[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652022":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":47,"responsibleParty":114,"collaborators":26,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":119,"sex":125,"minAge":126,"maxAge":26,"enrollmentInfo":127,"targetDuration":26,"studyType":130,"phases":131,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":104,"whyStopped":26,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Mount Sinai Hospital, Canada","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Hinged Revision TKA + Low-Dose Irradiation","EXPERIMENTAL","Patients undergo hinged revision total knee arthroplasty (TKA) with a rotating hinge prosthesis, followed by a single session of external beam low-dose irradiation (LDI) delivering 800 cGy to the operative knee on post-operative day 1 (or post-operative day 2 if medically necessary), coordinated with radiation oncology.",[13,14],"Radiation: Low-Dose External Beam Irradiation","Procedure: Hinged Revision Total Knee Arthroplasty",{"label":16,"type":17,"description":18,"interventionNames":19},"Hinged Revision TKA Alone","ACTIVE_COMPARATOR","Patients undergo hinged revision total knee arthroplasty (TKA) with a rotating hinge prosthesis and receive standard postoperative care without low-dose irradiation. All perioperative care, rehabilitation, and follow-up protocols are identical to the experimental arm.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"RADIATION","Low-Dose External Beam Irradiation","A single session of external beam irradiation (800 cGy) delivered to the operative knee on post-operative day 1 (or post-operative day 2 if medically necessary). At Mount Sinai Hospital and Humber River Hospital, LDI is delivered at Princess Margaret Cancer Centre. US sites coordinate through local radiation oncology departments.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Hinged Revision Total Knee Arthroplasty","Full component revision to a rotating hinge knee prosthesis, including synovectomy, posterior capsule debridement, and release of fibrosed collateral ligaments, performed by the treating orthopaedic surgeon at each participating site.",[9,16],[33],{"name":34,"affiliation":35,"role":36},"Jesse Wolfstadt, MD, MSc","MOUNT SINAI HOSPITAL","PRINCIPAL_INVESTIGATOR",[38,43],{"name":34,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","416-586-4800","8457","jesse.wolfstadt@sinaihealth.ca",{"name":44,"role":39,"phone":40,"phoneExt":45,"email":46},"Ravianne Tuazon, BSc","4759","Ravianne.Tuazon@sinaihealth.ca",[48,68,84,102],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University of Southern California","NOT_YET_RECRUITING","Los Angeles","California","90007","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-118.24368,34.05223,{"lat":60,"lon":59},[63,67],{"name":64,"role":39,"phone":65,"phoneExt":26,"email":66},"Nathanael Heckmann, MD","323-442-6984","nathanael.heckmann@med.usc.edu",{"name":64,"role":36,"phone":26,"phoneExt":26,"email":26},{"facility":69,"status":50,"city":70,"state":71,"zip":72,"country":54,"countryCode":55,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"University of Utah","Salt Lake City","Utah","84112",{"type":57,"coordinates":74},[75,76],-111.89105,40.76078,{"lat":76,"lon":75},[79,83],{"name":80,"role":39,"phone":81,"phoneExt":26,"email":82},"Lucas Anderson, MD","801-587-7109","lucas.anderson@hsc.utah.edu",{"name":80,"role":36,"phone":26,"phoneExt":26,"email":26},{"facility":85,"status":50,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Humber River Hospital","Toronto","Ontario","M3M 0B2","Canada","CA",{"type":57,"coordinates":92},[93,94],-79.39864,43.70643,{"lat":94,"lon":93},[97,101],{"name":98,"role":39,"phone":99,"phoneExt":26,"email":100},"Justin Chang, MD","416-291-5553","JuChang@hrh.ca",{"name":98,"role":36,"phone":26,"phoneExt":26,"email":26},{"facility":103,"status":104,"city":86,"state":87,"zip":105,"country":89,"countryCode":90,"cosmosGeoPoint":106,"geoPoint":108,"contacts":109},"Mount Sinai Hospital","RECRUITING","M5G 1X5",{"type":57,"coordinates":107},[93,94],{"lat":94,"lon":93},[110,112,113],{"name":111,"role":39,"phone":40,"phoneExt":41,"email":42},"Jesse Wolfstadt, MD",{"name":44,"role":39,"phone":40,"phoneExt":45,"email":46},{"name":111,"role":36,"phone":26,"phoneExt":26,"email":26},{"type":36,"investigatorFullName":115,"investigatorTitle":116,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Jesse Wolfstadt","Division Head of Orthopaedic Surgery","100652022","stiffness-and-low-dose-irradiation-rct-100652022",false,"NCT07767097","Stiffness and Low Dose Irradiation RCT","Treatment of Acquired Idiopathic Stiffness in Revision Total Knee Arthroplasty With Hinged Knee Prosthesis With or Without Low Dose Irradiation: A Multicentre Prospective Randomized Controlled Trial","LDI TKR RCT","Inclusion Criteria:\n\n* Adults (≥18 years) undergoing revision TKA with a hinged prosthesis for AIS after primary TKA\n* Patient with a ROM arc \\\u003C70 degrees or flexion contracture of \\>20 degrees without any identifiable cause for stiffness (e.g. component oversizing, malrotation, infection, or periprosthetic fracture).\n\nExclusion Criteria:\n\n* Revision for causes other than AIS (e.g., component malposition, infection, periprosthetic fracture)\n* Prior ipsilateral knee infection\n* Revision to non-hinged prosthesis\n* Medical contraindications to surgery\n* Medical contraindications to irradiation\n* Currently pregnant or planning to become pregnant during the study period","ALL","18 Years",{"count":128,"type":129},36,"ESTIMATED","INTERVENTIONAL",[132],"NA","Acquired idiopathic stiffness (AIS) is a common complication following total knee arthroplasty (TKA). It is caused by excessive scar formation, which leads to pain, loss of motion, and functional impairment. When early noninvasive treatments fail, some patients require more surgery. In these cases, surgeons often use a special type of replacement called a hinged prosthesis, which allows more thorough removal of scar tissue and stiffened ligaments. Unfortunately, even after more surgery, many patients continue to struggle with stiffness, pain, and impaired function. Low-dose irradiation (LDI) is a safe, established therapy for conditions with abnormal scar formation. Its role in the setting of AIS has not been defined. The goal of this study is to compare outcomes of revision TKA with or without the addition of LDI. The primary outcome is range of motion at one year following surgery. Secondary outcomes include patient-reported functional scores, repeat surgeries, and complications like wound breakdown or infection. This project has the potential to address a common, debilitating complication after TKA, improve outcomes, reduce repeat interventions and healthcare costs, and broader implementation and standardization of care.",[135],"Arthrofibrosis of Knee",[137,138,139,140,141],"arthrofibrosis","stiffness","revision knee","low dose irradiation","hinged knee prosthesis","2026-08-11",{"date":144,"type":145},"2026-08-17","ACTUAL",{"date":147,"type":145},"2026-04-01",{"date":149,"type":129},"2029-01-31",{"name":5,"class":6},4]