Nctid:
NCT06617338
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010003", "term"=>"Osteoarthritis"}], "ancestors"=>[{"id"=>"D000001168", "term"=>"Arthritis"}, {"id"=>"D000007592", "term"=>"Joint Diseases"}, {"id"=>"D000009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D000012216", "term"=>"Rheumatic Diseases"}], "browseLeaves"=>[{"id"=>"M12926", "name"=>"Osteoarthritis", "asFound"=>"Osteoarthritis", "relevance"=>"HIGH"}, {"id"=>"M4476", "name"=>"Arthritis", "relevance"=>"LOW"}, {"id"=>"M10621", "name"=>"Joint Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M15045", "name"=>"Rheumatic Diseases", "relevance"=>"LOW"}, {"id"=>"M6323", "name"=>"Collagen Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"BASIC_SCIENCE", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Prospective, randomized cohort analysis study"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>200}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-11-07", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2026-05-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-25", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-04-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Overall Satisfaction", "timeFrame"=>"1-year postoperatively", "description"=>"Overall Satisfaction with TKA using a Likert scale"}, {"measure"=>"Pain VAS", "timeFrame"=>"preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively", "description"=>"Level of knee pain (scale of zero to ten) using the Visual Analog Scale (VAS)"}, {"measure"=>"KOOS JR", "timeFrame"=>"preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively", "description"=>"KOOS JR questionnaire"}, {"measure"=>"Forgotten Joint Score", "timeFrame"=>"preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively", "description"=>"FJS-12 questionnaire"}, {"measure"=>"PROMIS-10 Mental and Physical Health scores", "timeFrame"=>"preoperatively and 1-year postoperatively", "description"=>"PROMIS-10 Global Health questionnaire"}, {"measure"=>"Incidence of revision TKA", "timeFrame"=>"1 year postop", "description"=>"postoperative complication requiring a revision total knee arthroplasty"}, {"measure"=>"non-revision complication", "timeFrame"=>"1 year postop", "description"=>"postoperative complication requiring a non-revision procedure"}], "secondaryOutcomes"=>[{"measure"=>"Active ROM", "timeFrame"=>"preoperatively, 6 weeks (± 2 weeks), and 1-year postoperatively", "description"=>"Active knee range of motion: active extension, active flexion"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>true}, "conditionsModule"=>{"keywords"=>["osteoarthritis", "knee", "total knee arthroplasty", "target alignment"], "conditions"=>["Osteoarthritis (OA) of the Knee"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this clinical trial is to learn if preparing the target alignment of the operative side in total knee arthroplasty (TKA) based on the non-arthritic side will give the patient better overall alignment, function, and improved results compared to basing our implant alignment and positioning off the arthritic side, which is currently the traditional method.\n\nThe main questions it aims to answer are:\n\n* Will a patient have improved postoperative TKA results if the implant alignment is based off the non-arthritic side compared to the standard arthritic side?\n* What are the similarities or differences between study arms with respect to final implant alignment and positioning angles? Researchers will compare the outcomes of two cohorts of patients undergoing primary robotic-assisted total knee arthroplasty (RA-TKA) with normal contralateral knee. Based on preoperative CT imaging, the researchers will use normal contralateral side joint numbers as the target alignment for one group (Experimental arm) and utilize the traditional method for the other group (Active comparator arm). Clinical outcomes and patient-reported outcome measures (PROMs) will be compared between groups.\n\nParticipants will:\n\n* Be randomized into one of two study arms and will receive either a unilateral knee CT or bilateral knee CT preoperatively\n* Follow-up in the clinic at 2 weeks, 6 weeks and 1-year postoperatively, per standard-of-care for x-ray and clinical evaluation.\n* Complete postop questionnaires (PROMs) at the prescribed follow-up intervals"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"89 years", "minimumAge"=>"21 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Patient age is 21-89 at time of surgery\n2. Patient is indicated to undergo a unilateral primary TKA, secondary to osteoarthritis\n3. Patient's contralateral knee is non-arthritic\n4. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document\n5. Patient is able to read and speak English.\n\nExclusion Criteria:\n\n1. Patient is under the age of 21\n2. Patient's primary diagnosis is not osteoarthritis\n3. Patient is unable to read and speak English\n4. History of previous DVT/PE\n5. History of stroke, CABG, or A fib\n6. Current smoker"}, "identificationModule"=>{"nctId"=>"NCT06617338", "briefTitle"=>"Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Louisville"}, "officialTitle"=>"Native Alignment in the Setting of an Arthritic Knee in Total Knee Arthroplasty", "orgStudyIdInfo"=>{"id"=>"24.0701"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Participant receives bilateral knee CT preoperatively", "description"=>"The P.I. (Dr. Malkani) will use normal contralateral side joint numbers as the target alignment for RA-TKA", "interventionNames"=>["Diagnostic Test: CT scan bilateral knee"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Participant receives unilateral CT of the operative knee preoperatively", "description"=>"The P.I. will use the traditional method to obtain target alignment for RA-TKA.", "interventionNames"=>["Diagnostic Test: CT scan unilateral knee"]}], "interventions"=>[{"name"=>"CT scan unilateral knee", "type"=>"DIAGNOSTIC_TEST", "description"=>"Intervention given to the Active Comparator arm", "armGroupLabels"=>["Participant receives unilateral CT of the operative knee preoperatively"]}, {"name"=>"CT scan bilateral knee", "type"=>"DIAGNOSTIC_TEST", "description"=>"Intervention given to the Experimental Arm", "armGroupLabels"=>["Participant receives bilateral knee CT preoperatively"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"40202", "city"=>"Louisville", "state"=>"Kentucky", "country"=>"United States", "contacts"=>[{"name"=>"Langan S Smith, BS", "role"=>"CONTACT", "email"=>"langan.smith@uoflhealth.org", "phone"=>"5025878222", "phoneExt"=>"65585"}, {"name"=>"Arthur Malkani, MD", "role"=>"CONTACT"}], "facility"=>"UofL Health", "geoPoint"=>{"lat"=>38.25424, "lon"=>-85.75941}}], "centralContacts"=>[{"name"=>"Langan S Smith, BS", "role"=>"CONTACT", "email"=>"langan.smith@uoflhealth.org", "phone"=>"5025878222", "phoneExt"=>"65585"}, {"name"=>"Seth Knight, BS", "role"=>"CONTACT", "email"=>"seth.knight@louisville.edu", "phone"=>"5025878222"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Louisville", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Orthopedic Surgeon", "investigatorFullName"=>"Arthur Malkani", "investigatorAffiliation"=>"University of Louisville"}}}}
