Antibiotic Impregnated Beads in Osteomyelitis

Not Applicable

Not yet recruiting

• Conditions: Osteomyelitis of the Foot; Antibiotic Impregnated Beads; Osteomyelitis of Lower Extremities
• Interventions: Device: Calcium sulfate beads (sham beads); Drug: Antibiotic loaded calcium sulfate beads

• Registration Number: NCT07072923
• Lead Sponsor: University of Arizona

Brief Summary

Lower extremity bone infections, such as osteomyelitis, often occur after bone fractures, surgery, or when prosthetic joints or hardware become infected. Treatment usually includes antibiotics, chosen based on the infection's specifics. Options include intravenous (IV) or oral antibiotics, and sometimes local treatment with antibiotic-loaded beads placed directly at the infection site. Traditionally, these beads are made of non-absorbable materials, requiring a second surgery to remove them. However, a newer approach uses absorbable calcium sulfate beads, which can deliver higher antibiotic doses and don't need removal. This study will compare the use of IV and/or antibiotics in combination with absorbable antibiotic calcium sulfate beads with IV and/or oral antibiotics without absorbable beads, which serves as the current standard of care.

Detailed Description

The purpose of this study is to evaluate the effectiveness of absorbable antibiotic beads in treating lower extremity (LE) infections and compare it to the current standard care. The study has several objectives: (1) to compare treatment failure rates between patients receiving intravenous (IV) and/or oral antibiotics plus antibiotic loaded absorbable beads with IV and/or oral antibiotics plus beads without antibiotics (sham beads). The primary question to be answered is whether patients treated with oral and/or IV antibiotics in conjunction with absorbable antibiotic beads have outcome (failure rate) that is not higher than those treated with standard care alone. The study's hypothesis is that the failure rate for patients receiving IV and/or oral antibiotics combined with antibiotic beads will be non-inferior to those receiving the standard care of IV or oral antibiotics without beads. The study will primarily focus on treatment failure rates as a key endpoint to measure effectiveness and compare the two treatment approaches.

Study Timeline

• Study First Submitted: 2025-03-07
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Study Start: 2025-09-01
• Primary Completion: 2027-07-31
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• patients with lower extremity osteoarticular infections with or without hardware

Exclusion Criteria

• patients who are hemodynamically unstable or have altered mental status and cannot give consent
• patient per investigators discretion are excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV and/or oral antibiotics with local antibiotic loaded calcium sulfate beads	Calcium sulfate beads (sham beads)	These will be patient who will receive active systemic antibiotics plus calcium sulfate beads loaded with antibiotics
IV and/or oral antibiotics plus calcium sulfate beads without antibiotics (sham beads)	Antibiotic loaded calcium sulfate beads	These patients will receive IV and/or oral antibiotics plus sham beads. They will receive antibiotics systemically.

Primary Outcome Measures

Name	Time	Method
End of Therapy - Clinical Failure	End of Therapy (usually 4-6 weeks)	1. Presence of at least one clinical criterium for failure (frank pus adjacent to bone or implant or draining sinus tract), OR; 2. phenotypically indistinguishable bacteria isolated from two or more deep-tissue samples or a single closed aspirate or biopsy OR; 3. histologic criteria including presence of characteristic inflammatory infiltrate or microorganisms.