[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532741":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":31,"responsibleParty":134,"collaborators":20,"id":136,"slug":20,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":20,"eligibilityCriteria":141,"healthyVolunteers":137,"sex":142,"minAge":143,"maxAge":144,"enrollmentInfo":145,"targetDuration":20,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":20,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"AlloSource","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Osteochondral transplant on the femoral condyle","EXPERIMENTAL","Eligible and enrolled patients will receive one or more cryopreserved osteochondral allograft core as part of their osteochondral transplant procedure",[13],"Procedure: osteochondral transplant on the femoral condyle",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","osteochondral transplant on the femoral condyle","Patients between the ages of ≥12 years and ≤ 60 years who have a symptomatic full-thickness cartilage lesion (Grade 3 or 4) on the femoral condyle, in a mechanically stable knee, or is being mechanically stabilized in the same procedure, between 0.9-8.0 cm2 in size, and cystic changes requiring osseous repair, as confirmed by MRI , CT scan, or arthroscopy and will undergo a osteochondral transplant by removing the damaged cartilage and replacing that cartilage with a cryopreserved osteochondral allograft core.",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Elizabeth Esterl, DNP, MS, RN","CONTACT","7207326231","eesterl@allosource.org",{"name":28,"role":24,"phone":29,"phoneExt":20,"email":30},"Paige McHenry, MS, ATC, CCRA","2154997062","pmchenry@allosource.org",[32,53,70,85,100,117],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Banner- University Medical Center- Phoenix Orthopedic and Sports Medicine Institute","RECRUITING","Phoenix","Arizona","85006","United States",{"type":40,"coordinates":41},"Point",[42,43],-112.07404,33.44838,{"lat":43,"lon":42},[46,50],{"name":47,"role":24,"phone":48,"phoneExt":20,"email":49},"Maria Jimenez, CRC II","602-614-8549","Maria.Jimenez2@bannerhealth.com",{"name":51,"role":52,"phone":20,"phoneExt":20,"email":20},"Thomas Carter, MD","PRINCIPAL_INVESTIGATOR",{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":38,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Cedars-Sinai Kerlan Jobe Institute","NOT_YET_RECRUITING","Los Angeles","California","90045",{"type":40,"coordinates":60},[61,62],-118.24368,34.05223,{"lat":62,"lon":61},[65,68],{"name":66,"role":24,"phone":20,"phoneExt":20,"email":67},"Karla Gonzalez, CRC","karla.gonzalez@csh.org",{"name":69,"role":52,"phone":20,"phoneExt":20,"email":20},"Michael Banffy, MD",{"facility":71,"status":34,"city":72,"state":57,"zip":73,"country":38,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Stanford Medicine-Orthopaedics and Sports Medicine in Redwood City","Redwood City","94063",{"type":40,"coordinates":75},[76,77],-122.23635,37.48522,{"lat":77,"lon":76},[80,83],{"name":81,"role":24,"phone":20,"phoneExt":20,"email":82},"Allen Seo","allenseo@stanford.edu",{"name":84,"role":52,"phone":20,"phoneExt":20,"email":20},"Seth Sherman, MD",{"facility":86,"status":34,"city":87,"state":57,"zip":88,"country":38,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"University of California San Francisco","San Francisco","94158",{"type":40,"coordinates":90},[91,92],-122.41942,37.77493,{"lat":92,"lon":91},[95,98],{"name":96,"role":24,"phone":20,"phoneExt":20,"email":97},"Jocelyn Carpio","jocelyn.carpio@ucsf.edu",{"name":99,"role":52,"phone":20,"phoneExt":20,"email":20},"Drew Lansdown, MD",{"facility":101,"status":34,"city":102,"state":103,"zip":104,"country":38,"cosmosGeoPoint":105,"geoPoint":109,"contacts":110},"Rush Copley Medical Center","Aurora","Illinois","60504",{"type":40,"coordinates":106},[107,108],-88.32007,41.76058,{"lat":108,"lon":107},[111,115],{"name":112,"role":24,"phone":113,"phoneExt":20,"email":114},"Starlyn Nadeau, RN","630-361-4267","starlyn_nadeau@rush.edu",{"name":116,"role":52,"phone":20,"phoneExt":20,"email":20},"Brian E Walczak, DO, PhD",{"facility":118,"status":34,"city":119,"state":120,"zip":121,"country":38,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"University of Kentucky Research Foundation","Lexington","Kentucky","40506",{"type":40,"coordinates":123},[124,125],-84.47772,37.98869,{"lat":125,"lon":124},[128,132],{"name":129,"role":24,"phone":130,"phoneExt":20,"email":131},"Caitlin Conley","859-257-1939","caitlin.conley2@uky.edu",{"name":133,"role":52,"phone":20,"phoneExt":20,"email":20},"Austin Stone, MD, PhD",{"type":135,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100532741",false,"NCT06216756","Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee","A Prospective, Open Label, Single-Arm, Multi-Center Study Evaluating Cryopreserved Osteochondral Allograft Cores for the Treatment of Osteochondral Lesions in the Knee","Inclusion Criteria:\n\n* Patients are ≥12 years and ≤ 60 years of age at the time of surgery.\n* Symptomatic patient presenting with moderate to severe pain in the index knee - unresponsive to conservative treatment (i.e., medication, bracing, physical therapy) and\u002For previous surgical intervention OR unsalvageable lesion that requires transplantation at the discretion of the treating physician.\n* Radiographically diagnosed, by MRI or CT scans, or through arthroscopy, to have a cartilage defect on the femoral condyle between 0.9-8.0 cm2 in size.\n* Will be having an osteochondral transplant procedure.\n* Has a mechanically stable knee or can be mechanically stabilized in the same procedure.\n* Has a normally aligned knee as confirmed by anatomic comparison to contralateral limb, or \\\u003C5° varus or valgus malalignment that has been corrected or will be corrected in same procedure.\n* Ipsilateral knee compartment has intact menisci or requires partial meniscectomy ≤ 50% resulting in stable menisci.\n* Confirmation MRI, CT scan, or arthroscopy obtained pre-operatively within 90 days of surgery\n* Willingness to follow standardized rehabilitation procedures.\n* Has the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.\n\nExclusion Criteria:\n\n* Bipolar articular cartilage involvement (kissing lesions) of the ipsilateral compartment (i.e., \\> than ICRS Grade 2 on the opposing articular surface).\n* Has had a prior osteochondral allograft transplant procedure in the same knee.\n* Will be receiving a meniscus allograft transplantation in the same procedure.\n* Body Mass Index (BMI)of ≥ 35 kg\u002Fm2.\n* Active malignancy: undergoing treatment for tumor or boney traumatic injury or a history of any invasive malignancy (except non-melanoma skin cancer) unless the patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years.\n* Clinical and\u002For radiographic disease in the affected joint that includes generalized osteoarthritis, gout or a history of gout or pseudo-gout.\n* Active local microbial infection or a systemic infection, including HIV, syphilis, Hepatitis B or Hepatitis C.\n* Currently immunologically suppressed or immunocompromised, or a medical condition requiring radiation and\u002For chemotherapy.\n* Unstable cardiovascular, renal, hepatic, endocrine and\u002For pulmonary disease, cancer, or uncontrolled diabetes.\n* Has a history of any inflammatory joint arthropathy.\n* Currently using\u002Fchronic on oral corticosteroids.\n* Received interarticular corticosteroid injection ≤ 90 days prior to surgery.\n* Received hyaluronic acid injections into the joint space ≤ 45 days prior to surgery.\n* Is a female patient who is pregnant.\n* Physically or mentally compromised (i.e., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease) in a manner that would compromise his\u002Fher ability to participate in the clinical study.\n* Has a history of substance abuse- (including but not limited to recreational drugs, alcohol) or has been treated in the last 6 months before enrollment for alcohol and\u002For drug abuse in an in-patient substance abuse program.\n* Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol.\n* Is currently involved in a study of another investigational product for similar purpose or has been in the previous 90 days.\n* Has any contraindications for MRI.\n* Is having the procedure as part of a Worker's Compensation claim.\n* Is a ward of the state, prisoner, or transient.","ALL","12 Years","60 Years",{"count":146,"type":147},68,"ESTIMATED","INTERVENTIONAL",[150],"NA","The primary objective of this study is to obtain evidence of the effectiveness of Cryopreserved Osteochondral Allograft Core in the treatment of osteochondral lesions on the femoral condyle.",[153],"Osteochondral Defect","2025-11-20",{"date":156,"type":157},"2025-11-25","ACTUAL",{"date":159,"type":157},"2024-12-01",{"date":161,"type":147},"2031-03",{"name":5,"class":6},6]