NCT05361941 Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities
| NCT ID | NCT05361941 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Elute, Inc. |
| Condition | Periprosthetic Joint Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2023-08-31 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 204 participants in total. It began in 2023-08-31 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
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
Contact & Investigator
Bruce Evans, MD
STUDY CHAIR
Holy Cross Jordan Valley Hospital
Frequently Asked Questions
Who can join the NCT05361941 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Periprosthetic Joint Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05361941 currently recruiting?
Yes, NCT05361941 is actively recruiting participants. Contact the research team at ak@elutinc.com for enrollment information.
Where is the NCT05361941 trial being conducted?
This trial is being conducted at Los Angeles, United States, Skokie, United States, Indianapolis, United States, Boston, United States and 8 additional locations.
Who is sponsoring the NCT05361941 clinical trial?
NCT05361941 is sponsored by Elute, Inc.. The principal investigator is Bruce Evans, MD at Holy Cross Jordan Valley Hospital. The trial plans to enroll 204 participants.