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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 is a NA study of Periprosthetic Joint Infections that is actively recruiting participants, run by Elute. The registered enrollment target is 204 participants. The trial reports 12 study locations across 11 states.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05361941
The ClinicalTrials.gov registry entry for NCT05361941 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Elute, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 12 study locations spanning 11 distinct geographic areas - top geographies include 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.
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