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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

empty voids: Voids are left empty

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 + 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).

Eligibility

Primary outcome measure(s)

• A single composite outcome of new bone growth and reduction in infection rates, with absence of serious device related adverse events. — 24 months after stage 1 surgery
  A\] New bone growth observed in voids at 12 months versus pre-op stage 1 and B\] Absence of infection at 24 months versus pre-op stage 1 surgery.
• Absence of serious device related adverse events requiring re- operation — 24 months after stage 1 surgery
  A serious device related adverse event requiring re-operation * Success = no adverse event occurs * Failure = adverse event occurs

Trial sites (16)