[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638529":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":41,"locations":47,"responsibleParty":58,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":26,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":26,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":26,"overallStatus":49,"whyStopped":26,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Hospital Italiano de Buenos Aires","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Compressive Cryotherapy","EXPERIMENTAL","Participants assigned to this arm will receive compressive cryotherapy using the Game Ready® device after primary total knee arthroplasty. The device delivers circulating cold water combined with intermittent pneumatic compression. Cryotherapy will be applied for 20 minutes, four times per day, during the first 7 postoperative days. Compression will not be applied during the first two postoperative days and will be applied at medium pressure from postoperative day 3 to day 7. All participants will also receive the standard postoperative analgesia and rehabilitation protocol.",[13],"Device: Game Ready® compressive cryotherapy device",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Cryotherapy (Ice Packs)","ACTIVE_COMPARATOR","Participants assigned to this arm will receive standard postoperative care consisting of conventional cryotherapy using ice packs applied to the operated knee as needed during the first 7 postoperative days. Participants will also be advised to elevate the operated limb to help control postoperative swelling. All participants will receive the same postoperative analgesia and rehabilitation protocol as the intervention group.",[19],"Other: Standard cryotherapy (ice packs)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Game Ready® compressive cryotherapy device","The Game Ready® system provides continuous cold water circulation combined with intermittent pneumatic compression using a circumferential wrap applied to the operated knee. The device will be used for 20 minutes per session, four times per day during the first 7 postoperative days after total knee arthroplasty.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard cryotherapy (ice packs)","Conventional cryotherapy consisting of ice packs applied to the operated knee after surgery according to standard postoperative care. Ice packs will be applied intermittently during the first 7 postoperative days.",[15],[32,35,38],{"name":33,"affiliation":5,"role":34},"Ivan A Huespe, MD","STUDY_CHAIR",{"name":36,"affiliation":5,"role":37},"Igancio Garcia Mansilla, MD","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":5,"role":40},"Matias Costa Paz, MD","STUDY_DIRECTOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":26,"email":46},"Ivan Huespe, MD","CONTACT","+543425382554","ivan.huespe@hospitalitaliano.org.ar",[48],{"facility":5,"status":49,"city":50,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":26,"geoPoint":26,"contacts":54},"RECRUITING","Buenos Aires","C1181","Argentina","AR",[55],{"name":56,"role":44,"phone":57,"phoneExt":26,"email":46},"Ivan a Huespe, md","03425382554",{"type":37,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Ignacio Garcia Mansilla","Knee Orthopedic Surgeon",[62],{"name":63,"class":6},"Avanos Medical","100638529","cryotherapy-versus-standard-care-in-reducing-opioid-consumption-after-total-knee-arthroplasty-100638529",false,"NCT07630337","Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty","Efficacy of Cryotherapy Versus Standard Care in Reducing Opioid Consumption After Total Knee Arthroplasty: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 60 and 80 years\n* Scheduled to undergo primary total knee arthroplasty for knee osteoarthritis\n* Ability to understand the study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* Revision total knee arthroplasty\n* Vascular disorders affecting the lower limbs\n* Body mass index (BMI) greater than 35 kg\u002Fm²\n* Active knee infection\n* Severe preoperative limitations in knee mobility","ALL","18 Years",{"count":74,"type":75},74,"ESTIMATED","INTERVENTIONAL",[78],"NA","The goal of this clinical trial is to learn if compressive cryotherapy can reduce postoperative opioid consumption in patients undergoing primary total knee arthroplasty. It will also evaluate whether compressive cryotherapy improves postoperative recovery compared with standard care using conventional ice application. The main questions it aims to answer are:\n\nDoes compressive cryotherapy reduce the total consumption of opioids during the first 7 days after total knee arthroplasty?\n\nDoes compressive cryotherapy reduce postoperative pain and improve early recovery compared with standard cryotherapy?\n\nResearchers will compare compressive cryotherapy using the Game Ready® device with standard care using traditional ice packs to determine whether the intervention reduces opioid consumption and improves postoperative outcomes.\n\nParticipants will:\n\nBe randomly assigned to receive compressive cryotherapy or standard cryotherapy with ice packs after surgery.\n\nApply the assigned treatment four times per day during the first 7 postoperative days.\n\nRecord daily pain levels using a visual analog scale (VAS) and document opioid consumption in a pain diary.\n\nAttend a follow-up visit on postoperative day 7 for evaluation of knee swelling, hematoma size, and recovery using the QoR-15 questionnaire.",[81,82,83],"Osteoarthritis, Knee","Postoperative Pain","Total Knee Arthroplasty","2026-06-01",{"date":86,"type":87},"2026-06-05","ACTUAL",{"date":89,"type":87},"2026-02-01",{"date":91,"type":75},"2027-06-01",{"name":5,"class":6},1]