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Over-the-Top vs. Anteromedial ACLR med lateral extraartikulär tenodes

27 september 2026 uppdaterad av: Enejd Veizi, MD, Ankara City Hospital Bilkent

Radiologiska och kliniska resultat av over-the-top ACL-rekonstruktion vs. Anteromedial ACL-rekonstruktion med ytterligare lateral extraartikulär tenodes: en prospektivt randomiserad kontrollerad studie

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.

Studieöversikt

Detaljerad beskrivning

Anterior cruciate ligament reconstruction (ACLR) is one of the most commonly performed procedures in orthopedic sports medicine, aimed at restoring knee stability, facilitating return to activities, and preventing secondary injuries to the cartilage and menisci. Improved understanding of knee joint anatomy and biomechanics has led to advancements in surgical techniques, and modern 'anatomic' techniques have shown favorable outcomes in most patients. However, despite technical advancements, ACL reconstruction techniques still fail to fully restore normal knee biomechanics, particularly with regard to tibial rotation, leaving some patients with residual instability. Additionally, the rate of return to high-level sports has been reported as low as 63% at two years.

Residual anterolateral subluxation, as measured by the pivot shift test, is a clinical indicator of internal rotation laxity and is associated with poor outcomes and low patient satisfaction. Such altered kinematics may contribute further to the development of osteoarthritis (OA). The inability of traditional ACLR to reliably restore normal tibial rotational kinematics could be one reason for this outcome.

Lateral extra-articular tenodesis (LET) is performed alongside ACLR to control anterolateral rotational instability in knees with ACL deficiency. Recent studies have shown that this procedure reduces the risk of ACL graft re-rupture, better restores knee joint kinematics, and improves return-to-sport rates. ACLR and LET procedures are now routinely performed in many centers.

The over-the-top (OTT) ACL reconstruction technique involves passing the graft over the superomedial edge of the lateral femoral condyle and securing it to the lateral femoral cortex. The proposed advantages of this technique include its safety, ease of use, reproducibility, low cost, and compatibility with all graft types and fixation methods. Additionally, the OTT technique can be used to reinforce ACL remnants, thus minimizing technical challenges encountered during anatomic reconstruction procedures. These challenges include difficulty visualizing the femoral placement, mismatches between tibial and femoral tunnels, reliance on clock-face systems for femoral tunnel positioning, and instrument impingement during excessive knee flexion.

Currently, there is limited literature comparing the outcomes of OTT and anatomic ACLR techniques, and no studies compare the OTT and ACLR + LET procedures.

The aim of this study is to compare the clinical and radiological outcomes, as well as return-to-sport rates, between patients undergoing the Over-the-Top ACL Reconstruction technique and those undergoing the Anteromedial ACL Reconstruction technique with Lateral Extra-Articular Tenodesis.

Studietyp

Interventionell

Inskrivning (Faktisk)

118

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 50 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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.

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.

Aktiv komparator: 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.

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Re-rupture
Tidsram: Postoperative 1.st year

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

Postoperative 1.st year
Tibial tunnel widening
Tidsram: Postoperative 1.st year

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

Postoperative 1.st year
Tegner Activity Scale
Tidsram: Postoperative 1.st year

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

Postoperative 1.st year
Knee Score ve Knee Injury & Osteoarthritis Outcome (KOOS)
Tidsram: Postoperative 1.st year

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

Postoperative 1.st year

Samarbetspartners och utredare

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Utredare

  • Huvudutredare: Enejd Veizi, MD, Ankara City Hospital Bilkent

Publikationer och användbara länkar

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 oktober 2024

Primärt slutförande (Beräknad)

1 november 2028

Avslutad studie (Beräknad)

1 november 2028

Studieregistreringsdatum

Först inskickad

27 oktober 2024

Först inskickad som uppfyllde QC-kriterierna

27 oktober 2024

Första postat (Faktisk)

29 oktober 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

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Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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