[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657467":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":23,"overallOfficials":23,"centralContacts":33,"locations":43,"responsibleParty":88,"collaborators":91,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":23,"enrollmentInfo":105,"targetDuration":23,"studyType":108,"phases":23,"briefSummary":109,"conditions":110,"keywords":112,"overallStatus":123,"whyStopped":23,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Ohio State University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"UIV Screw Loosening Rate","Rate of UIV screw loosening as assessed on x-rays","12-month follow-up",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Adverse Events Associated with UIV Screws","Adverse events reported that were related to the screws at the UIV",{"measure":18,"description":19,"timeFrame":12},"Rate of Subsequent Surgical Intervention Involving the UIV","Rate of subsequent surgical intervention including the UIV level",{"measure":21,"description":22,"timeFrame":12},"Rate of UIV Screw Removal","Rate of UIV screw removal",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"COHORT","RETROSPECTIVE","The REESE (Retrospective Evaluation of Upper Instrumented Vertebrae Screw Loosening Following Spine Surgery) study is a multicenter, retrospective chart review that aims to determine the rate of screw loosening at the upper instrumented vertebra (UIV) following thoracolumbar spinal fusion surgery and identify associated risk factors. Up to 400 patients from up to 10 U.S. sites will be included. Eligible patients must be adults who underwent thoracolumbar fusion with bilateral UIV screws and have at least 12 months of postoperative imaging follow-up.","Adults (≥18 years of age) who previously underwent thoracolumbar spinal fusion with bilateral pedicle screw fixation at the upper instrumented vertebra (UIV), with or without pelvic fixation, and who have a minimum of 12 months of postoperative follow-up imaging. Eligible patients will be identified retrospectively from participating U.S. sites and evaluated for UIV screw loosening and related outcomes using existing clinical and radiographic records.",[30],{"label":31,"type":23,"description":32,"interventionNames":23},"Thoracolumbar Fusion Cohort","Adults who underwent thoracolumbar spinal fusion with bilateral pedicle screw fixation at the upper instrumented vertebra (UIV) within the previous 5 years and had at least 12 months of postoperative follow-up imaging. Patients will be identified retrospectively from participating sites and evaluated for the incidence of UIV screw loosening and associated clinical and radiographic risk factors.",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":23,"email":38},"Courtney Wright","CONTACT","614-366-8327","Courtney.Wright@osumc.edu",{"name":40,"role":36,"phone":41,"phoneExt":23,"email":42},"Aladdin AlQaisi","614-293-4876","Aladdin.Alqaisi@osumc.edu",[44,61,74],{"facility":45,"status":23,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Indiana University Health","Indianapolis","Indiana","46202","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-86.15804,39.76838,{"lat":55,"lon":54},[58],{"name":59,"role":60,"phone":23,"phoneExt":23,"email":23},"David W Stockwell, MD, FAANS","PRINCIPAL_INVESTIGATOR",{"facility":62,"status":23,"city":63,"state":64,"zip":65,"country":49,"countryCode":50,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"University of Minnesota","Minneapolis","Minnesota","55414",{"type":52,"coordinates":67},[68,69],-93.26384,44.97997,{"lat":69,"lon":68},[72],{"name":73,"role":60,"phone":23,"phoneExt":23,"email":23},"Ann Parr, MD, PhD",{"facility":75,"status":23,"city":76,"state":77,"zip":78,"country":49,"countryCode":50,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"The Ohio State University Wexner Medical Center Hospitals","Columbus","Ohio","43210",{"type":52,"coordinates":80},[81,82],-82.99879,39.96118,{"lat":82,"lon":81},[85,86],{"name":40,"role":36,"phone":41,"phoneExt":23,"email":42},{"name":87,"role":60,"phone":23,"phoneExt":23,"email":23},"Bryan Ladd, MD",{"type":60,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Bryan Ladd","Principle Investigator",[92],{"name":93,"class":94},"SI-BONE, Inc.","INDUSTRY","100657467","retrospective-evaluation-of-upper-instrumented-vertebrae-uiv-screw-loosening-following-spine-surgery-100657467",false,"NCT07838571","Retrospective Evaluation of Upper Instrumented Vertebrae (UIV) Screw Loosening Following Spine Surgery","REESE - Retrospective Evaluation of Upper Instrumented Vertebrae (UIV) Screw Loosening Following Spine Surgery","REESE","Inclusion Criteria:\n\n* ≥ 18 years of age at the time surgery\n* Underwent thoracolumbar spinal fusion with bilateral screws at the UIV\n\n  1. Construct \\\u003C4 levels ending at the sacrum may be treated with or without pelvic fixation\n  2. Constructs ≥4 levels ending at the sacrum must include pelvic fixation\n  3. Constructs not ending at the sacrum may be included\n* Patient must have a minimum of 12-month follow-up including imaging (AP and lateral x-rays)\n\nExclusion Criteria:\n\n* Treated for high grade (grade III, IV, or V) spondylolisthesis\n* Diagnosed with primary or metastatic tumor involving the spine, history of spinal malignancy, or active cancer at the time of surgery","ALL","18 Years",{"count":106,"type":107},400,"ESTIMATED","OBSERVATIONAL","The REESE study is looking at information from past spine surgeries to learn how often screws placed at the top of a spinal fusion become loose over time. Researchers will review existing medical records and X-rays from adults who have already had thoracolumbar spinal fusion surgery. The study will also look at factors that may increase the risk of screw loosening and whether it leads to additional complications or surgeries. No new procedures, treatments, or patient visits are required because the study uses information that has already been collected during routine medical care.",[111],"Thoracolumbar Spinal Fusion",[113,114,115,116,117,118,119,120,121,122],"UIV","Thoracolumbar Fusion","Upper Instrumented Vertebra","Proximal junctional kyphosis (PJK)","proximal junctional failure (PJF)","Spine Surgery","Screw Lucency","Pedicle Screw Loosening","Adult Spinal Deformity","Instrumentation Failure","NOT_YET_RECRUITING","2026-09-18",{"date":126,"type":127},"2026-09-24","ACTUAL",{"date":129,"type":107},"2026-09",{"date":131,"type":107},"2027-12",{"name":5,"class":6},3]