Early Failures of Total Knee Patients with Nickel Allergies Secondary to Carbon Fiber Debris

Abstract

Aim: Currently, there are not many studies on the long-term outcomes of the specific implants used in patients with metal hypersensitivities. The purpose of this study is to report a significant number of TKA revision failures with the CFR-PEEK prosthetic knee implant with an anatomic hinge. Background: Patients can experience multiple issues following a primary Total Knee Arthroplasty (TKA). A growing body of research is finding a correlation between primary TKA failure and metal hypersensitivity, most commonly with nickel and cobalt. Because of this, knee prosthetics are being made from hypoallergenic metals, such as zirconium nitride (ZrN), to minimize the number of failures due to metal allergy. Given the relatively new development of the hypoallergenic prostheses, there is sparse data about their overall success. Objective: The purpose of this study is to report a significant number of TKA revision failures with the CFR-PEEK prosthetic knee implant with an anatomic hinge. Methods: In this study, we analyzed the sequelae of 84 patients between May 2015 to June 2020 who received a total knee revision due to a failed primary TKA with metal hypersensitivity. These patients were revised with the rotating anatomic hinge knee system, which consisted of Carbon Fiber Reinforced Poly-Ether-Ether-Ketone (CFR-PEEK implant) coated with a ZrN, Zirconium, and Chrome Nitride multi-layer surface coating with 30% polyacrylonitrile fiber content. The patients requiring an additional revision operation presented with increasing pain that showed evidence of osteolysis on plain radiographs, CT imaging, positive indium labeled WBC scans and increased uptake on bone scan. Intraoperatively, an open incisional biopsy of the surgical bed was obtained, followed by radical debridement and implantation of porex knee prosthesis. In addition, intraoperative findings included black debris that grossly stained the surrounding synovial tissue black, indicative of wear and debris from carbon fiber bearings and the anatomic hinge. Histology of the intraoperative biopsy showed the accumulation of black debris in the histiocyte, fibrosis, and perivascular cuffing of lymphocytes and multinucleated giant cells stained with black debris. Results: Of the 84 patients, 22 failed, requiring an additional revision procedure, equating to a 26 percent failure rate of the CFR-PEEK implant, averaging 25 months to failure. Conclusion: This study was meant to report the extremely high failure rate of the anatomic hinge secondary to carbon fiber debris. Perhaps carbon fiber-laden implants are not as good an option for total knee revision prosthesis because of the high failure rate compared to those with polyethylene in their hinge mechanism.