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临床试验/NCT06238934
NCT06238934尚未招募3 期

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

Instituto Nacional de Traumatologia e Ortopedia2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
90
试验地点
2
主要终点
Knee Society Score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Knee Society Score

时间窗: before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration

Visual analog scale for pain

时间窗: before infiltration, 1 month after first infiltration, three months after infiltration, six months and one year after infiltration

Western Ontario and Mcmaster (WOMAC) score

时间窗: before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration

次要结局

未报告次要终点

研究者

发起方
Instituto Nacional de Traumatologia e Ortopedia
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Eduardo Branco de Sousa

Orthopaedic surgeon

Instituto Nacional de Traumatologia e Ortopedia

研究点 (2)

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