[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554267":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":238,"collaborators":241,"id":248,"slug":249,"hasResults":250,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":254,"eligibilityCriteria":255,"healthyVolunteers":250,"sex":256,"minAge":257,"maxAge":25,"enrollmentInfo":258,"targetDuration":25,"studyType":261,"phases":262,"briefSummary":264,"conditions":265,"keywords":270,"overallStatus":63,"whyStopped":25,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":285},{"fullName":5,"class":6},"University of Southern California","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early Internal Fixation","EXPERIMENTAL","Early internal fixation of the LC1 fragility fracture of the pelvis will be defined as percutaneous anterior and\u002For posterior pelvic internal fixation with cannulated screw(s), medullary implant(s), or sacroiliac joint fusion device(s).",[13],"Procedure: Early Internal Fixation",{"label":15,"type":16,"description":17,"interventionNames":18},"Nonoperative Care with Early Rehabilitation","ACTIVE_COMPARATOR","Nonoperative care with early rehabilitation will consist of nonoperative treatment of the pelvis fracture, including early consultation of the physical therapist, physiotherapist, or local equivalent rehabilitation provider at the time of randomization for a first attempt at mobilization of the patient within 24 hours of randomization",[19],"Other: Nonoperative Care with Early Rehabilitation",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Early internal fixation of the LC1 fragility fracture of the pelvis will be defined as percutaneous anterior and\u002For posterior pelvic internal fixation with cannulated screw(s), medullary implant(s), or sacroiliac joint fusion device(s). The implant number, design, diameter, thread type (fully-threaded or partially-threaded), sacral segment (S1, S2, S3, or any combination there of), length, trajectory including sacroiliac or transsacral-transiliac, application with or without a washer, and ingrowth or ongrowth surface designs will be at the discretion of the treating surgeon.",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Nonoperative care with early rehabilitation will consist of nonoperative treatment of the pelvis fracture, including early consultation of the physical therapist, physiotherapist, or local equivalent rehabilitation provider at the time of randomization for a first attempt at mobilization of the patient within 24 hours of randomization. Patients who are unable to ambulate with assistance after five or more days of attempted mobilization by rehabilitation providers may be considered for delayed internal fixation treatment at the discretion of the patient and the treating surgeon. Delayed internal fixation after five or more days of attempted mobilization by rehabilitation providers will not be considered a treatment crossover event.",[15],[30],{"name":31,"affiliation":5,"role":32},"Joseph Patterson, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Pui Yan, MS","CONTACT","323-442-6984","puiyan@med.usc.edu",[40,61,76,84,96,111,126,142,158,174,190,206,221],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of Arizona","NOT_YET_RECRUITING","Phoenix","Arizona","85006","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-112.07404,33.44838,{"lat":52,"lon":51},[55,59],{"name":56,"role":36,"phone":57,"phoneExt":25,"email":58},"Brock Walker, MD","602-521-3250","Joseph.Walker@bannerhealth.com",{"name":60,"role":32,"phone":25,"phoneExt":25,"email":25},"Joseph Walker, MD",{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":46,"countryCode":47,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Keck Medical Center of USC","RECRUITING","Los Angeles","California","90033",{"type":49,"coordinates":68},[69,70],-118.24368,34.05223,{"lat":70,"lon":69},[73,75],{"name":35,"role":36,"phone":74,"phoneExt":25,"email":38},"(323) 442-6984",{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"facility":77,"status":63,"city":64,"state":65,"zip":66,"country":46,"countryCode":47,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Los Angeles General Medical Center",{"type":49,"coordinates":79},[69,70],{"lat":70,"lon":69},[82,83],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"facility":85,"status":63,"city":64,"state":65,"zip":86,"country":46,"countryCode":47,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},"Cedars-Sinai Medical Center","90048",{"type":49,"coordinates":88},[69,70],{"lat":70,"lon":69},[91,95],{"name":92,"role":36,"phone":93,"phoneExt":25,"email":94},"Geoffrey Marecek, MD","310-423-4566","Geoffrey.Marecek@cshs.org",{"name":92,"role":32,"phone":25,"phoneExt":25,"email":25},{"facility":97,"status":63,"city":98,"state":65,"zip":99,"country":46,"countryCode":47,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"University of California, Davis","Sacramento","95817",{"type":49,"coordinates":101},[102,103],-121.4944,38.58157,{"lat":103,"lon":102},[106,110],{"name":107,"role":36,"phone":108,"phoneExt":25,"email":109},"Augustine Saiz, MD","916-734-2182","saizamjr@gmail.com",{"name":107,"role":32,"phone":25,"phoneExt":25,"email":25},{"facility":112,"status":63,"city":113,"state":65,"zip":114,"country":46,"countryCode":47,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"University of California San Francisco","San Francisco","94143",{"type":49,"coordinates":116},[117,118],-122.41942,37.77493,{"lat":118,"lon":117},[121,125],{"name":122,"role":36,"phone":123,"phoneExt":25,"email":124},"Saam Morshed, MD","415-647-3733","Saam.Morshed@ucsf.edu",{"name":122,"role":32,"phone":25,"phoneExt":25,"email":25},{"facility":127,"status":63,"city":128,"state":129,"zip":130,"country":46,"countryCode":47,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Indiana University","Indianapolis","Indiana","46202",{"type":49,"coordinates":132},[133,134],-86.15804,39.76838,{"lat":134,"lon":133},[137,141],{"name":138,"role":36,"phone":139,"phoneExt":25,"email":140},"Yohan Jang, MD","317-963-1966","jangyoha@iu.edu",{"name":138,"role":32,"phone":25,"phoneExt":25,"email":25},{"facility":143,"status":63,"city":144,"state":145,"zip":146,"country":46,"countryCode":47,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center","Baltimore","Maryland","21201",{"type":49,"coordinates":148},[149,150],-76.61219,39.29038,{"lat":150,"lon":149},[153,157],{"name":154,"role":36,"phone":155,"phoneExt":25,"email":156},"Mark Gage, MD","410-328-1868","MGage@som.umaryland.edu",{"name":154,"role":32,"phone":25,"phoneExt":25,"email":25},{"facility":159,"status":42,"city":160,"state":161,"zip":162,"country":46,"countryCode":47,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":49,"coordinates":164},[165,166],-71.05977,42.35843,{"lat":166,"lon":165},[169,173],{"name":170,"role":36,"phone":171,"phoneExt":25,"email":172},"Arun Aneja, MD","617-726-9111","aaneja@mgh.harvard.edu",{"name":170,"role":32,"phone":25,"phoneExt":25,"email":25},{"facility":175,"status":63,"city":176,"state":177,"zip":178,"country":46,"countryCode":47,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"The Curators of the University of Missouri - Missouri Orthopaedic Institute","Columbia","Missouri","65201",{"type":49,"coordinates":180},[181,182],-92.33407,38.95171,{"lat":182,"lon":181},[185,189],{"name":186,"role":36,"phone":187,"phoneExt":25,"email":188},"Brett Crist, MD","573-882-6562","cristb@health.missouri.edu",{"name":186,"role":32,"phone":25,"phoneExt":25,"email":25},{"facility":191,"status":63,"city":192,"state":193,"zip":194,"country":46,"countryCode":47,"cosmosGeoPoint":195,"geoPoint":199,"contacts":200},"University of Utah","Salt Lake City","Utah","84112",{"type":49,"coordinates":196},[197,198],-111.89105,40.76078,{"lat":198,"lon":197},[201,205],{"name":202,"role":36,"phone":203,"phoneExt":25,"email":204},"Lucas Marchand, MD","801-581-2121","Lucas.Marchand@hsc.utah.edu",{"name":202,"role":32,"phone":25,"phoneExt":25,"email":25},{"facility":207,"status":63,"city":208,"state":209,"zip":210,"country":46,"countryCode":47,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"University of Washington - Harborview Medical Center","Seattle","Washington","98104",{"type":49,"coordinates":212},[213,214],-122.33207,47.60621,{"lat":214,"lon":213},[217],{"name":218,"role":36,"phone":219,"phoneExt":25,"email":220},"Reza Firoozabadi, MD","206-744-3298","rezaf2@uw.edu",{"facility":222,"status":42,"city":223,"state":224,"zip":225,"country":224,"countryCode":226,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Research Institute Vall d'Hebrón - Vall d'Hebron University Hospital","Barcelona","Spain","08035","ES",{"type":49,"coordinates":228},[229,230],2.15899,41.38879,{"lat":230,"lon":229},[233,237],{"name":234,"role":36,"phone":235,"phoneExt":25,"email":236},"Jordi Teixidor-Serra, MD","34 934 89 30 00","email@email.email",{"name":234,"role":32,"phone":25,"phoneExt":25,"email":25},{"type":32,"investigatorFullName":239,"investigatorTitle":240,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Joseph Patterson","Assistant Professor",[242,244,246],{"name":243,"class":6},"Orthopaedic Trauma Association",{"name":245,"class":6},"McMaster University",{"name":247,"class":6},"University of Maryland, Baltimore","100554267","early-internal-fixation-versus-nonoperative-care-with-early-rehabilitation-for-lc1-fragility-fractures-of-the-pelvis-100554267",false,"NCT06496867","Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis","Multicenter Randomized Controlled Trial Comparing Early Internal Fixation Versus NonOperative Care With Early Rehabilitation for LC1 Fragility Fractures of the Pelvis: A Pilot Study","PIVOT-LC1-Pi","Inclusion Criteria:\n\n1. Patient 60 years of age or older.\n2. Low energy injury mechanism defined as a fall from standing height.\n3. LC1 pelvis fracture (AO\u002FOTA 61B1.1 or 61B2.1) confirmed with antero-posterior, inlet, and outlet pelvis radiographs, computed tomography, or magnetic resonance imaging.\n4. Fracture pattern that could be, in the judgment of the attending surgeon, managed with either early internal fixation or nonoperative care with early rehabilitation.\n5. Fracture displacement of \\\u003C10 mm of the posterior pelvic ring on computed tomography of the pelvis.\n6. Injury occurred within 21 days of screening.\n\nExclusion Criteria:\n\n1. Patient did not ambulate prior to injury.\n2. Patient has another condition, injury, or fracture that prevents post-operative weightbearing on any extremity.\n3. Retained implants around the pelvis that precludes or limits either study treatment.\n4. Infection around the hip (soft tissue or bone).\n5. Pathologic fracture with a lytic lesion in the pelvis or sacrum that precludes internal fixation.\n6. Patient is too ill, in the judgement of the attending surgeon, for internal fixation.\n7. Patient is too ill, in the judgement of the attending surgeon, for nonoperative care.\n8. Problems, in the judgment of study personnel, with maintaining follow-up with the patient.\n9. Expected injury survival of less than 12 months.\n10. Terminal illness with expected survival of less than 12 months.\n11. Currently enrolled in a study that does not permit co-enrollment.\n12. Prior enrollment in the trial.\n13. Unable to obtain informed consent due to language barriers.\n14. Unable to obtain informed consent because a legally authorized representative (LAR) was unavailable.\n15. Did not provide informed consent (declined participation).\n16. Patient or LAR not approached to participate in the trial (missed patient).\n17. Other reason to exclude the patient, as approved by the Methods Centre.","ALL","60 Years",{"count":259,"type":260},48,"ESTIMATED","INTERVENTIONAL",[263],"NA","The goal of this randomized pilot study is to assess feasibility of the trial and to collect information to inform the design of a definitive trial. Adult patients ages 60 years or older with a low-energy lateral compression type 1 (LC1) pelvis fracture with \\\u003C10 mm initial displacement of the posterior pelvic ring will be eligible to participate in the study. Patients will be randomized to one of two treatment groups, early internal fixation or nonoperative care with early rehabilitation, defined as at least five days of attempted mobilization by rehabilitation providers. Participants will be followed for 1 year.",[266,267,268,269],"Multiple Closed Pelvic Fractures With Disruption of Pelvic Ring","Fragility Fracture","Internal Fixation","Nonoperative Care",[267,271,272,273,268,269,274,275],"Lateral Compression type 1","Pelvis Fracture","Older Adults","Physical Therapy","Early","2025-10-10",{"date":278,"type":279},"2025-10-15","ACTUAL",{"date":281,"type":279},"2024-11-12",{"date":283,"type":260},"2027-12-31",{"name":5,"class":6},13]