[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100434399":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":36,"locations":45,"responsibleParty":426,"collaborators":428,"id":445,"slug":446,"hasResults":447,"nctId":448,"briefTitle":449,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":447,"sex":452,"minAge":453,"maxAge":24,"enrollmentInfo":454,"targetDuration":24,"studyType":457,"phases":458,"briefSummary":460,"conditions":461,"keywords":463,"overallStatus":48,"whyStopped":24,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":474},{"fullName":5,"class":6},"St George's, University of London","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Duroplasty","ACTIVE_COMPARATOR","Duroplasty (includes Surgery with Laminectomy)",[13,14],"Procedure: Duroplasty","Procedure: Spinal surgery",{"label":16,"type":10,"description":17,"interventionNames":18},"No duroplasty","No duroplasty (but includes surgery with Laminectomy)",[14],[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Expansion Duroplasty",[9],null,{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Spinal surgery","Spinal surgery including laminectomy",[9,16],[30,34],{"name":31,"affiliation":32,"role":33},"Marios C Papadopoulos","St George's, University of London, U.K.","PRINCIPAL_INVESTIGATOR",{"name":35,"affiliation":32,"role":33},"Samira Saadoun",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":24,"email":41},"Sophie Reynolds","CONTACT","079 17100953","discus@nds.ox.ac.uk",{"name":43,"role":39,"phone":24,"phoneExt":24,"email":44},"Ghazal Ebrat","gebrat@sgul.ac.uk",[46,61,72,83,96,109,128,142,155,170,183,196,204,217,230,243,254,265,276,287,298,309,320,331,346,354,359,367,378,386,397,410,418],{"facility":47,"status":48,"city":49,"state":24,"zip":24,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Universität Klinik für Neurochirurgie","RECRUITING","Innsbruck","Austria","AT",{"type":53,"coordinates":54},"Point",[55,56],11.39454,47.26266,{"lat":56,"lon":55},[59],{"name":60,"role":33,"phone":24,"phoneExt":24,"email":24},"Claudius Thome",{"facility":62,"status":48,"city":63,"state":24,"zip":24,"country":50,"countryCode":51,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Kepler University Hospital","Linz",{"type":53,"coordinates":65},[66,67],14.28611,48.30639,{"lat":67,"lon":66},[70],{"name":71,"role":33,"phone":24,"phoneExt":24,"email":24},"Wolfgang Senker",{"facility":73,"status":48,"city":74,"state":24,"zip":24,"country":50,"countryCode":51,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"University Hospital Salzburg","Salzburg",{"type":53,"coordinates":76},[77,78],13.04399,47.79941,{"lat":78,"lon":77},[81],{"name":82,"role":33,"phone":24,"phoneExt":24,"email":24},"Lukas Grassner",{"facility":84,"status":48,"city":85,"state":24,"zip":24,"country":50,"countryCode":51,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"St Polten University Hospital","Sankt Pölten",{"type":53,"coordinates":87},[88,89],15.63725,48.20762,{"lat":89,"lon":88},[92],{"name":93,"role":39,"phone":94,"phoneExt":24,"email":95},"Franz Marhold","43 2742\u002F9004-12961","neurochirurgie@stpoelten.lknoe.at",{"facility":97,"status":48,"city":98,"state":24,"zip":24,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"UZ Leuven","Leuven","Belgium","BE",{"type":53,"coordinates":102},[103,104],4.70093,50.87959,{"lat":104,"lon":103},[107],{"name":108,"role":33,"phone":24,"phoneExt":24,"email":24},"Bart Depreitere",{"facility":110,"status":48,"city":111,"state":112,"zip":24,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","China","CN",{"type":53,"coordinates":116},[117,118],114.26667,30.58333,{"lat":118,"lon":117},[121,125],{"name":122,"role":39,"phone":123,"phoneExt":24,"email":124},"Xiaodong Guo","027 85726646","xiaodongguo@hust.edu.cn",{"name":126,"role":39,"phone":24,"phoneExt":24,"email":127},"Peiran Xue","xuepeiran@outlook.com",{"facility":129,"status":48,"city":130,"state":24,"zip":24,"country":131,"countryCode":24,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Masaryk Hospital","Ústí nad Labem","Czechia",{"type":53,"coordinates":133},[134,135],14.03227,50.6607,{"lat":135,"lon":134},[138],{"name":139,"role":39,"phone":140,"phoneExt":24,"email":141},"Aleš Hejčl","420477112884","ales.hejcl@kzcr.eu",{"facility":143,"status":48,"city":144,"state":24,"zip":24,"country":145,"countryCode":146,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Aarhus University Hospital","Aarhus","Denmark","DK",{"type":53,"coordinates":148},[149,150],10.21076,56.15674,{"lat":150,"lon":149},[153],{"name":154,"role":33,"phone":24,"phoneExt":24,"email":24},"Mikkel Mylius Rasmussen",{"facility":156,"status":48,"city":157,"state":24,"zip":24,"country":158,"countryCode":159,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Kuopio University Hospital","Kuopio","Finland","FI",{"type":53,"coordinates":161},[162,163],27.67703,62.89238,{"lat":163,"lon":162},[166],{"name":167,"role":39,"phone":168,"phoneExt":24,"email":169},"Nils Danner","358400911568","Nils.Danner@pshyvinvointialue.fi",{"facility":171,"status":48,"city":172,"state":24,"zip":24,"country":173,"countryCode":174,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"BG Unfallklinik Frankfurt am Main","Frankfurt","Germany","DE",{"type":53,"coordinates":176},[177,178],10.53333,49.68333,{"lat":178,"lon":177},[181],{"name":182,"role":33,"phone":24,"phoneExt":24,"email":24},"Jonathan Neuhoff",{"facility":184,"status":48,"city":185,"state":24,"zip":24,"country":186,"countryCode":187,"cosmosGeoPoint":188,"geoPoint":192,"contacts":193},"Hadassah Medical Center","Jerusalem","Israel","IL",{"type":53,"coordinates":189},[190,191],35.21633,31.76904,{"lat":191,"lon":190},[194],{"name":195,"role":33,"phone":24,"phoneExt":24,"email":24},"Guy Rosenthal",{"facility":197,"status":48,"city":185,"state":24,"zip":24,"country":186,"countryCode":187,"cosmosGeoPoint":198,"geoPoint":200,"contacts":201},"Shaare Zedek Medical Centre",{"type":53,"coordinates":199},[190,191],{"lat":191,"lon":190},[202],{"name":203,"role":33,"phone":24,"phoneExt":24,"email":24},"Cezar Mizrahi",{"facility":205,"status":48,"city":206,"state":24,"zip":24,"country":207,"countryCode":208,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"University Medical Centre Ljubljana","Ljubljana","Slovenia","SI",{"type":53,"coordinates":210},[211,212],14.50513,46.05108,{"lat":212,"lon":211},[215],{"name":216,"role":33,"phone":24,"phoneExt":24,"email":24},"Marko Jug",{"facility":218,"status":48,"city":219,"state":24,"zip":24,"country":220,"countryCode":221,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"12 de Octubre University Hospital","Madrid","Spain","ES",{"type":53,"coordinates":223},[224,225],-3.70256,40.4165,{"lat":225,"lon":224},[228],{"name":229,"role":33,"phone":24,"phoneExt":24,"email":24},"Igor Paredes",{"facility":231,"status":48,"city":232,"state":24,"zip":24,"country":233,"countryCode":234,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"Skåne University Hospital","Lund","Sweden","SE",{"type":53,"coordinates":236},[237,238],13.19321,55.70584,{"lat":238,"lon":237},[241],{"name":242,"role":33,"phone":24,"phoneExt":24,"email":24},"Niklas Marklund",{"facility":244,"status":245,"city":246,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":249,"geoPoint":253,"contacts":24},"National Spinal Injuries Centre","ACTIVE_NOT_RECRUITING","Aylesbury","United Kingdom","UK",{"type":53,"coordinates":250},[251,252],-0.81458,51.81665,{"lat":252,"lon":251},{"facility":255,"status":48,"city":256,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":257,"geoPoint":261,"contacts":262},"Queen Elizabeth Hospital Birmingham","Birmingham",{"type":53,"coordinates":258},[259,260],-1.89983,52.48142,{"lat":260,"lon":259},[263],{"name":264,"role":33,"phone":24,"phoneExt":24,"email":24},"Vladimir Petrik",{"facility":266,"status":48,"city":267,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":268,"geoPoint":272,"contacts":273},"Addenbrooke's Hospital","Cambridge",{"type":53,"coordinates":269},[270,271],0.11667,52.2,{"lat":271,"lon":270},[274],{"name":275,"role":33,"phone":24,"phoneExt":24,"email":24},"Ivan Timofeev",{"facility":277,"status":48,"city":278,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":279,"geoPoint":283,"contacts":284},"Royal Infirmary of Edinburgh","Edinburgh",{"type":53,"coordinates":280},[281,282],-3.19648,55.95206,{"lat":282,"lon":281},[285],{"name":286,"role":33,"phone":24,"phoneExt":24,"email":24},"Andreas Demetriades",{"facility":288,"status":48,"city":289,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":290,"geoPoint":294,"contacts":295},"Queen Elizabeth University Hospital","Glasgow",{"type":53,"coordinates":291},[292,293],-4.25763,55.86515,{"lat":293,"lon":292},[296],{"name":297,"role":33,"phone":24,"phoneExt":24,"email":24},"Likhith Alakandy",{"facility":299,"status":48,"city":300,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":301,"geoPoint":305,"contacts":306},"Hull Royal Infirmary","Hull",{"type":53,"coordinates":302},[303,304],-0.33525,53.7446,{"lat":304,"lon":303},[307],{"name":308,"role":33,"phone":24,"phoneExt":24,"email":24},"Vasileios Arzoglou",{"facility":310,"status":48,"city":311,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":312,"geoPoint":316,"contacts":317},"Leeds General Infirmary","Leeds",{"type":53,"coordinates":313},[314,315],-1.54785,53.79648,{"lat":315,"lon":314},[318],{"name":319,"role":33,"phone":24,"phoneExt":24,"email":24},"Christopher Derham",{"facility":321,"status":48,"city":322,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":323,"geoPoint":327,"contacts":328},"The Walton Centre","Liverpool",{"type":53,"coordinates":324},[325,326],-2.97794,53.41058,{"lat":326,"lon":325},[329],{"name":330,"role":33,"phone":24,"phoneExt":24,"email":24},"Martin Wilby",{"facility":332,"status":48,"city":333,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":334,"geoPoint":338,"contacts":339},"St George's Hospital","London",{"type":53,"coordinates":335},[336,337],-0.12574,51.50853,{"lat":337,"lon":336},[340,344],{"name":341,"role":39,"phone":342,"phoneExt":24,"email":343},"Marios C Papadopoulos, MD","02087254179","mpapadop@sgul.ac.uk",{"name":345,"role":33,"phone":24,"phoneExt":24,"email":24},"Marios Papadopoulos",{"facility":347,"status":48,"city":333,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":348,"geoPoint":350,"contacts":351},"St Mary's Hospital",{"type":53,"coordinates":349},[336,337],{"lat":337,"lon":336},[352],{"name":353,"role":33,"phone":24,"phoneExt":24,"email":24},"Haider Kareem",{"facility":355,"status":245,"city":333,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":356,"geoPoint":358,"contacts":24},"The London Spinal Cord Injury Centre",{"type":53,"coordinates":357},[336,337],{"lat":337,"lon":336},{"facility":360,"status":48,"city":333,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":361,"geoPoint":363,"contacts":364},"The Royal London Hospital",{"type":53,"coordinates":362},[336,337],{"lat":337,"lon":336},[365],{"name":366,"role":33,"phone":24,"phoneExt":24,"email":24},"Christopher Uff",{"facility":368,"status":48,"city":369,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":370,"geoPoint":374,"contacts":375},"Queen's Medical Centre","Nottingham",{"type":53,"coordinates":371},[372,373],-1.15047,52.9536,{"lat":373,"lon":372},[376],{"name":377,"role":33,"phone":24,"phoneExt":24,"email":24},"Daniel D'Aquino",{"facility":379,"status":245,"city":380,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":381,"geoPoint":385,"contacts":24},"Midlands Centre for Spinal Injuries,","Oswestry",{"type":53,"coordinates":382},[383,384],-3.05497,52.86195,{"lat":384,"lon":383},{"facility":387,"status":48,"city":388,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":389,"geoPoint":393,"contacts":394},"Salford Royal","Salford",{"type":53,"coordinates":390},[391,392],-2.29042,53.48771,{"lat":392,"lon":391},[395],{"name":396,"role":33,"phone":24,"phoneExt":24,"email":24},"Shrijit Panikkar",{"facility":398,"status":48,"city":399,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":400,"geoPoint":404,"contacts":405},"Sheffield Teaching Hospitals NHS Foundation Trust","Sheffield",{"type":53,"coordinates":401},[402,403],-1.4659,53.38297,{"lat":403,"lon":402},[406,408],{"name":407,"role":33,"phone":24,"phoneExt":24,"email":24},"Marcel Ivanov",{"name":409,"role":33,"phone":24,"phoneExt":24,"email":24},"Rohit Bhide",{"facility":411,"status":245,"city":412,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":413,"geoPoint":417,"contacts":24},"North West Regional Spinal Injuries Centre","Southport",{"type":53,"coordinates":414},[415,416],-3.01008,53.64581,{"lat":416,"lon":415},{"facility":419,"status":245,"city":420,"state":24,"zip":24,"country":247,"countryCode":248,"cosmosGeoPoint":421,"geoPoint":425,"contacts":24},"Pinderfields Hospital","Wakefield",{"type":53,"coordinates":422},[423,424],-1.49768,53.68331,{"lat":424,"lon":423},{"type":427,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[429,431,433,435,437,439,441,443],{"name":430,"class":6},"St George's University Hospitals NHS Foundation Trust",{"name":432,"class":6},"St. Mary's University, Twickenham",{"name":434,"class":6},"University of Bristol",{"name":436,"class":6},"Ohio State University",{"name":438,"class":6},"University of Cambridge",{"name":440,"class":6},"University of Oxford",{"name":442,"class":6},"Buckinghamshire Healthcare NHS Trust",{"name":444,"class":6},"Paracelsus Medical University","100434399","duroplasty-for-injured-cervical-spinal-cord-with-uncontrolled-swelling-100434399",false,"NCT04936620","Duroplasty for Injured Cervical Spinal Cord With Uncontrolled Swelling","DISCUS","Inclusion Criteria:\n\n1. Age ≥16 years\n2. Severe cervical (C2 - T1) traumatic spinal cord injury (AIS grade A-C)\n3. Deemed to require and be suitable for surgery that includes laminectomy by local surgeon\n4. Surgery within 72 hours of traumatic spinal cord injury\n5. Able to provide informed consent or consultee declaration or proxy consent.\n\nExclusion Criteria:\n\n1. Dural tear due to traumatic spinal cord injury\n2. Life-limiting or rehabilitation-restricting co-morbidities\n3. Thoracic or lumbar traumatic spinal cord injury\n4. Other central nervous system disease","ALL","16 Years",{"count":455,"type":456},222,"ESTIMATED","INTERVENTIONAL",[459],"NA","QUESTION. Does duroplasty improve outcome after spinal cord injury?\n\nWHAT DO WE STUDY? We will investigate whether performing a surgical procedure called duroplasty improves outcomes after spinal cord injury.\n\nWHY SPINAL CORD INJURY? Spinal cord injury is a devastating condition that causes permanent disability such as paralysis, numbness and loss of bladder and bowel control. Currently, there are no treatments shown to improve outcome after spinal cord injury.\n\nWHAT IS DUROPLASTY? Duroplasty is an operation that involves opening the tough membrane around the cord, called the dura, and stitching a patch of artificial dura to expand the space around the swollen cord.\n\nWHY IS DUROPLASTY BEING STUDIED? Based on our preliminary evidence, we think that the dura causes cord pressure after injury. We have shown in a small study of patients that performing this operation safely and effectively reduces pressure on the injured cord.\n\nWHO IS ELIGIBLE? Adult patients with severe spinal cord injuries in the neck who will have surgery within 72 hours.\n\nWHAT TREATMENT? Those who agree to take part will be allocated by chance (like tossing a coin) to standard treatment or standard treatment plus duroplasty. Some patients will also be asked to take part in a smaller study that involves placing probes at the injury site.\n\nWHERE? We will recruit patients from U.K. Major Trauma Centres. Most assessments will be done in U.K. Spinal Injury Centres. Later on, we may recruit from overseas.\n\nHOW LONG? We aim to recruit 222 - 260 patients over 4 years. Patients will be followed up for a year.\n\nWHAT DO WE ASSESS? Patients will be assessed (using questionnaires and by examination) how well they can use their hands, walk, control their bladder and bowel and their quality of life. Some of these assessments will be repeated at 3, 6 and 12 months after surgery.\n\nWHAT IS THE OPTIONAL MECHANISTIC STUDY? DISCUS includes an optional study for at least 50 patients who will take part in the randomised controlled trial. The aim of the mechanistic study is to determine how duroplasty improves outcome, i.e. whether duroplasty reduces cord compression, improves blood flow to the injured cord perfusion, improves cord metabolism and reduces cord inflammation.\n\nWHAT IS THE OPTIONAL INFORMATION STUDY? For the first two years, a study called QuinteT Recruitment Intervention (QRI) is designed to optimise patient recruitment and informed consent in the trauma setting.",[462],"Spinal Cord Injuries",[464],"Decompression, surgical; Neurosurgery; Paralysis","2026-01-26",{"date":467,"type":468},"2026-01-28","ACTUAL",{"date":470,"type":468},"2021-10-08",{"date":472,"type":456},"2028-06-30",{"name":5,"class":6},33]