[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586542":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":10,"locations":35,"responsibleParty":122,"collaborators":124,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":10,"eligibilityCriteria":132,"healthyVolunteers":129,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":10,"studyType":139,"phases":10,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":147,"whyStopped":10,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Smith & Nephew, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Marketed Product - MP01",null,"Subjects who had joint surface lesions of the knee randomized to be treated with Marketed Product - MP01 in the Pivotal study.",[13],"Device: Marketed Product - MP01",{"label":15,"type":10,"description":16,"interventionNames":17},"Surgical Standard of Care - SSOC","Subjects who had joint surface lesions of the knee randomized to be treated with Surgical Standard of Care (SSOC) - microfracture or debridement in the Pivotal study.",[18],"Procedure: Surgical Standard of Care",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","Marketed Product - MP01 was implanted via a mini-arthrotomy or arthrotomy approach, using the designated surgical tools and surgical technique.",[9],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"PROCEDURE","Surgical Standard of Care","As no single, current therapy could be used as a single comparator for the treatment of the knee lesions treated in the pivotal study which included focal cartilage lesions on the one hand and moderate knee osteoarthritis on the other, current general practice (e.g., SSOC: Deb and MFx) was used.\n\nDeb (SSOC) is a common orthopedic surgical procedure that removes damaged cartilage and tissue from the knee. MFx (SSOC) is another common orthopedic surgical procedure that treats knee cartilage defects by creating small holes in the bone beneath the damaged cartilage.",[15],[30,33],{"name":31,"affiliation":5,"role":32},"Samantha Andrews","STUDY_CHAIR",{"name":34,"affiliation":5,"role":32},"Galit Reske",[36,49,60,71,82,91,102,113],{"facility":37,"status":10,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":10},"Horizon Clinical Research","La Mesa","California","91942-3026","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-117.02308,32.76783,{"lat":47,"lon":46},{"facility":50,"status":10,"city":51,"state":10,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":59,"contacts":10},"AZ Monica","Antwerp","2018","Belgium","BE",{"type":44,"coordinates":56},[57,58],4.40026,51.22047,{"lat":58,"lon":57},{"facility":61,"status":10,"city":62,"state":10,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":70,"contacts":10},"Hadassah Medical Center","Jerusalem","9103401","Israel","IL",{"type":44,"coordinates":67},[68,69],35.21633,31.76904,{"lat":69,"lon":68},{"facility":72,"status":10,"city":73,"state":10,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":81,"contacts":10},"Humanitas Gavazzeni","Bergamo","24125","Italy","IT",{"type":44,"coordinates":78},[79,80],9.66721,45.69601,{"lat":80,"lon":79},{"facility":83,"status":10,"city":84,"state":10,"zip":85,"country":75,"countryCode":76,"cosmosGeoPoint":86,"geoPoint":90,"contacts":10},"Istituto Clinico Humanitas","Milan","20089",{"type":44,"coordinates":87},[88,89],9.18951,45.46427,{"lat":89,"lon":88},{"facility":92,"status":10,"city":93,"state":10,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":101,"contacts":10},"County Hospital Timis Othopedy and Trauma Clinic II","Timișoara","300736","Romania","RO",{"type":44,"coordinates":98},[99,100],21.22571,45.75372,{"lat":100,"lon":99},{"facility":103,"status":10,"city":104,"state":10,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":112,"contacts":10},"Institut za Ortopedsko hiruske Bolesti \"Banjica\"","Belgrade","11000","Serbia","RS",{"type":44,"coordinates":109},[110,111],20.46513,44.80401,{"lat":111,"lon":110},{"facility":114,"status":10,"city":115,"state":10,"zip":116,"country":106,"countryCode":107,"cosmosGeoPoint":117,"geoPoint":121,"contacts":10},"Klinika Orto MD","Novi Sad","21000",{"type":44,"coordinates":118},[119,120],19.83694,45.25167,{"lat":120,"lon":119},{"type":123,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[125],{"name":126,"class":6},"Cartiheal (2009) Ltd","100586542","a-post-approval-multicenter-10-year-follow-up-observational-trial-of-marketed-product---mp01-vs-surgical-standard-of-care-ssoc-used-for-the-treatment-of-joint-surface-lesions-of-the-knee-100586542",false,"NCT06916728","A Post Approval Multicenter 10 Year Follow-up Observational Trial of Marketed Product - MP01 vs. Surgical Standard of Care (SSOC) Used for the Treatment of Joint Surface Lesions of the Knee","Inclusion Criteria:\n\n1. Participated in the pivotal study.\n2. Must be physically and mentally willing and able to comply with the follow-up schedule.\n3. Signed and dated the IEC\u002FIRB approved Informed Consent Form and HIPPA (if applicable).\n\nExclusion Criteria:\n\n1. Withdrawn from the pivotal study due to index knee requiring a unicompartmental or total knee arthroplasty.\n2. Chemotherapy in the past 12 months.\n3. Participation in other clinical trials involving knee procedures.\n4. Vulnerable individual including prisoners (i.e., unable to fully understand all aspects of the study that are relevant to the decision to participate or could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response).","ALL","21 Years","75 Years",{"count":137,"type":138},170,"ESTIMATED","OBSERVATIONAL","The purpose of the study is to support market adoption and global market access via collection of long-term effectiveness, safety, and radiographic data. The primary hypothesis is that Marketed Product (MP01) retains its superiority over Surgical Standard of Care (SSOC) at 7 years in term of mean improvement in the overall Knee Injury and Osteoarthritis Outcome Score (KOOS).",[142,143],"Knee Injuries","Joint Surface Knee Lesions",[145,146],"Knee cartilage lesions","joint surface lesions of the knee","ENROLLING_BY_INVITATION","2026-07-14",{"date":150,"type":151},"2026-07-16","ACTUAL",{"date":153,"type":151},"2025-05-05",{"date":155,"type":138},"2030-02-04",{"name":5,"class":6},8]