Actively Recruiting
Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities
Led by Elute, Inc. · Updated on 2025-01-08
204
Participants Needed
12
Research Sites
121 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 22 years old, male or female
- Known infected total knee arthroplasty (TKA)
- Life expectancy of at least 1 year
- Willing to provide informed consent
- Geographically stable and able to comply with follow-up visits, testing, and medication
- Adequate soft tissue coverage
- Signed institutional review board approved informed consent form
You will not qualify if you...
- Severe renal impairment with eGFR less than 50 ml/min/1.73 m2 or on dialysis
- Known hypersensitivity to aminoglycoside antibiotics or calcium hydroxyapatite
- Pre-existing calcium metabolism disorder
- Uncontrolled diabetes mellitus with hemoglobin A1c levels greater than 8
- Current endocrine or metabolic disorders affecting bone growth (e.g., Paget's disease, renal osteodystrophy, hyperthyroid parathyroid hormone disorder, Ehler-Danlos syndrome, osteogenesis imperfecta)
- Neuromuscular disorders such as myasthenia gravis
- Untreated malignant tumors or currently receiving radiation chemotherapy
- Inadequate neurovascular status in the involved limb
- HIV infection
- Pregnancy
- Adult patients requiring a legal guardian to sign informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
University of Southern California
Los Angeles, California, United States, 90033
Actively Recruiting
2
Endeavor Health Skokie Hospital
Skokie, Illinois, United States, 60076
Actively Recruiting
3
OrthoIndy
Indianapolis, Indiana, United States, 46278
Actively Recruiting
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
5
Brigham & Womens Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
6
U Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
7
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
8
Sanford South University Medical Center
Fargo, North Dakota, United States, 58103
Actively Recruiting
9
JIS Orthopedics
Columbus, Ohio, United States, 43054
Actively Recruiting
10
UT Health San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
11
Jordan Valley Medical Center
West Jordan, Utah, United States, 84088
Actively Recruiting
12
West Virginia University Medical Center
Morgantown, West Virginia, United States, 26506
Actively Recruiting
Research Team
A
Ashok Khandkar, PhD
CONTACT
E
Eva Serio, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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