Study of EP Granules with Tobramycin Device to Promote Bone Growth and Reduce Infection in Patients Undergoing Surgery for Periprosthetic Joint Infections

What this Trial Is About

Researchers are evaluating a new treatment for patients with periprosthetic joint infections (PJIs) undergoing staged revision surgery. This study is a pivotal, prospective, multi-center, randomized, patient and assessor-blinded trial comparing the investigational device EP Granules with Tobramycin against the standard-of-care surgical treatment. The goal is to promote new bone growth and reduce recurring infections, improving outcomes for patients during the first stage of revision surgery. The study has two arms: one group receives the EP Granules with Tobramycin, a calcium-salt resorbable bone void filler with antibiotic properties used during the first stage of a 2-stage or 1.5-stage revision. The control group receives the standard treatment with empty bone voids left during surgery. Both approaches aim to address bone loss caused by infection and support the revision implant. The study compares these treatments over a 24-month follow-up period. Participants will undergo assessments to measure new bone growth and infection rates, with a focus on the absence of serious device-related adverse events, including those requiring re-operation. Follow-up visits and testing schedules will monitor the safety and effectiveness of the treatments. Participants are expected to remain engaged for at least 24 months after the initial surgery to evaluate long-term outcomes and implant survival.

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