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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005332

Enrollment

Registered

2013-09-27

Start date

2010-11-04

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M86.6 M86.3

Interventions

Group 1: Patients treated with BAGS53P4

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
Absence of local or systemic side effects connected with the use of the BAG.	—

Countries

Italy

Contacts

Public ContactCarlo L. Romanò

IRCCS Galeazzi Orthopaedic Institute

carlo.romano@grupposandonato.it00390266214743

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 22, 2026