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NCT05361941 · ClinicalTrials.gov registry record · NA
Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities
A NA study of Periprosthetic Joint Infections, sponsored by Elute.
- Recruiting
- Registry status
- NA
- Development phase
- 204
- Enrollment target
- 12
- Study locations
NCT05361941: Recruiting NA study of Periprosthetic Joint Infections, sponsored by Elute.
NCT05361941 is a NA study of Periprosthetic Joint Infections that is actively recruiting participants, run by Elute. The registered enrollment target is 204 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05361941, a NA study of Periprosthetic Joint Infections, is actively recruiting participants, sponsored by Elute.
- RECRUITING
- Registry status
- NA
- Development phase
- 204 participants
- Enrollment target
- 12
- Study locations
Study 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).
Primary Outcome
A\] New bone growth observed in voids at 12 months versus pre-op stage 1 and B\] Absence of infection at 24 months versus pre-op stage 1 surgery.
Conditions Studied
Interventions
- DEVICE EP Granules with Tobramycin
- DEVICE empty voids
Study Locations (12)
Massachusetts
- Massachusetts General Hospital - Boston
- Brigham & Womens Hospital - Boston
California
- University of Southern California - Los Angeles
Illinois
- Endeavor Health Skokie Hospital - Skokie
Indiana
- OrthoIndy - Indianapolis
Michigan
- U Michigan Medical Center - Ann Arbor
New York
- Hospital for Special Surgery - New York
North Dakota
- Sanford South University Medical Center - Fargo
Ohio
- JIS Orthopedics - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2023-08-31 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
What NCT05361941 shows while recruiting
NCT05361941 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Periprosthetic Joint Infections appearing as the primary indexed condition, and to 2 interventions - of which EP Granules with Tobramycin is the first listed.
NCT05361941 lists 12 locations in 11 states (Massachusetts, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT05361941 about?
NCT05361941 is a clinical study titled "Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities". 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 i...
What is the current status of trial NCT05361941?
This trial is currently recruiting. It is a NA study. The enrollment target is 204 participants. The study started on 2023-08-31. Estimated completion is 2025-12-31.
What conditions does trial NCT05361941 study?
This clinical trial studies the following conditions: Periprosthetic Joint Infections.
What interventions are being tested in trial NCT05361941?
The interventions under investigation include: EP Granules with Tobramycin (DEVICE), empty voids (DEVICE).
Who is sponsoring clinical trial NCT05361941?
This trial is sponsored by Elute, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05361941 being conducted?
This trial has 12 study locations across California, Illinois, Indiana, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05361941's enrollment target sits among peer trials
204 500th of 2000 higher than 1,497 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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