Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Elute, Inc.
- Study ID
- NCT05361941
- Status
- Recruiting
Conditions
- Periprosthetic Joint Infections
Eligibility Criteria
- Sex
- ALL
- Age
- 22 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- EP Granules with Tobramycin — DEVICEEP Granules with Tobramycin is a Ca-salt resorbable intended for orthopedic applications as a bone void filler for bone gaps or voids and in cases where risk of post-operative infection is high, such as the first stage of a 2-stage or 1.5 stage revision of an infected total joint.
- empty voids — DEVICEVoids are left empty
Study Details
This is a pivotal, prospective, multi-center, randomized, concurrent control, patient and assessor-blinded study with two arms: a treatment arm (where subjects will be treated with the EP Granules with Tobramycin investigational device in the 1st stage of a staged revision for periprosthetic joint infection (PJIs), and a control arm (where subjects are treated with the standard-of-care revision for infected PJIs).
Key Dates
- Start date
- Aug 31, 2023
- Status verified
- Jan 2025
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 204 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment ArmThe device will be placed in voids at Stage 1. This will be followed by IV therapy for about six weeks, followed by assessment of infection, with a stage 2 surgery to follow. (For 1.5-stage, stage 2 procedure is optional). During the stage 2 surgery, the surgeon completes the procedure with affixing the revision implants.
- Active Comparator: Control ArmIn the standard of care arm, voids are left empty and a bone cement spacer placed during stage 1 surgery. This is followed by IV therapy for a minimum of six weeks, followed by a pathology assessment of infection by needle aspiration, after week 8, with a stage 2 surgery scheduled after week 9. During the stage 2 surgery, the spacer is removed and procedure completed by affixing the revision implants. For 1.5-stage procedures, the stage 2 procedure is optional.
Primary Outcome Measure
A single composite outcome of new bone growth and reduction in infection rates, with absence of serious device related adverse events. [ Time Frame: 24 months after stage 1 surgery ]
Central Contacts
- Ashok Khandkar, PhD801-410-4330
- Eva Serio, BS801-410-4330
Locations (12)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | Pui Yan Jay Lieberman, MD Daniel Oakes, MD Donald Longjohn, MD |
| Endeavor Health Skokie Hospital | Skokie | Illinois | 60076 | Hristo Piponov, MD |
| OrthoIndy | Indianapolis | Indiana | 46278 | Christopher Pomeroy, MD Greg Dikos, MD Michael Cross, MD |
| Brigham & Womens Hospital | Boston | Massachusetts | 02115 | Jeffrey Lange, MD |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | - |
| U Michigan Medical Center | Ann Arbor | Michigan | 48109 | Michael Kheir, MD Christopher Carender, MD Elizabeth Klag, MD |
| Hospital for Special Surgery | New York | New York | 10021 | Alberto Carli, MD |
| Sanford South University Medical Center | Fargo | North Dakota | 58103 | Todd Sekundiak, MD |
| JIS Orthopedics | Columbus | Ohio | 43054 | David Crawford, MD Zackary Byrd, MD Adolph Lombardi, MD |
| UT Health San Antonio | San Antonio | Texas | 78229 | Frank Buttacavoli, MD Chance Moore, MD |
| Jordan Valley Medical Center | West Jordan | Utah | 84088 | |
| West Virginia University Medical Center | Morgantown | West Virginia | 26506 | Adam Klein, MD Matthew Dietz, MD Benjamin Frye, MD Timothy Murphy, MD |
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