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NCT Number: NCT06238934

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto Nacional de Traumatologia e Ortopedia

Rio de Janeiro, 20940-070, Brazil

Location contact

Eduardo B de Sousa, MD, PhD

CONTACT

[email protected]

21998913144

Phelippe Augusto V Maia, MD, MSC

SUB_INVESTIGATOR

Sandra T Minamoto, MD,MSC

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Bone marrow aspirate matrix

Biological

Bone marrow aspirate * Hyaluronic acid

Bone marrow aspirate

Biological

Bone marrow aspirate

Hyaluronic Acid

Device

Hyaluronic acid

Primary outcomes

  1. Knee Society Score

    Time frame: before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration

  2. Western Ontario and Mcmaster (WOMAC) score

    Time frame: before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration

  3. Visual analog scale for pain

    Time frame: before infiltration, 1 month after first infiltration, three months after infiltration, six months and one year after infiltration

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Traumatologia e Ortopedia

Other Gov

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Feb 2, 2024
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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