Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone… (NCT05361941) | Clinical Trial Compass
RecruitingNot Applicable
Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities
United States204 participantsStarted 2023-08-31
Plain-language 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).
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
A single composite outcome of new bone growth and reduction in infection rates, with absence of serious device related adverse events.
Timeframe: 24 months after stage 1 surgery
2
Absence of serious device related adverse events requiring re- operation