Nctid:
NCT06233539
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000004204", "term"=>"Joint Dislocations"}], "ancestors"=>[{"id"=>"D000007592", "term"=>"Joint Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D000014947", "term"=>"Wounds and Injuries"}], "browseLeaves"=>[{"id"=>"M7385", "name"=>"Joint Dislocations", "asFound"=>"Dislocation", "relevance"=>"HIGH"}, {"id"=>"M10621", "name"=>"Joint Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M17685", "name"=>"Wounds and Injuries", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"OTHER", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>3000}, "targetDuration"=>"1 Year", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2022-12-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-04-01", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-22", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-03", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"The incidence of special attention adverse events in patients within 12 months after surgery", "timeFrame"=>"12 month follow up", "description"=>"The proportion of adverse events occurring in patients during the study period to the total number of study patients.\n\nRecording and reporting of adverse events, including: • deterioration of neurological function\n\n* Incision infection\n* Vascular injury\n\nAirway obstruction\n\nPoor reset\n\n• Unplanned readmission and unplanned reoperation • Internal fixation failure\n\nFusion failure\n\nSurgical related lower cervical spine deformities"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Atlantoaxial Dislocation", "Treatment", "Diagnostic"]}, "descriptionModule"=>{"briefSummary"=>"The most effective treatment for atlantoaxial dislocation is surgical treatment, with the principle of achieving reduction, reconstruction, and fusion of the atlantoaxial joint. The surgical strategies mainly include simple anterior approach, simple posterior approach, and combined anterior posterior approach. The investigators have summarized 904 cases of atlantoaxial instability or dislocation from 1998 to 2010 and preliminarily published the diagnosis and treatment strategy tree of the Third Hospital of Beijing Medical University. This strategy is divided into four types based on the severity of atlantoaxial dislocation: unstable, reversible, difficult to recover, and skeletal, and enters different surgical treatment processes. With the increase in the number of cases, accumulation of experience, and technological improvements in the past decade, spinal surgery colleagues have updated their classification diagnosis, diagnosis and treatment processes, and surgical techniques for atlantoaxial instability or dislocation.\n\nHowever, the selection of treatment strategies for atlantoaxial dislocation is mostly based on the surgeon's own experience, and there is a lack of standardized, large-scale, and high-level evidence-based medical research on the safety and effectiveness of current empirical strategies. Based on this, this study intends to adopt a multicenter, retrospective, and prospective study to construct a high-quality clinical cohort of atlantoaxial dislocation, update the classification and diagnosis and treatment strategies of atlantoaxial dislocation. And conduct long-term follow-up on patients to evaluate their safety and effectiveness, guide the surgical treatment of atlantoaxial dislocation, and thus form a recognized diagnostic and treatment standard for atlantoaxial dislocation."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients diagnosed with atlantoaxial dislocation and treated with surgery", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients diagnosed with atlantoaxial dislocation and treated with surgery\n\nExclusion Criteria:\n\n* Disagree to participate in this study."}, "identificationModule"=>{"nctId"=>"NCT06233539", "briefTitle"=>"A Study on Diagnosis and Treatment Strategies for Atlantoaxial Dislocation", "organization"=>{"class"=>"OTHER", "fullName"=>"Peking University Third Hospital"}, "officialTitle"=>"A Study on Diagnosis and Treatment Strategies for Atlantoaxial Dislocation", "orgStudyIdInfo"=>{"id"=>"M2022822"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Retrospective section", "interventionNames"=>["Other: Observational research without intervention"]}, {"label"=>"Prospective section", "interventionNames"=>["Other: Observational research without intervention"]}], "interventions"=>[{"name"=>"Observational research without intervention", "type"=>"OTHER", "description"=>"Observational research without intervention", "armGroupLabels"=>["Prospective section", "Retrospective section"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"100191", "city"=>"Beijing", "state"=>"Beijing", "status"=>"RECRUITING", "country"=>"China", "contacts"=>[{"name"=>"Shenglin Wang", "role"=>"CONTACT", "email"=>"pkuwsl@126.com", "phone"=>"+8613501380281"}], "facility"=>"Shenglin Wang", "geoPoint"=>{"lat"=>39.9075, "lon"=>116.39723}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Peking University Third Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
