[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06447922":3,"trial-entities:NCT06447922":85,"trial-summary:NCT06447922":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":41,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":65,"locations":68,"central_contacts":78,"overall_officials":79,"references":83,"see_also_links":84},"NCT06447922","24-004661","Metal Ion Concentrations After Total Knee Arthroplasty","Analysis of Metal Ion Concentrations After Robotic-assisted Total Knee Arthroplasty Compared to Conventional Total Knee Arthroplasty","ENROLLING_BY_INVITATION","2026-10","2026-07","2026-07-13","2024-06-25","Mayo Clinic","OTHER",false,"The purpose of this study is to analyze the metal ion concentrations in the patients blood following robotic-assisted total knee arthroplasty (TKA) compared to conventional total knee arthroplasty using cutting guides.","This study focuses on comparing metal ion levels in 50 inpatient participants undergoing primary total knee arthroplasty (TKA) with either conventional cutting guides or robotic assistance. Baseline blood examinations for Cobalt, Chromium, Titanium, and Nickel will be performed before TKA implantation at preoperative visits and on the first day following the procedure. The investigation will encompass patients receiving both conventional and robotic-assisted primary TKA, framed within a prospective cohort study design. Baseline characteristics and additional follow-up information will be gathered.",[19,20,21],"Arthroplasty, Replacement, Knee","Total Knee Replacement","Blood Metal Ion Concentration",[],"OBSERVATIONAL",null,[],{"count":27,"type":28},60,"ESTIMATED",[30],{"type":14,"name":31,"description":32,"armGroupLabels":33},"Metal ion level testing","Patients will undergo a pre- and post-operative blood draw to analyze metal ion levels (Cobalt, Chromium, Titanium and Nickel)",[34,35],"Conventional TKA with Cutting Guides","Robot-Assisted TKA",[37],{"measure":38,"description":39,"timeFrame":40},"Overall blood metal ion differences between procedures (Conventional TKA vs Robot-Assisted TKA)","Difference in overall blood metal ion levels (Cobalt, Chromium, Titanium, and Nickel) between patients undergoing total knee arthroplasty (TKA) with conventional cutting guides and those undergoing TKA with robotic assistance.","Pre-operatively, first post-operative day.",[42,46,48,50],{"measure":43,"description":44,"timeFrame":45},"Comparison of post-operative blood metal levels between procedures: Cobalt","Difference in post-operative levels, adjusted for the pre-operative levels, between Conventional TKA with Cutting Guides vs Robot-Assisted TKA","First post-operative day",{"measure":47,"description":44,"timeFrame":45},"Comparison of post-operative blood metal levels between procedures: Chromium",{"measure":49,"description":44,"timeFrame":45},"Comparison of post-operative blood metal levels between procedures: Titanium",{"measure":51,"description":44,"timeFrame":45},"Comparison of post-operative blood metal levels between procedures: Nickel","ALL","18 Years","100 Years",true,{"inclusion":57,"exclusion":60,"raw_text":64},[58,59],"Adults undergoing conventional or robotic-assisted TKA","Consent to the study",[61,62,63],"Patients who have undergone any previous arthroplasty procedures.","Patients with metal implants, such as plates, nails, and screws, used in the repair of traumatic injuries.","Patients below 110 pounds.","Inclusion Criteria:\n\n* Adults undergoing conventional or robotic-assisted TKA\n* Consent to the study\n\nExclusion Criteria:\n\n* Patients who have undergone any previous arthroplasty procedures.\n* Patients with metal implants, such as plates, nails, and screws, used in the repair of traumatic injuries.\n* Patients below 110 pounds.",[66,67],"ADULT","OLDER_ADULT",[69],{"facility":70,"city":71,"state":72,"zip":73,"country":74,"geoPoint":75},"Mayo Clinic in Rochester","Rochester","Minnesota","55905","United States",{"lat":76,"lon":77},44.02163,-92.4699,[],[80],{"name":81,"affiliation":13,"role":82},"Matthew P Abdel","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":86,"biomarkers":87},[20],[],{"nct_id":4,"found":55,"summary":89,"prompt_version":98},{"design":90,"status":91,"heading":6,"summary":92,"follow_up":93,"word_count":94,"commitments":95,"compensation":96,"drugs_mentioned":97},"This is an observational study involving 60 participants. It compares two groups: those having conventional total knee replacement and those having robotic-assisted total knee replacement.","completed","This study is looking at the levels of certain metals (Cobalt, Chromium, Titanium, and Nickel) in your blood after you have a total knee replacement (TKA). Researchers want to see if there are differences in these metal levels between people who have a traditional TKA using cutting guides and those who have a robotic-assisted TKA. You can join if you are an adult between 18 and 100 years old, are having your first knee replacement, and do not have other metal implants in your body or weigh less than 110 pounds. The study will consider itself successful if it finds differences in metal ion levels between the two types of knee replacement procedures. The current status of this study is unclear.","Your metal ion levels will be measured pre-operatively and on the first post-operative day.",121,"You would have a blood draw before your surgery and another on the first day after your surgery to check metal ion levels.","Not stated in the trial record.",[],"v2"]