Clinical trial NCT06238934: Treatment of Knee Osteoarthritis With Bone Marrow Aspirate Matrix: Prospective, Randomized Trial
Official title: Treatment of Knee Osteoarthritis With Bone Marrow Aspirate Matrix: Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Knee Osteoarthritis
Keywords: osteoarthritis
knee
hyaluronic acid
bone marrow aspirate
bone marrow aspirate matrix
Lead sponsor: Instituto Nacional de Traumatologia e Ortopedia
Sponsor class: OTHER_GOV
First posted: 2024-02-02
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Knee Society Score
timeFrame: before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration
measure: Western Ontario and Mcmaster (WOMAC) score
timeFrame: before infiltration, 1 month after first infiltration, three months, six months and one year after infiltration
measure: Visual analog scale for pain
timeFrame: before infiltration, 1 month after first infiltration, three months after infiltration, six months and one year after infiltration
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Traumatologia e Ortopedia
state: RJ
Study officials:
References: