SBIR Phase I: Antibiotic Dispensing Spacer for improved treatment of PJI in TKA

This SBIR Phase I project will help to address a critical need for patients who have suffered an infection in a total knee replacement joint. Unfortunately, doctors have few good options for effectively treating this type of infection to avoid the potential for limb amputation or even death should the infection persist and spread. Today, treatment requires surgical replacement of part or all of the existing implant while using oral or intravenous antibiotics. Due to the capsule around the joint (isolated from blood vessels) these methods deliver marginal amounts of antibiotic within the knee where the bacteria reside. Patients suffer elongated treatment, many times without the use of their knee, waiting for the bacterial infection to slowly resolve. ForCast Orthopedics' Antibiotic Dispensing Knee Spacer provides a refillable reservoir within the artificial knee that can distribute antibiotic directly into the knee capsule for effective infection treatment. Physicians can prescribe the antibiotic most appropriate for the bacteria diagnosed. The patient returns to the doctor's office once per week for a checkup and antibiotic refill injection until the infection is cured. No follow up surgery is required. Duplicating the antibiotic delivery of previous successful clinical studies (using representative but intolerable daily injections) should result in similar highly successful patient outcomes, reduced patient suffering and reduced healthcare costs. This SBIR Phase I project addresses an underserved clinical need for improved treatment of Periprosthetic Joint Infection (PJI). Today, doctors have few good options for treatment to avoid the potential for limb amputation or even death should PJI persist and spread. All methods require surgical debridement and replacement of part or all of the existing implant (to reduce bacterial load) while using oral or intravenous antibiotics that cannot reach the remaining bacteria within the knee capsule (blood/synovial fluid barrier). Temporary eluting antibiotic spacers and beads are too short lived. Patients suffer elongated treatment, many times without a load-bearing knee. ForCast Orthopedics is developing an Antibiotic Dispensing Spacer (AD Spacer) to replace the standard spacer in a total knee implant. The AD Spacer provides a refillable reservoir to hold the antibiotic of choice for the bacteria identified and a delivery system to maintain a therapeutic concentration within the knee for the entire therapy duration, typically a minimum of 6 weeks. As a permanent spacer, no further surgery is required after treatment. Emulating the delivery characteristics of previously successful clinical studies (using intolerable daily injections) should result in similar highly successful patient outcomes, reduced morbidity and reduced total cost of care. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.