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

NCT07506304 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-04-16

No results posted yet for this study

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 Reconstruction
  • Cruciate Ligament Rupture
  • Cruciate Ligament Injury

Interventions

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.

Sponsors & Collaborators

  • Arthrex GmbH

    collaborator INDUSTRY

  • University Hospital Dubrava

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-12-31
Completion
2032-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07506304 on ClinicalTrials.gov