Knee osteoarthritis
Conditions
Interventions
This is a single-arm, randomized, controlled clinical trial. A total of 75 individuals who meet the eligibility criteria will be probabilistically allocated to an intervention group using the randomiz
s group membership, and participants will not be blinded due to the impossibility of blinding due to the procedure performed. Selected participants will be diagnosed with stage II and III knee arthrit
4 on a visual analog scale (VAS, 2000). After a complete history, orthopedic physical examination, and plain radiographs of the affected knee in the AP (weight-bearing) and lateral views, they will be
Sponsors
Universidade de Taubaté
Universidade de Taubaté
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients diagnosed with knee arthritis stages II and III of Kellgren and Lawrence (KL); pain according to the visual analogue scale greater than 4 (VAS 2000); between 18 and 65 years old; both genders
Exclusion criteria
Exclusion criteria: Patients with knee arthritis stages I and IV of Kellgren and Lawrence (KL); previous infiltration; previous knee surgery in the last year; use of immunosuppressants; chronic use of corticosteroid therapy; focal chondral lesion; collagen deposition diseases; patients with rheumatological conditions; immunosuppressive pathologies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvements in pain, function, and stiffness parameters are expected after the three interventions (bone marrow aspirate, corticosteroid, and hyaluronic acid) at one, three, and six months after injections, as verified using the Visual Analogue Scale (VAS) for PAIN and the WOMAC (The Western Ontario and McMaster Universities Arthritis Index) pain, function, and stiffness questionnaire;To assess the existence of superiority between infiltration procedures, after statistical analysis, during the period evaluated | — |
Secondary
| Measure | Time frame |
|---|---|
| Find a statistically significant difference in the comparative results between the interventions through the VAS and WOMAC assessments at 1, 3 and 6 months after the procedures;Finding superiority or non-inferiority in the application of BMA compared to the applications of hyaluronic acid and corticosteroids | — |
Countries
Brazil
Contacts
Public ContactMaikon de Souza Pinto
Universidade de Taubaté
Outcome results
None listed