Are Clinical Outcomes Unchanged by ALL Fixation at 0° or 30° of Knee Flexion in Combined ACL-ALL Reconstruction? Despite Numerous Technical Descriptions of Anterolateral Procedures, There is Limited Knowledge Regarding the Effect of Knee Flexion Angle During Graft Fixation.

Официальное название

Are Clinical Outcomes Unchanged by ALL Fixation at 0° or 30° of Knee Flexion in Combined ACL-ALL Reconstruction?

Обзор

This study evaluates whether the knee flexion angle used during fixation of the anterolateral ligament (ALL) affects clinical outcomes in patients undergoing combined anterior cruciate ligament (ACL) and ALL reconstruction. Combined ACL and ALL reconstruction is increasingly used to improve rotational knee stability and reduce the risk of graft failure after ACL injury. However, the optimal knee position for fixing the ALL graft during surgery remains unclear. In this study, patients were treated with ALL fixation performed either in full knee extension (0 degrees) or at 30 degrees of knee flexion. Clinical outcomes, knee stability, patient-reported function, and graft failure rates were compared between the two groups at a minimum follow-up of two years. Outcomes were assessed using validated questionnaires, clinical examinations, and objective measurements of knee stability. The study aims to determine whether the knee flexion angle at the time of ALL fixation influences postoperative function, stability, or complication rates, and to provide clinical evidence to guide surgical technique in combined ACL and ALL reconstruction.

Вмешательства

• Процедура anterolateral ligament reconstruction
  The intervention consists of a standardized combined anterior cruciate ligament (ACL) and anterolateral ligament (ALL) reconstruction performed using anatomical single-bundle ACL reconstruction and anatomical ALL reconstruction. The surgical technique, graft selection, tunnel placement, fixation devices, and postoperative rehabilitation protocol are identical in both study arms. The only variable distinguishing the interventions is the knee flexion angle at the time of femoral fixation of the A

Первичные конечные точки

• graft rerupture rate [Срок оценки: 24 months]

Вторичные конечные точки (4)

• anterior knee laxity [Срок оценки: 24 months]
• pivot shift test [Срок оценки: 24 months]
• kinesiophobia [Срок оценки: 24 months]
• subjective knee function [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Patients with a unilateral anterior cruciate ligament (ACL) rupture confirmed by clinical examination and magnetic resonance imaging (MRI)
• Persistent knee instability despite conservative treatment
• Ability to understand the study procedures and provide written informed consent
• Willingness to comply with the postoperative rehabilitation protocol and follow-up schedule

Критерии исключения

• Previous ACL reconstruction or revision surgery on the affected knee
• Bilateral ACL injuries
• Concomitant knee osteoarthritis greater than Kellgren-Lawrence grade 1
• Concomitant ligament injuries requiring additional surgical procedures (except meniscal treatment)
• History of neurological, vestibular, or visual disorders affecting balance or gait
• Inflammatory joint disease or systemic musculoskeletal disorders
• Incomplete baseline clinical data
• Inability to complete patient-reported outcome questionnaires or attend follow-up visits

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Kelly SR, Cutter BM, Huish EG Jr. Biomechanical Effects of Combined Anterior Cruciate Ligament Reconstruction and Anterolateral Ligament Reconstruction: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2021 Jun 24;9(6):23259671211009879. doi: 10.1177/23259671211009879. eCollection 2021 Jun. PMID 34250171
• Ariel de Lima D, de Lima LL, de Souza NGR, de Moraes Perez RA, Sobrado MF, Guimaraes TM, Helito CP. Clinical outcomes of combined anterior cruciate ligament and anterolateral ligament reconstruction: a systematic review and meta-analysis. Knee Surg Relat Res. 2021 Sep 23;33(1):33. doi: 10.1186/s43019-021-00115-1. PMID 34556187

Идентификаторы

NCT: NCT07451743 · Jacopo Conteduca

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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