Antibiotic Impregnated Beads in Osteomyelitis

Utility of Antibiotic Impregnated Beads in Lower Extremity 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteomyelitis of the Foot; Antibiotic Impregnated Beads; Osteomyelitis of Lower Extremities
• Intervention / Treatment: Device: Calcium sulfate beads (sham beads); Drug: Antibiotic loaded calcium sulfate beads

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Talha Riaz, MD; Phone Number: +1 520 626 8569; Email: riazt@arizona.edu
• Study Contact Backup: Name: Jose Elizondo; Phone Number: +15206210316; Email: joselizondo5@arizona.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IV and/or oral antibiotics with local antibiotic loaded calcium sulfate beads; These will be patient who will receive active systemic antibiotics plus calcium sulfate beads loaded with antibiotics	Device: Calcium sulfate beads (sham beads); Calcium sulfate beads will be prepared without added antibiotics and placed during the second surgery.
Active Comparator: IV and/or oral antibiotics plus calcium sulfate beads without antibiotics (sham beads); These patients will receive IV and/or oral antibiotics plus sham beads. They will receive antibiotics systemically.	Drug: Antibiotic loaded calcium sulfate beads; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End of Therapy - Clinical Failure	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.	End of Therapy (usually 4-6 weeks)

Collaborators and Investigators

• Sponsor: University of Arizona

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: July 9, 2025
• First Posted (Estimated): July 18, 2025

Study Record Updates

• Last Update Posted (Estimated): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 9, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: osteomyelitis, lower extremity, foot, calcium sulfate beads
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Infections; Bone Diseases, Infectious; Osteomyelitis; Calcium-Regulating Hormones and Agents; Anti-Infective Agents; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium, Dietary; Calcium; Anti-Bacterial Agents
• Other Study ID Numbers: STUDY00005515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No