Comparison of Bone-patellar Tendon-bone and Patellar Tendon-bone Grafts in ACL Reconstruction
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Bone-Patellar tendon-Bone, Patellar tendon-Bone.
- Кому может быть актуально
- Состояния в реестре: Anterior Cruciate Ligament (ACL) Reconstruction, Anterior Cruciate Ligament Injury. Базовые параметры: 12 лет — 40 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Comparison of Morbidity and Functional Outcomes After Anterior Cruciate Ligament Reconstruction With Bone-Tendon-Bone Graft Versus Patellar Tendon Graft Without Patellar Bone Plug in Competitive Athletes
Обзор
The purpose of this randomized study is to compare donor site morbidity and clinical and functional outcomes of both surgery techniques (bone-patellar tendon-bone (BPTB) graft versus bone-patellar tendon without patellar bone plug (PT) graft) for anterior cruciate ligament reconstruction (ACLR) in athletes. The main questions it aims to answer are: * Does PT graft reduce donor site morbidity compared to the standard BPTB graft? * Does PT technique provide clinical and functional results comparable to the BPTB technique? Researchers will compare the incidence of complications and clinical and functional outcomes between the BPTB and PT grafts groups. Patients will: * Undergo ACLR surgical intervention using one of the two assigned techniques (BPTB or PT) * Follow a two-year assessment program, including visits at three, eight, 12 and 24 months after surgery.
Подробное описание
Anterior cruciate ligament (ACL) rupture is the most prevalent type of knee ligament injury, representing approximately 50% of all reported knee injuries. This injury has a particularly high impact on most athletes due to the demands of pivoting, jumping and cutting movements required during play. In addition, its consequences include a prolonged recovery period, the risk of reinjury and complications arising from ACL insufficiency, such as knee instability, meniscal tears or osteoarthritis. Given that the primary indicator of successful treatment is the athlete's ability to return to competitive levels, surgical reconstruction of the ACL (ACLR) has become the standard treatment. However, the choice of the optimal graft for ACLR remains controversial. For many authors, bone-patellar tendon-bone (BPTB) graft is considered gold-standard option due to optimal biomechanical properties and low reinjury rate. However, BPTB is usually associated with donor site morbidity, specifically related to kneeling, dysesthesia and anterior knee pain.
Given the disadvantages of the BPTB graft, an ACLR based on a bone-patellar tendon graft may be a viable alternative. This technique utilizes an autograft composed of the central third of the patellar tendon and a tibial tubercle bone plug without inclusion of the patellar bone plug, called bone-patellar tendon (BPT). Previous studies have demonstrated lower rates of anterior knee pain in BPT compared to BPTB. However, there is a lack of evidence regarding objective and specific donor site morbidity assessment for both techniques.
The main hipothesis of this study is that BPT has similar clinical an functional recovery compared to BPTB with lower rates of anterior knee morbidity.
Вмешательства
- Процедура Bone-Patellar tendon-Bone
After an arthroscopic examination via an anterolateral viewing portal to confirm the ACL injury, two additional portals will be established: an accessory medial portal slightly above the joint line (approximately 2cm from the medial border of the patellar tendon) and a high anteromedial portal. Once associated lesions are addressed, the graft is harvested through a 6cm longitudinal midline incision. Following paratenon dissection, the patellar tendon dimensions are measured: * Minimum length: - Процедура Patellar tendon-Bone
After an arthroscopic examination via an anterolateral viewing portal to confirm the ACL injury, two additional portals will be established: an accessory medial portal slightly above the joint line (approximately 2cm from the medial border of the patellar tendon) and a high anteromedial portal. Once associated lesions are addressed, the graft is harvested through a 6cm longitudinal midline incision. Following paratenon dissection, the patellar tendon dimensions are measured: * Minimum length:
Первичные конечные точки
- Donor Site Morbidity [Срок оценки: At 3, 8, 12 and 24 months after surgery]
Вторичные конечные точки (12)
- Function and activity level [Срок оценки: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery]
- Subjective knee status [Срок оценки: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery]
- Psychological readiness [Срок оценки: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery]
- Joint Awareness [Срок оценки: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery]
- Patient-reported symptoms [Срок оценки: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery]
- Quadriceps strength [Срок оценки: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery]
- Hamstrings strength [Срок оценки: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery]
- Hamstring/Quadriceps ratio [Срок оценки: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery]
- Functional Hop Test Battery [Срок оценки: Baseline (Pre-intervention) and 8, 12 and 24 months after surgery]
- Donor-site pain pressure threshold [Срок оценки: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery]
- Quadriceps thickness [Срок оценки: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery]
- Patellar tendon morphology [Срок оценки: Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery]
Критерии участия
Критерии включения
- Time for injury to surgery of less than six months.
- Active athletes (federated or recreational)
- Patellar tendon length > 42mm measured by MRI.
- Age between 12 and 40 years old
- Genders eligible for Study: both
Критерии исключения
- Previous surgery or history of ligamentous knee injuries.
- Concomitant knee ligament injury
- Major meniscal injury (more than 50% of the lateral or medial meniscus)
- Chondral injury greater than Outerbridge Grade I-II
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
Испания · 1 центр
- Health Sciences Faculty, University of Granada — Granada
Идентификаторы
NCT: NCT07475351 · P36/24/01