COPAL® exchange G – Preformed Hip and Knee Spacer for Supporting PJI Treatment
preformed hip and knee PMMA spacer preloaded with antibiotic gentamicin
limited patient mobility during 2-stage revision surgeries with limited range of motion for patients
hip: hip spacer with an inner stainless steel reinforcing structure
knee: tibial and femoral components together create an articulating bearing surface
COPAL® exchange G hip and knee trials for intraoperative size determination of COPAL® exchange G hip and knee spacer
Your Element of Success in Infection Management
In addition to being a clinically devastating complication, periprosthetic joint infections (PJI) in the U.S. number over 30,000 annually, with a yearly cost exceeding $1.62 billion.1 Which is why it is more important than ever to have an effective, efficient, go-to solution within reach.
For two-stage revision procedures, COPAL® exchange G spacer with gentamicin represents a preformed antibiotic-impregnated joint spacer designed for the first stage of a two-stage revision arthroplasty procedure to temporarily (max. 180 days) replace an implant due to an infection of the implant site.
COPAL® exchange G trials are accessory devices to the spacer to be used for a short (few minutes) intraoperative determination of the correct size of the COPAL® exchange G spacer.
Indications
COPAL® exchange G hip spacer (polymethylmethacrylate / gentamicin) is indicated for temporary use (maximum of 180 days) as a total hip replacement (THR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The device is inserted into the femoral medullary canal and acetabular cavity following removal of the existing implant and radical debridement. The device is assigned to be used in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
COPAL® exchange G hip spacer is not intended for use for more than 180 days, at which time it must be explanted, and a permanent device implanted, or another appropriate treatment performed (e.g., resection arthroplasty, fusion etc.). COPAL® exchange G hip spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.