Antibiotic Impregnated Beads in Osteomyelitis

NCT ID: NCT07072923

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-09-30

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.

Conditions

Osteomyelitis of the Foot; Antibiotic Impregnated Beads; Osteomyelitis of Lower Extremities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Calcium sulfate beads (sham beads)

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Antibiotic loaded calcium sulfate beads

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

Calcium sulfate beads (sham beads)

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Talha Riaz

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Talha Riaz, MD

Role: CONTACT

riazt@arizona.edu

+1 520 626 8569

Jose Elizondo

Role: CONTACT

joselizondo5@arizona.edu

+15206210316

Other Identifiers

STUDY00005515

Identifier Type: -

Identifier Source: org_study_id