About this trial
Aim: Comparison of tendon to bone ingrowth in bone tunnels and intra-articular remodeling of the graft after anterior cruciate ligament surgery with a muscle-tendon graft and those with a tendon graft. Subjects and methods: It is a single-blind prospective randomized study that would include at least 40 patients with an anterior cruciate ligament rupture. Patients would be randomly divided into two groups of minimally 20 patients each. Patients in the first study group would undergo ACL reconstruction with a muscle-tendon graft, while patients in the control group would be treated with the standard method of ACL reconstruction with a tendon graft.
Expected contribution to the field: The assumption is that the obtained results could enable a better understanding of the contribution of remaining muscle fibers on the tendon in anterior cruciate ligament reconstruction operations to the tendon to bone ingrowth and intra-articular remodeling of the graft of operated patients.
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
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 muscle-tendon semitendinosus graft is used, with preservation of muscle fibers on the tendon. In the control intervention, a standard tendon-only semitendinosus graft is used. In both groups, graft preparation, tunnel creation, fixation technique, and concomitant lateral tenodesis are identical, and all procedures are performed by the same surgeon following a standardized protocol.
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
Bone Tunnel Diameter - Femur
Description: The diameter of the femoral 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
Bone Tunnel Diameter - Tibia
Description: The diameter of the 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.
Knee Stability - Anterior Tibial Translation
Description: 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)
KOOS - Pain Subscale
Description: 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)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.