Arthrosis, arthritis
Conditions
Interventions
150 patients of both gender, male and female, diagnostic with knee osteoarthritis, will hold a surgery where a specific implant to this area of the body, replace the knee joint, ie, the implant will h
Device
Procedure/surgery
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - Instituto de Ortopedia e Traumatologia
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - Instituto de Ortopedia e Traumatologia
Eligibility
Age
60 Years to 70 Years
Inclusion criteria
Inclusion criteria: Healthy participants; both sexes; 60 to 70 aged years; with a diagnosis of osteoarthritis of grade IV and V according to Ahlback classification modified by Keyes; not have performed arthroplasty knee surgery earlier; failure of nonsurgical treatment (medication or physical therapy); not psychiatric disorders; not have diseases that have bone loss; not have chronic diseases including rheumatic diseases; not an alcoholic.
Exclusion criteria
Exclusion criteria: Participants with serious injuries in the operated knee; have deep infection; deep vein thrombosis without control with medical treatment; leaving treatment or follow-up; participant who no longer wish to perform the stipulated protocol; participant's death.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical evaluations will be collected using a questionnaire validated in the literature during the stipulated monitoring periods before surgery and during the two years; Functional capacity is checked on the Knee Society Score, this method evaluates the performance in running exercises and mobility; Quality of life assessment with the SF-36 questionnaire, which analyzes the functioning, bodily pain, general health, vitality, social functioning, emotional and mental health. Radiographic analysis will bring success prosthesis information, identifying the device migration, breakage or device failure and wear of the components of the devices. Thus both methods verifies the presence or absence of faults of the devices and clinical complications. | — |
Secondary
| Measure | Time frame |
|---|---|
| No additional surgery on the joint in question; Statistically significant improvement clinic; Significant change in quality of life assessed by the SF-36 questionnaire; Significant change of physical disability assessed by questionnaire Knee Society Score; Secondary operations (revision, removal, re-operation) related to the device, procedure related, unrelated. | — |
Countries
Brazil
Contacts
Public ContactJosé Pécora
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - Instituto de Ortopedia e Traumatologia
Outcome results
None listed