[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Spine Centre of Southern Denmark\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":101},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"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":20,"type":21},64,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Osteoporotic Vertebral Compression Fractures",[29,30,31,32,33,34,35,36,37,38,39],"Accelerometer","Global Positioning System","Vertebroplasty","Physical Activity","Mobility","Osteoporosis","Spinal Surgery","ActiGraph","Accelerometry","GPS","Osteoporotic","RECRUITING","2025-06-19",{"date":43,"type":44},"2025-06-25","ACTUAL",{"date":46,"type":44},"2025-02-20",{"date":48,"type":21},"2026-12",{"name":50,"class":51},"Spine Centre of Southern Denmark","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":68,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":52},"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":62,"type":21},240,[24],"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.",[66,67],"Osteoporotic Fractures","Vertebral Fracture",[69,70],"vertebroplasty","Pain","2025-01-03",{"date":73,"type":44},"2025-01-06",{"date":75,"type":44},"2024-01-01",{"date":77,"type":21},"2030-12-31",{"name":50,"class":51},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":52},"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","18 Years",{"count":88,"type":21},90,[24],"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).",[67,92],"Multiple Myeloma","2024-11-27",{"date":95,"type":44},"2024-12-03",{"date":97,"type":44},"2021-03-29",{"date":99,"type":21},"2026-07-31",{"name":50,"class":51},""]