M86
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria were the existence of COM and/ or infected non-unions (evidence of positive bacteriology and/ or positive histology of intraoperative removed samples). Period of treatment/ data analysis: 07/13 - 12/16
Exclusion criteria
Exclusion criteria: Exclusion criteria were aseptic non-unions and unavailable follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the successful control of infection during the follow-up period. Clinical control of signs of reinfection during consultation hours, as a rule after 6 weeks, 3, 6, 12 and 18 months. No reexacerbation: no signs of infection (redness, fistula etc) and no reoperations | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints were the absence of local or systemic reactions due to the implanted BAG (e.g. foreign body reactions, redness, swelling, increased secretion or allergic reactions), the time period to full weight bearing as well as the time period to radiologic detectable incorporation of BAG. | — |
Countries
Germany
Contacts
BG Klinikum Duisburg