Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
ID06664047

Radiological and Clinical Outcomes of Over-the-Top ACL Reconstruction vs. Anteromedial ACL Reconstruction With Additional Lateral Extraarticular Tenodesis: A Prospectively Randomized Controlled Trial

Led by Ankara City Hospital Bilkent · Updated on 2024-10-31

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two surgical methods for reconstructing the anterior cruciate ligament (ACL) to improve knee stability and return to sports. The study compares the over-the-top (OTT) ACL reconstruction technique, which routes the graft over the lateral femoral condyle and is simpler, with the anteromedial ACL reconstruction combined with lateral extraarticular tenodesis (LET), which aims to better control rotational instability. This randomized controlled trial seeks to clarify the benefits and outcomes of these techniques for patients with ACL tears. Participants will receive either the OTT technique, which includes intra-articular and extra-articular components functioning as LET, or the conventional anteromedial ACL reconstruction combined with LET using the iliotibial band. Both surgical approaches aim to restore knee function but differ in how the graft is positioned and how additional rotational stability is provided. The trial observes patients for one year post-surgery, including imaging and clinical assessments. Throughout the study, patients will be monitored with MRI and CT scans at one year after surgery. Outcomes measured include graft re-rupture rates, tibial tunnel widening, activity levels using the Tegner Activity Scale, and knee function and osteoarthritis outcomes using the KOOS score. This follow-up will help determine the clinical and radiological effectiveness of each technique in restoring knee stability and supporting return to sport activities.

CONDITIONS

Brief Title

Over-the-Top vs. Anteromedial ACLR With Lateral Extraarticular Tenodesis

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Presence of an isolated anterior cruciate ligament (ACL) tear
  • Age between 18 and 50 years
  • No previous history of surgery on the same knee
  • MRI and CT scans performed at the end of the first postoperative year
Not Eligible

You will not qualify if you...

  • Additional ligamentous injury along with the ACL tear
  • Incomplete clinical scores
  • History of previous surgery on the same knee
  • Presence or history of infection in the knee

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day plus immediate recovery period

Participants undergo either the Over-the-Top ACL Reconstruction technique or the Anteromedial ACL Reconstruction with Lateral Extraarticular Tenodesis to restore knee stability.

1 surgical procedure visit

Post-operative Follow-up

Duration - Up to 1 year after surgery

Participants are monitored for clinical and radiological outcomes, including graft integrity, knee function, and activity levels.

Regular follow-up visits including MRI and CT scans at 1 year post-op

Trial Site Locations

Total: 1 location

1

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye), 06800

Actively Recruiting

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Research Team

E

Enejd Veizi, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Editorial Commentary: The Number One Cause of Anterior Cruciate Ligament Reconstruction Graft Failure Is a Misplaced Femoral Tunnel: Over-the-Top Technique Plus Lateral Extra-Articular Tenodesis Is Recommended.

Gian Andrea Lucidi, Tommaso Roberti di Sarsina, Stefano Zaffagnini

https://pubmed.ncbi.nlm.nih.gov/38296446

The 25-year experience of over-the-top ACL reconstruction plus extra-articular lateral tenodesis with hamstring tendon grafts: the story so far.

Stefano Zaffagnini, Gian Andrea Lucidi, Luca Macchiarola...

https://pubmed.ncbi.nlm.nih.gov/37005946

Comparison of clinical outcomes between anterior cruciate ligament reconstruction with over-the-top route procedure and anatomic single-bundle reconstruction in pediatric patients.

Goki Kamei, Atsuo Nakamae, Kyohei Nakata...

https://pubmed.ncbi.nlm.nih.gov/36700965

High return to sport rate and few re-ruptures at long term in professional footballers after anterior cruciate ligament reconstruction with hamstrings.

Tommaso Bonanzinga, Alberto Grassi, Daniele Altomare...

https://pubmed.ncbi.nlm.nih.gov/35451640