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NOT YET RECRUITING
NCT06238934
PHASE3

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

Sponsor: Instituto Nacional de Traumatologia e Ortopedia

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

40 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-03

Completion Date

2027-03

Last Updated

2024-02-02

Healthy Volunteers

No

Interventions

BIOLOGICAL

Bone marrow aspirate matrix

Bone marrow aspirate \* Hyaluronic acid

BIOLOGICAL

Bone marrow aspirate

Bone marrow aspirate

DEVICE

Hyaluronic acid

Hyaluronic acid

Locations (1)

Instituto Nacional de Traumatologia e Ortopedia

Rio de Janeiro, Rio de Janeiro, Brazil