Идёт набор NCT05985785

Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection

Без фазы С лечением Osteoarthritis of the Knee

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: Autologous bone marrow aspirate concentrate (BMAC), Corticosteroid injections, Crossover Autologous bone marrow aspirate concentrate (BMAC).
Кому может быть актуально: Состояния в реестре: Osteoarthritis of the Knee. Базовые параметры: 18 лет — 70 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: США
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

Bone Marrow Aspirate Concentrate vs Corticosteroid Injection for Symptomatic Osteoarthritis (OA) of the Knee: A Randomized Controlled Trial

Обзор

Prospective single-masked (study participant will be masked), randomized controlled trial to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis.

Подробное описание

The purpose of this study is to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis and compare that to patients receiving corticosteroid injections with six-month follow-up.

All patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms. This study will aim to recruit and enroll a total of 100 patients (50 per group). Treatment arms include BMAC injections (ARM1) and corticosteroid injections (ARM 2). Patients in the corticosteroid injection group (ARM 2) will receive a sham incision. Follow-up will be up to six months (12-months if crossover (ARM 3)).

Вмешательства

Другое Autologous bone marrow aspirate concentrate (BMAC)
Bone marrow aspirate concentrate BMAC is a biologically substance harvested from a patient for autologous use. Bone marrow aspirate concentrate (BMAC) has been determined by the FDA to be a minimally manipulated biologic prepared for autologous use and does not require premarket FDA approval for clinical use.
Препарат Corticosteroid injections
Current standard of treatment for OA of the knee is corticosteroid injection.
Другое Crossover Autologous bone marrow aspirate concentrate (BMAC)
Subjects who participate in this study and who are randomized to receive the BMAC may experience decreased pain and increased functionality after the injection compared to those that receive a corticosteroid injection. As such, participants who continue to have pain after a corticosteroid injection will be allowed to crossover to a BMAC injection at 24 weeks or 6 months post-surgery.(ARM 3)

Первичные конечные точки

Visual analogue scale (VAS) for pain [Срок оценки: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)]
Intermittent and Constant Osteoarthritis Pain (ICOAP) [Срок оценки: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)]
Knee Injury and Osteoarthritis Outcome Score (KOOS) [Срок оценки: Enrollment up to 6 months postoperatively (12 months if crossover from ARM 3 to ARM 1)]

Критерии участия

Критерии включения

Patients between the ages of 18-70
Long standing knee pain from osteoarthritis (KL grade 2-3) despite conventional treatments such as activity modification, weight loss, physical therapy, analgesics, nonsteroidal anti-inflammatory drugs, or injection therapy for at least 6 weeks
7-day average pain score of at least 4 on VAS scale