Arthroplasty, Replacement, Hip
Conditions
Interventions
The proposal is a single-center, single-surgeon, single-approach, pragmatic, triple-blinded, prospective randomized trial to analyze the non-inferiority of the uncemented hip replacement to the hybrid
Sponsors
Suprema - Sociedade Universitária para o Ensino Médico Assistencial
Hospital e Maternidade Therezinha de Jesus
VINCULA
Eligibility
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria include age between 40 and 80 years old; with clinical and radiographic diagnosis of hip arthritis (both primary or secondary); uni or bilateral; both sexes
Exclusion criteria
Exclusion criteria: We will exclude patients with pathological fractures; metabolic and/or rheumatic diseases; patients with acetabular defects that require bone graft for correction; type III protrusio acetabuli deformity; patient with history of previous infection of the hip
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of complications (during and after surgery). We estimate that the hybrid group will have less complications, specially intraoperative fractures.;Ability to restore anatomical normality parameters on postoperative radiographs according to the surgical plan (namely the limb length discrepancy and the horizontal off-set of the hip). We expect to find no differences between the two groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life as measured by the SF-12 V.2 questionnaire (Damásio, Andrade & Koller, 2015). We expect to find no differences between the two groups. ;Pain using the Visual Analogue Scale VAS (Begum & Hossain, 2019). We expect to find no differences between the two groups.;Satisfaction assessment will be done using a three-degree Likert scale in dissatisfied/partially to satisfied/satisfied (Batterton & Hale, 2017). We expect to find no differences between the two groups.;Hip function using the Harris Hip Score. We expect to find no differences between the two groups.;Clinical evaluation will comprise the measurement of hip range of motion, leg length discrepancies and gait pattern. We expect to find no differences between the two groups. | — |
Countries
Brazil
Contacts
Public ContactBruno e Souza
Hospital e Maternidade Therezinha de Jesus
Outcome results
None listed