Study Claims Customized iTotal Knee from ConforMIS Can Improve Hospital Outcomes

ConforMIS Inc. reported 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 by Steven D. Culler, Ph.D., associate professor, Department of Health Policy and Management, Rollins School of Public Health at Emory University in Atlanta, Ga., at the 2014 International Congress for Joint Reconstruction (ICJR) Pan Pacific Orthopaedic Congress, held July 16-19 in Hawaii.

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 percent while the ConforMIS rate was significantly lower at 1.6 percent. Data also showed that patients treated with ConforMIS customized implants had significantly lower blood transfusion rates of 2.4 percent compared with 10.7 percent 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 percent for ConforMIS vs. 7.4 percent 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 Culler. “These findings indicate that patients were 4.5 times more likely to receive a blood transfusion and 8.7 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 percent rate of patient dissatisfaction,” said Philipp Lang, M.D., 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.”

Privately held ConforMIS develops patient-specific orthopedic implants and instrumentation. The company’s partial and total knee replacement solutions—the iUni G2, iDuo G2 and iTotal G2, are individually designed for each patient. Products are provided in a pre-sterilized single package delivery system that the company claims can help hospitals reduce costs and treat more patients by reducing instrument re-sterilization costs and shortening setup, procedure and turnover times. The iUni G2, iDuo G2 and iTotal G2, have been cleared by the U.S. Food and Drug Administration and are CE marked in Europe.

References:

1. Szubski, et al; National Trends in Utilization and Outcomes of Allogenic Blood Transfusions in Primary Total Knee Artrhroplasty, 2000-2009. ISTA Annual Meeting 2013. Poster #2451.

2. Ramos, et al; Correlation Between Physician Specific Discharge Costs, LOS, and 30-Day Readmission Rates: An Analysis of 1,831 cases. Journal of Arthroplasty; 2014, 29 #4: 674-677