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ACLR over-the-top versus anteromedial con tenodesis extraarticular lateral

27 de septiembre de 2026 actualizado por: Enejd Veizi, MD, Ankara City Hospital Bilkent

Resultados radiológicos y clínicos de la reconstrucción exagerada del LCA frente a la reconstrucción anteromedial del LCA con tenodesis extraarticular lateral adicional: un ensayo controlado prospectivamente aleatorizado

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

118

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 50 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.

Comparador activo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Re-rupture
Periodo de tiempo: Postoperative 1.st year

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

Postoperative 1.st year
Tibial tunnel widening
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: Postoperative 1.st year

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

Postoperative 1.st year

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Enejd Veizi, MD, Ankara City Hospital Bilkent

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

24 de octubre de 2024

Finalización primaria (Estimado)

1 de noviembre de 2028

Finalización del estudio (Estimado)

1 de noviembre de 2028

Fechas de registro del estudio

Enviado por primera vez

27 de octubre de 2024

Primero enviado que cumplió con los criterios de control de calidad

27 de octubre de 2024

Publicado por primera vez (Actual)

29 de octubre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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