ConforMIS has announced results from a clinical study evaluating hospital outcomes and costs in patients undergoing total knee arthroplasty (TKA) using either ConforMIS iTotal customized, individually made knee implants or standard off-the-shelf (OTS) implants.

Results were presented today by Steven D. Culler, PhD, Associate Professor, Department of Health Policy and Management, Rollins School of Public Health at Emory University, at the 2014 International Congress for Joint Reconstruction (ICJR) Pan Pacific Orthopaedic Congress.

Researchers conducted a retrospective analysis of 248 TKA hospitalizations for patients having received either a ConforMIS iTotal customized knee implant (126) or a standard OTS implant (122) between March 2010 and November 2013. Patients with OTS implants demonstrated an adverse event rate of 13.9% while the ConforMIS rate was significantly lower at 1.6%. Data also showed that patients treated with ConforMIS customized implants had significantly lower blood transfusion rates of 2.4% compared with 10.7% for the OTS implants. Other studies have found that the average costs associated with blood transfusion is about $2,200 which coincides with higher risk of complications and longer hospital stays.1

An analysis of total hospital costs (excluding costs associated with discharge) found no statistical difference between the ConforMIS and OTS knee replacement. However, the study showed that significantly fewer ConforMIS patients were discharged to more costly acute care facilities (0.8% for ConforMIS vs. 7.4% for OTS). According to a recent study of discharge costs following TKA, the average cost of discharge to an acute inpatient rehabilitation facility was $16,464 on top of the hospitalization costs.2

"It is exciting that an important advance in medical technology can improve outcomes, shorten hospital stays and reduce the risk of adverse events while remaining cost neutral to the hospital," said Stephen Culler, PhD, Associate Professor, Department of Health Policy and Management, Rollins School of Public Health at Emory University. "These findings indicate that patients were 4.9 times more likely to receive a blood transfusion and 10 times more likely to experience an adverse event with an off-the-shelf implant compared with a ConforMIS customized knee implant. I believe ConforMIS can present a number of significant advantages to patients, providers and payers without increasing hospital costs and while reducing the need for costly inpatient rehabilitation care."

"ConforMIS iTotal was designed to address the shortcomings we see in today’s knee replacements which have a 20% rate of patient dissatisfaction," said Philipp Lang, MD, MBA, Chairman and CEO of ConforMIS. "This study underscores the value that a customized implant provides by reducing the negative outcomes of total knee replacement without increasing, and likely decreasing, the overall cost to the healthcare system."