[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02040714":3,"trial-entities:NCT02040714":440,"trial-summary:NCT02040714":445},{"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":19,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":30,"interventions":33,"primary_outcomes":63,"secondary_outcomes":68,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":76,"eligibility_criteria":77,"std_ages":85,"locations":88,"central_contacts":430,"overall_officials":431,"references":435,"see_also_links":436},"NCT02040714","IPSG 001","Multicenter Prospective Cohort Study on Current Treatments of Legg-Calvé-Perthes Disease","ENROLLING_BY_INVITATION","2032-09","2025-05","2025-05-06","2012-08","Texas Scottish Rite Hospital for Children","OTHER",true,"Legg-Calvé-Perthes disease is a childhood hip disorder which is common enough to be a significant public health problem (affects 1 in 740 boys between ages 0-14), but uncommon enough to have a sufficient number of patients from a single institution to perform a definitive prospective study comparing the results of current treatments. The present study will establish a database of prospectively identified patients with Legg-Calvé-Perthes (LCP) Disease and collect information regarding their presentation, treatment, and outcomes in the course of receiving currently available treatments.\n\nThis study seeks to compare the outcomes of current treatments in the management of different age groups (ages 1-6, 6-8, 8-11, \\>11) of patients with Perthes disease at two- and five-year followup and at skeletal maturity. For each age group, two to three common treatment regimens currently used by practicing pediatric orthopaedic surgeons will be compared. The intervention a patient receives is determined through physician treatment expertise, and is not pre-determined by the study.","Approximately 50 pediatric orthopaedic surgeons from pediatric centers in the US and other countries have agreed to participate in this database as members of the International Perthes Study Group (IPSG). TSRH will be the lead center. Sites who agree to participate will seek IRB approval from their own institutions. Data will be collected prospectively and entered into REDCap (Research Electronic Data Capture), a browser-based research database.\n\n1-6 Cohort: For the 1-6 age patient group, patients involved in any treatment will be asked to participate in the study.\n\n6-8 Cohort: For the 6-8 age patient group, patients presenting in an early stage of the disease (stage I or IIa), the surgeons who treat their patients with one of the following three treatment regimens currently used in practice will be asked to participate in the study :\n\n1. Non-operative management (i.e., no osteotomy but can include soft tissue release);\n2. Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty).\n\n8-11 Cohort: For the 8-11 patient age group, patients presenting in an early stage of the disease (stage I or IIa), the surgeons who treat their patients with one of the following treatment regiments currently used in practice will be asked to participate in the study:\n\n1. Non-operative management (i.e., no osteotomy);\n2. Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) followed by 6 weeks of postoperative non-weight bearing; and,\n3. Operative containment treatment (femoral or pelvic osteotomy or Shelf acetabuloplasty) followed by 6 months of postoperative non-weight bearing.\n\n\\>11 Cohort Registry: For the \\>11 patient age group, we will collect prospective data from surgeons who are currently treating their patients with any treatment regimens.\n\nPatients who present to an IPSG member or their group during the late stages of the disease (stage IIb or stage III) will also be arranged into four separate age cohorts, identical to the list above. We will collect prospective data for these cases, as well.\n\nRegardless of the patient's stage at enrollment, the patient's age at diagnosis or assigned cohort, the following data will be collected: information regarding patient characteristics at presentation, physical exam findings, responses to Perthes patient and\u002For outcomes questionnaires, and results of radiographic and MR imaging.\n\nParticipants will be assigned a unique study number. A secure web application, REDCap, will be used to capture and store research information including radiographic and MR images, clinical information, and de-identified outcomes questionnaire responses. Data will be transmitted and stored on a secure and dedicated server for the purpose of this study.",[18],"Legg Calve Perthes Disease",[20,21,22,23,24,25,26],"femur head necrosis","hip","pediatric orthopedics","MRI","Osteonecrosis","Bone diseases","Legg Calve Perthes Syndrome","OBSERVATIONAL",null,[],{"count":31,"type":32},1500,"ESTIMATED",[34,44,49,59],{"type":35,"name":36,"description":37,"armGroupLabels":38},"PROCEDURE","Osteotomy + Long Term Non-Weight Bearing","Surgical procedure that improves femoral head containment, plus a post-operative protocol that requires patient to maintain non-weight bearing for 6 months.",[39,40,41,42,43],"Late Stage Surgical Containment group","Operative containment for over 11 age group","Operative containment with prolonged non-weightbearing in early stage","Operative management between age 6-8 in early stage","Operative management in 1-6 age group",{"type":35,"name":45,"description":46,"armGroupLabels":47},"Osteotomy + Short Term Non-Weight Bearing","Surgical procedure that improves femoral head containment, plus a post-operative protocol that allows early return to function after 6 weeks of non-weight bearing.",[39,40,48,42,43],"Operative containment with short-term non-weightbearing in early stage",{"type":35,"name":50,"description":51,"armGroupLabels":52},"Nonoperative Observation","Group will not undergo any surgical or invasive procedures during course of treatment.",[53,54,55,56,57,58],"Late Stage Bracing group","Late Stage Symptomatic treatment group","Nonoperative management between age 8-11 in early stage","Nonoperative management between ages 6-8 in early stage","Nonoperative management in 1-6 age group","Nonoperative management in over 11 age group",{"type":35,"name":60,"description":61,"armGroupLabels":62},"Multiple Epiphyseal Drilling","Multiple epiphyseal drilling is a procedure that creates small holes in the femoral head growth plate to increase blood flow into the femoral head.",[39,40,43],[64],{"measure":65,"description":66,"timeFrame":67},"Sphericity deviation score of the femoral head","The primary outcome for each age group will be a quantitative estimate of the sphericity of the femoral head as a measure of femoral head deformity. A more deformed head will be less spherical. Greater deformity leads to an increased risk of arthritis early in life.","5 years post intervention",[69],{"measure":70,"description":71,"timeFrame":72},"Perfusion percentage","The perfusion percentage is a measure of the amount of blood flow in the femoral head relative to the volume of the whole head. This measure is calculated from the perfusion MRI images that are collected just prior to the application of the intervention.","Just after diagnosis of Perthes disease","ALL","1 Year","18 Years",false,{"inclusion":78,"exclusion":82,"raw_text":84},[79,80,81],"Diagnosed with Legg-Calvé-Perthes disease","Between age 1-18","Patients with possible secondary femoral osteonecrosis if over the age of 11 due to trauma or corticosteroid therapy are also eligible.",[83],"Patients with previous surgical treatment on the affected hip","Inclusion Criteria:\n\n* Diagnosed with Legg-Calvé-Perthes disease\n* Between age 1-18\n* Patients with possible secondary femoral osteonecrosis if over the age of 11 due to trauma or corticosteroid therapy are also eligible.\n\nExclusion Criteria:\n\n* Patients with previous surgical treatment on the affected hip",[86,87],"CHILD","ADULT",[89,98,106,109,116,123,131,139,147,155,163,171,179,187,195,202,209,213,220,228,236,243,251,259,267,275,282,289,297,306,314,323,331,339,347,354,357,365,372,380,387,395,402,409,416,423],{"facility":90,"city":91,"state":92,"zip":93,"country":94,"geoPoint":95},"Children's Hospital of Alabama","Birmingham","Alabama","35294","United States",{"lat":96,"lon":97},33.52066,-86.80249,{"facility":99,"city":100,"state":101,"zip":102,"country":94,"geoPoint":103},"Children's Hospital of Los Angeles","Los Angeles","California","90027",{"lat":104,"lon":105},34.05223,-118.24368,{"facility":107,"city":100,"state":101,"zip":102,"country":94,"geoPoint":108},"Kaiser Permanente Hospital",{"lat":104,"lon":105},{"facility":110,"city":111,"state":101,"zip":112,"country":94,"geoPoint":113},"Rady Children's Hospital California","San Diego","92024",{"lat":114,"lon":115},32.71571,-117.16472,{"facility":117,"city":118,"state":101,"zip":119,"country":94,"geoPoint":120},"UCSF Benioff Children's Hospitals","San Francisco","94158",{"lat":121,"lon":122},37.77493,-122.41942,{"facility":124,"city":125,"state":126,"zip":127,"country":94,"geoPoint":128},"Children's Hospital Colorado","Aurora","Colorado","80045",{"lat":129,"lon":130},39.72943,-104.83192,{"facility":132,"city":133,"state":134,"zip":135,"country":94,"geoPoint":136},"Connecticut Children's Medical Center","Hartford","Connecticut","06106",{"lat":137,"lon":138},41.76371,-72.68509,{"facility":140,"city":141,"state":142,"zip":143,"country":94,"geoPoint":144},"Alfred I. DuPont Hospital for Children of the Nemours Foundation","Wilmington","Delaware","19803",{"lat":145,"lon":146},39.74595,-75.54659,{"facility":148,"city":149,"state":150,"zip":151,"country":94,"geoPoint":152},"Children's National Medical Center","Washington D.C.","District of Columbia","20010",{"lat":153,"lon":154},38.89511,-77.03637,{"facility":156,"city":157,"state":158,"zip":159,"country":94,"geoPoint":160},"Children's Orthopaedics of Atlanta","Atlanta","Georgia","30342",{"lat":161,"lon":162},33.749,-84.38798,{"facility":164,"city":165,"state":166,"zip":167,"country":94,"geoPoint":168},"Ann & Robert H. Lurie Children's Hospital of Chicago","Chicago","Illinois","60611",{"lat":169,"lon":170},41.85003,-87.65005,{"facility":172,"city":173,"state":174,"zip":175,"country":94,"geoPoint":176},"Johns Hopkins","Baltimore","Maryland","21218",{"lat":177,"lon":178},39.29038,-76.61219,{"facility":180,"city":181,"state":182,"zip":183,"country":94,"geoPoint":184},"Children's Hospital Boston","Boston","Massachusetts","02115-5724",{"lat":185,"lon":186},42.35843,-71.05977,{"facility":188,"city":189,"state":190,"zip":191,"country":94,"geoPoint":192},"Mayo Clinic","Rochester","Minnesota","55905",{"lat":193,"lon":194},44.02163,-92.4699,{"facility":196,"city":197,"state":190,"zip":198,"country":94,"geoPoint":199},"Gillette Children's Specialty Healthcare","Saint Paul","55101",{"lat":200,"lon":201},44.94441,-93.09327,{"facility":203,"city":204,"state":204,"zip":205,"country":94,"geoPoint":206},"NYU Langone\u002FHospital for Joint Disease","New York","10003",{"lat":207,"lon":208},40.71427,-74.00597,{"facility":210,"city":204,"state":204,"zip":211,"country":94,"geoPoint":212},"New York Presbyterian Hospital (Columbia Campus)","10032",{"lat":207,"lon":208},{"facility":214,"city":215,"state":204,"zip":216,"country":94,"geoPoint":217},"Children's Hospital at Montefiore","The Bronx","10467",{"lat":218,"lon":219},40.84985,-73.86641,{"facility":221,"city":222,"state":223,"zip":224,"country":94,"geoPoint":225},"OrthoCarolina","Charlotte","North Carolina","28207",{"lat":226,"lon":227},35.22709,-80.84313,{"facility":229,"city":230,"state":231,"zip":232,"country":94,"geoPoint":233},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"lat":234,"lon":235},39.12711,-84.51439,{"facility":237,"city":238,"state":231,"zip":239,"country":94,"geoPoint":240},"Nationwide Children's Hospital","Columbus","43205",{"lat":241,"lon":242},39.96118,-82.99879,{"facility":244,"city":245,"state":246,"zip":247,"country":94,"geoPoint":248},"Oklahoma University Health Science Center","Oklahoma City","Oklahoma","73104",{"lat":249,"lon":250},35.46756,-97.51643,{"facility":252,"city":253,"state":254,"zip":255,"country":94,"geoPoint":256},"Oregon Health and Science University","Portland","Oregon","97239",{"lat":257,"lon":258},45.52345,-122.67621,{"facility":260,"city":261,"state":262,"zip":263,"country":94,"geoPoint":264},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"lat":265,"lon":266},39.95238,-75.16362,{"facility":268,"city":269,"state":270,"zip":271,"country":94,"geoPoint":272},"University of Tennessee-Campbell Clinic","Germantown","Tennessee","38138",{"lat":273,"lon":274},35.08676,-89.81009,{"facility":12,"city":276,"state":277,"zip":278,"country":94,"geoPoint":279},"Dallas","Texas","75219",{"lat":280,"lon":281},32.78306,-96.80667,{"facility":283,"city":284,"state":277,"zip":285,"country":94,"geoPoint":286},"Texas Children's Hospital","Houston","77030",{"lat":287,"lon":288},29.76328,-95.36327,{"facility":290,"city":291,"state":292,"zip":293,"country":94,"geoPoint":294},"Seattle Children's Hospital","Seattle","Washington","98105",{"lat":295,"lon":296},47.60621,-122.33207,{"facility":298,"city":299,"state":300,"zip":301,"country":302,"geoPoint":303},"Women and Children's Hospital of Adelaide","Adelaide","South Australia","5006","Australia",{"lat":304,"lon":305},-34.92866,138.59863,{"facility":307,"city":308,"zip":309,"country":310,"geoPoint":311},"Universidade de São Paulo","São Paulo","05508-070","Brazil",{"lat":312,"lon":313},-23.5475,-46.63611,{"facility":315,"city":316,"state":317,"zip":318,"country":319,"geoPoint":320},"Alberta Children's Hospital, Division of Paediatric Surgery","Calgary","Alberta","T3B6A8","Canada",{"lat":321,"lon":322},51.05011,-114.08529,{"facility":324,"city":325,"state":326,"zip":327,"country":319,"geoPoint":328},"British Columbia Children's Hospital","Vancouver","British Columbia","V6H 3V4",{"lat":329,"lon":330},49.24966,-123.11934,{"facility":332,"city":333,"zip":334,"country":335,"geoPoint":336},"Tianjin Hospital Pediatric Orthopedics","Tianjin","85016","China",{"lat":337,"lon":338},39.14222,117.17667,{"facility":340,"city":341,"zip":342,"country":343,"geoPoint":344},"Children's Hospital Hamburg-Altona","Hamburg","22763","Germany",{"lat":345,"lon":346},53.55073,9.99302,{"facility":348,"city":349,"zip":350,"country":343,"geoPoint":351},"Hospital of Schleswig-Holstein","Lübeck","23538",{"lat":352,"lon":353},53.86893,10.68729,{"facility":355,"city":349,"country":343,"geoPoint":356},"University Hospital of Schleswig-Holstein (Campus Lubeck)",{"lat":352,"lon":353},{"facility":358,"city":359,"state":360,"country":361,"geoPoint":362},"Kasturba Medical College (KMC), Manipal","Udupi","Karnataka","India",{"lat":363,"lon":364},13.33467,74.74617,{"facility":366,"city":367,"country":368,"geoPoint":369},"Children's Health Ireland at Temple Street","Dublin","Ireland",{"lat":370,"lon":371},53.33306,-6.24889,{"facility":373,"city":374,"zip":375,"country":376,"geoPoint":377},"Oslo University Hospital","Oslo","0372","Norway",{"lat":378,"lon":379},59.91273,10.74609,{"facility":381,"city":382,"country":383,"geoPoint":384},"Medical University of Lodz","Lodz","Poland",{"lat":385,"lon":386},51.77058,19.47395,{"facility":388,"city":389,"zip":390,"country":391,"geoPoint":392},"San Jorge Children's Hospital","San Juan","00912","Puerto Rico",{"lat":393,"lon":394},18.46633,-66.10572,{"facility":396,"city":397,"country":398,"geoPoint":399},"Hospital Infantil Universitario Nino Jesus","Madrid","Spain",{"lat":400,"lon":401},40.4165,-3.70256,{"facility":403,"city":404,"country":405,"geoPoint":406},"Uppsala University","Uppsala","Sweden",{"lat":407,"lon":408},59.85882,17.63889,{"facility":410,"city":411,"country":412,"geoPoint":413},"Centre hopsitalier universitaire Vaudois","Lausanne","Switzerland",{"lat":414,"lon":415},46.516,6.63282,{"facility":417,"city":418,"country":419,"geoPoint":420},"Alder Hey Children's Hosopital (University of Oxford)","Liverpool","United Kingdom",{"lat":421,"lon":422},53.41058,-2.97794,{"facility":424,"city":425,"zip":426,"country":419,"geoPoint":427},"Southampton Children's Hospital","Southampton","SO166YD",{"lat":428,"lon":429},50.90395,-1.40428,[],[432],{"name":433,"affiliation":12,"role":434},"Harry KW Kim, MD, MS","STUDY_CHAIR",[],[437],{"label":438,"url":439},"IPSG Website","http:\u002F\u002Fwww.perthesdisease.org",{"nct_id":4,"conditions":441,"biomarkers":444},[442,443],"Femoral osteosclerosis","Perthes Disease",[],{"nct_id":4,"found":76,"summary":28,"prompt_version":28}]