Biological Potentials in Arthroscopic All-inside Semitendinosus Anterior Cruciate Ligament Reconstruction

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity Hospital Dubrava

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

70 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators