[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539044":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":62,"collaborators":64,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":26,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":26,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care TKA","ACTIVE_COMPARATOR","Patients scheduled to undergo TKA at Cleveland Clinic will follow the standardized TKA Care Pathway as part of Standard of care. Patients enter the TKA care path after consenting to undergo TKA for symptomatic knee pain that has not relieved with nonoperative measures. They stay in the care path until 90-days after the operation is complete. The TKA care path guides the care delivered through the preoperative, intraoperative and postoperative phases.",[13],"Behavioral: Standard of Care TKA",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care TKA + Personalized Outcome Prediction Tool with targeted interventions","EXPERIMENTAL","Patients who are identified to have a TKA PROMs phenotype which includes lower than median scores for VR-12 MCS will be further screened for:\n\nDistress ➔ using the NCCN Distress Thermometer (DT) Depression ➔ using the Patient Health Questionnaire-9 Those patients with a score ≥ 8 on the DT, or a score ≥ 10 on the PHQ-9, or any response other than 0 to question 9 on the PHQ-9 will have a consult with Psychiatry and Behavioral Science to determine a mental health diagnosis.\n\nPatients who are identified to have a TKA PROMS phenotype which includes lower than median scores for KOOS-PS (score of =\\\u003C51.5) will be scheduled for a 4 to 8 week intervention of pre-rehabilitation. All patients who undergo the PT intervention will have a an assessment before and after the rehab TKA.",[19],"Behavioral: Personalized outcome prediction tool + targeted interventions",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Personalized outcome prediction tool + targeted interventions","* TKA Personalized Outcome Prediction Tool to aid in setting expectations\n* Mental Health Screening\u002FIntervention\n* Physical Therapy Pre-surgery Assessments \\& Rehabilitation",[15],null,{"type":22,"name":9,"description":28,"armGroupLabels":29,"otherNames":26},"\\- Standard of care preoperative TKA clinic appointment to discuss plan for surgery and get consent",[9],[31],{"name":32,"affiliation":33,"role":34},"Nicolas S Piuzzi, MD","Cleveland Clinic Ohio","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Shujaa T Khan, MD","CONTACT","4199658274","khans34@ccf.org",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Alison Klika","216 444-4954","klikaa@ccf.org",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Cleveland Clinic Foundation","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-81.69541,41.4995,{"lat":58,"lon":57},[61],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[65],{"name":66,"class":6},"American Association of Hip and Knee Surgeons","100539044","improving-total-knee-arthroplasty-dissatisfaction-through-a-personalized-approach-focusing-on-proms-phenotypes-100539044",false,"NCT06298721","Improving Total Knee Arthroplasty Dissatisfaction Through a Personalized Approach Focusing on PROMs Phenotypes","Improving Total Knee Arthroplasty Dissatisfaction at 1-year Through a Personalized Approach Focusing on PROMs Phenotypes: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Adult subject (Age \\>18 and \\\u003C 80 years of age)\n2. The subject is proficient in the English language\n3. The patient is voluntarily prepared to sign the 'Informed Consent Form'\n4. The patient is scheduled for a unilateral primary TKA\n5. TKA PROMs Phenotypes with higher risk of dissatisfaction\n6. Patient is willing and able to complete the protocol required follow-up\n\nExclusion Criteria:\n\n1. Patient requires simultaneous or staged bilateral knee replacements, staged \\\u003C90 days apart\n2. Patients undergoing revision TKA\n3. Inflammatory arthritis\n4. History of infection in the joint undergoing TKA\n5. Patient is considered a member of a protected population (e.g., prisoner, mentally incompetent, etc.)","ALL","18 Years","80 Years",{"count":78,"type":79},300,"ESTIMATED","INTERVENTIONAL",[82],"NA","This study is a randomized controlled trial to assess whether the implementation of a TKA Personalized Outcome Prediction Tool to set expectation, in addition to targeted interventions to address patients with poor baseline mental health and poor physical function, improves satisfaction at 1-year (when compared to standard of care).",[85,86,87],"Knee Osteoarthritis","Knee Arthropathy","Surgery","2026-06-09",{"date":90,"type":91},"2026-06-11","ACTUAL",{"date":93,"type":91},"2024-03-12",{"date":95,"type":79},"2027-03-01",{"name":5,"class":6},1]