Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction

Официальное название

MRI-based Graft Maturity After Blood Flow Restriction Training in Bone-patellar Tendon-bone Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Study

Обзор

Rationale Graft maturity is correlated with strength and biomechanical properties of the reconstructed ACL. There are concerns that heavy-load resistance training (HLRT) may have detrimental effects on ACL graft maturation. Therefore, low-load blood flow restriction training (LL-BFRT) has been suggested as an alternative to HLRT. As LL-BFRT is an increasingly popular method for the rehabilitation after an ACL reconstruction, it is important to evaluate the value of this treatment. Objectives The main objective is to evaluate the effect of LL-BFRT on MRI-based graft maturity after ACL reconstruction compared to HLRT. The secondary objectives are the effect of LL-BFRT on donor-site morbidity, range of motion, knee stability, patient reported outcome measurements, muscle strength, safe return to pre-injury level of sport and patient satisfaction. Furthermore, feasibility and safety of rehabilitation will be assessed. Study design Randomized controlled trial . Study population Patients who will undergo primary bone-patellar tendon-bone ACL reconstruction and rehabilitation at Knie-Heup centrum Plus will be assessed for eligibility. The exclusion criteria are: venous thromboembolism, sickle cell anemia, severe hypertension, contra-indication for accelerated rehabilitation, contra-indication for MRI scan or patients who are not willing/able to participate. Intervention LL-BFRT includes 12 weeks of biweekly strength training and starts two weeks after surgery. Comparison HLRT includes 12 weeks of biweekly strength training and starts two weeks after surgery. Main study endpoints The main endpoints are MRI-based graft maturity defined as signal-to-noise quotient three and nine months after surgery.

Вмешательства

• Поведенческое Blood flow restriction training
  BFR will be achieved using an automatic personalized tourniquet system (MAD-UP, Angers, France) designed to automatically calculate limb occlusion pressure
• Поведенческое Resistance training
  Resistance training will be performed without any blood flow restriction

Первичные конечные точки

• Graft Maturity [Срок оценки: 3 and 9 months after surgery]

Вторичные конечные точки (9)

• Range of motion [Срок оценки: 3 and 9 months after surgery]
• Knee stability [Срок оценки: 3 and 9 months after surgery]
• Anterior knee pain [Срок оценки: 3 and 9 months after surgery]
• Knee pain and function [Срок оценки: 3 and 9 months after surgery]
• Knee function [Срок оценки: 3 and 9 months after surgery]
• patient confidence [Срок оценки: 3 and 9 months after surgery]
• hamstring strength [Срок оценки: 3 and 9 months after surgery]
• isokinetic quadriceps strength [Срок оценки: 3 and 9 months after surgery]
• Return to pre-injury level of sport [Срок оценки: 9 months after surgery]

Критерии участия

Критерии включения

• Patients (18-64 years) who will undergo primary BPTB reconstruction at Zuyderland Medical Center and rehabilitation at Knie-Heup centrum Plus.

Критерии исключения

• venous thromboembolism, sickle cell anemia, severe hypertension, contra-indication for accelerated rehabilitation, contra-indication for MRI scan or not willing/able to participate.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Zuyderland Medical Center — Sittard

Идентификаторы

NCT: NCT05972876 · NL83376.096.22

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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