Comparison of Clinical Outcomes Between All-Inside and Complete Tibial Tunnel Techniques in Anterior Cruciate Ligament Reconstruction Among Patients With ACL Ruptures

Обзор

This study aims to compare the functional outcomes of patients with ACL rupture following ACL reconstruction surgery using hamstring grafts, between the all-inside technique and the complete tibial tunnel technique. The hamstring graft, which serves as the tissue substitute for the damaged ACL, is harvested from the posterior thigh of the patient and used to replace the torn ligament during reconstruction

Подробное описание

This Study was conducted usingdouble blind randomized controlled trial (RCT), patients who agree to participate in the study will be randomized to undergo ACL reconstruction using either the All-inside technique or the complete tibial tunnel technique. Clinical outcomes, including tibial translation, pain severity, IKDC score, and Tegner score, will be evaluated through anamnesis and physical examination at the outpatient orthopedic clinic at 3, 6, 9, and 12 months postoperatively.

Вмешательства

• Процедура All-Inside Techniques
  All-inside ACL reconstruction technique avoids creating full-length bone tunnels. Instead, it uses retrograde drilling to form bone sockets, and the graft is secured with adjustable-loop suspensory fixation on both the femur and tibia.
• Процедура Complete Tibial Tunnel techniques
  Complete Tibial Tunnel Technique is a conventional technique for ACL reconstruction which involves the creation of full-length bone tunnels in the tibia for graft passage via an anterograde approach. Graft fixation is typically achieved using a bio-interference screw on the tibial side and a fixed-loop suspensory device on the femoral side

Первичные конечные точки

• Tibial Translation [Срок оценки: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery]
• Pain scale using Visual Analogue Scales [Срок оценки: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery]
• International Knee Documentation Comittee (IKDC) Score [Срок оценки: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery]
• Tegner-Lysholm Score Knee Scoring Scale [Срок оценки: Before surgery, 3rd month, 6th month, 9th month, and 12 month after surgery]
• Hamstring Graft Diameter [Срок оценки: Intra-operative]

Критерии участия

Критерии включения

• Patients with anterior cruciate ligament rupture
• Patients within the age range of 18 to 65 years

Критерии исключения

• Patients with Multiple Ligament Injuries in the Knee Joint
• Patients with a pregnancy condition
• Patients with Severe Osteochondral Defect (ICRS 4)
• Patients with signs of inflamation in knee joint

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

Индонезия · 2 центра

• Indonesian University Hospital — Depok
• Cipto Mangunkusumo Hospital — Jakarta Pusat

Публикации

• Kouloumentas P, Kavroudakis E, Charalampidis E, Kavroudakis D, Triantafyllopoulos GK. Superior knee flexor strength at 2 years with all-inside short-graft anterior cruciate ligament reconstruction vs a conventional hamstring technique. Knee Surg Sports Traumatol Arthrosc. 2019 Nov;27(11):3592-3598. doi: 10.1007/s00167-019-05456-9. Epub 2019 Mar 19. PMID 30888448
• Rahardja R, Zhu M, Love H, Clatworthy MG, Monk AP, Young SW. Effect of Graft Choice on Revision and Contralateral Anterior Cruciate Ligament Reconstruction: Results From the New Zealand ACL Registry. Am J Sports Med. 2020 Jan;48(1):63-69. doi: 10.1177/0363546519885148. Epub 2019 Nov 15. PMID 31730379
• Samitier G, Vinagre G. Hamstring Braid Graft Technique for Anterior Cruciate Ligament Reconstruction. Arthrosc Tech. 2019 Jul 19;8(8):e815-e820. doi: 10.1016/j.eats.2019.03.022. eCollection 2019 Aug. PMID 31696044
• Kennedy JC, Weinberg HW, Wilson AS. The anatomy and function of the anterior cruciate ligament. As determined by clinical and morphological studies. J Bone Joint Surg Am. 1974 Mar;56(2):223-35. No abstract available. PMID 4452683
• Girgis FG, Marshall JL, Monajem A. The cruciate ligaments of the knee joint. Anatomical, functional and experimental analysis. Clin Orthop Relat Res. 1975 Jan-Feb;(106):216-31. doi: 10.1097/00003086-197501000-00033. PMID 1126079
• Tan JL, Chang PC, Mitra AK, Tay BK. Anthropometry of anterior cruciate ligament in Singaporean Chinese. Ann Acad Med Singap. 1998 Nov;27(6):776-9. PMID 10101548
• Pontoh LA, Rahyussalim AJ, Widodo W, Fiolin J, Rhatomy S. Anthropometric study as a predictor of anterior cruciate ligament sizes in Asian Indonesian population. J Orthop Surg (Hong Kong). 2021 Jan-Apr;29(1):23094990211000462. doi: 10.1177/23094990211000462. PMID 33745362
• Brown JA, Brophy RH, Franco J, Marquand A, Solomon TC, Watanabe D, Mandelbaum BR. Avoiding allograft length mismatch during anterior cruciate ligament reconstruction: patient height as an indicator of appropriate graft length. Am J Sports Med. 2007 Jun;35(6):986-9. doi: 10.1177/0363546506298584. Epub 2007 Mar 2. PMID 17337725

Идентификаторы

NCT: NCT07023653 · 24-07-0995

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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