Intramedullary nail infection Musculoskeletal Diseases Intramedullary nail infection
Conditions
Interventions
A noninferiority, randomized clinical trial was carried out involving patients of whom a locked IMN implant of the femur and/or tibia was retrieved and who all met the clinical and radiological criter
Sponsors
Federal University Of São Paulo (UNIFESP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years and over 2. Previous tibia or femur intramedullary locking nail fixation who met the definitive clinical and radiological diagnosis of osseous infection
Exclusion criteria
Exclusion criteria: 1. Diaphyseal diameter < 10 mm 2. Previous infection of the affected bone and patients with HIV or chronic renal failure were excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intramedullary infection two-year remission rate, performed using all randomized patients that completed at least one-year of follow-up in the per-protocol (PP) analysis. Patients were considered in remission when there was an absence of clinical, laboratory and radiological signs of infection, assessed in the last medical consultation (at least 12 months follow-up). Cases that did not require re-operation or further antibiotic administration for the same site of infection were also considered to be in remission. | — |
Secondary
| Measure | Time frame |
|---|---|
| Preoperative and postoperative pain measured by the Visual Analog Scale (EVA) scale at baseline and 1, 3, 6, 12 and 24 months postoperatively | — |
Countries
Brazil
Outcome results
None listed