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Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth In/near Infected Bone Cavities

NCT05361941 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-01-08

No results posted yet for this 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

  • Periprosthetic Joint Infections

Interventions

DEVICE

EP Granules with Tobramycin

EP Granules with Tobramycin is a Ca-salt resorbable intended for orthopedic applications as a bone void filler for bone gaps or voids and in cases where risk of post-operative infection is high, such as the first stage of a 2-stage or 1.5 stage revision of an infected total joint.

DEVICE

empty voids

Voids are left empty

Sponsors & Collaborators

  • Elute, Inc.

    lead INDUSTRY

Principal Investigators

  • Bruce Evans, MD · Holy Cross Jordan Valley Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05361941 on ClinicalTrials.gov