About this trial
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.
Eligibility criteria
Qualifiers
Clinically and radiologically confirmed anterior cruciate ligament (ACL) rupture.
Age between 18 and 50 years.
Intact posterior cruciate ligament and collateral ligaments.
Signed informed consent to participate in the study.
Disqualifiers
Previous ACL reconstruction of the same knee.
Inability to use a graft prepared by quadruple folding of the semitendinosus tendon.
Graft diameter < 7.5 mm.
MRI-confirmed unsuccessful meniscal healing after repair.
Trial design
Treatments tested in this trial
- ACL reconstruction
Treatment groups
Locations
Sponsors and collaborators
University Hospital Dubrava
Lead sponsor
Arthrex GmbH
Collaborator