NCT06664047 Over-the-Top vs. Anteromedial ACLR With Lateral Extraarticular Tenodesis
| NCT ID | NCT06664047 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ankara City Hospital Bilkent |
| Condition | Anterior Cruciate Ligament Rupture |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-10-24 |
| Primary Completion | 2028-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-10-24 with a primary completion date of 2028-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Enejd Veizi, MD
PRINCIPAL INVESTIGATOR
Ankara City Hospital Bilkent
Frequently Asked Questions
Who can join the NCT06664047 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Anterior Cruciate Ligament Rupture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06664047 currently recruiting?
Yes, NCT06664047 is actively recruiting participants. Contact the research team at dr.nad89@hotmail.com for enrollment information.
Where is the NCT06664047 trial being conducted?
This trial is being conducted at Ankara, Turkey (Türkiye).
Who is sponsoring the NCT06664047 clinical trial?
NCT06664047 is sponsored by Ankara City Hospital Bilkent. The principal investigator is Enejd Veizi, MD at Ankara City Hospital Bilkent. The trial plans to enroll 150 participants.