[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03076658":3,"trial-entities:NCT03076658":119,"trial-summary:NCT03076658":124},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":67,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":89,"locations":92,"central_contacts":111,"overall_officials":115,"references":117,"see_also_links":118},"NCT03076658","15-2433","Open Access Database of Standing Full Body Radiographs in Asymptomatic Volunteers","RECRUITING","2031-01","2023-09","2023-09-28","2016-09","University of Colorado, Denver","OTHER",false,"A study of the skeletal structure and how the structure changes over time. The aim of the study is to evaluate the skeleton in 10 year increments to determine an understanding of the normal skeleton as a person ages. By using x-ray analysis, a new low dose x-ray system (EOS) can be used to evaluate the whole body to see changes in the bone structure over time. Subjects will be asked to undertake one x-ray analysis of their whole body skeletal structure. There will be 25 male and 25 female subjects per decade. The averaging of the measured skeletal parameters will provide information on changes over time generating a standardized expectation of general changes in skeletal structure as participants age.","Current techniques of advanced spinal surgery allow physicians to correct complex spinal deformity to nearly any alignment desired. The investigators ability to analyze spino-pelvic alignment has evolved concurrently; however, the investigators goals in deformity correction are still not completely understood. With increasing ability to assess whole body alignment, the investigators must establish a baseline for the \"normal\" population inclusive of age related changes. the investigators hypothesis is that global body alignment will vary based on sex and progressively vary with age.\n\nThe goal of this study is to create an open access database of \"normal\" volunteer full body radiographic images obtained using the new EOS biplanar x-ray imaging system. The system provides a radiographic view of the weight-bearing skeleton equivalent to plain radiography. The development of an open access database of full body images and global spine parameters will provide spine surgeons with normative data that can be used to guide clinical decision making and surgical planning. Furthermore, the database can be used by researchers to obtain control measurements for comparison in studies of various spine, and potentially non-spine, pathologies.\n\nSpecific Aims\n\n1. To create an open access database of radiographic full body images in the sagittal and coronal planes of subjectswithout spine deformities or acute or severe chronic disease, across a range of age groups from 20 to 80 year old males and females.\n2. To document age related changes that occur in radiographic parameters in the spine and pelvis by including subjects across a wide range of ages.",[18,19],"Intervertebral Disc Degeneration","Osteoarthritis, Spine",[],"INTERVENTIONAL","DIAGNOSTIC",[24],"NA",{"count":26,"type":27},60,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"RADIATION","EOS imaging","The EOS imaging system will be utilized to obtain full-body radiographs in frontal and sagittal projections obtained in the upright standing position. Measurements will include a coronal plumb-line, sagittal vertebral axis (SVA), external auditory meatus plumb-line, cervical lordosis, thoracic kyphosis, lumbar lordosis, hip flexion\u002Fextension, knee flexion\u002Fextension, ankle flexion\u002Fextension, T1 tilt, T1 spino-pelvic instance, acetabular index, pelvic tilt (PT), pelvic incidence (PI), and sacral slope (SS).",[34],"asymptomatic EOS Imaging",[36,39,41,43,45,47,49,51,53,55,57,59,61,63,65],{"measure":37,"timeFrame":38},"Coronal plumb-line","Through 1 EOS scan, 20 minutes",{"measure":40,"timeFrame":38},"Sagittal vertebral axis (SVA)",{"measure":42,"timeFrame":38},"External auditory meatus plumb-line",{"measure":44,"timeFrame":38},"Cervical lordosis",{"measure":46,"timeFrame":38},"Thoracic kyphosis",{"measure":48,"timeFrame":38},"Lumbar lordosis",{"measure":50,"timeFrame":38},"Hip flexion\u002Fextension",{"measure":52,"timeFrame":38},"Knee flexion\u002Fextension",{"measure":54,"timeFrame":38},"Ankle flexion\u002Fextension",{"measure":56,"timeFrame":38},"T1 tilt",{"measure":58,"timeFrame":38},"T1 spino-pelvic instance",{"measure":60,"timeFrame":38},"Acetabular index",{"measure":62,"timeFrame":38},"Pelvic tilt (PT)",{"measure":64,"timeFrame":38},"Pelvic incidence (PI)",{"measure":66,"timeFrame":38},"Sacral slope (SS)",[],"ALL","21 Years","85 Years",true,{"inclusion":73,"exclusion":75,"raw_text":88},[74],"Males and females age 21-85 without a history of spine surgery.",[76,77,78,79,80,81,82,83,84,85,86,87],"History of spine or neural axis surgery","History of cancer with or without metastatic disease","Connective tissue, rheumatologic (or other inflammatory arthropathies), or neurologic disorders","History of knee replacement surgery, as these may have contractures causing unexpected changes in alignment","Severe osteoarthritis of the hips\u002Fknees\u002Fankles","Spondylitis","Compression fractures or other trauma of the spinal column","Previous trauma\u002Ffractures of the pelvis whether or not surgery was required","Previous trauma or fractures of the lower extremities requiring surgery","Pregnant women","BMI \\>37","Oswestry Disability Index score \\>25","Inclusion Criteria:\n\n* Males and females age 21-85 without a history of spine surgery.\n\nExclusion Criteria:\n\n* History of spine or neural axis surgery\n* History of cancer with or without metastatic disease\n* Connective tissue, rheumatologic (or other inflammatory arthropathies), or neurologic disorders\n* History of knee replacement surgery, as these may have contractures causing unexpected changes in alignment\n* Severe osteoarthritis of the hips\u002Fknees\u002Fankles\n* Spondylitis\n* Compression fractures or other trauma of the spinal column\n* Previous trauma\u002Ffractures of the pelvis whether or not surgery was required\n* Previous trauma or fractures of the lower extremities requiring surgery\n* Pregnant women\n* BMI \\>37\n* Oswestry Disability Index score \\>25",[90,91],"ADULT","OLDER_ADULT",[93],{"facility":94,"status":7,"city":95,"state":96,"zip":97,"country":98,"contacts":99,"geoPoint":108},"University of Coloardo Denver","Aurora","Colorado","80045","United States",[100,105],{"name":101,"role":102,"phone":103,"email":104},"David Calabrese","CONTACT","303-724-9265","David.Calabrese@ucdenver.edu",{"name":106,"role":107},"Christopher Kleck, MD","PRINCIPAL_INVESTIGATOR",{"lat":109,"lon":110},39.72943,-104.83192,[112],{"name":101,"role":102,"phone":113,"email":114},"303-524-2550","david.calabrese@ucdenver.edu",[116],{"name":106,"affiliation":12,"role":107},[],[],{"nct_id":4,"conditions":120,"biomarkers":123},[121,122],"Intervertebral Disc Degenerative Disorder","Osteoarthritis",[],{"nct_id":4,"found":71,"summary":125,"prompt_version":134},{"design":126,"status":127,"heading":6,"summary":128,"follow_up":129,"word_count":130,"commitments":131,"compensation":132,"drugs_mentioned":133},"This is an interventional study planning to enroll 60 participants. It aims to create a database of full-body X-ray images from healthy volunteers.","completed","This study aims to create a public database of full-body X-ray images from healthy volunteers using a special low-dose X-ray system called EOS imaging. Researchers want to understand how the skeleton changes naturally as people age, by looking at measurements like spinal curves (coronal plumb-line, sagittal vertebral axis, external auditory meatus plumb-line). This information will help doctors better understand what a \"normal\" spine looks like at different ages and guide decisions for spinal surgeries. You can join if you are between 21 and 85 years old and have not had spine surgery. The study plans to enroll 60 people, and its current recruitment status is unclear.","Measurements for the primary endpoints are taken during the single EOS scan, which lasts 20 minutes.",106,"You would undergo one EOS imaging scan of your whole body skeletal structure, which takes about 20 minutes.","Not stated in the trial record.",[31],"v2"]