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Over-the-Top vs. Anteromedial ACLR med lateral ekstraartikulær tenodese

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

Radiologiske og kliniske resultater av over-the-top ACL-rekonstruksjon vs. Anteromedial ACL-rekonstruksjon med ytterligere lateral ekstraartikulær tenodese: en prospektivt randomisert kontrollert prøvelse

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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

118

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 50 år (Voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Re-rupture
Tidsramme: Postoperative 1.st year

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

Postoperative 1.st year
Tibial tunnel widening
Tidsramme: 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
Tidsramme: 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)
Tidsramme: Postoperative 1.st year

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

Postoperative 1.st year

Samarbeidspartnere og etterforskere

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Etterforskere

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

Publikasjoner og nyttige lenker

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. oktober 2024

Primær fullføring (Antatt)

1. november 2028

Studiet fullført (Antatt)

1. november 2028

Datoer for studieregistrering

Først innsendt

27. oktober 2024

Først innsendt som oppfylte QC-kriteriene

27. oktober 2024

Først lagt ut (Faktiske)

29. oktober 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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