Evaluation of Effectiveness of Combined Intra-articular and Intra-osseus Injection VS a Single Intra-articular Injection of Bone Marrow Concentrate for the Treatment of Osteoarthritis in the Knee. (INTERFACE) Double Blind, Randomized Clinical Trial

INTERFACE

Osteoarthritis (OA) is one of the most common diseases resulting in large burdens on society. Among the emerging treatments, Bone Marrow Concentrate (BMC) intra-articular injections are a promising regenerative approach. However, they offer only a temporary benefit since they target synovial and chondral tissues but fail to address the osteochondral interface, which plays a key role in the onset and progression of joint degeneration. This project will investigate the efficacy of combined BMC injections, targeting both intra-articular tissues and subchondral bone, to treat OA in a Randomized Controlled Trial (RCT).

2019-11-08

2023-03-01

2023-03-01

Completed

Early phase I

86

Inclusion Criteria: 1. Male or female patients, aged between 40 and 70; 2. Arthrosis of the medial compartment (grade 2-3 according to the Kellgren-Lawrence score\> 4 months); 3. Failure after at least 6 months of conservative treatment (drug therapy with NSAIDs and painkillers, hyaluronic acid infiltration, corticosteroid infiltration, PRP); 4. Patients' ability and consent to participate in clinical and radiological follow-up; 5. Signature of informed consent. Exclusion Criteria: 1. Patients with trauma in the 6 months prior to surgery; 2. Patients with maligncy; 3. Patients suffering from rheumatic diseases; 4. Patients suffering from non-compensated diabetes; 5. Patients suffering from uncompensated thyroid metabolic disorders; 6. Patients abusing alcoholic beverages, drugs or drugs; 7. Patients with axial deviations\> 5 °; 8. Body Mass Index\> 35; 9. Patients treated with joint infiltrations in the previous 6 months; 10. Patients treated with surgery at the same knee in the previous 12 months.

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2023-04-19