Study: Customized Knee Implants Linked to Significantly Lower Adverse Event Rates

ConforMIS Inc. has announced the publication of a retrospective study comparing adverse events rates and cost of care for total knee arthroplasty (TKA) patients treated with either customized individually made (CIM) implants or standard off-the-shelf (OTS) implants. Results were published in Arthroplasty Today.
 
According to the study results, a smaller percentage of TKA patients treated with customized implants experienced adverse events at both discharge (3.3 percent vs. OTS 14.1 percent; P = .003) and 90 days after discharge (8.1 percent vs. OTS 18.2 percent; P = .023). A greater proportion of patients who received customized implants were discharged in less than three days (42.1 percent vs. OTS 30.3 percent; P = .037). In addition, a smaller percentage of patients treated with customized implants (4.8 percent vs. OTS 16.4 percent; P = .003) were discharged to a rehabilitation center or other post-acute care facility. Further, fewer patients treated with customized implants (2.4 percent vs. OTS 11.6 percent; P = .005) required blood a transfusion.
 
Furthermore, the total average real hospital costs between the CIM and OTS groups were nearly identical (customized implant $16,192 vs. OTS $16,240; P = .913), suggesting that patients with customized implants received improved hospital outcomes at no additional cost to the hospital. However, risk-adjusted per patient total cost of care showed a net savings of $913.87 (P = .240) per patient for the customized implant group for bundle of care, including the preoperative computed tomography scan, TKA hospitalization, and discharge disposition. Follow-up care costs demonstrated a savings of $1,313 (customized implant $5,048 vs OTS $6,361; P = .007).
 
“Our results in this single-site population of patients illustrate that treatment with a customized implant led to significantly lower transfusion rates, fewer adverse events and reduced need for discharge to a rehabilitation facility or post-acute care facility,” said Steven Culler, Ph.D., a healthcare economist at Emory University. “We also found that improved outcomes among patients treated with customized implants were achieved without increasing overall costs and that post-discharge costs were significantly lower among patients treated with customized implants.”
 
In this study, which was financially supported by ConforMIS, researchers completed a retrospective review of outcomes and costs for 248 consecutive TKA patients treated at a single institution and by the same surgeon. All surgeries occurred between April 1, 2010, and Nov. 11, 2013, based on consistent intraoperative protocols. Patients received either a customized knee implant (designed and developed based on their unique anatomy (n=126)) or an OTS implant selected from a range of pre-manufactured sizes (n=122). Study data were collected from patients’ medical record or the hospital’s administrative billing record.
 
When controlling for gender, age, body mass index (BMI) and selected comorbid conditions, patients in the OTS arm were 5.5 times more likely to be discharged to a rehab or post-acute care facility. Patients treated with OTS implants were also 4.6 times more likely to require blood transfusion and 4.4 times more likely to experience an adverse event.
 
“This study provides compelling data indicating that patients treated with customized total knee implants achieve better outcomes on several important measures without increasing real hospital costs and while reducing the average total cost of the episode of care and the average cost of follow-up care,” said Mark Augusti, CEO and president of ConforMIS. “These findings further demonstrate the benefits of customized total knee implants technology to patients, surgeons, hospitals and payers.  Additionally, they are part of an important and changing conversation about the role of total knee implants in the delivery of better outcomes at lower costs – a conversation that we are committed to pursuing.”
 
ConforMIS uses proprietary iFit Image-to-Implant technology platform to develop, manufacture, and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 450 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints. The company is based in Billerica, Mass.