[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498085":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":43,"studyPopulation":36,"armGroups":44,"interventions":57,"overallOfficials":69,"centralContacts":74,"locations":84,"responsibleParty":129,"collaborators":131,"id":136,"slug":36,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":36,"eligibilityCriteria":141,"healthyVolunteers":137,"sex":142,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":36,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":87,"whyStopped":36,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"HealthPartners Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Timed Up and Go (TUG) assessment","Valid outcome that measures mobility for elderly patients. The TUG assessment measures the time it takes for a patient, with assistance of physical therapy to get up from a chair, walk 3 meters turn around walk 3 meters back to the chair and sit down.","Day 2 after treatment",[14,18,20,24,27,30,33],{"measure":15,"description":16,"timeFrame":17},"Sacral Region Pain by Visual Analog Scale","Patient reported pain on a scale of 0-10. Minimum score 0 (no pain) to maximum score 10 (worst possible pain)","Day 2, 2 weeks, 6 weeks, and 3 months after treatment",{"measure":10,"description":11,"timeFrame":19},"2 weeks, 6 weeks, and 3 months after treatment",{"measure":21,"description":22,"timeFrame":23},"Discharge Disposition Location","Where a patient went after being discharged from the hospital (home, rehabilitation center, skilled nursing facility)","Post discharge from treatment, an average of 5 days from being admitted to the hospital",{"measure":25,"description":26,"timeFrame":12},"Longest Distance of Ambulation","How far a patient was able to walk",{"measure":28,"description":29,"timeFrame":12},"Use of Narcotic Pain Medication","Use of narcotic pain medication, total in milligram equivalents (MME)",{"measure":31,"description":32,"timeFrame":23},"Hospital Length of Stay","Number of days admitted to hospital during treatment",{"measure":34,"description":35,"timeFrame":19},"Rate of Complications","Unplanned surgery, new neurological deficit after treatment, surgical site infection, re-admission, decubitus ulcer, pneumonia, deep vein thrombosis, pulmonary embolism, delirium, myocardial infarction, 90 days mortality",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":36},"NONE","This study is a prospective, randomized control trial (RCT) of 100 patients with fragility pelvic ring fractures. All patients presenting with pelvic ring fractures classified as LC1 confirmed with plain radiographs, CT and\u002For MRI, resulting from a low energy mechanism or an insufficiency fracture without a precipitating event will undergo a trial of physical therapy with mobilization and multimodal pain management. If the subject has substantial posterior pelvic pain (score ≥ 7 with the Visual Analogue Scale (VAS)) or inability to ambulate after the physical therapy trial for 48 hours, the subject is eligible for enrollment in the RCT. Patients will either be grouped into an operative group, defined as percutaneous screw fixation, or a nonoperative group, defined as treatment with physical therapy and pain management only.\n\n1. Group 1-Operative treatment: Percutaneous screw fixation will be performed for stabilization of the pelvic fracture\n2. Group 2-Conservative (non-operative) treatment: Pain management and physical therapy advanced with weight bearing as tolerated.",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"Operative","EXPERIMENTAL","Percutaneous screw fixation",[50],"Procedure: Percutaneous screw fixation",{"label":52,"type":47,"description":53,"interventionNames":54},"Non-operative","Pain management and physical therapy advanced with weight bearing as tolerated.",[55,56],"Other: Pain management","Other: Physical therapy",[58,62,66],{"type":59,"name":48,"description":60,"armGroupLabels":61,"otherNames":36},"PROCEDURE","Surgical intervention in the form of percutaneous screw fixation",[46],{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":36},"Pain management","Non-operative management in the form of pain management and physical therapy advanced with weightbearing as tolerated",[52],{"type":6,"name":67,"description":64,"armGroupLabels":68,"otherNames":36},"Physical therapy",[52],[70],{"name":71,"affiliation":72,"role":73},"Mai P. Nguyen, MD","University of Minnesota and HealthPartners","PRINCIPAL_INVESTIGATOR",[75,80],{"name":76,"role":77,"phone":78,"phoneExt":36,"email":79},"Mai P Nguyen, MD","CONTACT","651-254-3669","mai.p.nguyen@healthpartners.com",{"name":81,"role":77,"phone":82,"phoneExt":36,"email":83},"Sandy Vang, BA","651-254-6961","sandy.x.vang@healthpartners.com",[85,104,118],{"facility":86,"status":87,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"Allina, Mercy Hospital","RECRUITING","Coon Rapids","Minnesota","55433","United States","US",{"type":94,"coordinates":95},"Point",[96,97],-93.28773,45.11997,{"lat":97,"lon":96},[100],{"name":101,"role":77,"phone":102,"phoneExt":36,"email":103},"Gennadiy A Busel, MD","651-254-1513","gennadiy.busel@allina.com",{"facility":105,"status":87,"city":106,"state":89,"zip":107,"country":91,"countryCode":92,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Park Nicollet, Methodist Hospital","Saint Louis Park","55426",{"type":94,"coordinates":109},[110,111],-93.34801,44.9483,{"lat":111,"lon":110},[114],{"name":115,"role":77,"phone":116,"phoneExt":36,"email":117},"Brian P Cunningham, MD","952-977-0438","brian.cunningham@parknicollet.com",{"facility":119,"status":87,"city":120,"state":89,"zip":121,"country":91,"countryCode":92,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"HealthPartners, Regions Hospital","Saint Paul","55101",{"type":94,"coordinates":123},[124,125],-93.09327,44.94441,{"lat":125,"lon":124},[128],{"name":76,"role":77,"phone":78,"phoneExt":36,"email":79},{"type":130,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[132,134],{"name":133,"class":6},"Orthopaedic Trauma Association",{"name":135,"class":6},"Allina Health System","100498085",false,"NCT05765669","Geriatric Lateral Compression 1 Pelvic Fractures","Percutaneous Screw Fixation for Operative Treatment Versus Non-Operative Treatment of Geriatric Lateral Compression 1 Pelvic Fractures - A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients \\>\u002F= 60 years of age\n* Lateral compression 1 pelvic ring fractures confirmed with plain radiographs, CT and\u002For MRI\n* Low energy mechanism of injury or an insufficiency fracture without a precipitating event\n* Acute injury within four weeks of presentation\n* Inability or significant pain to mobilize with physical therapy assistance for 48 hours: Significant pain as determined by a pain score ≥ 7 with the Visual Analogue Scale (VAS) after a Timed \"Up \\& Go\" (TUG) assessment, or inability to complete the TUG assessment.\n\nExclusion Criteria:\n\n* Dementia\n* Vertically or rotationally unstable pelvic ring injuries\n* Pathologic fracture secondary to tumor\n* Non-ambulatory prior to injury\n* Acute neurologic deficit\n* High-energy mechanism of injury\n* Concomitant injuries affecting ambulation\n* Presence of another injury or medical condition that prevents ambulation\n* Presence of implant or sacral morphology that prevents percutaneous sacral fixation\n* Enrollment in another research study the precludes co-enrollment\n* Likely problems, in the judgement of the investigators, with maintaining follow-up (i.e. patients with no fixed address, etc.)\n* Incarcerated or pending incarceration","ALL","60 Years","100 Years",{"count":146,"type":147},100,"ESTIMATED","INTERVENTIONAL",[150],"NA","Lateral compression-1 (LC1) pelvic ring fragility fractures cause significant pain and morbidity. These fragility injuries are associated with prolonged immobility and long hospital stays. Currently there is no consensus on operative stabilization of LC1 pelvic fractures, nor are there evidence-based guidelines to aid in management of these injury types. Furthermore, there is variability in operative indications, improvement in pain and mobilization. The purpose of this study is to compare percutaneous screw fixation to non-operative management in symptomatic LC1 fragility fractures in elderly patients.",[153],"Lateral Compression 1 Pelvic Fracture",[155,46,52,156,157,158,159],"Lateral compression","Fragility fracture","Pelvic fracture","Percutaneous pelvis screw","Osteoporosis","2025-06-12",{"date":162,"type":163},"2025-06-13","ACTUAL",{"date":165,"type":163},"2023-05-05",{"date":167,"type":147},"2026-09-30",{"name":5,"class":6},3]