Treatment of Knee Osteoarthritis With Bone Marrow Aspirate Matrix: Prospective, Randomized Trial

Обзор

Knee osteoarthritis (KOA) first manifests itself as a molecular derangement followed by anatomical and/or physiological changes. Conservative treatment of osteoarthritis should be the first approach to patients with this disease. The interest in biological therapies, including viscosupplementation and cell therapy, involves the recent update in knowledge about the pathophysiology of OA and its natural history. The aim of the present study is to compare the clinical results of intra-articular hyaluronic acid infiltration (IHA), bone marrow aspirate (BMA) and BMA matrix in the treatment of knee osteoarthritis. The sample will consist of 90 patients with osteoarthritis of the knee followed up at the INTO, who will be divided into three groups: group A, treatment with BMA; group B, treatment with IHA ; and group C, treatment with BMA matrix. Patients will be submitted to clinical, subjective functional and radiographic evaluation by an observer independent of the one who applied the selected treatment, at moments before application and 3 months, 6 months and 12 months after application. We believe that treatment with BMA and the BMA matrix have a better effect in improving symptoms and for a longer period of time than treatment with hyaluronic acid.

Вмешательства

• Биопрепарат Bone marrow aspirate matrix
  Bone marrow aspirate \* Hyaluronic acid
• Биопрепарат Bone marrow aspirate
  Bone marrow aspirate
• Устройство Hyaluronic acid
  Hyaluronic acid

Первичные конечные точки

• Knee Society Score [Срок оценки: before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration]
• Western Ontario and Mcmaster (WOMAC) score [Срок оценки: before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration]
• Visual analog scale for pain [Срок оценки: before infiltration, 1 month after first infiltration, three months after infiltration, six months and one year after infiltration]

Критерии участия

Критерии включения

Bilateral knee OA according to the American College of Rheumatology criteria Kellgren-Lawrence ≤ III in both knees Full range of movement (0 a 120°).

Критерии исключения

1\) history of trauma, infection or previous surgery in the affected limb two years before procedure (2)limb malalignment: varus> 10° or valgus >15° (3) corticosteroids 3 months before the procedure (4) viscosupplementation 12 months before procedure (5) inflammatory, rheumatological or autoimmune disease (6) body mass index >35 kg/m2 (7) use of immunosuppresors or anticoagulants (8) active tumor (9) haematological disorder (10) Hip OA > Tonnis grade 3 (11) history of transmissible disease (12) patients unable for positioning for the procedure (13) patients living outside Rio de Janeiro metropolitan area

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

Бразилия · 1 центр

• Instituto Nacional de Traumatologia e Ortopedia — Rio de Janeiro

Идентификаторы

NCT: NCT06238934 · 74952423.1.0000.5273

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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