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New treatment option for Periprosthetic Joint Infections
Official title Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities
ClinicalTrials.gov ID: NCT05361941
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Adequate soft tissue coverage
You likely can't join if
- 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...
- Neuromuscular disorders such as myasthenia gravis
See the full eligibility 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
- 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
- Pregnancy
- Adult patients requiring a legal guardian to sign informed consent form
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Washington D.C., District of Columbia, United States
- Skokie, Illinois, United States
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Fargo, North Dakota, United States
- Columbus, Ohio, United States
- Carrollton, Texas, United States
- San Antonio, Texas, United States
- West Jordan, Utah, United States
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Washington D.C., District of Columbia, United States; Skokie, Illinois, United States; Indianapolis, Indiana, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.