[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07647354":3,"trial-entities:NCT07647354":175,"trial-summary:NCT07647354":180},{"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":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":39,"secondary_outcomes":44,"sex":52,"minimum_age":53,"maximum_age":22,"healthy_volunteers":14,"eligibility_criteria":54,"std_ages":67,"locations":70,"central_contacts":163,"overall_officials":172,"references":173,"see_also_links":174},"NCT07647354","113","Mako-MORE Registry","A Prospective, Multi-center, Post-market, Registry-based Evaluation of the Clinical Outcomes in Patients Receiving a Stryker Implant With Use of the Mako Robotic-Arm Assisted System (Mako-MORE)","NOT_YET_RECRUITING","2037-03-15","2026-05","2026-06-15","Stryker Orthopaedics","INDUSTRY",false,"This is a prospective, post-market, multi-center, registry-based observational study designed to collect real-world clinical data on patients undergoing joint arthroplasty with Stryker implants, with or without the use of the Mako Robotic-Arm Assisted System. The registry will collect prospective data on patient characteristics, procedural details, patient-reported outcomes, radiographic assessments, and adverse events. Patients will be enrolled into procedure-specific cohorts and followed for up to five years postoperatively.","The Mako-MORE Registry is a prospective, post-market, multi-center registry-based evaluation of the Mako Robotic-Arm Assisted System used in total hip arthroplasty (primary and revision), total knee arthroplasty, and partial knee arthroplasty. The registry includes both Mako-assisted and manual arthroplasty cohorts to support real-world data collection.\n\nEligible patients undergoing arthroplasty using cleared Mako SmartRobotics™ applications or manual procedures will be enrolled and followed according to standard-of-care clinical practice. Data collected include demographics, procedural details, patient-reported outcomes, health utility measures, radiographic imaging, and adverse event information. Follow-up assessments will occur from the preoperative period through five years postoperatively.\n\nThe primary purpose of the registry is observational and descriptive. No investigational devices or experimental interventions are used, and all procedures are performed in accordance with FDA-cleared labeling and institutional standards of care.",[18,19],"Arthropathy of Knee","Arthropathy of Hip",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},950,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":37},"DEVICE","Mako Robotic-Arm Assisted Arthroplasty","This observational registry does not assign or mandate any intervention. Participants included in this group undergo hip or knee arthroplasty using the FDA-cleared Mako Robotic-Arm Assisted System as part of routine clinical care. Surgical approach, implant selection, and perioperative management are determined by the treating surgeon according to standard practice. Outcomes are observed prospectively without alteration to clinical care.",[33,34,35,36],"3.0 TKA (Primary)","3.1 PKA (Primary)","5.0 THA (Primary)","5.0 THA (Revision)",[38],"Mako SmartRobotics™ System",[40],{"measure":41,"description":42,"timeFrame":43},"Implant Survivorship at 2 Years Postoperative","To evaluate survival rate at 2-years postoperative for Stryker devices implanted with the Mako Robotic-Arm Assisted System. Survival is defined as the absence of revision for implanted devices.","2-years postoperative",[45,49],{"measure":46,"description":47,"timeFrame":48},"Implant Survivorship at 5 Years Postoperative","To evaluate survival rate at 5-years postoperative for Stryker devices implanted with the Mako Robotic-Arm Assisted System. Survival is defined as the absence of revision for implanted devices.","5-years postoperative",{"measure":50,"description":51,"timeFrame":48},"Change in Patient-Reported Outcomes From Baseline","To evaluate changes between preoperative and postoperative patient reported outcomes (PROs).","ALL","18 Years",{"inclusion":55,"exclusion":60,"raw_text":66},[56,57,58,59],"The subject is skeletally mature, and ≥ 18 years old.","The Subject has signed and dated an IRB\u002FEC approved, study specific Informed Patient Consent Form (ICF).","The subject is scheduled to undergo manual arthroplasty or Mako Robotic-Arm Assisted Arthroplasty according to IFU.","The subject is willing and able to comply with postoperative scheduled clinical evaluations.",[61,62,63,64,65],"The subject is not able to express his\u002Fher consent as deemed by the investigator.","The subject is not able to fulfill a self-assessment questionnaire or follow-up visits as deemed by the investigator.","The subject is a prisoner.","Per surgeon discretion the subject is not a candidate for the study.","The subject is pregnant or breastfeeding.","Inclusion Criteria:\n\n* The subject is skeletally mature, and ≥ 18 years old.\n* The Subject has signed and dated an IRB\u002FEC approved, study specific Informed Patient Consent Form (ICF).\n* The subject is scheduled to undergo manual arthroplasty or Mako Robotic-Arm Assisted Arthroplasty according to IFU.\n* The subject is willing and able to comply with postoperative scheduled clinical evaluations.\n\nExclusion Criteria:\n\n* The subject is not able to express his\u002Fher consent as deemed by the investigator.\n* The subject is not able to fulfill a self-assessment questionnaire or follow-up visits as deemed by the investigator.\n* The subject is a prisoner.\n* Per surgeon discretion the subject is not a candidate for the study.\n* The subject is pregnant or breastfeeding.",[68,69],"ADULT","OLDER_ADULT",[71,92,108,129,147],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":89},"Mayo Clinic (Jacksonville)","Jacksonville","Florida","32224","United States",[78,83,86],{"name":79,"role":80,"phone":81,"email":82},"Lauren Evans, DPT","CONTACT","9049535416","Evans.Lauren2@mayo.edu",{"name":84,"role":80,"email":85},"Bre Jenkins, MPH","Jenkins.Breana@mayo.edu",{"name":87,"role":88},"Bryan D. Springer, MD","PRINCIPAL_INVESTIGATOR",{"lat":90,"lon":91},30.33218,-81.65565,{"facility":93,"city":94,"state":95,"zip":96,"country":76,"contacts":97,"geoPoint":105},"UofL Health","Louisville","Kentucky","40202",[98,103],{"name":99,"role":80,"phone":100,"phoneExt":101,"email":102},"Langan Smith","5025878222","65585","langan.smith@uoflhealth.org",{"name":104,"role":88},"Arthur Malkani, MD",{"lat":106,"lon":107},38.25424,-85.75941,{"facility":109,"city":110,"state":110,"zip":111,"country":76,"contacts":112,"geoPoint":126},"NYU Langone Orthopedic Hospital","New York","10003",[113,117,121,123],{"name":114,"role":80,"phone":115,"email":116},"Daniel Warren, MSPH","9545592251","daniel.warren@nyulangone.org",{"name":118,"role":80,"phone":119,"email":120},"Stephanie Frezzo, MHA","9172277486","stephanie.Frezzo@nyulangone.org",{"name":122,"role":88},"Joshua Rozell, MD",{"name":124,"role":125},"Matthew Hepinstall, MD","SUB_INVESTIGATOR",{"lat":127,"lon":128},40.71427,-74.00597,{"facility":130,"city":131,"state":132,"zip":133,"country":76,"contacts":134,"geoPoint":144},"Cleveland Clinic","Cleveland","Ohio","44195",[135,139,142],{"name":136,"role":80,"phone":137,"email":138},"Sanalkumar Krishnan, Ph.D.","2164457194","KRISHNS11@ccf.org",{"name":140,"role":80,"email":141},"Laura Stiegel","stiegel@ccf.org",{"name":143,"role":88},"Nicolas S Piuzzi, MD",{"lat":145,"lon":146},41.4995,-81.69541,{"facility":148,"city":149,"state":150,"zip":151,"country":76,"contacts":152,"geoPoint":160},"Ortho Rhode Island","Wakefield","Rhode Island","02879",[153,158],{"name":154,"role":80,"phone":155,"phoneExt":156,"email":157},"Kelly Taylor, BSN, RN","4017777000","2260","ktaylor@orthopedicsri.com",{"name":159,"role":88},"Robert Marchand, MD",{"lat":161,"lon":162},41.43732,-71.50145,[164,168],{"name":165,"role":80,"phone":166,"email":167},"Yonandy Barrientos","347-281-3196","yonandy.barrientos@stryker.com",{"name":169,"role":80,"phone":170,"email":171},"Marissa M Puccio","201-675-1416","marissa.puccio@stryker.com",[],[],[],{"nct_id":4,"conditions":176,"biomarkers":179},[177,178],"Hip joint incision","Total Knee Replacement",[],{"nct_id":4,"found":14,"summary":22,"prompt_version":22}]