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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
ACL reconstruction
Procedure/SurgeryParticipants 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Standard ACL Reconstruction (Control Group)Active comparator 1 intervention
Group B: Biologically Augmented ACL Reconstruction (Experimental Group)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
SNQ
To analyze and compare T2 signal-to-noise ratio values on magnetic resonance imaging at 6 weeks, 6 and 12 months postoperatively within and between the two study groups. The SNQ is calculated as the ratio of the graft T2 signal intensity to the signal intensity of a reference tissue on MRI. Higher SNQ values indicate higher graft signal, which corresponds to lower graft maturity/quality. Scale: Continuous numerical value (exact values depend on MRI signal calibration).
Time frame
6 weeks, 6 and 12 months postoperativelySecondary outcomes
1
Bone Tunnel Diameter
The diameter of the femoral and tibial bone tunnel measured on MRI at 6 and 12 months postoperatively compared to the intraoperatively drilled diameter. Units: Millimeters (mm) Directionality: Higher values indicate tunnel widening
Time frame
6 and 12 months postoperatively2
Knee Stability - Anterior Tibial Translation
The anterior-posterior stability of the operated knee measured with the Lachmeter device at 12 months postoperatively. Units: Millimeters (mm) of anterior tibial translation Directionality: Higher values indicate greater laxity (worse stability)
Time frame
12 months postoperatively3
KOOS - Pain Subscale
Knee Injury and Osteoarthritis Outcome Score (KOOS) - Pain subscale, assessing knee pain. Scale: 0-100 (0 = extreme pain, 100 = no pain; higher scores = better outcome)
Time frame
Before surgery, 6 weeks, 6 months, 12 months postoperatively4
KOOS - Symptoms Subscale
KOOS - Symptoms subscale, assessing knee symptoms (e.g., swelling, stiffness). Scale: 0-100 (0 = severe symptoms, 100 = no symptoms; higher scores = better outcome)
Time frame
Before surgery, 6 weeks, 6 months, 12 months postoperativelyLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Dubrava
Lead sponsor
Arthrex GmbH
Collaborator
Source ClinicalTrials.gov
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