Multicenter Trial of Antibiotic Eluting Graft for Promoting New Bone Growth in/Near Infected Bone Cavities

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 + Tobramycin (EP G + T) investigational device, a combination device + antibiotic, 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).

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Periprosthetic Joint Infections

Eligibility basics and study details

Study type

Interventional

Phase

Not applicable

Ages

22 years and older

Sex

All

Healthy volunteers

Accepted

Sponsor

Elute, Inc.

Last updated on ClinicalTrials.gov

July 14, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites