fluoroscopy",[13],"Procedure: Vertebroplasty",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham vertebroplasty","SHAM_COMPARATOR","A short needle is passed through the skin, but not as far as the periosteum. PMMA is mixed to mimic the PVP procedure but not injected into the vertebral body.",[19],"Procedure: Sham Vertebroplasty",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","PVP",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Sham Vertebroplasty","Sham PVP",[15],[31],{"name":32,"affiliation":33,"role":34},"Mikkel Ø Andersen, MD","Sygehus Lillebælt","PRINCIPAL_INVESTIGATOR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+45 2320 9173","mikkel.andersen2@rsyd.dk",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Rygcenter Syddanmark","RECRUITING","Middelfart","Fyn","5500","Denmark","DK",{"type":50,"coordinates":51},"Point",[52,53],9.73054,55.50591,{"lat":53,"lon":52},[56,58],{"name":32,"role":37,"phone":25,"phoneExt":25,"email":57},"Mikkel.andersen2@rsyd.dk",{"name":59,"role":37,"phone":25,"phoneExt":25,"email":60},"Andreas K Andresen, MD","Andreas.Andresen@rsyd.dk",{"type":62,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100526933","percutaneous-vertebroplasty-vs-sham-for-osteoporotic-vertebral-compression-fractures-focusing-on-pain-and-economy-100526933",false,"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.","ALL","50 Years",{"count":74,"type":75},240,"ESTIMATED","INTERVENTIONAL",[78],"NA","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.",[81,82],"Osteoporotic Fractures","Vertebral Fracture",[84,85],"vertebroplasty","Pain","2025-01-03",{"date":88,"type":89},"2025-01-06","ACTUAL",{"date":91,"type":89},"2024-01-01",{"date":93,"type":75},"2030-12-31",{"name":5,"class":6},1]