The U.S. Food and Drug Administration (FDA) has approved the Patient Specific Talus Spacer 3D-printed talus implant for the treatment of avascular necrosis (AVN) of the ankle joint.

AVN of the ankle joint is a serious and progressive condition that causes the death of bone tissue stemming from a lack of blood supply to the area. AVN is usually caused by a sudden injury—such as a broken bone or a dislocated joint — or sustained damage to the tissue that develops over time. It occurs when there is a lack of blood supply to bone tissue, causing it to become necrotic. When the bones of a joint are affected, such as in the case of the ankle, the cartilage can deteriorate, causing arthritis and pain. Late-stage AVN of the ankle may result in the talus bone partially or fully collapsing. Current available treatments include fusing the joints in the foot and ankle together—a procedure that helps to alleviate pain but eliminates motion in the joint—or below-the-knee amputation.

The Patient Specific Talus Spacer is a 3D-printed implant that can be used in talus replacement surgery. The talus spacer is made for each patient individually, modeled from CT imaging, and is fitted to a patient’s specific anatomy. During the replacement surgery, the patient’s talus bone is removed and replaced with the implant, which is made from cobalt-chromium alloy. Talus replacement surgery with the Patient Specific Talus Spacer is intended to be a joint-sparing procedure, though joint fusion may become necessary for patients if their condition worsens.

The FDA approval was based on positive results from 31 patients and 32 talus replacement surgeries with the Patient Specific Talus Spacer. At three years post-operation, the average reported pain decreased from “moderate to severe” prior to surgery to “mild” post-surgery, and average range of motion in the ankle joint also improved. The most common reported adverse events were pain and scar tissue at the surgery site.

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