[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acl-tears\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acl-tears":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"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":20,"type":21},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.",[25],"ACL Tears","NOT_YET_RECRUITING","2026-04-23",{"date":29,"type":30},"2026-04-24","ACTUAL",{"date":32,"type":21},"2026-08-01",{"date":34,"type":21},"2028-02",{"name":36,"class":37},"Skye Biologics Holdings, LLC","INDUSTRY",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":49,"conditions":50,"keywords":51,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":38},"100588990","biobrace-augmentation-in-anterior-cruciate-ligament-reconstruction-procedures-100588990","NCT06948591","BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures","Real World Evaluation of the Safety and Effectiveness of BioBrace® Augmentation in Anterior Cruciate Ligament (ACL) Reconstruction Procedures","Inclusion Criteria:\n\n1. Underwent ACL reconstruction with a tissue graft augmented with BioBrace® within the past 24 months from study start date or scheduled to undergo ACL reconstruction with a tissue graft augmented with BioBrace®.\n2. Between 14 and 70 years old at the time of surgery.\n3. Can understand the content of the subject information \u002F Informed Consent Form (ICF) for the prospective portion of the study.\n4. Is willing and able to participate in the prospective data collection protocol and comply with the required data collection.\n5. If the subject has already undergone ACLR within the past 24 months, subject must have at least two (2) of the following measures at baseline and 1 year post-operatively:\n\n   1. International Knee Documentation Committee (IKDC)\n   2. Knee Injury and Osteoarthritis Outcome Score Junior (KOOS, JR.)\n   3. Patient-Reported Outcomes Measurement Information System (PROMIS-10)\n   4. Tegner Activity Scale (TAS)\n   5. Anterior Cruciate Ligament - Return to Sport After Injury (ACL-RSI)\n6. Positive diagnostic imaging by MRI at baseline indicating an ACL tear\n\nExclusion Criteria:\n\n1. Has other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render subject ineligible for the study.\n2. Is currently participating in an investigational therapy (device and\u002For pharmaceutical) within 30 days prior to entering the study or such treatment is planned during the 3 years following enrollment into the study.\n3. Underwent or scheduled to undergo a multi-ligament reconstruction procedure (excluding cases where a torn MCL is treated non-operatively).\n4. Females of child-bearing potential who are either pregnant or breastfeeding at the time of surgery.","70 Years",{"count":48,"type":21},500,"This research study will evaluate mid-term clinical safety and performance outcomes of the BioBrace® Reinforced Implant when used to augment a tissue graft during anterior cruciate ligament (ACL) reconstruction.",[25],[52,53,54],"ACL reconstruction","BioBrace","augmentation","RECRUITING","2026-04-13",{"date":58,"type":30},"2026-04-14",{"date":60,"type":30},"2025-04-08",{"date":62,"type":21},"2030-06",{"name":64,"class":37},"CONMED Corporation"]