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Clinical Trials in Turkey / NCT06664047
Recruiting Not applicable

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

NCT06664047 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-10-24
Last updated
2024-10-31

Condition(s) studied

Anterior Cruciate Ligament RuptureAnterior Cruciate Ligament InjuriesAnterior Cruciate Ligament Tear

Investigational drug(s) / intervention(s)

OTT ACLRACLR LET

OTT ACLR: Patients in this group will undergo a reconstruction with the OTT technique which includes an intra-articular component and an extra-articular one, functioning as a LET.

ACLR LET: Patients in this group will undergo a reconstruction with the conventional ACL technique accompanied by a routine LET, obtained from the iliotibial band.

Study summary

This study aims to compare the over-the-top (OTT) anterior cruciate ligament (ACL) reconstruction (ACL-R) technique with the anteromedial ACL-R + lateral extraarticular tenodesis (LET). It aims to provide valuable insights into two different surgical approaches aimed at enhancing knee stability. The over-the-top ACL-R technique, which involves routing the graft over the posterior aspect of the lateral femoral condyle, is known for its simplicity and ability to preserve the anatomical footprint of the ACL. Although a non-anatomical reconstruction, the OTT technique has shown comparable clinical results and good return to sports (RTS) ratios when compared to the conventional ACLR alone. It is also favored in revision surgeries or when there is difficulty accessing the femoral tunnel through conventional approaches. However, concerns regarding its ability to fully restore rotational stability persist, especially in high-demand athletes.

In contrast, the anteromedial portal technique for ACL-R, combined with LET, has gained popularity due to its effectiveness in controlling both anterior tibial translation and rotational instability. LET augments the intra-articular reconstruction by providing additional restraint against pivot shifts, which can be critical in patients with high-risk profiles for re-injury, such as those participating in pivoting sports. Comparing these two approaches in terms of clinical outcomes, graft integrity, rotational control, and return-to-sport rates with a prospectively randomized controlled trial will help clarify their roles in contemporary ACL surgery and could guide surgeons in choosing the most appropriate method based on patient-specific factors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * Presence of an isolated anterior cruciate ligament (ACL) tear (isolated ligament injury). * 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. Exclusion Criteria: * Presence of additional ligamentous injury (e.g., posterior cruciate ligament or collateral ligament) along with the ACL tear. * Incomplete clinical scores. * History of previous surgery on the same knee. * Presence or history of infection.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ankara Bilkent City Hospital Ankara Turkey (Türkiye) Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06664047 on ClinicalTrials.gov ↗ ← All trials in Turkey