[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07286513":3,"trial-entities:NCT07286513":106,"trial-summary:NCT07286513":120},{"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":28,"study_type":32,"primary_purpose":17,"phases":33,"enrollment_info":34,"interventions":37,"primary_outcomes":47,"secondary_outcomes":52,"sex":75,"minimum_age":76,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":77,"std_ages":81,"locations":84,"central_contacts":102,"overall_officials":103,"references":104,"see_also_links":105},"NCT07286513","CMU2025-04K","Persona SoluTion PPS Femur PMCF","A Prospective, Multi-Center Post-Market Clinical Study Evaluating the Safety, Performance, and Clinical Benefits of the Persona® SoluTion® PPS Femur","ENROLLING_BY_INVITATION","2037-12","2026-02","2026-07-08","2026-02-26","Zimmer Biomet","INDUSTRY",false,"The goal of this study is to generate clinical evidence and evaluate the safety and performance of the Persona® SoluTion® PPS Femurs in the US market, with data supporting global regulatory submissions, including CE marking under EU MDR.\n\nThe target population consists of adults undergoing knee arthroplasty with the Persona SoluTion femoral component paired with a Medial Congruent (MC) or Posterior Stabilized (PS) articulating surface in line with its current cleared Instructions for Use (IFU).\n\nThe primary endpoint is the assessment of clinical performance and benefits by evaluating the average change in the KOOS JR score between pre-operative and 2-year post-operative follow-up.",null,[19,20,21,22,23,24,25,26,27],"Rhematoid Arthritis","Osteo Arthritis of the Knee","Traumatic Arthritis of Knee (Diagnosis)","Polyarthritis","Collagen Disorders","Avascular Necrosis of Femoral Condyle","Valgus Deformity","Varus Deformity","Flexion Deformity of Knee",[29,30,31],"Total Knee","Total knee arthroplasty","Knee replacement","OBSERVATIONAL",[],{"count":35,"type":36},200,"ESTIMATED",[38],{"type":39,"name":30,"description":40,"armGroupLabels":41,"otherNames":45},"DEVICE","The screening population will consist of patients for whom clinical decision has been made to use the Persona® SoluTion® PPS femoral implant in total knee arthroplasty prior to enrollment in the research.",[42,43,44],"Persona® SoluTion PPS CR Femur with MC Bearing, cementless","Persona® SoluTion PPS CR or PS Femur, cemented","Persona® SoluTion PPS PS Femur with PS Bearing, cementless",[46],"Total Knee replacement",[48],{"measure":49,"description":50,"timeFrame":51},"Change in KOOS JR Score between pre-op and 2 years post-op","A 7-item shortened version of the Knee injury and Osteoarthritis Outcome Score (KOOS), specifically designed to assess knee health in patients undergoing total knee arthroplasty (TKA). Raw scores are converted to an interval score ranging from 0 to 100, where 0 represents complete knee disability and 100 represents perfect knee health (higher scores indicate less pain and better function).","2 years",[53,56,59,62,65,69,72],{"measure":54,"description":50,"timeFrame":55},"KOOS JR Score","5 years",{"measure":57,"description":58,"timeFrame":55},"Oxford Knee Score (OKS)","A 12-item PROM was specifically designed and developed to assess function and pain after TKA. This tool is short, reproducible, valid, and sensitive to clinically important changes. Possible scores range from a minimum 0 to maximum 48 points, with higher scores indicating less pain and fewer functional limitations.",{"measure":60,"description":61,"timeFrame":55},"EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire","The EQ-5D-5L instrument comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS). The questionnaire produces an \"index\" score that ranges from 0 to 1, where 0 is the value of a health state equivalent to dead; and 1 is the value of full health, with higher scores indicating higher health utility. The EQ VAS is a 0 -100 scale where patients are asked to indicate their overall health on the day of questionnaire completion. 100 indicates the best health imaginable and 0 indicates the worst health imaginable. Change in Index and EQ VAS scores will be compared from baseline to 2-year follow-up as well as from baseline to 5-year postoperative follow-up for each cohort. This change will also be compared between the cohorts.",{"measure":63,"description":64,"timeFrame":55},"Numeric Rating Scale (Pain)","The 11-item pain NRS asks patients to rate their current pain intensity from 0 (\"no pain\") to 10 (\"worst possible pain\"). It is the most widely used instrument for pain screening with higher scores indicating greater pain intensity.",{"measure":66,"description":67,"timeFrame":68},"Survival Rate of Implant","Survival Rate (Survivorship) will be both assessed by revision\u002Fadditional surgeries to the affected joint due to aseptic loosening only or by revision, removal, exchange of the implanted device due to any reason. Aseptic loosening and other reasons for additional surgeries may be identified by radiographic imaging.","10 years",{"measure":70,"description":71,"timeFrame":68},"Frequency and types of Adverse Events","The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Relation of the events to implant, instrumentation and\u002For procedure should be specified.",{"measure":73,"description":74,"timeFrame":68},"Assessment of the prevalence of metal hypersensitivities using a metal Lymphocyte Transformation Test (LTT)","The Orthopedic Panel 2 tests for hypersensitivity to aluminum, cobalt, chromium, iron, molybdenum, nickel, vanadium, zirconium, titanium alloy particles, cobalt alloy particles, bone cement particles, and bone cement liquid.","ALL","18 Years",{"inclusion":78,"exclusion":79,"raw_text":80},[],[],"Inclusion Criteria:\n\n1. Patient is of legal age of consent and skeletally mature\n2. Patient is willing and able to provide written Informed Consent by signing and dating the IRB\u002FEC approved Informed Consent document\n3. Patient is willing and able to complete scheduled follow-up evaluations as defined in the study protocol\n4. Patient qualifies for total knee arthroplasty based upon physical exam and medical history and meets the approved indications for use of the Persona® SoluTion® PPS femoral implant and appropriate compatible components, within a pre-specified variant configuration (cohort).\n5. A clinical decision has been made to use the Persona® SoluTion® PPS femoral implant prior to enrollment in the research\n\nExclusion Criteria:\n\n1. Patient is currently participating in any other surgical intervention or pain management study\n2. Patient is pregnant or considered a member of a protected (vulnerable) population whose inclusion in the study is inappropriate (e.g. prisoner, mentally incompetent)\n3. Patient has a mental or neurologic condition who is unwilling or incapable of following postoperative care instructions\n4. Patient has a condition which would, in the judgement of the Investigator, place the patient at undue risk or interfere with the conduct of the study\n5. Patient is institutionalized or is a known drug abuser, a known alcoholic or cannot understand the requirements of study participation\n6. Previous history of infection in the affected joint and\u002For other local\u002Fsystematic infection that may affect the prosthetic joint\n7. Insufficient bone stock on femoral or tibial surfaces\n8. Skeletal immaturity\n9. Neuropathic arthropathy\n10. Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb\n11. A stable, painless arthrodesis in a satisfactory functional position\n12. Severe instability secondary to the absence of collateral ligament integrity\n13. Rheumatoid arthritis (RA) accompanied by an ulcer of the skin or a history of recurrent breakdown of the skin\n14. Study device not implanted during surgery, or surgery did not occur\n15. KOOS JR score not collected pre-operatively\n16. Patient requires simultaneous bilateral knee surgery for treatment of the diagnosed condition",[82,83],"ADULT","OLDER_ADULT",[85,94],{"facility":86,"city":87,"state":88,"zip":89,"country":90,"geoPoint":91},"Denver Hip and Knee, Inc.","Denver","Colorado","80134","United States",{"lat":92,"lon":93},39.73915,-104.9847,{"facility":95,"city":96,"state":97,"zip":98,"country":90,"geoPoint":99},"Medstar Health Research Institute","Baltimore","Maryland","21218",{"lat":100,"lon":101},39.29038,-76.61219,[],[],[],[],{"nct_id":4,"conditions":107,"biomarkers":119},[108,109,110,111,112,113,114,115,116,117,118],"Avascular Necrosis","Charcot's arthropathy","Flexion deformity of knee","Inflammatory Polyarthropathy","Osteoarthritis of knee","Osteoporosis","Rheumatoid Arthritis","Rheumatoid arthritis of knee","Rheumatologic Disorder","Valgus deformity","Varus angulation",[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]