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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.

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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).

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

FieldValue
Enrollment Target 204 participants
Start Date 2023-08-31
Est. Completion 2025-12-31
Phase NA

Sponsor

Elute

1 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.