The use of Bioactive Glass S53P4 as bone graft substitute in the treatment of chronic osteomyelitis and infected non-unions- a retrospective study of 50 patients.

• Conditions: M86; Osteomyelitis

• Registration Number: DRKS00011679
• Lead Sponsor: BG Klinikum Duisburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-05-20
• Study Start: 2017-05-24
• Results First Posted: 2018-04-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 68

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 were aseptic non-unions and unavailable follow-up.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint is the successful control of infection during the follow-up period. <br>Clinical control of signs of reinfection during consultation hours, as a rule after 6 weeks, 3, 6, 12 and 18 months.<br>No reexacerbation: no signs of infection (redness, fistula etc) and no reoperations

Secondary Outcome Measures

Name	Time	Method
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.<br>