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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06238934
• Other study ID #: 74952423.1.0000.5273
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 2024
• Est. completion date: March 2027

Study information

• Verified date: January 2024
• Source: Instituto Nacional de Traumatologia e Ortopedia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: March 2027
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Bone marrow aspirate matrix
Bone marrow aspirate * Hyaluronic acid
• Bone marrow aspirate
Bone marrow aspirate

Device:
• Hyaluronic acid
Hyaluronic acid

Locations

Country	Name	City	State
Brazil	Instituto Nacional de Traumatologia e Ortopedia	Rio de Janeiro	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Traumatologia e Ortopedia

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knee Society Score		before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration
Primary	Western Ontario and Mcmaster (WOMAC) score		before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration
Primary	Visual analog scale for pain		before infiltration, 1 month after first infiltration, three months after infiltration, six months and one year after infiltration