Clearance for Implant that Retains Articulation During Knee Replacement Infection Treatment

Ortho Development® Corporation has received FDA clearance for its patented KASM® Knee Articulating Spacer Molds. KASM is a cement spacer mold intended for use in treating patients who develop an infection after undergoing total knee replacement surgery.

Background

Infection in total knee arthroplasty(TKA) is relatively uncommon, but when it happens it represents a challenge for the medical professionals and a worrying, painful and temporarily disabling experience for the patient. As the number of TKAs continues to grow, so will the number of infection cases, goes the theory. The current approach in treating infection in TKA is a two-stage revision surgery involving removal of the original implants and temporarily packing the infected joint with antibiotic bone cement as either a static or articulating spacer. Static spacers force patients to keep their infected joint immobilized for 6-8 weeks until the infection is cured and the second-stage procedure is performed. KASM articulating spacers are designed to help preserve the range of motion, joint space, soft tissue tension, and allow for protected ambulation during that time.

KASM offers disposable femur and tibia molds that allow for the creation of temporary articulating spacers. The molds form a smooth articulating condylar surface using antibiotic-laden bone cement. The molds come in various sizes, offer the ability for a surgeon to customize the spacer thickness based on patient anatomy, and can be overfilled to accommodate existing bony defects.

Physician comments

E. Marc Mariani, M.D. and Michael H. Bourne, M.D. from the Salt Lake Orthopaedic Clinic in Salt Lake City, Utah assisted Ortho Development’s engineers with the development of KASM. Dr. Bourne commented, “The KASM spacer molds are a distinctive new option for the treatment of serious TKA infection. The combined benefit of elution of antibiotics and continued knee motion lead to improved patient comfort and activity both before and at the time of final knee implantation. We anticipate KASM will be invaluable in the treatment of difficult knee infection cases.”

Company comments

“KASM is a unique product that addresses a growing need in the total joint replacement market,” says Brent Bartholomew, President of Ortho Development. “We have used KASM with clinical success for the past several years in Japan and are excited to finally have FDA approval.”

Source: Ortho Development Corporation, PR Newswire

 

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