[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631870":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":24,"responsibleParty":31,"collaborators":35,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":41,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":24,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":67,"whyStopped":24,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":24},{"fullName":5,"class":6},"University Hospital Dubrava","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard ACL Reconstruction (Control Group)","ACTIVE_COMPARATOR","Standard all-inside ACL reconstruction with internal brace augmentation Patients undergo arthroscopic all-inside ACL reconstruction using a quadrupled semitendinosus tendon autograft. The graft is prepared using standard techniques. Fixation is achieved using suspensory fixation devices and internal brace augmentation. No biological augmentation is applied.",[13],"Procedure: ACL reconstruction",{"label":15,"type":10,"description":16,"interventionNames":17},"Biologically Augmented ACL Reconstruction (Experimental Group)","Biologically augmented all-inside ACL reconstruction\n\nPatients undergo arthroscopic all-inside ACL reconstruction using a semitendinosus tendon autograft with biological augmentation. The procedure includes:\n\nPreservation of a thin layer of muscle tissue on the tendon graft (candy stripe technique) Collection of autologous cancellous bone during tunnel drilling Preparation of autologous platelet-rich fibrin (PRF) from peripheral blood Creation of a composite graft using autologous bone mixed with fibrin glue Application of the biological composite material into femoral and tibial sockets to enhance graft integration Fixation is performed using standard suspensory devices consistent with the control group.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","ACL reconstruction","Participants will undergo arthroscopic all-inside anterior cruciate ligament reconstruction using an autologous semitendinosus graft. In the experimental intervention, a biologically augmented graft is used, including preservation of muscle tissue on the tendon (candy stripe technique) and application of autologous cancellous bone combined with platelet-rich fibrin at the graft-bone interface. In the control intervention, a standard tendon-only graft is used without biological augmentation. In both groups, graft configuration, tunnel creation, fixation technique, and surgical protocol are identical, and all procedures are performed by the same surgeon.",[15,9],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Marin Glavčić, MD","CONTACT","Marin Glavčić , MD +385 1","mglavcic@kbd.hr",{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Marin Glavčić","Principal Investigator",[36],{"name":37,"class":38},"Arthrex GmbH","INDUSTRY","100631870","biological-potentials-in-arthroscopic-all-inside-semitendinosus-anterior-cruciate-ligament-reconstruction-100631870",false,"NCT07506304","Biological Potentials in Arthroscopic All-inside Semitendinosus Anterior Cruciate Ligament Reconstruction","A Double-blind, Randomized, Prospective, Single-center Study of Biological Potentials in Arthroscopic All-inside Semitendinosus Anterior Cruciate Ligament Reconstruction","BioACL","Inclusion Criteria:\n\n* Clinically and radiologically confirmed anterior cruciate ligament (ACL) rupture.\n* Age between 18 and 50 years.\n* Intact posterior cruciate ligament and collateral ligaments.\n* Signed informed consent to participate in the study.\n* Patients meeting at least one indication for concomitant lateral tenodesis, including: age under 25 years, positive pivot-shift test, presence of Segond fracture, participation in sports with frequent changes of direction and rotational knee loads, or joint hypermobility (Beighton score ≥ 7).\n\nExclusion Criteria:\n\n* Previous ACL reconstruction of the same knee.\n* Inability to use a graft prepared by quadruple folding of the semitendinosus tendon.\n* Graft diameter \\\u003C 7.5 mm.\n* MRI-confirmed unsuccessful meniscal healing after repair.\n* Acute joint infection or history of joint infection.","ALL","18 Years","50 Years",{"count":51,"type":52},70,"ESTIMATED","INTERVENTIONAL",[55],"NA","A randomized, double-blind, prospective single-center clinical trial evaluating the effect of biological augmentation in anterior cruciate ligament (ACL) reconstruction. The study compares standard all-inside semitendinosus ACL reconstruction versus biologically enhanced reconstruction incorporating muscle tissue preservation and autologous bone and fibrin augmentation. The primary aim is to assess whether biological augmentation improves graft healing, integration, and clinical outcomes.",[58,59,60],"Cruciate Ligament Reconstruction","Cruciate Ligament Rupture","Cruciate Ligament Injury",[62,63,64,65,66],"Tissue Remodeling","Anterior Cruciate Ligament","Semitendinosus Muscle","Knee","Arthroscopy","NOT_YET_RECRUITING","2026-04-13",{"date":70,"type":71},"2026-04-16","ACTUAL",{"date":73,"type":52},"2026-09-01",{"date":75,"type":52},"2032-12-31",{"name":5,"class":6}]