Gonarthrosis
Conditions
Interventions
A injection (single dose) of viscupplumentation will be applied to the knee of 22 patients with knee osteoarthritis (Kellgran-Lawrance III and IV), guided by ultrasound. In the sham group (n = 22) (si
Drug
E02.319
Sponsors
Instituto Brasil de Tecnologias da Saúde
Hospital de Força Aérea do Galeão
Eligibility
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients registered in the surgery waiting queue; older than 60 yo; able to walk ten meters independently; without external aid.
Exclusion criteria
Exclusion criteria: valgus or varus deformity higher than fifteen degrees; neurological impairment; indication for bilateral TKA; OA related to periarticular fracture or of septic origin; who have functional limitations in ankle or ipsilateral hip as a result of prior trauma; who do not agree with the consent terms to the research; who refuse to receive the articular infiltrations or perform biomechanical tests; who have no autonomy to raise, sit and/or walk without assistance from other people; illiterate individuals or those who are unable to answer independently the IKDC and LEFS questionnaires; who have used in the last six months or at any time during the study period corticosteroid drugs or surgery in the affected limb.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Improvement in peak angulation of the knee in the sagittal plane during gait support phase after 12 weeks of intervention, verified by the application of statistical tests (linear mixed longitudinal models).;Expected outcome 2: Improvement in peak angulation of the knee in the frontal plane during gait support phase after 12 weeks of intervention, verified by the application of statistical tests (linear mixed longitudinal models).;Expected outcome 3: Improvement in peak angulation of the knee in the transverse plane during gait support phase after 12 weeks of intervention, verified by the application of statistical tests (linear mixed longitudinal models). | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 1: Improvement of pain magnitude after 12 weeks of intervention, verified by improvement of at least 2 points on the analog pain scale applied.;Expected outcome 2: Improvement of knee function after 12 weeks of intervention, verified by improvement of at least 8 points in the IKDC evaluation questionnaire. | — |
Countries
Brazil
Contacts
Public ContactGustavo Leporace
Instituto Brasil de Tecnologias da Saúde
Outcome results
None listed