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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorAnkara City Hospital Bilkent

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • OTT ACLR

    Procedure/Surgery

    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

    Procedure/Surgery

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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: OTT ACLRActive comparator 1 intervention
Group B: ACLR LETActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Re-rupture

Re-rupture prevalence detected on MRI (yes/no)

Time frame
Postoperative 1.st year
2

Tibial tunnel widening

Tibial tunnel diameter measured at the widest point on axial CT scans (number, mm)

Time frame
Postoperative 1.st year
3

Tegner Activity Scale

minimum value:0, maximum value 10, higher values mean better outcome

Time frame
Postoperative 1.st year
4

Knee Score ve Knee Injury & Osteoarthritis Outcome (KOOS)

minimum value:0, maximum value 100, higher values mean better outcome

Time frame
Postoperative 1.st year

Secondary outcomes

Other outcomes

Sponsors and contacts

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