Knee Osteoarthritis
Conditions
Keywords
osteoarthritis, knee, hyaluronic acid, bone marrow aspirate, bone marrow aspirate matrix
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.
Interventions
BIOLOGICALBone marrow aspirate matrix
Bone marrow aspirate \* Hyaluronic acid
BIOLOGICALBone marrow aspirate
Bone marrow aspirate
DEVICEHyaluronic acid
Hyaluronic acid
Sponsors
Instituto Nacional de Traumatologia e Ortopedia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed