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NCT06664047

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

Recruiting now NA Last updated 31 October 2024
What this trial tests

NA trial testing OTT ACLR in Anterior Cruciate Ligament Rupture in 150 participants. Currently enrolling.

Timeline
24 October 2024
Primary endpoint
1 November 2028
1 November 2028

Quick facts

Lead sponsorAnkara City Hospital Bilkent
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment150
Start date24 October 2024
Primary completion1 November 2028
Estimated completion1 November 2028
Sites1 location across Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

Ankara City Hospital Bilkent

Who can join

Adults 18 to 50, any sex, with Anterior Cruciate Ligament Rupture or Anterior Cruciate Ligament Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Anterior Cruciate Ligament Rupture

Currently open trials in the same condition.

Other Ankara City Hospital Bilkent trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06664047.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing