Osteoarthritis, Knee
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled clinical trial. A total of 34 individuals who meet the eligibility criteria will be probabilistically allocated to one or the other intervention
s group. Experimental group: 17 individuals (both sexes) with mild-to-moderate primary knee osteoarthritis will receive a joint single dose of laser-assisted (1210nm) stromal vascular fraction infiltr
Sponsors
Instituto Nacional de Traumatologia e Ortopedia
Instituto Nacional de Traumatologia e Ortopedia
Eligibility
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: Adult participants aged between 40 and 75; Both gender; Presenting full range of motion (0 to 120°); Patients with mild to moderate primary osteoarthritis classified by radiographs (anteroposterior projection) using the Kelgren-Lawrence classification less than or equal to III; residents of the city of Rio de Janeiro
Exclusion criteria
Exclusion criteria: Rheumatological disease; systemic inflammatory disease; active neoplasia; heart disease; renal or hepatic failure; grade III obesity (BMI> 40); positive viral diagnosis by serology or antigen (hepatitis B, C and HIV); patients with a history of trauma, infection or previous surgery in the involved joint; patients with alteration in the measurement of the mechanical axis of the lower limbs (varus or valgus greater than 5°; corticosteroid infiltration in the last 6 weeks; patients who used non-steroidal anti-inflammatory drug (NSAIDs) in the previous two weeks; patients undergoing viscosupplementation in the last year
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of cell number obtained, the percentages of viability and cell precursors | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety analysis with collection of adverse events occurring in the immediate (up to 1 day), intermediate (between 2 and 7 days), and late (after 7 days) postoperative periods ;Pain assessment using a visual analog scale at pre-procedure, 7 , 30, 60, and 90 day appointments;Quality of life assessment using the SF-36 questionnaire at pre-procedure, 7, 30, 60, and 90 day appointments;Functional assessment using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at pre-procedure, 7, 30, 90, and 180 day appointments;Functional assessment using the Knee Society Score (KSS) at pre-procedure, 7, 30, 90, and 180 day appointments | — |
Countries
Brazil
Contacts
Public ContactPatrícia;José Paulo dos Santos Costa;Aramburu Filho
Instituto Nacional de Traumatologia e Ortopedia;Instituto Nacional de Traumatologia e Ortopedia
Outcome results
None listed