Study Says Customized iTotal® Knee Reduces Adverse Events and Transfusion Rates

As recently as 2011 we were talking about the iTotal customized knee from ConforMIS, Inc., pointing to its CE marking and controlled release onto the market.  Less than three years on the company tells us about results from a comparative 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.


ConforMIS, pioneering a patient-specific approach to orthopedic implants and instrumentation, aiming to exploit the potential advantages of customization such as shorter hospital stay, less blood loss, more bone preservation, and better functional outcomes, coupled with more “natural” feeling knees. So goes the theory, and now it seems there’s clinical evidence to back up the claims.

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

A retrospective analysis was performed 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.

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). Discharge costs following TKA to an acute inpatient rehabilitation facility has been reportedly quantified at $16,464 on top of the hospitalization costs, supporting at least one facet of the argument for customization.

Physician comments

“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.”

Company comments

“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.”

Source: ConforMIS, Inc., Business Wire

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