Anterior Cruciate Ligament (ACL) Reconstruction With Bone Tendon Bone Autograft With Versus Without Internal Bracing

Официальное название

ACL Reconstruction With Bone Tendon Bone (BTB) Autograft With Versus Without Internal Brace - Clinical and Radiographic Outcomes

Обзор

There is no consensus regarding the best surgical management of primary ACL tears. Recent evidence suggests that internal brace augmentation may increase load failure and therefore stabilize the graft in-situ at the time of ACL reconstruction. This prospective randomized controlled trial aims to compare the time to return to activity, and participant reported outcomes in participants with bone-tendon-bone ACL reconstruction with and without (control) internal brace augmentation.

Подробное описание

Despite the wide variety of surgical approaches and grafts that can be used in an ACL reconstruction, graft failure and recurrent knee instability are nevertheless ubiquitous issues that have facilitated interest in ways to strengthen the graft at the time of surgery. While both animal and biomechanical models have strongly suggested improved graft strength and patient outcomes by utilizing suture tape augmentation in ACL reconstructions, there is scant clinical literature available to assess these extrapolations. A retrospective cohort study of 60 patients undergoing ACL reconstruction with a hamstring autograft or allograft (30 suture tape vs 30 no suture tape; mean age: 30), found shorter time to return to activity (9.2 months suture tape group vs 12.9 months no suture tape group; p=0.002), lower Western Ontario and McMaster University Osteoarthritis Indices (WOMAC) (2.2 suture tape group vs 6.2 no suture tape group; p=0.024), higher international knee documentation committee (IKDC) scores (87.6 suture tape group vs 73.2 no suture tape group; p=0.006), lower average pain on the national pain rating scale (NPRS) (0.6 suture tape group vs 1.66 no suture tape group; p=0.021) and no significant difference in range of motion in degrees (129 suture tape group vs 127 no suture tape group; p=0.46), knee injury and osteoarthritis outcome score (KOOS) (92.2 suture tape group vs 87.1 no suture tape group; p=0.68), or complications (13% suture tape vs 10% no suture tape; p\>0.05) at 2 years follow up. A retrospective cohort study of 108 patients undergoing ACL reconstruction with a hamstring autograft with and without suture tape reinforcement (36 suture tape vs 72 no suture tape; mean age: 25), found a significantly higher Tegner activity score (7.1 suture tape group vs 6.4 no suture tape group; p=0.026) but otherwise no significant difference in time to preinjury activity level (11.9 mos suture tape group vs 11.6 no suture tape group; p=0.59), range of motion (degrees) (136 suture tape group vs 137 no suture tape group; p=0.44) , Lysholm knee score (95.6 suture tape group vs 94 no suture tape group; p=0.165), IKDC score (94.4 suture tape group vs 93.8 no suture tape group; p=0.44), or complications (6% suture tape group vs 5% no suture tape group; p\>0.05) at 2 years follow up. A prospective cohort study of 50 ACL reconstructions with hamstring autograft with and without suture tape reinforcement (25 suture tape group vs 25 no suture tape group; mean age: 30), found a significant improvement in greater than 2 grades of Lachman testing from preoperative assessment compared to 6 months follow-up (68% suture tape group vs 32% no suture tape group; p=0.039) but no difference in Lysholm knee score at 6 months (87.0 suture tape group vs 87.0 no suture tape group; p=0.756). Moreover, none of the already-limited clinical data investigates the use of internal braces with bone-tendon-bone grafts, which are a popular choice for young adults and athletes. Furthermore, there are no current level 1 data on this subject. Therefore, this study aims to compare the time to return to pre- injury activity level, incidence of recurrent knee instability, and patient reported outcomes of patients treated with ACL reconstruction using bone-tendon-bone autograft with and without (control group) internal brace stabilization.

Вмешательства

• Процедура ACL reconstruction with BTB autograft with internal brace augmentation (suture tape)
  The ACL will be reconstructed using a participant's own patella tendon (BTB autograft), and the graft will be fortified by suture tape during the surgery in order to strengthen it.
• Процедура ACL reconstruction with BTB autograft without internal brace augmentation (suture tape)
  The ACL will be reconstructed using a participant's own patella tendon (BTB autograft). The graft will not be fortified by suture tape in this group. It will be used as is without any modification.
• Другое Standardized Rehabilitation Protocol
  Participants will undergo a standardized rehabilitation protocol with twice weekly physical therapy

Первичные конечные точки

• Time to Return to Full Activity or Sports [Срок оценки: Measured once per participant, depending on the time required to return to full activity (up to 10 years)]
• Percentage of Participants with Recurrent Knee Instability [Срок оценки: 2 weeks, 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years]
• Change in Patient Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) Computer Adaptive Test (CAT) at 2 weeks [Срок оценки: Baseline and 2 weeks]
• Change in PROMIS PF CAT at 6 weeks [Срок оценки: Baseline and 6 weeks]
• Change in PROMIS PF CAT at 3 months [Срок оценки: Baseline and 3 months]
• Change in PROMIS PF CAT at 6 months [Срок оценки: Baseline and 6 months]
• Change in PROMIS PF CAT at 1 year [Срок оценки: Baseline and 1 year]
• Change in PROMIS PF CAT at 2 years [Срок оценки: Baseline and 2 years]
• Change in PROMIS PF CAT at 5 years [Срок оценки: Baseline and 5 years]
• Change in PROMIS PF CAT at 10 years [Срок оценки: Baseline and 10 years]

Вторичные конечные точки (12)

• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 weeks [Срок оценки: Baseline and 2 weeks]
• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 weeks [Срок оценки: Baseline and 6 weeks]
• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 3 months [Срок оценки: Baseline and 3 months]
• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 6 months [Срок оценки: Baseline and 6 months]
• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 1 year [Срок оценки: Baseline and 1 year]
• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 2 years [Срок оценки: Baseline and 2 years]
• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 5 years [Срок оценки: Baseline and 5 years]
• Change in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Score at 10 years [Срок оценки: Baseline and 10 years]
• Change in International Knee Documentation Committee (IKDC) Score at 2 weeks [Срок оценки: Baseline and 2 weeks]
• Change in International Knee Documentation Committee (IKDC) Score at 6 weeks [Срок оценки: Baseline and 6 weeks]
• Change in International Knee Documentation Committee (IKDC) Score at 3 months [Срок оценки: Baseline and 3 months]
• Change in International Knee Documentation Committee (IKDC) Score at 6 months [Срок оценки: Baseline and 6 months]

Критерии участия

Критерии включения

• patients 12 and older
• patients seen by the Columbia University Sports Medicine Service
• patients diagnosed with a first time ACL injury by clinical exam and MRI

Критерии исключения

• previous knee surgery
• concurrent knee fracture or ligamentous injury on ipsilateral knee
• neuromuscular disorder involving lower limb
• inability/ unwillingness to adhere to protocol
• anesthesia contraindications
• lost to follow up

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Columbia University Irving Medical Center — New York

Публикации

• Mall NA, Chalmers PN, Moric M, Tanaka MJ, Cole BJ, Bach BR Jr, Paletta GA Jr. Incidence and trends of anterior cruciate ligament reconstruction in the United States. Am J Sports Med. 2014 Oct;42(10):2363-70. doi: 10.1177/0363546514542796. Epub 2014 Aug 1. PMID 25086064
• Cohen SB, Yucha DT, Ciccotti MC, Goldstein DT, Ciccotti MA, Ciccotti MG. Factors affecting patient selection of graft type in anterior cruciate ligament reconstruction. Arthroscopy. 2009 Sep;25(9):1006-10. doi: 10.1016/j.arthro.2009.02.010. PMID 19732639
• Spindler KP, Wright RW. Clinical practice. Anterior cruciate ligament tear. N Engl J Med. 2008 Nov 13;359(20):2135-42. doi: 10.1056/NEJMcp0804745. No abstract available. PMID 19005197
• Engebretsen L, Benum P, Fasting O, Molster A, Strand T. A prospective, randomized study of three surgical techniques for treatment of acute ruptures of the anterior cruciate ligament. Am J Sports Med. 1990 Nov-Dec;18(6):585-90. doi: 10.1177/036354659001800605. PMID 2285086
• Bowman EN, Limpisvasti O, Cole BJ, ElAttrache NS. Anterior Cruciate Ligament Reconstruction Graft Preference Most Dependent on Patient Age: A Survey of United States Surgeons. Arthroscopy. 2021 May;37(5):1559-1566. doi: 10.1016/j.arthro.2021.01.042. Epub 2021 Feb 1. PMID 33539983
• Bodendorfer BM, Michaelson EM, Shu HT, Apseloff NA, Spratt JD, Nolton EC, Argintar EH. Suture Augmented Versus Standard Anterior Cruciate Ligament Reconstruction: A Matched Comparative Analysis. Arthroscopy. 2019 Jul;35(7):2114-2122. doi: 10.1016/j.arthro.2019.01.054. Epub 2019 Jun 2. PMID 31167738
• Parkes CW, Leland DP, Levy BA, Stuart MJ, Camp CL, Saris DBF, Krych AJ. Hamstring Autograft Anterior Cruciate Ligament Reconstruction Using an All-Inside Technique With and Without Independent Suture Tape Reinforcement. Arthroscopy. 2021 Feb;37(2):609-616. doi: 10.1016/j.arthro.2020.09.002. Epub 2020 Nov 2. PMID 33144236
• Batty LM, Norsworthy CJ, Lash NJ, Wasiak J, Richmond AK, Feller JA. Synthetic devices for reconstructive surgery of the cruciate ligaments: a systematic review. Arthroscopy. 2015 May;31(5):957-68. doi: 10.1016/j.arthro.2014.11.032. Epub 2015 Jan 22. PMID 25620500

Идентификаторы

NCT: NCT05532189 · AAAU0966

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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