[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630891":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":34,"locations":40,"responsibleParty":65,"collaborators":33,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":33,"enrollmentInfo":77,"targetDuration":33,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":94,"whyStopped":33,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Hull University Teaching Hospitals NHS Trust","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sacroplasty","EXPERIMENTAL","Participants in this arm will undergo percutaneous sacroplasty under local anesthesia, with optional conscious sedation. The procedure will be performed by interventional radiologists to stabilize sacral or posterior pelvic fragility fractures. Participants will be followed for 6 weeks and 6 months to assess pain, mobility, quality of life, healthcare use, and safety outcomes.",[13],"Procedure: Percutaneous Sacroplasty",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard conservative management","ACTIVE_COMPARATOR","Participants in this arm will receive non-surgical management, including analgesia, mobilization, and physiotherapy according to local protocols. Participants will be followed for 6 weeks and 6 months to assess pain, mobility, quality of life, healthcare use, and safety outcomes.",[19],"Other: Standard conservative management",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Percutaneous Sacroplasty","Percutaneous image-guided cement augmentation of sacral fractures performed under local anesthetic with optional conscious sedation. The procedure is performed by an interventional radiologist with the aim of reducing pain.",[9],[27,28],"Sacral cement augmentation","Sacral vertebroplasty",{"type":30,"name":15,"description":31,"armGroupLabels":32,"otherNames":33},"OTHER","Standard non-surgical management including analgesia, mobilisation and physiotherapy according to local clinical practice.",[15],null,[35],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":39},"Research Coordinator","CONTACT","01482315506","hyp-tr.orthopaedic.research@nhs.net",[41],{"facility":42,"status":33,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Hull University Teaching Hospitals","Hull","East Yorkshire","HU3 2JZ","United Kingdom","UK",{"type":49,"coordinates":50},"Point",[51,52],-0.33525,53.7446,{"lat":52,"lon":51},[55,57,60,63],{"name":36,"role":37,"phone":38,"phoneExt":33,"email":56},"mukai.c-gordon@nhs.net",{"name":58,"role":59,"phone":33,"phoneExt":33,"email":33},"Mukai Chimutengwende-Gordon, PhD,FRCS","PRINCIPAL_INVESTIGATOR",{"name":61,"role":62,"phone":33,"phoneExt":33,"email":33},"Hemant Sharma, MCh, FRCS","SUB_INVESTIGATOR",{"name":64,"role":62,"phone":33,"phoneExt":33,"email":33},"Paul Maliakal, FRCR",{"type":66,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100630891","sacroplasty-for-sacral-insufficiency-fractures-100630891",false,"NCT07493564","Sacroplasty for Sacral Insufficiency Fractures.","Sacroplasty for Sacral Insufficiency Fractures: a Randomised Controlled Trial.","SACRA","Inclusion Criteria:\n\n* Age 50 years or older\n* Low-energy sacral or posterior pelvic fracture confirmed on CT or MRI\n* Symptom duration ≤6 weeks with ongoing pain ≥48 hours\n* Suitable for sacroplasty under local anesthetic with optional sedation\n* Informed consent provided by participant or consultee agreement under the Mental Capacity Act 2005\n\nExclusion Criteria:\n\n* High-energy or unstable pelvic ring fracture requiring open fixation\n* Active infection or malignancy at fracture site\n* Uncorrectable coagulopathy or anatomy precluding safe sacroplasty\n* Life expectancy \\\u003C3 months\n* Participation in conflicting interventional trial\n* Previous sacroplasty\n* Patient not suitable for sacroplasty under local anesthetic with optional sedation","ALL","50 Years",{"count":78,"type":79},78,"ESTIMATED","INTERVENTIONAL",[82],"NA","This study is designed to determine whether sacroplasty, a minimally invasive procedure to stabilize sacral fractures, improves quality of life and functional recovery in adults aged 50 years or older with sacral or posterior pelvic fragility fractures. These fractures are common in older adults and can cause prolonged pain, reduced mobility, and an increased rate of mortality and risk of complications such as pneumonia, blood clots and pressure sores. Standard treatment usually involves pain management, physiotherapy and mobilization but recovery can be slow.\n\nParticipants will be randomly assigned to receive either sacroplasty under local anaesthetic (with optional sedation) performed by interventional radiologists or standard non-surgical care including analgesia and physiotherapy. Follow-up assessments will take place at 6 weeks and 6 months to evaluate pain, mobility, healthcare use, safety and overall quality of life.\n\nThe goal of the study is to provide evidence on whether sacroplasty can accelerate recovery, reduce complications and improve independence and quality of life in older adults with these fractures.",[85,86],"Sacral Fracture","Osteoporotic Fracture",[88,89,90,91,92,93],"sacroplasty","Sacral insufficiency fracture","Pelvic fragility fracture","Minimally invasive","Pain management","Functional recovery","NOT_YET_RECRUITING","2026-03-23",{"date":97,"type":98},"2026-03-25","ACTUAL",{"date":100,"type":79},"2027-01",{"date":102,"type":79},"2030-12",{"name":5,"class":6},1]