se of bioactive glass BAG-S53P4 for the treatment of chronic osteomyelitis of the long bones.

Not Applicable

• Conditions: M86.6; M86.3; Chronic multifocal osteomyelitis; Other chronic osteomyelitis

• Registration Number: DRKS00005332
• Lead Sponsor: IRCCS Galeazzi Orthopaedic Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Presence of osteomyelitis of a long bone for at least 6 months requiring surgical debridement and bone defect filling

Exclusion Criteria

Need for local plastic procedures, segmental bone defects, associated septic arthritis.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absence of infection recurrence/persistence at follow-up, defined as: absence of draining sinus or local clinical signs of acute inflammation (redness, swelling, warmth, pain), elevated values of C reactive protein (CRP) and erythrocyte sedimentation rate (ESR) and no need for further surgery whenever during follow-up. Time visits for follow-up are: 15 and 30 days and 3, 6, 9, 12, 18, 24 months after surgery.

Secondary Outcome Measures

Name	Time	Method
Absence of local or systemic side effects connected with the use of the BAG.