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NCT Number: NCT07072923

Antibiotic Impregnated Beads in Osteomyelitis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic loaded calcium sulfate beads

Drug

Calcium sulfate beads will be loaded with best available antibiotics based on surgeon/infectious disease specialist determination from the following options (vancomycin, daptomycin, cefazolin, cefepime, tobramycin, amphotericin B, micafungin, and voriconazole).

Calcium sulfate beads (sham beads)

Device

Calcium sulfate beads will be prepared without added antibiotics and placed during the second surgery.

Primary outcomes

  1. End of Therapy - Clinical Failure

    Time frame: End of Therapy (usually 4-6 weeks)

    • Presence of at least one clinical criterium for failure (frank pus adjacent to bone or implant or draining sinus tract), OR
    • phenotypically indistinguishable bacteria isolated from two or more deep-tissue samples or a single closed aspirate or biopsy OR
    • histologic criteria including presence of characteristic inflammatory infiltrate or microorganisms.

Study contacts

Contact information is provided by the study sponsor or research team.

Jose Elizondo

CONTACT

[email protected]

+15206210316

Talha Riaz, MD

CONTACT

[email protected]

+1 520 626 8569

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

Utility of Antibiotic Impregnated Beads in Lower Extremity Osteomyelitis

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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