[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635417":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":54,"studyPopulation":30,"armGroups":55,"interventions":68,"overallOfficials":30,"centralContacts":30,"locations":76,"responsibleParty":107,"collaborators":111,"id":115,"slug":30,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":30,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":30,"enrollmentInfo":123,"targetDuration":30,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":79,"whyStopped":30,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Hospital for Special Surgery, New York","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Range of motion (degrees) - knee joint; measured using digital goniometer","Active and Passive knee flexion and extension range of motion will be measured in degrees using a standardized digital goniometer at each timepoint.","3 months postoperatively",[14,18,22,25,28,32,35,37,39,41,43],{"measure":15,"description":16,"timeFrame":17},"Range of motion (degrees) - knee joint; measured using a digital goniometer","Active and passive knee flexion and extension will be measured in degrees using a standardized digital goniometer. Measurements will be obtained with the patient seated for flexion and supine for extension at each timepoint.","2 weeks, 6 months, and 1 year postoperatively",{"measure":19,"description":20,"timeFrame":21},"Swelling (mid-patellar circumference in centimeters) - knee joint; measured using a flexible measuring tape","Knee swelling will be measured as mid-patellar circumference (cm) with knee in full extension using a standardized flexible measuring tape at each postoperative timepoint.","6 weeks, 3 months, 6 months, and 1 year postoperatively",{"measure":23,"description":24,"timeFrame":21},"Stiffness - Knee Joint","Incidence of knee stiffness",{"measure":26,"description":27,"timeFrame":21},"Wound complications","Incidence of wound complications",{"measure":29,"description":30,"timeFrame":31},"Time to achieve physical therapy milestones",null,"6 weeks, 3 months, 6 months, and 1 year",{"measure":33,"description":34,"timeFrame":31},"Knee Society Scale Score Delta","Delta compared to preoperative value",{"measure":36,"description":34,"timeFrame":31},"Functional Knee Society Scale Score Delta",{"measure":38,"description":34,"timeFrame":31},"KOOS Jr. Score Delta",{"measure":40,"description":34,"timeFrame":31},"PROMIS-10 Score Delta",{"measure":42,"description":34,"timeFrame":31},"VAS Pain Score Delta",{"measure":44,"description":30,"timeFrame":45},"Total 90 day opioid consumption","90 days postoperatively",{"allocation":47,"interventionModel":48,"interventionModelDescription":30,"primaryPurpose":49,"observationalModel":30,"timePerspective":30,"maskingInfo":50},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":51,"maskingDescription":30,"whoMasked":52},"SINGLE",[53],"OUTCOMES_ASSESSOR","Knee immobilization after revision total knee arthroplasty (TKA) remains unexplored in the literature despite its potential to address key challenges in the post-operative management and rehabilitation in these patients. Revision TKA is typically associated with higher rates of complications such as instability, malalignment, extensor mechanism disruption, and stiffness. Given the intricate nature of revision procedures and the increased risk of suboptimal outcomes, effective strategies for optimizing functional recovery and minimizing post-operative pain are critical. Semirigid extension bracing, a form of knee immobilization, has shown promise in primary TKA in improving pain management, promoting knee range of motion (ROM), and reducing opioid consumption. However, its role in revision TKA remains unknown. Exploring the use of knee immobilization in the revision TKA population could provide a non-pharmacological, cost-effective approach to addressing pain, minimizing complications, and improving long-term functional outcomes.",[56,62],{"label":57,"type":58,"description":59,"interventionNames":60},"Study Group","EXPERIMENTAL","Participants will wear a knee immobilizer brace for 10 days postoperatively and exclude knee range of motion exercises from postoperative physical therapy protocol during this period. They will resume all standard postoperative protocol after this period.",[61],"Device: Knee immobilizer",{"label":63,"type":64,"description":65,"interventionNames":66},"Control Group","PLACEBO_COMPARATOR","Participants will not wear a knee immobilizer and will perform all exercises included in postoperative physical therapy protocol.",[67],"Device: No Knee Immobilizer",[69,73],{"type":70,"name":71,"description":59,"armGroupLabels":72,"otherNames":30},"DEVICE","Knee immobilizer",[57],{"type":70,"name":74,"description":65,"armGroupLabels":75,"otherNames":30},"No Knee Immobilizer",[63],[77],{"facility":78,"status":79,"city":80,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Hospital for Special Surgery","RECRUITING","New York","10021","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-74.00597,40.71427,{"lat":88,"lon":87},[91,96,100,103,105],{"name":92,"role":93,"phone":94,"phoneExt":30,"email":95},"Dr. Brian P. Chalmers MD","CONTACT","212-606-1999","chalmersb@hss.edu",{"name":97,"role":93,"phone":98,"phoneExt":30,"email":99},"Allina Nocon, PhD","646-714-6015","nocona@hss.edu",{"name":101,"role":102,"phone":30,"phoneExt":30,"email":30},"Alexis G Gonzalez, MS","SUB_INVESTIGATOR",{"name":104,"role":102,"phone":30,"phoneExt":30,"email":30},"David A Kolin, MD",{"name":106,"role":102,"phone":30,"phoneExt":30,"email":30},"Gwo-Chin Lee, MD",{"type":108,"investigatorFullName":109,"investigatorTitle":110,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Brian Chalmers","Principal Investigator",[112],{"name":113,"class":114},"Orthopaedic Research and Education Foundation (OREF)","UNKNOWN","100635417",false,"NCT07552415","Does Joint Immobilization Following Revision Total Knee Arthroplasty Improve Range of Motion Following Surgery?","Does Joint Immobilization Following Revision Total Knee Arthroplasty (rTKA) Improve Range of Motion Following Surgery?","Inclusion Criteria:\n\n* Patients undergoing revision TKA for aseptic indications including aseptic loosening, polyethylene wear, instability, malalignment, periprosthetic fracture.\n* Patients undergoing revision TKA of one or both components.\n\nExclusion Criteria:\n\n* Patients who are undergoing revision TKA for stiffness.\n* Patients with occult infection not recognized prior to revision.\n* Patients with hinged TKA component reconstructions.\n* Patients undergoing revision for liner exchange.\n* History of VTE\u002FPE.\n* Patients on pre-operative anticoagulation.\n* BMI ≥ 40.\n* Patients with preoperative opioid use equal to or exceeding 150 Morphine Milligram Equivalents (MMEs)\u002Fday within 90 days of revision TKA.","ALL","18 Years",{"count":124,"type":125},170,"ESTIMATED","INTERVENTIONAL",[128],"NA","The goal of this study is to evaluate if knee immobilization for 10 days following revision total knee arthroplasty (rTKA) improves knee joint range of motion at 3 months postoperatively compared to standard of care postoperative protocol.\n\nParticipants will be assigned to one of two groups.\n\nOne group will wear a knee brace that keeps the knee straight for 10 days after surgery and will not perform knee range of motion exercises during that time. The other group will not wear a brace and will follow the standard physical therapy program, including knee range of motion exercises, starting after surgery.",[131,132],"Aseptic Revision Knee Arthroplasty","Stiffness Following Revision Knee Arthroplasty",[134,135,136],"revision arthroplasty","stiffness","knee swelling","2026-04-20",{"date":139,"type":140},"2026-04-27","ACTUAL",{"date":142,"type":125},"2026-04",{"date":144,"type":125},"2028-04",{"name":5,"class":6},1]