[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06080152":3,"trial-entities:NCT06080152":97,"trial-summary:NCT06080152":101},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":14,"eligibility_criteria":58,"std_ages":67,"locations":70,"central_contacts":89,"overall_officials":94,"references":95,"see_also_links":96},"NCT06080152","70192","Observation of Wheeled Device Use After TKA","RECRUITING","2028-08","2026-03","2026-03-17","2024-10-02","Stanford University","OTHER",false,"Maneuverability is currently under appreciated by patients who are seeking mobility. This pilot study is examining how patients maneuverability and mobility will change with this novel mobility tool.","Individuals living with challenges that affect their mobility may lead to loss of independence, loss of activity and engagement with life. We are seeking individuals who are having a Total Knee Replacement and are seeking increased mobility using the Alinker, which is a non-motorized walking bike without pedals.\n\nEach participant will receive the Alinker prior to surgery, and will be encouraged to use it as much as possible before surgery and during the 3-month post-operative period.",[18],"Total Knee Arthroplasty",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[23],"NA",{"count":25,"type":26},19,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","Mobility Tool","An A-Linker device will be given to 12 patients 3 months before their total knee arthroplasty",[33],"1",[35],{"measure":36,"description":37,"timeFrame":38},"Mobility after surgery","Mobility will be assessed by using a bicycle odometer to track usage and mobility. The odometer will be checked 2 weeks, 6 weeks, and 3 months after surgery during a post-op clinical exam.","6 months",[40,43,46,49,52],{"measure":41,"description":42,"timeFrame":38},"Determining intensity of pain","We plan to use VAS pain scale as measurement scale ( range; 0-10, higher scores correspond to greater pain",{"measure":44,"description":45,"timeFrame":38},"Change in knee society score","To assess the effectiveness of the device by calculating Initial knee society score (KSS) and Knee society score at 2 weeks, 3 months and 2 years after surgery. The scale ranges from 0-100 with grading as Score 80-100 - Excellent Score 70-79 - Good Score 60-69 - Fair Score below 60 - Poor",{"measure":47,"description":48,"timeFrame":38},"surgery cancellation","To determine if surgery was cancelled as a result of effectiveness of device",{"measure":50,"description":51,"timeFrame":38},"Use of gait aide","To assess the effectiveness of the device by examining Gait Aide use at discharge, 2 weeks, 3 months and 2 years after surgery. This is done to examine performance . The gait aide use provident ranges as Nothing \\> Cane \\> crutch \\> walker",{"measure":53,"description":54,"timeFrame":38},"Time with Device","Determining compliance of device usage","ALL","18 Years","99 Years",{"inclusion":59,"exclusion":62,"raw_text":66},[60,61],"Any person receiving Primary Total Knee Arthroplasty, ages 18-99","Patient is mobile with no more than a single cane\u002Fsingle crutch assist preoperatively",[63,64,65],"Any person not receiving knee arthroplasty, ages under 18 or greater than 99","Patient requires simultaneous or staged bilateral replacements, staged \\\u003C90 days apart.","Patients who have active claudication from a lumbar stenosis or peripheral vascular disease","Inclusion Criteria:\n\n* Any person receiving Primary Total Knee Arthroplasty, ages 18-99\n* Patient is mobile with no more than a single cane\u002Fsingle crutch assist preoperatively\n\nExclusion Criteria:\n\n* Any person not receiving knee arthroplasty, ages under 18 or greater than 99\n* Patient requires simultaneous or staged bilateral replacements, staged \\\u003C90 days apart.\n* Patients who have active claudication from a lumbar stenosis or peripheral vascular disease",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":72,"status":7,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":86},"450 Broadway","Redwood City","California","94063","United States",[78,82],{"name":79,"role":80,"email":81},"Angela Bye CRC, MA","CONTACT","abye@stanford.edu",{"name":83,"role":80,"phone":84,"email":85},"Agnes Ith Associate Director of Research","650-721-7600","mith@stanford.edu",{"lat":87,"lon":88},37.48522,-122.23635,[90],{"name":91,"role":80,"phone":92,"email":93},"Derek Amanatullah, MD","(650) 723-2257","DFA@stanford.edu",[],[],[],{"nct_id":4,"conditions":98,"biomarkers":100},[99],"Total Knee Replacement",[],{"nct_id":4,"found":102,"summary":103,"prompt_version":113},true,{"design":104,"status":105,"heading":106,"summary":107,"follow_up":108,"word_count":109,"commitments":110,"compensation":111,"drugs_mentioned":112},"This is an interventional study with 19 participants. It is not specified if it is randomized or blinded.","completed","Observing Wheeled Device Use After Total Knee Arthroplasty","This study is looking at how a special wheeled device, called an A-Linker, might help people move around better after having a total knee replacement (Total Knee Arthroplasty). Researchers want to see if using this device before and after surgery can improve your mobility. You might be able to join if you are between 18 and 99 years old, are having a total knee replacement, and can currently move with no more than a single cane or crutch. The study will measure your mobility 6 months after your surgery to see how well the A-Linker worked. The current recruitment status is unclear, but the study plans to enroll 19 participants.","Your mobility will be measured 6 months after your surgery.",110,"You will receive an A-Linker device 3 months before your surgery and be encouraged to use it before and for 3 months after surgery.","Not stated in the trial record.",[],"v2"]