[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596479":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":10,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":10,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":10,"overallStatus":61,"whyStopped":10,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},{"fullName":5,"class":6},"Skye Biologics Holdings, LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ACL Reconstruction with Allograft",null,"Subjects who have undergone ACL reconstruction with allograft",[13],"Diagnostic Test: MRI",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","MRI","MRI to assess graft maturation",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Kyle Borque, MD","CONTACT","281-690-4678","kaborque@houstonmethodist.org",[27],{"facility":28,"status":10,"city":29,"state":30,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Houston Methodist Sugar Land","Sugar Land","Texas","77479","United States","US",{"type":35,"coordinates":36},"Point",[37,38],-95.63495,29.61968,{"lat":38,"lon":37},[41],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"type":43,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100596479","mri-evaluation-of-graft-maturation-following-acl-reconstruction-100596479",false,"NCT07046000","MRI Evaluation of Graft Maturation Following ACL Reconstruction","Magnetic Resonance Imaging (MRI) Evaluation of Graft Maturation Following Anterior Cruciate Ligament (ACL) Reconstruction With a Connective Tissue Allograft","Inclusion Criteria:\n\n* ACL tear and reconstruction; no other knee ligaments needing reconstruction\n* Primary (first-time) ACL tear in the affected knee\n* ACL injury occurred less than 12 months before ACL reconstruction\n* Have no contraindications or allergies to the treatment administered\n* Have current imaging studies (plain radiographs and MRI exams within the past 12 months) of the knee to rule out other etiologic diagnoses\n* Patient underwent ACL reconstruction with a Bone-Patellar Tendon-Bone (BTB) graft harvested from the same knee (ipsilateral autograft) with the Active Matrix tissue\n* Able and willing to comply with the post-operative study follow-up schedule\n\nExclusion Criteria:\n\n* Prior surgery on the index knee within 12 months of enrollment\n* Steroid injection into the index knee within 6 weeks of enrollment\n* Chronic ACL tear whereas the injury occurred more than 12 months ago\n* Multiligamentous injuries whereas any ligament (MCL, PCL, or PLC) in addition to the ACL needs to be reconstructed\n* Patient underwent ACL reconstruction with a hamstring tendon, Achilles tendon or quadriceps tendon graft (any graft other than a patellar tendon BTB)\n* Contraindication to MRI (eg, implanted devices incompatible with MRI).\n* Chrondral lesion of the knee that requires treatment during ACL reconstruction surgery\n* History of advanced osteoarthritis of the knee or patella-femoral joint; KL grade III or higher\n* History of malignant tumor and osseous metastatic disease,\n* History of chronic pain disorders (i.e., fibromyalgia),\n* Current substance abuse (drug or alcohol), by the investigator's judgment,\n* Females who are pregnant, nursing or breastfeeding, or who intend to become pregnant during participation in the study.\n* Currently participating in, or have been recently exited from (within 30 days from enrollment in this study), or plan to enroll in another clinical study for a bone allograft or drug that may impact participation or outcomes of this study,\n* Currently involved in any injury litigation or workers compensation claims,\n* Has a condition, disorder or other factor that, in the investigator's opinion, would interfere with study participation.","ALL","14 Years","50 Years",{"count":55,"type":56},10,"ESTIMATED","OBSERVATIONAL","Post-surgical ACL Graft maturation will be assessed at 4.5, 6, 7.5, 9, 10.5, and 12 months with MRI.",[60],"ACL Tears","NOT_YET_RECRUITING","2026-04-23",{"date":64,"type":65},"2026-04-24","ACTUAL",{"date":67,"type":56},"2026-08-01",{"date":69,"type":56},"2028-02",{"name":5,"class":6},1]