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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University Hospital Dubrava · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Anterior cruciate ligament (ACL) reconstruction outcomes depend on multiple factors including surgical technique, graft selection, fixation methods, and rehabilitation. Hamstring tendon autografts are commonly used due to favorable biomechanical properties and low donor-site morbidity. Traditionally, graft preparation involves complete removal of muscle tissue; however, emerging techniques such as the "candy stripe" method preserve residual muscle, which may provide a source of stem cells and enhance biological healing. In addition, biological augmentation strategies-including the use of autologous bone graft and platelet-rich fibrin (PRF)-have been proposed to improve tendon-to-bone integration and accelerate ligamentization. These approaches aim to enhance graft incorporation, structural integrity, and overall functional recovery. This study is a double-blind, randomized, prospective, single-center clinical trial including 70 patients with ACL rupture. Participants are randomly assigned into two groups (n=35 per group): A control group undergoing standard all-inside ACL reconstruction. An intervention group undergoing biologically augmented ACL reconstruction. All procedures are performed using an all-inside technique with semitendinosus tendon autografts. The biologically augmented group differs by: Preservation of a thin layer of muscle tissue on the graft (candy stripe technique) Use of autologous cancellous bone collected during tunnel drilling Application of autologous fibrin glue (platelet-rich fibrin) combined with bone graft to enhance healing at graft-tunnel interfaces The primary objective is to evaluate whether biological augmentation improves graft healing and clinical outcomes compared to standard reconstruction.

Conditions

• Cruciate Ligament Reconstruction
• Cruciate Ligament Rupture
• Cruciate Ligament Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-09-01
• Primary completion: 2027-12-31
• Completion: 2032-12-31
• First posted: 2026-04-01
• Last updated: 2026-04-16