Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
NCT07404046

Comparison of Tendon and Muscle-Tendon Semitendinosus Grafts After ACL Reconstruction

Led by University Hospital Dubrava · Updated on 2026-02-11

40

Participants Needed

1

Research Sites

82 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Aim: Comparison of tendon to bone ingrowth in bone tunnels and intra-articular remodeling of the graft after anterior cruciate ligament surgery with a muscle-tendon graft and those with a tendon graft. Subjects and methods: It is a single-blind prospective randomized study that would include at least 40 patients with an anterior cruciate ligament rupture. Patients would be randomly divided into two groups of minimally 20 patients each. Patients in the first study group would undergo ACL reconstruction with a muscle-tendon graft, while patients in the control group would be treated with the standard method of ACL reconstruction with a tendon graft. Expected contribution to the field: The assumption is that the obtained results could enable a better understanding of the contribution of remaining muscle fibers on the tendon in anterior cruciate ligament reconstruction operations to the tendon to bone ingrowth and intra-articular remodeling of the graft of operated patients.

CONDITIONS

Official Title

Comparison of Tendon and Muscle-Tendon Semitendinosus Grafts After ACL Reconstruction

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 6 7).
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

University hospital Dubrava

Zagreb, Croatia, 10000

Actively Recruiting

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Research Team

M

Marin Glavčić, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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