Comparative clinical trial between intra-articular corticosteroid infiltration or microfragmented adipose tissue in knee osteoarthritis

INTERVENTION: The work in question is a prospective, double‐blind, randomized, controlled study carried out in a single research center. Patients meeting the inclusion criteria will be randomized to receive either a single dose intra‐articular injection of autologous adipose tissue or receive a single dose corticosteroid injection (Triamcinolone hexacetonide). Prior to the start of treatment, patients will be randomly allocated to receive a single intra‐articular injection. For blinding purposes, all patients will be submitted to the autologous fat capture procedure, and in the intervention group, the fat will be manipulated with the lipogems® system for infiltration of microfragmented adipose tissue in the affected knee(s) . In addition, the physician responsible for patient follow‐up will not have access to the treatment received by the patient. Experimental group: 30 randomized patients with knee osteoarthritis will receive an intra‐articular infiltration with 10 ml of microfragmented autologous adipose tissue by the Lipogems® system in the affected knee. Control group: 30 patients randomized with knee osteoarthritis will receive an intra‐articular infiltration with 10ml of a solution containing 2ml triamcinolone hexacetonide (20mg/ml), 4ml bupivacaine (5mg/ml) and 4ml of saline solution in the affected knee. Patients will be followed for a period of one year. After the procedure, patients will be followed up at 7 days, 3 months, 6 months and 1 year. In all meetings, patients will answer questionnaires to assess functional improvement. E02.319.267.530.380 CONDITION: Knee osteoarthritis PRIMARY OUTCOME: It is expected to find an improvement in pain in patients with knee osteoarthritis undergoing the intervention in question. For this, the Womac‐A questionnaire, a subdivision of the Womac questionnaire, is used.; Derived from WOMAC, with a score from 0 to 20, this subdivision includes only pain‐related items.; The difference between the post‐intervention scores and the initial scores of both the group undergoing intervention with microfragmented adipose tissue and the control group will be compared SECONDARY OUTCOME: It is expected to find as a secondary outcome, an improvement in range of motion in patients with knee osteoarthritis undergoing the intervention. For this, the measurement is applied through measurement with a goniometer of the range of motion of the affected knees. ; The ranges of motion will be compared before and after intervention and between the groups in evaluated It is expected to find as a secondary outcome, an improvement in the visual pain scale in patients with knee osteoarthritis undergoing the intervention. For this, a visual analog scale is applied (VAS), from 0 (no pain) to 10 (worst pain in life). ; The difference between the post‐intervention scores and the initial scores of both the group undergoing intervention with microfragmented adipose tissue and the control group will be compared It is expected to find as a secondary outcome, an improvement in patients with knee osteoarthritis undergoing intervention in terms of quality of life. For this, the Eq‐5D questionnaire is used, which encompasses 5 health domains (mobility, personal care, usual activities, pain/discomfort and anxiety/depression). ; The difference between the post‐intervention scores and the initial scores of both the group undergoing intervention with microfragmented adipose tissue and the control group will be compared ; The difference between the post‐intervention scores and the initial scores of both the group undergoing intervention with microfragmented adipose tissue and the control group will be compared A secondary outcome is expected to be patient satisfaction with the procedure performed. For this, the Surgical Satisfaction Questionnaire ‐ SSQ‐8 is applied. ; The difference between the post‐intervention scores in the control and intervention groups will be compared to assess patients' satisfaction with the procedures performed. It is expected to find as a secondary outcome, an improvement in patients with knee osteoarthritis undergoing the intervention in question in the following categories: pain, joint stiffness and physical activity. For this, the Womac questionnaire is used. ; The difference between the post‐intervention scores and the initial scores of both the group undergoing intervention with microfragmented adipose tissue and the control group will be compared It is expected to find as a secondary outcome, an improvement in patients with knee osteoarthritis submitted to the intervention in question in the questions: specific symptoms of the knee. For this, the KOOS questionnaire is used. INCLUSION CRITERIA: Knee Osteoarthritis.Absence of local or systemic infection.Absence of arthritis of rheumatologic origin.Clinical deformity (varus/valgus/flexo/recurvate)or radiographic < 10 degrees.Patient able to understand the nature of the study.Informed consent filled in by the patient.Absence of any intra‐articular procedure less than 3 months before the start of the study.Absence of clinical contraindications to the study.Absence of congenital or acquired disease generating large deformity in the knee that could interfere with the application of mesenchymal cells or interpretation of results.Absence of neoplasm under treatment.Non‐pregnant patient.Absence of grade 3 obesity with BMI >40 (kg/height in m2)