High-viscosity bone cement is an attractive option for surgeons when performing total knee replacement surgeries, but it may put patients at greater risk of revision surgery regardless of the type of knee implant used, according to a study published in the journal Arthroplasty.
Aseptic loosening is the most common reason for total knee replacement revision surgeries. It occurs when the bond between an implant and bone failed not due to infection. Bone cement is an epoxy cement used to attach the components of a knee implant to human bone during these surgeries. Researchers wanted to understand if the type of bone cement used during knee replacement surgery played a role in aseptic loosening and thus the need for revision surgery.
Researchers reviewed institutional data involving total knee replacements performed from January 2007 to December 2016. Patients less than two years to follow-up were excluded from the research. Patients were divided into two groups — one in which high-viscosity cement (HVC) was used and the other in which low-viscosity was used. The type of implant patients received was also recorded.
Many surgeons prefer HVC over low- or medium-viscosity cements because it has a shorter mixing and waiting time, and surgeons can take longer to work with the epoxy before it hardens. But studies have shown that HVCs do not produce as strong of a bond as other bone cements. As a result, they are more apt to fail.
Bone cement manufacturers told federal regulators that HVC was “substantially equivalent” to epoxies already on the market in order to gain clearance under the Food and Drug Administration (FDA) fast-track approval process. But they failed to demonstrate the safety and efficacy of high-viscosity bone cement before the products were rushed to the market.
Bone cement ligitation
Beasley Allen lawyers continue to investigate cases involving early knee replacement failure due to high-viscosity bone cement. If you or a loved one has experienced complications from knee replacement surgery, requiring revision surgery, contact Roger Smith or Ryan Duplechin, lawyers in our firm’s Mass Torts Section.