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NCT Number: NCT07506304

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

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.

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Key information

Conditions

Cruciate Ligament Reconstruction Cruciate Ligament Injury Cruciate Ligament Rupture

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patients meeting at least one indication for concomitant lateral tenodesis, including: age under 25 years, positive pivot-shift test, presence of Segond fracture, participation in sports with frequent changes of direction and rotational knee loads, or joint hypermobility (Beighton score ≥ 7).

Exclusion criteria

  • 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.
  • Acute joint infection or history of joint infection.

Treatment and study plan

ACL reconstruction

Procedure

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.

Primary outcomes

  1. SNQ

    Time frame: 6 weeks, 6 and 12 months postoperatively

    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

  1. Bone Tunnel Diameter

    Time frame: 6 and 12 months postoperatively

    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

  2. Knee Stability - Anterior Tibial Translation

    Time frame: 12 months postoperatively

    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)

  3. KOOS - Pain Subscale

    Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively

    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)

  4. KOOS - Symptoms Subscale

    Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively

    KOOS - Symptoms subscale, assessing knee symptoms (e.g., swelling, stiffness). Scale: 0-100 (0 = severe symptoms, 100 = no symptoms; higher scores = better outcome)

  5. KOOS - Activities of Daily Living (ADL) Subscale

    Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively

    KOOS - ADL subscale, assessing functional ability in daily activities. Scale: 0-100 (0 = extreme limitation, 100 = no limitation; higher scores = better outcome)

  6. KOOS - Sports/Recreation Subscale

    Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively

    KOOS - Sports/Recreation subscale, assessing function during sport or recreational activity. Scale: 0-100 (0 = extreme limitation, 100 = no limitation; higher scores = better outcome)

  7. KOOS - Quality of Life (QoL) Subscale

    Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively

    KOOS - QoL subscale, assessing knee-related quality of life. Scale: 0-100 (0 = extreme problem, 100 = no problem; higher scores = better outcome)

  8. KDC-SKF (International Knee Documentation Committee - Subjective Knee Form)

    Time frame: Before surgery, 6 weeks, 6 months, 12 months postoperatively

    Patient-reported measure of knee function, symptoms, and sports activity. Scale: 0-100 (0 = worst knee function, 100 = best knee function; higher scores = better outcome)

  9. Rerupture rate

    Time frame: 1 year, 2 years and 5 years postoperatively

    Rates of reruptures of ACL graft in operated patients

Study contacts

Contact information is provided by the study sponsor or research team.

Marin Glavčić, MD

CONTACT

[email protected]

Marin Glavčić , MD +385 1

Sponsors and collaborators

Lead sponsor

University Hospital Dubrava

Other

Collaborators

  • Arthrex GmbH

Registry information

Official study title

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

Acronym: BioACL

Important dates

Study start
2026
Primary completion
2027
Study completion
2032
First posted
Apr 1, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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