[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610236":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":26,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Rush University Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ROAM OA brace","EXPERIMENTAL","Participants receive the ROAM OA Single Upright Knee Brace (Enovis) to wear daily for the study duration. The brace is designed to offload the medial compartment of the knee and improve pain and function.",[13],"Device: ROAM OA Single Upright Knee Brace",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Comparator: Unloader brace or standard of care","ACTIVE_COMPARATOR","Participants receive the Ossur Unloader One knee brace or no brace (standard of care) and will follow standard pain management and physical therapy guidelines. This group serves as an active comparator to the ROAM OA brace.",[19],"Device: Ossur Unloader One Knee Brace or Standard of Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","ROAM OA Single Upright Knee Brace","A commercially available single-upright knee brace designed to offload the medial compartment of the knee in patients with unicompartmental osteoarthritis; manufactured by Enovis. Participants will wear the brace daily for the duration of the study.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Ossur Unloader One Knee Brace or Standard of Care","Participants will receive the Ossur Unloader One knee brace or no brace (standard of care) and will follow standard management and physical therapy guidelines. This group serves as the active comparator to the ROAM OA brace.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Markus Wimmer, PhD","CONTACT","3129422789","markus_a_wimmer@rush.edu",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Chicago","Illinois","60612","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-87.65005,41.85003,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":55},"Christopher Knowlton, PhD","312-942-6938","christopher_knowlton@rush.edu",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Markus Wimmer","Principal Investigator, Grainger Director of the RUSH Arthritis and Orthopedics Institute",[61],{"name":62,"class":63},"Enovis","INDUSTRY","100610236","roam-oa-functional-and-patient-reported-outcomes-wearing-a-knee-brace-for-unicompartmental-oa-100610236",false,"NCT07224958","ROAM OA: Functional and Patient Reported Outcomes Wearing a Knee Brace for Unicompartmental OA","Inclusion Criteria:\n\n* Inclusion Criteria:\n* Age 40-85 years.\n* BMI ≤ 35.\n* Physician-diagnosed medial compartment knee osteoarthritis.\n* Visual Analog Scale (VAS) walking pain ≥ 4.\n* Willing to wear assigned brace ≥ 4 hours\u002Fday.\n* Able to walk independently for 20 minutes unaided.\n* Stable pain medication regimen ≥ 4 weeks.\n* ≥3 months since last hyaluronic acid (HA), platelet-rich plasma (PRP), or steroid injection.\n\nExclusion Criteria:\n\n* Lateral or patellofemoral osteoarthritis.\n* Prior knee replacement.\n* Significant ligament injury or acute lower limb injury.\n* Neurological condition affecting gait.\n* Severe psychiatric or neurological disorder affecting pain perception.\n* Skin condition or allergy preventing brace use.\n* Current use of another brace or assistive device.\n* Recent opioid or corticosteroid use (\\\u003C4 weeks).\n* Pregnant.\n\nExclusion Criteria:\n\n\\-","ALL","40 Years","85 Years",{"count":74,"type":75},30,"ESTIMATED","INTERVENTIONAL",[78],"NA","The aim of this study is to conduct a comparative evaluation of the ROAM OA Single Upright Brace and the Ossur Unloader One Knee Brace in subjects with medial compartment osteoarthritis. The focus is on comparing the immediate and short-term biomechanical effects of these braces on knee adduction moments and spatiotemporal gait parameters, as well as assessing the long-term efficacy of the ROAM OA brace in improving pain and functional outcomes for individuals with osteoarthritis.",[81],"Knee Osteoarthritis",[83,84],"knee brace","gait analysis","2026-05-10",{"date":87,"type":88},"2026-05-12","ACTUAL",{"date":90,"type":88},"2026-04-27",{"date":92,"type":75},"2027-04",{"name":5,"class":6},1]