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

NCT06238934 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: 74952423.1.0000.5273
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

osteoarthritis; knee; hyaluronic acid; bone marrow aspirate; bone marrow aspirate matrix

Outcome Measures

Primary Outcomes (3)

• Knee Society Score

  before infiltration, 1 month after first infiltration, three months, 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

• Visual analog scale for pain

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

Study Arms (3)

Group A

EXPERIMENTAL

Bone marrow aspirate matrix

Biological: Bone marrow aspirate matrix

Group B

ACTIVE COMPARATOR

Bone marrow aspirate

Biological: Bone marrow aspirate

Group C

ACTIVE COMPARATOR

Hyaluronic acid

Device: Hyaluronic acid

Interventions

Bone marrow aspirate matrix BIOLOGICAL

Bone marrow aspirate \* Hyaluronic acid

Group A

Bone marrow aspirate BIOLOGICAL

Bone marrow aspirate

Group B

Hyaluronic acid DEVICE

Hyaluronic acid

Group C

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Instituto Nacional de Traumatologia e Ortopedia: lead

Study Sites (1)

Instituto Nacional de Traumatologia e Ortopedia

Rio de Janeiro, Rio de Janeiro, 20940-070, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic surgeon

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 2, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)