deltatrials
Not Yet Recruiting INTERVENTIONAL NCT07506304

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

A Double-blind, Randomized, Prospective, Single-center Study of Biological Potentials in Arthroscopic All-inside Semitendinosus Anterior Cruciate Ligament Reconstruction

Sponsor: Arthrex GmbH

Interventions ACL reconstruction
Updated 1 time since 2026 Last updated: Apr 13, 2026 Started: Sep 1, 2026 Primary completion: Dec 31, 2027 Completion: Dec 31, 2032
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Cruciate Ligament Injury and Cruciate Ligament Reconstruction, this trial is actively recruiting participants. The trial is conducted by Arthrex GmbH and has accumulated 1 data snapshot since 2026. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

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...

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.

Status Flow

Apr 17, 2026 – present · 3 months · daily APINot Yet Recruiting

Change History

1 version recorded
Not Yet Recruiting [daily]

Eligibility 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.

Contact Information

Sponsor contact:
  • Arthrex GmbH
  • University Hospital Dubrava
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.