Patients with closed epiphyses with metaphyseal non-union in tibia which are infected with pathogens Musculoskeletal Diseases
Conditions
Interventions
The intervention studied is the treatment of pseudoarthrosis and infection after surgical cleansing, antibiotic treatment and placement of the Ilizarov apparatus. The patient's clinical and functional
Sponsors
General University Hospital of Patras
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The participants in the study: 1. Must have completed their skeletal development by closing the epiphyses in the proximal and distal metaphysis of the tibia 2. Have septic pseudoarthrosis at the examined points 3. Freely consent to this study Patients with concomitant health problems or immunosuppressed ones are not excluded from the study as long as they meet the above criteria
Exclusion criteria
Exclusion criteria: 1. Underage patient or open epiphyses 2. Absence of infection 3. Infected non-union in another part of the tibia or anywhere else 4. No signed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Treatment success assessed using: 1.1. Healed fracture/non-union assessed using x-rays at pre-op, every month after Ilizarov removal and every 6 months up to the end of the follow-up period (min. 3 years) 1.2. Eradication of infection assessed using biomarkers (CRP, ESR, white blood count) at pre-op, every month after Ilizarov removal and every 6 months up to the end of the follow-up period (min. 3 years) 2. Treatment failure will be assessed by clinical examination and radiological evaluation monthly postoperatively until Ilizarov removal (end of the treatment period) and once per semester until the end of the follow-up period (3 years) 3. Side effects will be recorded when they appear either with modification of antibiotic therapy or calibration and cleaning of the Ilizarov device | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functionality of the limb calculated with the AOFAS score/KOS-ADSL (Greek version) at pre-op, 1 month after Ilizarov removal and every 6 months up to the end of the follow-up period (min. 3 years) 2. Quality of life assessed with the Short Form-12 (Mental Health) at pre-op, 3 months, 6 months, 1 month after Ilizarov removal and every 6 months up to the end of the follow-up period (min. 3 years) 3. General lower limb condition measured using the AAOS Lower Limb Core Scale at pre-op, 1 month after Ilizarov removal and every 6 months up to the end of the follow-up period (min. 3 years) 4. Pain measured using the Visual Analog Pain scale once per month until the removal of Ilizarov device and once each semester until the end of the follow-up period 5. Quality of life measured using QALY analysis and the Time Trade-off index at pre-op, 1 month after Ilizarov removal and every 6 months up to the end of the follow-up period (min. 3 years), and EQ-5D-3L at pre-op, 3 months, 6 months, 1 month after Ilizarov removal and every 6 months up to the end of the follow-up period (min. 3 years) 6. Limb discrepancy, where it exists, measured clinically, radiologically and functionally with the use of wooden wedges (use of the ASAMI score for bone health and function of the limb) at pre-op, 3 months, 6 months, 1 month after Ilizarov removal and every 6 months up to the end of the follow-up period (min. 3 years) | — |
Countries
Greece
Outcome results
None listed