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

NCT07506304 | Not Yet Recruiting

• 1 other identifier: 024/0719-3
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cruciate Ligament Rupture; Cruciate Ligament Injury; Cruciate Ligament Reconstruction

Keywords

Tissue Remodeling; Anterior Cruciate Ligament; Semitendinosus Muscle; Knee; Arthroscopy

Outcome Measures

Primary Outcomes (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).

  6 weeks, 6 and 12 months postoperatively

Secondary Outcomes (9)

• Bone Tunnel Diameter

  6 and 12 months postoperatively

• Knee Stability - Anterior Tibial Translation

  12 months postoperatively

• KOOS - Pain Subscale

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

• KOOS - Symptoms Subscale

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

• KOOS - Activities of Daily Living (ADL) Subscale

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

Study Arms (2)

Standard ACL Reconstruction (Control Group)

ACTIVE COMPARATOR

Standard 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.

Procedure: ACL reconstruction

Biologically Augmented ACL Reconstruction (Experimental Group)

ACTIVE COMPARATOR

Biologically 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.

Procedure: ACL reconstruction

Interventions

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.

Biologically Augmented ACL Reconstruction (Experimental Group); Standard ACL Reconstruction (Control Group)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arthrex GmbH: collaborator
• University Hospital Dubrava: lead

Central Study Contacts

Marin Glavčić, MD

CONTACT

Marin Glavčić , MD +385 1; mglavcic@kbd.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2032
• Last Updated: April 16, 2026

Record last verified: 2026-04