Knee osteoarthritis
Conditions
Interventions
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
Sponsors
Instituto de Ortopedia e Traumatologia de Universidade de São Paulo
Geistlich Pharma do Brasil
Eligibility
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Knee Osteoarthritis.Absence of local or systemic infection.Absence of arthritis of rheumatologic origin.Clinical deformity (varus/valgus/flexo/recurvate)or radiographic 40 (kg/height in m2)
Exclusion criteria
Exclusion criteria: Loss to follow-up.Presence of serious/debilitating clinical condition.Presence of new orthopedic injuries relevant during the study period (severe joint trauma to the knee.fractures of the lower limb or new ligament injuries).death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. 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;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 range of motion in patients with knee osteoarthritis undergoing the intervention. For this, the measurement is a | — |
Countries
Brazil
Contacts
Public ContactBruno Varone
Instituto de Ortopedia e Traumatologia de Universidade de São Paulo
Outcome results
None listed