Recruiting

Antibiotic Eluting GraftMulticenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities

Sponsor:

Elute, Inc.

Code:

NCT05361941

Conditions

Periprosthetic Joint Infections

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Interventions

EP Granules with Tobramycin

empty voids

Study Details

Brief summary:

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 + Tobramycin (EP G + T) investigational device, a combination device + antibiotic, 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).

Conditions

Periprosthetic Joint Infections

Study ID

NCT05361941

Start date

Aug 31, 2023

Status verified date

Jul, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Accepted

Inclusion Criteria:

Ages and sexes eligible: at least 22 years, male and female
Candidates with known infected TKA
Life expectancy of at least 1 year
Patient is willing to provide informed consent, is geographically stable and able to comply with the required follow up visits, testing schedule and medication regimen
Adequate soft tissue coverage
Signed institutional review board approved informed consent

Exclusion Criteria:

Severe renal impairment with eGFR <50 ml/min/1.73 m2, or being treated with dialysis

Known hypersensitivity to aminoglycoside antibiotics, or calcium hydroxyapatite
Pre-existing calcium metabolism disorder
Uncontrolled diabetes mellitus (hemoglobin A1c levels > 8)
A current endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, hyperthyroid parathyroid hormone disorder, Ehler- Danlos syndrome, osteogenesis imperfecta)
Neuromuscular disorders such as myasthenia gravis
Untreated malignant neoplasm(s), or currently undergoing radiation chemotherapy
Inadequate neurovascular status in the involved limb that may jeopardize healing
HIV
Pregnancy
Adult patients requiring a legal guardian to sign informed consent form

Study Design

Enrollment

204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

The 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 Arm

In 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.

Interventions

EP Granules with Tobramycin

EP 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

Voids are left empty

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 ]
Absence of serious device related adverse events requiring re- operation [ Time Frame: 24 months after stage 1 surgery ]

Central Contacts and Locations

Central contacts

Ashok Khandkar, PhD

801-410-4330 ak@elutinc.com

Eva Serio, BS

801-410-4330 eva@elutinc.com

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Contacts

Pui Yan

puiyan@med.usc.edu

Nathanael Heckmann, MD

800-872-2273 nathanael.heckmann@med.usc.edu

Georgetown University Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

Joshua Lawrence

240-863-1681 joshua.lawrence@medstar.net

Principal Investigator:

Brett Levine, MD

Endeavor Health Skokie Hospital

Recruiting

Skokie, Illinois, United States, 60076

Contacts

John Carroll

847-933-6328 jcarroll@northshore.org

Principal Investigator:

Hristo Piponov, MD

OrthoIndy

Recruiting

Indianapolis, Indiana, United States, 46278

Contacts

Melanie Glover

317-802-2880 mglover@orthoindy.com

Principal Investigator:

Christopher Pomeroy, MD

Sinai Hospital

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Makayla Crosby

410-601-2663 mcrosby@lifebridgehealth.org

Nate Helwig

410-601-8434 nhelwig@lifebridgehealth.org

Principal Investigator:

Janet Conway, MD

U Michigan Medical Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Justin Quimbo

734-232-4145 quimbo@med.umich.edu

Principal Investigator:

Michael Kheir, MD

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Contacts

Amar Ranawat, MD

212-606-1000 ranawatamar@hss.edu

OrthoCarolina

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Justin Norwood

704-323-3845 justin.norwood@orthocarolina.com

Principal Investigator:

Josef Jollisaint, MD

JIS Orthopedics

Recruiting

Columbus, Ohio, United States, 43054

Contacts

Michael Sneller

614-964-0348 snellerma@jisortho.com

Principal Investigator:

David Crawford, MD

Carrollton regional Medical Center

Recruiting

Carrollton, Texas, United States, 75010

Contacts

Angela Mealing

469-443-0924 mealing@dallaslimbrestoration.com

Principal Investigator:

Richard Buch, MD

UT Health San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Jhemima Rizalde

210-567-6176 rizalde@uthscsa.edu

Principal Investigator:

Frank Buttacavoli, MD

Jordan Valley Medical Center

Recruiting

West Jordan, Utah, United States, 84088

Contacts

David Evans, MD

(801) 891-5056 dcevans1@gmail.com

More Information

Sponsor

Elute, Inc.

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Elute, Inc. on 2026-07-14.