NCT05361941

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Elute, Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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).

Detailed description

This is a pivotal, prospective, multi-center, randomized, concurrent control, patient and assessor-blinded study to demonstrate superiority of new bone growth and a reduction in recurring infections, and thereby improve outcomes for patients undergoing a staged revision for periprosthetic joint infections (PJIs). The standard of care for treatment of PJIs typically involves either a 2-stage revision or 1.5 stage revision which entails loss of bone stock resulting from debridement of infected bone in Stage 1. In the Stage 2 procedure, surgeons use metal cones to make up for this bone loss and better support the revision implant. Inadequate bone growth could result in gaps at the the voids below the level of the cortical bone, resulting in regions with no contact with the revision implant or cement mantle. Such gaps could result in dead-space regions, and zones without new bone growth required to support the revision implant. Both deficiencies affect long-term survival of the revision implant. The study has two arms: a treatment arm (where subjects will be treated with the EP Granules with Tobramycin investigational device in the 1st stage of the staged surgical treatment, and a control arm where subjects are treated with the standard-of-care staged surgical treatment for infected PJIs. Outcomes are demonstration of new bone growth and reduction of recurrent infections.

Conditions

• Periprosthetic Joint Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-08-31
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-05-05
• Last updated: 2025-01-08

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study