RecruitingNot ApplicableNCT05361941

Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities


Sponsor

Elute, Inc.

Enrollment

204 participants

Start Date

Aug 31, 2023

Study Type

INTERVENTIONAL

Conditions

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 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).


Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a specialized bone graft material that releases antibiotics at the site of an infected knee replacement (TKA) to help treat the infection while also supporting new bone growth. It is designed for patients whose knee implant has become infected. You may be eligible if... - You are at least 22 years old - You have a confirmed infected total knee replacement (TKA) - You have adequate soft tissue covering the knee area - Your life expectancy is at least 1 year - You are willing and able to attend follow-up visits and follow the medication schedule You may NOT be eligible if... - You have severe kidney impairment (eGFR below 50) or are on dialysis - You have a known allergy to aminoglycoside antibiotics or calcium hydroxyapatite - You have a calcium metabolism disorder - You have uncontrolled diabetes (HbA1c above 8) - You have a bone disease such as Paget's disease, renal osteodystrophy, or osteogenesis imperfecta - You have a neuromuscular disorder such as myasthenia gravis - You have an untreated malignancy or are undergoing chemotherapy or radiation - Your leg has inadequate blood flow or nerve supply that could impair healing - You are HIV positive - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEP 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.

DEVICEempty voids

Voids are left empty


Locations(12)

University of Southern California

Los Angeles, California, United States

Endeavor Health Skokie Hospital

Skokie, Illinois, United States

OrthoIndy

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham & Womens Hospital

Boston, Massachusetts, United States

U Michigan Medical Center

Ann Arbor, Michigan, United States

Hospital for Special Surgery

New York, New York, United States

Sanford South University Medical Center

Fargo, North Dakota, United States

JIS Orthopedics

Columbus, Ohio, United States

UT Health San Antonio

San Antonio, Texas, United States

Jordan Valley Medical Center

West Jordan, Utah, United States

West Virginia University Medical Center

Morgantown, West Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT05361941