[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657303":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":40,"studyPopulation":40,"armGroups":49,"interventions":62,"overallOfficials":40,"centralContacts":73,"locations":80,"responsibleParty":96,"collaborators":40,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":40,"enrollmentInfo":108,"targetDuration":40,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":40,"overallStatus":117,"whyStopped":40,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Ottawa Hospital Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":40},[9,13],{"measure":10,"description":11,"timeFrame":12},"Timing of surgery","The time it take to complete the surgery, including the femoral stem extraction","From surgery start to surgery close",{"measure":14,"description":15,"timeFrame":16},"Time of Femoral Stem Extraction","Amount of time, in minutes, it takes to remove the femoral stem during surgery","From start of femoral stem extraction to end of femoral stem extraction, up to 60 minutes",[18,21,25,29,33,37],{"measure":19,"description":20,"timeFrame":12},"Intraoperative complication rate","Proportion of participants experiencing an intraoperative complication related to femoral stem extraction, including femoral fracture, cortical perforation, or extended trochanteric osteotomy use.",{"measure":22,"description":23,"timeFrame":24},"Postoperative Complication Rate","Proportion of participants experiencing a postoperative complication or require a reoperation relating to the hip revision.","From end of surgery to 3 months postoperative",{"measure":26,"description":27,"timeFrame":28},"Change in Patient-report Hip function from baseline to 3 months","Participants will complete the Oxford Hip Score to assess hip function, where 0 is worse possible hip function and 48 is best hip function.","Baseline and at 3 month following surgery",{"measure":30,"description":31,"timeFrame":32},"Change in Health Related Quality of Life from Baseline to 3 months","Participants will complete the EQ-5D-5L to assess health related quality of life, where an index scores range from -0.573 to 1.00, with higher scores indicating better health related quality of life.","At baseline and 3 months after surgery",{"measure":34,"description":35,"timeFrame":36},"Cost of OR time and resources","Unit costs of OR time and resources, as per institutional financial data and standard costing sources.","From start of surgery to end of surgery",{"measure":38,"description":39,"timeFrame":24},"Cost of complications","Unit cost of complications derived from institutional financial data and standard costing sources",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":44,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":46,"maskingDescription":40,"whoMasked":47},"SINGLE",[48],"PARTICIPANT",[50,56],{"label":51,"type":52,"description":53,"interventionNames":54},"Watson Extraction System (WES)","EXPERIMENTAL","Participants randomized to this arm will undergo stem extraction utilizing the WES in addition to other standard of care equipment, as required. Surgeons will use the WES device for extraction first.",[55],"Device: Watson Extraction System",{"label":57,"type":58,"description":59,"interventionNames":60},"Current Standard of Care at TOH","ACTIVE_COMPARATOR","Participants randomized to this arm will undergo stem extraction as per surgeon preference with the use of K-wires, burr and flexible osteotomes. An ETO will be performed as per surgical judgement.",[61],"Procedure: Standard of Care Stem Extraction",[63,68],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":40},"DEVICE","Watson Extraction System","The Watson Extraction System is a surgical instrumentation system used to facilitate femoral stem extraction during revision total hip arthroplasty. Participants randomized to the intervention group will undergo femoral stem extraction using the Watson Extraction System.",[51],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":40},"PROCEDURE","Standard of Care Stem Extraction","Femoral stem extraction will occur using standard surgical techniques and instrumentation routinely available for revision total hip arthroplasty.",[57],[74],{"name":75,"role":76,"phone":77,"phoneExt":78,"email":79},"Clinical Research Coordinator","CONTACT","613-737-8899","73032","meadufresne@ohri.ca",[81],{"facility":82,"status":40,"city":83,"state":84,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"The Ottawa Hospital","Ottawa","Ontario","K1H 8L6","Canada","CA",{"type":89,"coordinates":90},"Point",[91,92],-75.69812,45.41117,{"lat":92,"lon":91},[95],{"name":75,"role":76,"phone":77,"phoneExt":78,"email":79},{"type":97,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100657303","watson-extraction-system-for-femoral-stem-extraction-100657303",false,"NCT07836608","Watson Extraction System for Femoral Stem Extraction","Is Use of the Watson Extraction System Associated With Reduced Operative Time and Safer Stem Extraction? - A Randomized Controlled Trial","WES","Inclusion Criteria:\n\n* Over 18 years of age\n* Undergoing revision Total Hip Arthroplasty for septic or aseptic indications\n* Have well-fixed femoral components, of blade-stem design (collared and collarless)\n\nExclusion Criteria:\n\n* Tapered stem in situ less than 4 months\n* Cemented Stems\n* Femoral Stems with Trunnions \\> 14mm\n* Femoral Stems of alternative design not compatible for use with the WES","ALL","18 Years",{"count":109,"type":110},20,"ESTIMATED","INTERVENTIONAL",[113],"NA","A revision total hip replacement surgery requires the surgeon to remove, or extract, the femoral stem (the rod that was placed into the thigh bone during your first hip replacement). A variety of tools and techniques can be used to do this. At The Ottawa Hospital (TOH) surgeons attempt to remove the stem using less invasive measures, such as osteotomes, a tool that separates the stem from the bone, but if it doesn't work, they may need to perform an extended trochanteric osteotomy (ETO). An ETO is more invasive and increases the risk of complications.\n\nThe Watson Extraction System (WES) is another Health Canada approved tool that goes around the stem to help remove the femoral stem from the thigh bone. Research shows that the WES has been studied in case series of a few people, and the results seem promising, reducing the time of extraction and need for ETO. However, it is not clear if it offers better results than what is currently done at TOH.\n\nThe purpose of this study is to compare the WES to the current\u002Fusual care care at TOH to determine whether the WES can remove the femoral stem more efficiently (in less time and at a lower hospital cost) and effectively, while improving patient safety.",[116],"Revision Arthroplasty","NOT_YET_RECRUITING","2026-09-24",{"date":120,"type":121},"2026-09-29","ACTUAL",{"date":123,"type":110},"2026-10-01",{"date":125,"type":110},"2027-07-01",{"name":5,"class":6},1]