Infection and non-union of the upper and lower part of the shinbone: treatment with the Ilizarov method

Not Applicable

• Conditions: Patients with closed epiphyses with metaphyseal non-union in tibia which are infected with pathogens; Musculoskeletal Diseases

• Registration Number: ISRCTN30905788
• Lead Sponsor: General University Hospital of Patras

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36580353/ (added 30/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-25
• Last Update Posted: 9 January 2023
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 11

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Treatment success assessed using:<br> 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)<br> 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)<br> 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)<br> 3. Side effects will be recorded when they appear either with modification of antibiotic therapy or calibration and cleaning of the Ilizarov device<br>