[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575724":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":59,"collaborators":32,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":32,"enrollmentInfo":71,"targetDuration":32,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":45,"whyStopped":32,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"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\n\nInterventions:\n\nProcedure: Vertebroplasty",[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.\n\nInterventions:\n\nProcedure: Sham Vertebroplasty",[19],"Procedure: Sham Vertebroplasty",[21,28],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Polymethyl-methacrylate (PMMA) cement is injected slowly into the vertebral body under constant bi-plane fluoroscopy",[9],[26,27],"Percutaneous vertebroplasty","PVP",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Sham Vertebroplasty","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.",[15],null,[34],{"name":35,"affiliation":5,"role":36},"Mikkel Ø Andersen, Prof, MD","STUDY_CHAIR",[38],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Søren W Sørensen, MD","CONTACT","0045 76362000","soren.wittorff.sorensen@rsyd.dk",[44],{"facility":5,"status":45,"city":46,"state":32,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Kolding","6000","Denmark","DK",{"type":51,"coordinates":52},"Point",[53,54],9.47216,55.4904,{"lat":54,"lon":53},[57],{"name":39,"role":40,"phone":58,"phoneExt":32,"email":42},"0045 76 36 20 00",{"type":60,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100575724","continuous-mobility-and-physical-activity-in-vertebroplasty-vs-sham-for-osteoporotic-vertebral-fracture-100575724",false,"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.","ALL","50 Years",{"count":72,"type":73},64,"ESTIMATED","INTERVENTIONAL",[76],"NA","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.",[79],"Osteoporotic Vertebral Compression Fractures",[81,82,9,83,84,85,86,87,88,89,90],"Accelerometer","Global Positioning System","Physical Activity","Mobility","Osteoporosis","Spinal Surgery","ActiGraph","Accelerometry","GPS","Osteoporotic","2025-06-19",{"date":93,"type":94},"2025-06-25","ACTUAL",{"date":96,"type":94},"2025-02-20",{"date":98,"type":73},"2026-12",{"name":5,"class":6},1]