Gonarthrosis [Arthrosis of knee]
Conditions
Interventions
The 256 study participants may be men or women, aged 49 to 75 years (inclusive) who have a diagnosis of knee osteoarthritis and pain. Participants will be randomly assigned to one of the following gro
Drug
Biological/vaccine
Procedure/surgery
Z52.3
M20-M25
Sponsors
Prevent Senior Private Operadora de Saúde LTDA
Prevent Senior Private Operadora de Saúde LTDA
Instituto Prevent Senior
Eligibility
Age
49 Years to 75 Years
Inclusion criteria
Inclusion criteria: Adults with age in between 49 and 75 years old; Clinical and radiological diagnosis of primary knee osteoarthritis with lesion of mild to moderate intensity (II and III) based on the classification criteria of the American College of Rheumatology (Altman et al., 1986) with radiological confirmation following a Kellgren and Laurence scale (1957); History of knee edema, pain, stiffness, gait alteration and loss of movement due to the degenerative joint process; Availability of follow-up during the study period; Have provided written voluntary consent to participate in the study, confirmed by the signature of Informed Consent Form.
Exclusion criteria
Exclusion criteria: BMI greater than or equal to 35; Being a carrier of other joint diseases or joint trauma, autoimmune diseases or have been subjected to the use of disease modifying drugs or intra-articular medication in the last 6 months; Evidence of secondary osteoarthrosis or with a history of other diseases in the articulation study, such as fractures, neoplasms, primary hematological disease, autoimmune, rheumatologic, neurological disease; History of acute or chronic communicable diseases, including B hepatitis; History of bone or cartilaginous disorders; Diagnosis of type I or type II diabetes, poorly controlled; Diagnosis of Hip Arthrosis through alteration in the physical examination or report with radiographic changes in the hip of the same side or contralateral; Evidence of active infection or history of infection in the joint to be infiltrated in this study; Any disease that affects the contralateral lower limb, such as consequence of OA of the knee; Deviation of the axial axis varus of 10 degrees or 15 degrees in valgus or discrepancy greater than 2.5 cm diagnosed by panoramic radiographic examination of limbs lower; Comorbidity that the physician considers as a contraindication for the infiltration of autologous stem cells; Contraindication to aspiration of the bone marrow (severe coagulopathy, skin infection in the area of ??the posterior iliac crest); Chronic treatment with anticoagulant or immunosuppressive drugs, except AAS 100mg; Use of a systemic corticosteroid in the last 3 months; Use of nonsteroidal anti-inflammatory drug in the last 15 days; Change in the use of oral chondroprotection continued for less than 3 months; Previous surgery (at any time) of the affected knee or orthopedic surgery lower limbs in the last 12 months; Present renal and / or hepatic functions out of normality; Present values ??that are not normal in laboratory tests, according to reference values; Hypersensitivity to any investigational product; Other clinical conditions which may, according to medical criteria, discourage participation in the study; Pregnant or otherwise pregnant women who do not use methods contraceptives; Development of clinical conditions that compromise the response to questionnaire and that may influence the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate pain, stiffness, level of physical activity, development of knee osteoarthritis and the efficacy of the investigacional products in the participants of all study groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of intra-articular use of the products under investigation by analyzing the rates of occurrence of serious and non-serious adverse events in participants in all groups of the study. | — |
Countries
Brazil
Contacts
Public ContactDaniel;Teresa Oksman;Campos Mello
Prevent Senior Private Operadora de Saúde LTDA;Prevent Senior Private Operadora de Saúde LTDA
Outcome results
None listed