[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631880":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":34,"studyPopulation":34,"armGroups":44,"interventions":55,"overallOfficials":61,"centralContacts":66,"locations":72,"responsibleParty":84,"collaborators":34,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":34,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":34,"enrollmentInfo":95,"targetDuration":34,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":105,"overallStatus":107,"whyStopped":34,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"The University of The West Indies","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"Total perioperative blood loss","Calculated using the Haemoglobin Balance method","Hb values (pre- and postoperative day 3) will be measured",[14,18,22,26,30],{"measure":15,"description":16,"timeFrame":17},"Bone-cement interface quality","Standardized digital photographs will be taken at approximately 30 cm from the operating field, using the same camera, technique, and exposure settings for all cases. The quality of the bloodless surgical field on the tibial and femoral cutting surfaces will then be evaluated. The tibial cutting surface will be divided into four equal sections (25% each) and the femoral cutting surface into eight equal sections (12.5% each). A bloodless surgical field will be defined as the absence of visible bloodstain on the cancellous bone surfaces.\n\nTwo independent physicians, blinded to the intervention and not involved in the surgery, will grade the images. Discrepancies between assessors will be resolved by consensus or adjudicated by a third blinded reviewer.","Taken Intraoperatively",{"measure":19,"description":20,"timeFrame":21},"Postoperative pain","Instrument: Visual Analog Scale (VAS, 10 cm line; score 0-100). Personnel: Research coordinator or ward nurse (blinded to allocation) will administer and record scores","Patients will be asked to mark their pain level at 24 and 48 hours postoperatively.",{"measure":23,"description":24,"timeFrame":25},"Knee range of motion","Instrument: Universal goniometer.","Measured at postoperative day 2 and 6 weeks by a physiotherapist blinded to group allocation.",{"measure":27,"description":28,"timeFrame":29},"Knee Injury and Osteoarthritis Outcomes Score for Joint Replacement (KOOS JR) Survey score","Instrument: Standardized questionnaire Scored as raw sum (0-28) and converted to 0-100 interval scale (higher = better function)","Administered at postoperative day 2 and 6 weeks by the research coordinator.",{"measure":31,"description":32,"timeFrame":33},"Perioperative complications","Measured outcomes:\n\ni. Perioperative transfusion rates (from transfusion records) ii. Tourniquet-related complications (wound seepage, infection, subcutaneous hematoma\u002Fecchymosis, tension blisters), to be assessed during ward rounds and recorded by blinded surgical team members.\n\niii. Thromboembolic events - confirmed via venous Doppler ultrasound or CT pulmonary angiogram as clinically indicated.\n\niv. Wound complications (infection, delayed healing) - assessed at follow-up visits by blinded clinic staff.\n\nv. Neurovascular injury - documented by clinical exam postoperatively.","Recorded up to 6 weeks postoperatively",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":40,"maskingDescription":34,"whoMasked":41},"DOUBLE",[42,43],"PARTICIPANT","OUTCOMES_ASSESSOR",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"Tourniquet Group","ACTIVE_COMPARATOR","Total knee arthroplasty performed with the use of a pneumatic tourniquet throughout the entire procedure",[50],"Device: pneumatic tourniquet",{"label":52,"type":53,"description":54,"interventionNames":34},"No-Tourniquet Group","NO_INTERVENTION","Total knee arthroplasty performed without the use of a pneumatic tourniquet",[56],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":34},"DEVICE","pneumatic tourniquet","the use of a pneumatic tourniquet throughout the entire total knee replacement procedure",[46],[62],{"name":63,"affiliation":64,"role":65},"Maxim Christmas, DM (Orthopaedics), FACS, FCCS","University of the West Indies, Mona Campus","PRINCIPAL_INVESTIGATOR",[67],{"name":68,"role":69,"phone":70,"phoneExt":34,"email":71},"Dominic Landell, MBBS","CONTACT","+18763257551","d.landell@hotmail.com",[73],{"facility":74,"status":34,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":34,"geoPoint":34,"contacts":80},"University Hospital of the West Indies","Kingston","Saint Andrew Parish","00000","Jamaica","JM",[81,83],{"name":68,"role":69,"phone":82,"phoneExt":34,"email":71},"8763257551",{"name":34,"role":69,"phone":34,"phoneExt":34,"email":71},{"type":85,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100631880","tourniquet-vs-no-tourniquet-technique-in-total-knee-arthroplasty-at-the-university-hospital-of-the-west-indies-100631880",false,"NCT07506434","Tourniquet Vs. No-Tourniquet Technique in Total Knee Arthroplasty at the University Hospital of the West Indies","Is Routine Tourniquet Use Still Warranted? A Randomized Controlled Equivalence Trial Comparing Tourniquet Vs. No-Tourniquet Technique in Total Knee Arthroplasty at the University Hospital of the West Indies","Inclusion Criteria:\n\n* • Age ≥ 18 years.\n\n  * Clinical and radiographic diagnosis of knee osteoarthritis requiring primary unilateral Total Knee Arthroplasty.\n  * Medically fit for elective surgery (typically ASA I-III).\n  * Able to provide informed consent.\n\nExclusion Criteria:\n\n* • Revision TKA or bilateral simultaneous TKA.\n\n  * Preexisting coagulopathy or active anticoagulation that cannot be perioperatively managed per protocol.\n  * Known allergy or contraindication to tranexamic acid.\n  * Active infection or immunosuppression.\n  * Severe peripheral vascular disease in the operative limb.\n  * BMI \\> 45 kg\u002Fm²\n  * Inability to provide informed consent or comply with follow-up","ALL","18 Years",{"count":96,"type":97},30,"ESTIMATED","INTERVENTIONAL",[100],"NA","The goal of this clinical trial is to determine whether performing total knee replacement surgery (total knee arthroplasty, TKA) without a tourniquet is clinically equivalent to performing the procedure with a tourniquet in adults with symptomatic knee osteoarthritis.\n\nA tourniquet is commonly used during surgery to reduce bleeding and improve the surgeon's view. However, some studies suggest it may be associated with certain complications. It is currently unclear whether using a tourniquet meaningfully changes outcomes compared to not using one. This study aims to assess whether both approaches result in similar outcomes within a clinically acceptable range.\n\nThe main question this study aims to answer is:\n\nIs total blood loss during surgery equivalent between TKA performed with a tourniquet and TKA performed without a tourniquet, within a predefined margin of ±100 mL?\n\nAdditional questions include:\n\nAre surgical field quality, postoperative pain, functional recovery, and complication rates comparable between the two techniques?\n\nResearchers will compare:\n\nTKA performed with a pneumatic tourniquet TKA performed without a tourniquet\n\nto determine whether outcomes between the two approaches are equivalent rather than whether one is superior to the other.\n\nParticipants will:\n\nBe randomly assigned to one of the two surgical groups using a computer-generated process Undergo standard total knee replacement surgery and routine perioperative care Have blood loss assessed during and after surgery Be monitored for pain, recovery of function, wound healing, and complications during hospital stay and follow-up visits\n\nThis study is designed as a randomized controlled equivalence trial to determine whether both surgical approaches produce comparable outcomes within clinically acceptable limits, in a standardized local setting.",[103,104],"Knee Osteoarthritis (OA)","Total Knee Anthroplasty",[106],"tourniquet use","NOT_YET_RECRUITING","2026-03-27",{"date":110,"type":111},"2026-04-01","ACTUAL",{"date":113,"type":97},"2026-06",{"date":115,"type":97},"2027-09",{"name":5,"class":6},1]