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Cruciate Ligament ReconstructionBioACLNCT07506304

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

A study testing ACL reconstruction in people with Cruciate Ligament Reconstruction and Cruciate Ligament Rupture, run by University Hospital Dubrava.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 50 years
What is being tested?
ACL reconstruction
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
1 Sep 2026to 31 Dec 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Marin Glavčić, MD contact

Marin Glavčić , MD +385 1

mglavcic@kbd.hr

About this study

Official title: A Double-blind, Randomized, Prospective, Single-center Study of 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.

Read the 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.

Being tested
ACL reconstruction
Keywords
Tissue Remodeling, Anterior Cruciate Ligament, Semitendinosus Muscle, Knee, Arthroscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACL reconstructionProcedure or surgery

    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.

Study groups in NCT07506304
Study groupRoleWhat they receive
Standard ACL Reconstruction (Control Group)Active comparatorStandard all-inside ACL reconstruction with internal brace augmentation Patients undergo arthroscopic all-inside ACL reconstruction using a quadrupled semitendinosus tendon autograft. The graft is prepared using standard techniques. Fixation is achieved using suspensory fixation devices and internal brace augmentation. No biological augmentation is applied.
Receives: Procedure: ACL reconstruction
Biologically Augmented ACL Reconstruction (Experimental Group)Active comparatorBiologically augmented all-inside ACL reconstruction Patients undergo arthroscopic all-inside ACL reconstruction using a semitendinosus tendon autograft with biological augmentation. The procedure includes: Preservation of a thin layer of muscle tissue on the tendon graft (candy stripe technique) Collection of autologous cancellous bone during tunnel drilling Preparation of autologous platelet-rich fibrin (PRF) from peripheral blood Creation of a composite graft using autologous bone mixed with fibrin glue Application of the biological composite material into femoral and tibial sockets to enhance graft integration Fixation is performed using standard suspensory devices consistent with the control group.
Receives: Procedure: ACL reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 6 weeks, 6 and 12 months postoperatively

Secondary outcomes (9)

  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

    Measured: 6 and 12 months postoperatively

  2. 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)

    Measured: 12 months postoperatively

  3. 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)

    Measured: Before surgery, 6 weeks, 6 months, 12 months postoperatively

  4. 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)

    Measured: Before surgery, 6 weeks, 6 months, 12 months postoperatively

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

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

    Measured: Before surgery, 6 weeks, 6 months, 12 months postoperatively

  6. KOOS - Sports/Recreation Subscale

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

    Measured: Before surgery, 6 weeks, 6 months, 12 months postoperatively

  7. KOOS - Quality of Life (QoL) Subscale

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

    Measured: Before surgery, 6 weeks, 6 months, 12 months postoperatively

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

    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)

    Measured: Before surgery, 6 weeks, 6 months, 12 months postoperatively

  9. Rerupture rate

    Rates of reruptures of ACL graft in operated patients

    Measured: 1 year, 2 years and 5 years postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07506304
Sponsor's protocol ID
024/0719-3
Acronym
BioACL
Status last verified
Apr 2026
First submitted
26 Mar 2026
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing ACL reconstruction in people with Cruciate Ligament Reconstruction and Cruciate Ligament Rupture, run by University Hospital Dubrava.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marin Glavčić, MD (Marin Glavčić , MD +385 1, mglavcic@kbd.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SNQ (time frame: 6 weeks, 6 and 12 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07506304.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.

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