Arthrocentesis vs Observation Study for Acute ACL Tears (ASPIRATE)
Arthrocentesis Study for Perioperative Intervention on Reducing Arthritis and Trauma-related Effects
The ASPIRATE trial is a randomized controlled trial evaluating the effects of pre- and post-operative knee joint aspiration in patients with an ACL injury. The study aims to determine if removing knee joint fluid can mitigate the increasing inflammation after surgery, reduce quadriceps atrophy, improve short-term pain, enhance functional recovery, and lower long-term rates of post-traumatic knee osteoarthritis.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
While Anterior Cruciate Ligament Reconstruction (ACLR) successfully restores joint stability, patients still face challenges regarding long-term osteoarthritis and lower rates of returning to sports. Traumatic hemarthrosis-the buildup of blood in the joint following an injury and surgery-acts as a toxic agent that triggers cartilage degeneration. Furthermore, it causes arthrogenic muscle inhibition (AMI), which leads to quadriceps muscle shrinkage and abnormal walking patterns. This cycle is often referred to as the "second-hit phenomenon". While draining fluid from the knee (arthrocentesis) before surgery is common, performing repeat drainages after surgery to remove built-up blood is experimental. This study evaluates whether this low-cost, widely available procedure can safely interrupt that destructive cycle.
The main objective of this trial is to intervene in the hemarthrosis process to prevent or reduce the incidence of AMI and cartilage breakdown through pre- and post-operative joint drainage. Secondary objectives include assessing whether the procedure leads to less quadriceps muscle shrinkage, improves short-term pain, enhances leg strength at 3 and 6 months, accelerates return-to-sport rates, and reduces joint wear at a 1-year follow-up.
Eligible participants include individuals aged 15 to 40 years who experienced their injury 30 days or less prior, have a confirmed ACL tear, and have chosen to undergo ACLR using either a quadriceps tendon or bone-patellar tendon-bone autograft. Key exclusion criteria include previous knee or ACL surgery on the same leg, a cortisone injection within the previous 3 months, major multi-ligament repairs done at the same time (such as the MCL, PCL, or PLC), advanced osteoarthritis, pregnancy, or an inability to speak English fluently.
All participants will undergo standard ACLR surgery using their own tissue graft. Clinical assessments are conducted from baseline through 1 year, tracking patient surveys on knee pain, activity levels, and psychological readiness at baseline, 1 week, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year. Physical and imaging steps include measuring thigh circumference with a tape measure at every visit, performing leg strength tests on a special machine at 3 and 6 months, and taking standing knee X-rays with a specialized framing device at the 1-year mark to evaluate joint health.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Michael Keller
- Номер телефона: 614-293-2410
- Электронная почта: michael.keller@osumc.edu
Места учебы
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Ohio
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Columbus, Ohio, Соединенные Штаты, 43230
- Рекрутинг
- Jameson Crane Sports Medicine Institute
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Контакт:
- Michael Keller
- Номер телефона: 614-293-2410
- Электронная почта: michael.keller@osumc.edu
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Главный следователь:
- Jelle van der List, MD, PhD
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Dublin, Ohio, Соединенные Штаты, 43016
- Рекрутинг
- Ohio State Outpatient Care Dublin
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Контакт:
- Michael Keller
- Номер телефона: 614-293-2410
- Электронная почта: michael.keller@osumc.edu
-
Главный следователь:
- Jelle van der List, MD, PhD
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Age 15 -40
- Time from injury to aspiration ≤30 days
- Patient with a confirmed ACL tear and have elected to have an ACL reconstruction using a quadriceps tendon (QT) or bone-patellar tendon-bone (BPTB) autograft tendon
Exclusion Criteria:
- Fear of needles or rejection of arthrocentesis
- Previous knee or ACL surgery on the affected knee
- Previous cortisone injection in the affected knee within the previous 3 months
- Concomitant procedures that involve repair or reconstruction of the medial collateral ligament (MCL), posterolateral corner (PLC) or posterior cruciate ligament reconstruction (PCL)
- Osteoarthritis Kellgren-Lawrence grade ≥3.
- Cartilage procedures beyond microfracture or chondroplasty
- Planned osteotomies or meniscus allograft transplantation (MAT)
- Muscular, vascular or neurological diseases that influence rehabilitation or surgery
- Current use of prednisone or cytostatic medication
- Obesity with a BMI ≥45
- Daily smoking
- History of illicit drug or alcohol abuse
- History of prior infection in knee
- History of chemotherapy treatment
- History of sickle cell disease
- Pregnancy during injury or surgery
- No mastery of the English language
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Aspiration
Each subject that is randomized to this arm will receive a knee aspiration both before and after ACL surgery. |
Aspiration is a minimally invasive medical procedure in which a sterile needle and syringe are inserted into the intra-articular space of the knee joint to extract excess synovial fluid that is built up around the knee space. |
|
Без вмешательства: No Aspiration
Each subject that is randomized to this arm will not receive an intervention and will only complete questionnaires. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Quadriceps peak strength
Временное ограничение: 3 months and 6 months
|
The Biodex measurement physical device will be used to measure the isokinetic strength of the quadriceps muscle. The leg is brought from flexion to extension at 60 degrees per second and 300 degrees per second and the maximum force is measured for the quadriceps. This is compared to the contralateral side and expressed in the limb symmetry index (LSI) as the percentage of strength compared to the contralateral side. This is expressed N/m |
3 months and 6 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Quadriceps atrophy
Временное ограничение: 3 and 6 Months
|
The quadriceps circumference of the affected leg is measured in centimeters at 6 and 16 centimeters above the superior pole of the patella and compared to the contralateral side. |
3 and 6 Months
|
|
Short-term Pain
Временное ограничение: 1 week, 2 weeks, 6 weeks, 3 months, 6 months and 1 year
|
The overall pain in the knee is assessed using a visual analog scale (VAS) questionnaire that is standardized, and this is compared to the preoperative baseline score. The score ranges from 0 to 10 with 0 indicating no pain and 10 indicating worst pain imaginable |
1 week, 2 weeks, 6 weeks, 3 months, 6 months and 1 year
|
|
Patient-reported outcome measures
Временное ограничение: 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
The questionnaire subjective International Knee Documentation Committee (IKDC) will be obtained. The score ranges from 0 to 100 with 100 having a normal score and 0 an abnormal score. |
1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
|
Lysholm Score
Временное ограничение: 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
The questionnaire Lysholm Score will be obtained. The score ranges from 0 to 100 with 100 having a normal score and 0 an abnormal score. |
1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
|
Forgotten Joint Score
Временное ограничение: 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
The questionnaire Forgotten Joint Score will be obtained. The score ranges from 0 to 100 with 100 having a normal score and 0 an abnormal score. |
1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
|
Tegner activity score
Временное ограничение: 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
The questionnaire Tegner activity score will be obtained. The score ranges from 0 to 100 with 100 having a normal score and 0 an abnormal score. |
1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
|
Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI)
Временное ограничение: 1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
The questionnaire Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) will be obtained. The score ranges from 0 to 100 with 100 having a normal score and 0 an abnormal score. |
1 week, 2 weeks, 6 weeks, 3 months, 6 months, 1 year
|
|
Return to Sports
Временное ограничение: 3 months, 6 months and 1 year.
|
Return to sports will be assessed using questionnaires: when they return to sports (months after surgery), if they have reached preinjury level of performance (yes/no) and whether they are fully return to previous level (yes/no). |
3 months, 6 months and 1 year.
|
|
Joint space narrowing on radiographs
Временное ограничение: 1 year
|
Osteoarthritic changes at AP and Rosenberg views at 1 year of the medial and lateral compartment compared to preoperative radiographs measured in absolute millimeters at the narrowest area of the respective compartments |
1 year
|
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Osteoarthritis grade on radiographs
Временное ограничение: 1 year
|
Osteoarthritic changes at AP and Rosenberg views at 1 year of the medial and lateral compartment compared to preoperative radiographs measured as Kellgren-Lawrence scale (scale from 0 to 4 with 0 indicating no signs of osteoarthritis and 4 indicating end-stage bone-on-bone osteoarthritis) |
1 year
|
Соавторы и исследователи
Спонсор
Следователи
- Директор по исследованиям: Jelle van der List, MD, PhD, Ohio State University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- STUDY20252711
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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