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

Phase 3

Not yet recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Biological: Bone marrow aspirate matrix; Biological: Bone marrow aspirate; Device: Hyaluronic acid

• Registration Number: NCT06238934
• Lead Sponsor: Instituto Nacional de Traumatologia e Ortopedia

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-26
• Study First Submitted QC: 2024-01-26
• Last Update Submitted: 2024-01-26
• Study First Posted: 2024-02-02
• Last Update Posted: 2024-02-02
• Study Start: 2024-03
• Primary Completion: 2025-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Bone marrow aspirate matrix	Bone marrow aspirate matrix
Group B	Bone marrow aspirate	Bone marrow aspirate
Group C	Hyaluronic acid	Hyaluronic acid

Primary Outcome Measures

Name	Time	Method
Knee Society Score	before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration
Visual analog scale for pain	before infiltration, 1 month after first infiltration, three months after infiltration, six months and one year after infiltration
Western Ontario and Mcmaster (WOMAC) score	before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration

Trial Locations

Locations (1)

Instituto Nacional de Traumatologia e Ortopedia; 🇧🇷 Rio de Janeiro, RJ, Brazil