Comparing Over-the-Top ACL Reconstruction and Anteromedial ACL Reconstruction With Lateral Extraarticular Tenodesis for ACL Tear Treatment
Led by Ankara City Hospital Bilkent · Updated on 2024-10-31
150
Participants Needed
1
Research Sites
N/A
Total Duration
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
Research Team
E
Enejd Veizi, MD
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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
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
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
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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Published Research Related To This Trial
Comparison of clinical outcomes between anterior cruciate ligament reconstruction with over-the-top route procedure and anatomic single-bundle reconstruction in pediatric patients.
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
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...