[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540028":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":43,"centralContacts":47,"locations":53,"responsibleParty":82,"collaborators":84,"id":89,"slug":36,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":36,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":36,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":56,"whyStopped":36,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Hospital for Special Surgery, New York","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Investigational Arm","EXPERIMENTAL","Patients undergoing revision anterior cruciate ligament reconstruction surgery will get an intraoperative injection of concentrated bone marrow aspirate (cBMA).",[13,14],"Biological: Concentrated Bone Marrow Aspirate Injection","Procedure: Revision Anterior Cruciate Ligament Reconstruction",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Arm","SHAM_COMPARATOR","Patients undergoing revision anterior cruciate ligament reconstruction surgery will get a sham incision in lieu of bone marrow harvesting.",[20,14],"Procedure: Sham Incision",[22,31,37],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BIOLOGICAL","Concentrated Bone Marrow Aspirate Injection","Intraoperatively, bone marrow will be harvested from the iliac crest with a commercial kit, it will then be prepared via centrifugation and an injection of the resulting concentrated product (cBMA) will be administered in the operative knee. cBMA is an autologous biologic product.",[9],[28,29,30],"cBMA","BMAC","Bone Marrow Aspirate Concentrate",{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"PROCEDURE","Sham Incision","A 2 mm sham incision will be made in the anatomical site where bone marrow would be harvested.",[16],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Revision Anterior Cruciate Ligament Reconstruction","This is the standard-of-care surgical procedure.",[16,9],[42],"Revision ACLR",[44],{"name":45,"affiliation":5,"role":46},"Miguel Otero, Ph.D.","PRINCIPAL_INVESTIGATOR",[48],{"name":49,"role":50,"phone":51,"phoneExt":36,"email":52},"Daniel de la Huerta, MD","CONTACT","917-260-3159","delahuertamezad@hss.edu",[54,68],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":36},"Emory Orthopaedics & Spine Center","RECRUITING","Atlanta","Georgia","30097","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-84.38798,33.749,{"lat":66,"lon":65},{"facility":69,"status":56,"city":70,"state":70,"zip":71,"country":60,"countryCode":61,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Hospital for Special Surgery","New York","10021",{"type":63,"coordinates":73},[74,75],-74.00597,40.71427,{"lat":75,"lon":74},[78,81],{"name":49,"role":50,"phone":79,"phoneExt":80,"email":52},"212-606-1000","2603159",{"name":45,"role":46,"phone":36,"phoneExt":36,"email":36},{"type":83,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[85,87],{"name":86,"class":6},"Emory University",{"name":88,"class":6},"Arthritis Foundation","100540028",false,"NCT06311513","Concentrated Bone Marrow Aspirate in Revision ACL Reconstruction","Multi-Center Pilot Study to Evaluate Concentrated Bone Marrow Aspirate (cBMA) as a Treatment to Modify Post-Traumatic Osteoarthritis (PTOA) Following Revision Anterior Cruciate Ligament Reconstruction (ACLR)","Inclusion Criteria:\n\n* Males and Females\n* Age 18 to 55\n* Previous unilateral ACLR (Anterior Cruciate Ligament Reconstruction) within the last 5 years, and identified as having experienced failure of the primary ACLR\n* Scheduled to have a revision ACLR surgery, with any graft type (including patellar tendon, hamstring, quad or allograft)\n* Able to complete all study procedures and participate in a standardized physical therapy program\n\nExclusion Criteria:\n\n* History of inflammatory arthritis or joint sepsis\n* Prior or concurrent total or sub-total meniscectomy\n* Prior or present avascular necrosis of the index knee\n* Oral or intra-articular corticosteroid injection within 3 months\n* Hyaluronic acid or PRP (Platelet-Rich Plasma) injection within 6 months\n* Use of duloxetine, doxycycline, indomethacin, glucosamine and\u002For chondroitin (ongoing or within 2 months)\n* Any clinical or laboratory abnormality greater than grade 3 CTCAE, which in the view of the investigator, will compromise the participant's safety.\n* Planned arthroplasty in the index knee","ALL","18 Years","55 Years",{"count":99,"type":100},40,"ESTIMATED","INTERVENTIONAL",[103],"PHASE4","The goal of this pilot randomized clinical trial is to look into the efficacy of concentrated bone marrow aspirate (cBMA) in improving post traumatic osteoarthritis (PTOA) symptoms in patients undergoing revision anterior cruciate ligament reconstruction surgery. The main questions it aims to answer are whether clinical outcomes, such as pain, are improved in patients who get cBMA with surgery, if there is a change in circulating markers of inflammation and what part of the cellular and molecular composition of cBMA may explain its effects.",[106,107,30,108],"Anterior Cruciate Ligament Injuries","Post-Traumatic Osteoarthritis of Knee","ACL Injury",[110,111,112,42],"Regenerative Medicine","Orthobiologics","Concentrated Bone Marrow Aspirate","2025-11-19",{"date":115,"type":116},"2025-11-20","ACTUAL",{"date":118,"type":116},"2024-01-22",{"date":120,"type":100},"2028-12",{"name":5,"class":6},2]