[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513016":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":58,"collaborators":18,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":18,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":18,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"All India Institute of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Surgical arm","EXPERIMENTAL","Will undergo posterior cervical fixation surgery within 4 weeks of randomization",[13],"Procedure: Posterior cervical fixation surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Cervical collar arm","NO_INTERVENTION","Will be given cervical collar for regular use",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"PROCEDURE","Posterior cervical fixation surgery","These patients will undergo posterior cervical fixation in the form of cervical lateral mass screw fixation in extension without decompression under general anesthesia.",[9],[26],{"name":27,"affiliation":5,"role":28},"Deepti Vibha","PRINCIPAL_INVESTIGATOR",[30,34],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},"CONTACT","+91-011-26594485","deeptivibha@aiims.edu",{"name":35,"role":31,"phone":36,"phoneExt":18,"email":37},"Kanwaljeet Garg","+91-968569905","kanwaljeet@aiims.edu",[39],{"facility":27,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","New Delhi","National Capital Territory of Delhi","110029","India","IN",{"type":47,"coordinates":48},"Point",[49,50],77.2148,28.62137,{"lat":50,"lon":49},[53,54,55],{"name":27,"role":31,"phone":32,"phoneExt":18,"email":33},{"name":35,"role":28,"phone":18,"phoneExt":18,"email":18},{"name":56,"role":57,"phone":18,"phoneExt":18,"email":18},"Ajay Garg","SUB_INVESTIGATOR",{"type":28,"investigatorFullName":27,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Professor, Neurology","100513016","cervical-fixation-surgery-cervical-collar-for-management-of-hirayama-disease-a-randomized-study-100513016",false,"NCT05959980","Cervical Fixation Surgery Cervical Collar for Management of Hirayama Disease: A Randomized Study","Posterior Cervical Fixation Versus Long-term Cervical Collar for Management of Hirayama Disease: Prospective Randomized Open Blinded Endpoint (PROBE), Phase III Study","Inclusion Criteria:\n\n* All the following:\n\n  1. Age ≥ 18 years\n  2. Patients with Hirayama disease as per the following criteria (All of the following) (16):\n\n     1. Clinical evidence of wasting and weakness confined to one limb (EMG evidence of denervation in the opposite limb will not be a reason for exclusion)\n     2. Progressive course, or initial progression followed by stationary course; and\n     3. No evidence of a compressive lesion of the spinal cord.\n  3. Disease duration of ≤4 years\n  4. Progression of clinical symptoms in the past six-months\n\nExclusion Criteria:\n\n* Any of the following:\n\n  1. Refusal to consent for randomization\n  2. Not willing to come for three- and six-months follow-up","ALL","18 Years","60 Years",{"count":71,"type":72},80,"ESTIMATED","INTERVENTIONAL",[75],"NA","The goal of this clinical trial\\] is to compare cervical collar versus neck stabilization surgery in diagnosed patients of Hirayama disease who have been reporting worsening of problems in the past six months. The main question\\[s\\] it aims to answer are:\n\n• Is cervical stabilization surgery (Posterior cervical fixation) superior to conservative management in the form of cervical collar placement in patients with progressive Hirayama disease, observed at six months after intervention\n\nParticipants will have equal chance to:\n\n* Undergo cervical fixation surgery\n* Cervical collar management The investigators will study and compare the efficacy of both treatments upto six months after intervention",[78],"Hirayama Disease",[80,81,82],"Hirayama disease","cervical collar","posterior cervical fixation surgery","2024-01-27",{"date":85,"type":86},"2024-01-30","ACTUAL",{"date":88,"type":86},"2023-10-01",{"date":90,"type":72},"2026-12",{"name":5,"class":6},1]